This study is a 2-arm, double blinded, randomised clinical trial where 40 participants will be assigned 1:1 to insulin treatment alone (control) or insulin treatment and tirzepatide treatment for 32 weeks. The primary objective is to demonstrate that tirzepatide treatment, dose incremented to 15mg QW for 32 weeks adjunctive to insulin treatment can reduce body weight in patients with T1D and overweight or obesity when compared to insulin treatment alone. The secondary objective is to demonstrate that tirzepatide treatment, dose incremented to 15mg QW for 32 weeks can improve glycaemic control (measured by hbA1c), improve time in range, reduce insulin requirements, and reduce the severity of comorbidities in people with obesity and T1D. This trial includes a 6 month follow-up period.

Start Date01 Dec 2026

Sponsor / Collaborator

Royal North Shore Hospital

NCT07468552

/ Not yet recruitingPhase 2IIT

Randomized, Double-Blind, Placebo-Controlled Pilot Trial of Tirzepatide for Treatment of Cannabis Use Disorder (CUD)

The purpose of this randomized, double-blind, placebo-controlled, multi-site clinical trial is to evaluate the safety and efficacy of tirzepatide in a sample of 100 patients diagnosed with moderate or severe CUD by DSM-5 criteria.

Start Date15 Nov 2026

Sponsor / Collaborator

National Institute on Drug Abuse

100 Clinical Results associated with Tirzepatide

100 Translational Medicine associated with Tirzepatide

100 Patents (Medical) associated with Tirzepatide

2,093

Literatures (Medical) associated with Tirzepatide

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Enhancing economic modelling in obesity: integrating novel type 2 diabetes progression & obstructive sleep apnea remission – a UK case study

Article

Author: Zimner-Rapuch, Sarah ; Annemans, Lieven ; van Hest, Naomi ; Johansson, Erin ; Wilding, John P. H. ; Grist, Josephine ; Spaepen, Erik

PURPOSE:

This study presents an updated health economic model for evaluating the long-term cost-effectiveness of interventions in overweight and obesity, integrating new clinical evidence from the SURMOUNT clinical trial programme and methodological advancements in type-2 diabetes and obstructive sleep apnea (OSA) modelling.

PATIENTS AND METHODS:

An updated individual patient simulation model evaluated the costs and long-term clinical outcomes of tirzepatide (5, 10, 15.0 mg) versus diet and exercise (D&E) alone in patients with a body mass index (BMI) ≥30 kg/m² (obesity), or BMI ≥27 to <30 kg/m² (overweight) + ≥1 obesity-related complication with a UK healthcare perspective. Key improvements over a previously published model were introduced, including modelling remission and progression of OSA, capturing realistic patterns of D&E discontinuation, incorporating HbA1c as a continuous cardiometabolic endpoint and transition to R-based implementation over VBA. Primary results include incremental cost-effectiveness ratios (ICERs; cost/QALY), costs, life years gained and quality-adjusted life years (QALYs). Secondary outcomes including clinical outcomes, random seed and cohort convergence, deterministic sensitivity results and run time were also calculated.

RESULTS:

The refined model predicted that all tirzepatide doses were cost-effective compared to D&E at a £20,000/QALY gained WTP (willingness-to-pay) threshold (ICERs: £8,327-£10,157). Refined estimation of long-term D&E discontinuation and OSA remission likely contributed to lower incremental costs, higher QALYs, and reduced ICERs compared with the previous model, aligning outcomes more closely with expected benefits from weight management treatment. Transitioning to R-based implementation reduced run time (e.g. by 4.52 h for deterministic sensitivity analyses) and enhanced model stability in all analyses conducted.

CONCLUSION:

This enhanced economic model represents a significant advancement in the evaluation of obesity pharmacotherapy, designed to enhance clinical relevance, technical robustness, and increase usability. It supports evidence-based decision-making for chronic weight management treatment in the UK, and beyond, while offering a scalable platform for future therapeutic evaluations.

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Annual pharmacy cost per patient achieving composite treatment endpoints: a cost to target analysis of tirzepatide versus subcutaneous semaglutide 1 mg in patients with type 2 diabetes in the UK

Article

Author: Kanumilli, Naresh ; Evans, Jerome ; Cattin, Juliette ; Debackere, Nele ; Osumili, Beatrice ; Buckingham, Mike ; Hunt, Barnaby ; Webb, Joanne ; Nowakowski, Piotr

INTRODUCTION:

Tirzepatide is a treatment for type 2 diabetes associated with improvements in glycemic control and weight loss, and a low risk of hypoglycemia when not used in combination with insulin or insulin secretagogues. A cost to target analysis of tirzepatide 5, 10 and 15 mg versus subcutaneous semaglutide 1 mg in the UK setting was performed, calculating the annual pharmacy cost per patient treated to six composite endpoints combining glycemic control (glycated hemoglobin [HbA1c] ≤ 6.5% [48 mmol/mol] and <7.0% [53 mmol/mol]) with weight loss (≥5%, ≥10%, ≥15%) and avoidance of hypoglycemia. The costing analysis was based on the tirzepatide costs appraised by NICE as part of TA924.

METHODS:

The proportions of patients achieving composite treatment targets with tirzepatide and semaglutide (both in combination with metformin) were taken from a post-hoc analysis of the SURPASS-2 clinical trial (N = 1,845). Costs per patient treated to target were calculated by dividing the annual treatment costs associated with each intervention by the proportion of patients achieving the treatment target with each intervention.

RESULTS:

Tirzepatide 5, 10 and 15 mg were associated with a lower pharmacy cost per patient achieving treatment target than semaglutide 1 mg for the majority of endpoints evaluated. Differences became greater at more strict treatment targets. For example, the cost per patient achieving HbA1c ≤6.5%, weight loss ≥15%, and no hypoglycemia was GBP 5,650, GBP 8,665 and GBP 9,462 lower with tirzepatide 5, 10 and 15 mg, respectively, compared with semaglutide 1 mg over a 1-year time horizon. The only endpoint where semaglutide 1 mg was associated with a lower cost per patient achieving target was HbA1c <7.0%, weight loss ≥5%, and no hypoglycemia.

CONCLUSIONS:

Compared to semaglutide, tirzepatide was associated with a lower annual pharmacy cost per patient with diabetes achieving treatment target in the UK for the majority of endpoints, with greater differences at more strict treatment targets.

31 Dec 2026·JOURNAL OF MEDICAL ECONOMICS

Cost-effectiveness of tirzepatide versus semaglutide for patients with obesity or overweight in the US: evidence from the SURMOUNT-5 head-to-head phase-3 trial

Article

Author: Zimner-Rapuch, Sarah ; Kirk, Myles ; Johansson, Erin ; van Hest, Naomi ; Annemans, Lieven ; Bays, Harold ; Wilding, John P. H. ; Spaepen, Erik ; Upadhyay, Navneet

PURPOSE:

This study evaluated the cost-effectiveness (from the United States [US] societal perspective) of tirzepatide at its maximum-tolerated-dose (MTD) compared to semaglutide (MTD), both administered adjunct to a reduced-calorie diet and increased physical activity. The analysis focused on individuals with obesity (body mass index [BMI] ≥ 30 kg/m²), or overweight (BMI ≥27 to <30 kg/m² + ≥1 obesity-related complication), using data from the head-to-head Phase-3 SURMOUNT-5 trial (patients without type 2 diabetes [T2D]).

PATIENTS AND METHODS:

This patient-level simulation modeling study assessed the cost and long-term clinical outcomes of tirzepatide (MTD) versus semaglutide (MTD), using data from the SURMOUNT-5 trial population. The modeled population were at risk of developing obesity-related complications including cardiovascular disease (CVD) and obstructive sleep apnea (OSA), amongst others. These outcomes were modeled using cardiometabolic parameters including weight, systolic blood pressure, high-density lipoprotein, glycated hemoglobin (HbA1c) and total cholesterol, by assessing their impact on healthcare and wider societal costs, quality of life, and mortality. Incremental cost-effectiveness ratios (ICERs; cost/quality-adjusted life year [QALY]) and incremental net health benefit (iNHBs) were calculated, and uncertainty was assessed through sensitivity and scenario analyses.

RESULTS:

Tirzepatide (MTD) was estimated to be less costly and more efficacious compared to semaglutide (MTD) with per patient cost savings of $41,688, 0.506 QALYs gained and positive iNHB of 0.784, indicating a net health benefit for tirzepatide. The model predicted that per 1,000 patients, 70 fewer patients will develop T2D, 10 fewer will develop CVD with tirzepatide (MTD) and patients spend 3.07 more years living with moderate/severe OSA when treated with semaglutide (MTD).

CONCLUSION:

Based on this simulation model, using head-to-head SURMOUNT-5 trial data, tirzepatide (MTD) had lower total costs and higher QALYs compared to semaglutide (MTD). This supports that tirzepatide (MTD) is a cost-effective treatment option for individuals with obesity or overweight compared to semaglutide (MTD).

2,059

News (Medical) associated with Tirzepatide

19 hours ago

·www.prnewswire.com

FDA approves Lilly's Mounjaro (tirzepatide) to reduce cardiovascular risk in adults with type 2 diabetes

Mounjaro is the first and only GIP and GLP-1 receptor agonist proven to lower heart attack, stroke or cardiovascular death risk in adults with type 2 diabetes at high risk for these events – in addition to its established A1C and weight loss benefits It is estimated that as many as one in three adults in the U.S. with type 2 diabetes have undetected cardiovascular disease1 INDIANAPOLIS, Aug. 28, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) approved Mounjaro (tirzepatide), a dual GIP and GLP-1 hormone receptor agonist, to lower the risk of major adverse cardiovascular (CV) events (MACE), including CV death, non-fatal heart attack, or non-fatal stroke in adults with type 2 diabetes who are at high risk for these events. Mounjaro is already approved as an adjunct to diet and exercise to improve blood sugar in adults and children 10 years of age and older with type 2 diabetes. "For people with type 2 diabetes, heart disease is the leading cause of death, and Mounjaro – the #1 most prescribed branded type 2 diabetes medicine for adults in the U.S. – now gives them a proven way to lower that risk, adding to the strong foundation it has already built in A1C and weight," said Kenneth Custer, Ph.D., executive vice president and president, Lilly Cardiometabolic Health. "We set a higher bar by testing Mounjaro against a GLP-1 medicine with proven cardiovascular benefit, one that reflects the depth of evidence Lilly continues to build in this field." The approval was based on results from SURPASS-CVOT, the first cardiovascular outcomes trial comparing two incretin medicines head-to-head rather than against a placebo, and the largest and longest tirzepatide study to date, enrolling more than 13,000 participants across 30 countries over more than four and a half years. In the trial, Mounjaro demonstrated non-inferiority to Trulicity (dulaglutide), a GLP-1 treatment with established cardiovascular benefit, with an 8% lower rate of cardiovascular death, heart attack or stroke (MACE-3). The estimated hazard ratio for time to first MACE was 0.92 (95.3% CI: 0.83, 1.01) for Mounjaro compared to Trulicity (dulaglutide). "Heart health deserves attention throughout the course of treatment, not just after a serious cardiovascular event," said David A. D'Alessio, M.D., study co-author and director of the Division of Endocrinology and Metabolism at Duke University School of Medicine. "While a large portion of type 2 diabetes care is focused on glucose control, mitigating cardiovascular risk is essential and can be overlooked. This approval gives patients a medicine that reduces the risk of cardiovascular events and supports metabolic health at the same time." The safety and tolerability of Mounjaro were generally consistent with its established profile. The most commonly reported adverse events in SURPASS-CVOT for Mounjaro were gastrointestinal-related, generally mild-to-moderate in severity, and occurred primarily during the dose-escalation period. Please see Indications and Safety Summary with Warnings below and full Prescribing Information and Medication Guide. For more information about Mounjaro, please visit . About Mounjaro (tirzepatide) Mounjaro (tirzepatide), the #1 prescribed branded type 2 diabetes medicine for adults in the U.S., is an injectable medicine for adults and children 10 years of age and older with type 2 diabetes used along with diet and exercise to improve blood sugar (glucose). In adults with type 2 diabetes who are at high risk for cardiovascular events, Mounjaro is also indicated to lower the risk of major adverse cardiovascular (CV) events (MACE), including CV death, non-fatal heart attack, or non-fatal stroke. As the first and only FDA-approved GIP and GLP-1 receptor agonist, Mounjaro is a single molecule that activates the body's receptors for GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1). About Trulicity (dulaglutide) Trulicity is a once-weekly injectable medicine for adults and children 10 years of age and older with type 2 diabetes that is used with diet and exercise to improve blood sugar (glucose). Trulicity is also used in adults with type 2 diabetes to reduce the risk of major cardiovascular events such as death, heart attack, or stroke, in people with established cardiovascular disease or multiple cardiovascular risk factors. About SURPASS-CVOT SURPASS-CVOT (Cardiovascular Outcomes Trial; NCT04255433) was an event-driven, randomized, double-blind, parallel group Phase 3 trial evaluating the efficacy and safety of Mounjaro (tirzepatide) compared with Trulicity (dulaglutide) in adults with type 2 diabetes and established atherosclerotic cardiovascular disease (ASCVD), which lasted approximately five years (with a median follow-up of four years). In the trial, 13,299 participants were randomized 1:1 across 640 sites in 30 countries to receive Mounjaro (15 mg or the maximum tolerated dose) or Trulicity (1.5 mg) administered subcutaneously once weekly. The primary objective of the trial was to demonstrate that Mounjaro provided a non-inferior reduction in the risk of major adverse cardiovascular events (MACE-3) — a composite of cardiovascular death, heart attack or stroke — compared to Trulicity. Over a median follow-up of 210.1 weeks, Mounjaro was non-inferior to dulaglutide for reducing the occurrence of MACE-3. Superiority to dulaglutide was not established. Full results from SURPASS-CVOT were published in The New England Journal of Medicine (NEJM). Data from the trial has been included in Mounjaro's product information in the European Union, and regulatory submissions based on the trial are under review in additional markets. INDICATIONS AND SAFETY SUMMARY WITH WARNINGS Mounjaro® (mown-JAHR-OH) is an injectable prescription medicine used along with diet and exercise to improve blood sugar (glucose) in adults and children 10 years of age and older with type 2 diabetes and to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes who are at high risk for these events. It is not known if Mounjaro is safe and effective for use in children under 10 years of age. Warnings - Mounjaro may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider. Do not use Mounjaro if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). Do not use Mounjaro if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use Mounjaro if you are allergic to it or any of the ingredients in Mounjaro. Mounjaro may cause serious side effects, including: Inflammation of the pancreas (pancreatitis). Stop using Mounjaro and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes you may feel the pain from your abdomen to your back. Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Mounjaro with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger, weakness and feeling jittery. Serious allergic reactions. Stop using Mounjaro and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat. Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away. Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Mounjaro. Tell your healthcare provider if you have stomach problems that are severe or will not go away. Changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Mounjaro. Gallbladder problems. Gallbladder problems have happened in some people who use Mounjaro. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), and clay-colored stools. Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Mounjaro may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Mounjaro before you are scheduled to have surgery or other procedures. Common side effects The most common side effects of Mounjaro include nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, and stomach (abdominal) pain. These are not all the possible side effects of Mounjaro. Talk to your healthcare provider about any side effect that bothers you or doesn't go away. Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or . Before using Mounjaro Your healthcare provider should show you how to use Mounjaro before you use it for the first time. Talk to your healthcare provider about low blood sugar and how to manage it. If you take birth control pills by mouth, talk to your healthcare provider before you use Mounjaro. Birth control pills may not work as well while using Mounjaro. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Mounjaro and for 4 weeks after each increase in your dose of Mounjaro. Review these questions with your healthcare provider: ❑ Do you have other medical conditions, including problems with your pancreas, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food? ❑ Do you take other diabetes medicines, such as insulin or sulfonylureas? ❑ Do you have a history of diabetic retinopathy? ❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)? ❑ Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? It is not known if Mounjaro will harm your unborn baby. Mounjaro may pass into your breast milk. ❑ Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements? How to take Read the Instructions for Use that come with Mounjaro. Use Mounjaro exactly as your healthcare provider says. A caregiver may give you Mounjaro injections, or you may self-inject if a healthcare provider determines that it is appropriate. Inject Mounjaro under the skin (subcutaneously) of your stomach (abdomen), thigh, or another person should inject in the back of the upper arm. Do not inject Mounjaro into a muscle (intramuscularly) or vein (intravenously). Use Mounjaro 1 time each week, at any time of the day. Do not mix insulin and Mounjaro together in the same injection. You may give an injection of Mounjaro and insulin in the same body area (such as your stomach area), but not right next to each other. Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection. If you take too much Mounjaro, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. Learn more Mounjaro is a prescription medicine available as a pre-filled single-dose pen in 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, or 15 mg per 0.5 mL injection. For more information, call 1-800-LillyRX (800-545-5979) or go to . This summary provides basic information about Mounjaro but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Mounjaro and how to take it. Your healthcare provider is the best person to help you decide if Mounjaro is right for you. TR CON BS AUG2026 Mounjaro® and its delivery device base are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. INDICATION[S] AND SAFETY SUMMARY WITH WARNINGS Trulicity® (Trū-li-si-tee) is for adults and children 10 years of age and older with type 2 diabetes used along with diet and exercise to improve blood sugar (glucose). Trulicity is also used in adults with type 2 diabetes to reduce the risk of major cardiovascular events (problems having to do with the heart and blood vessels) such as death, heart attack, or stroke in people who have heart disease or multiple cardiovascular risk factors. It is not known if Trulicity is safe and effective to lower blood sugar (glucose) in children under 10 years of age. Trulicity is given through an injection (needle). You take it once a week by injecting it under the skin of your stomach, thigh, or upper arm. Warnings: Trulicity may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, trouble swallowing, hoarseness, or shortness of breath. If you have any of these symptoms, tell your healthcare provider. Do not use Trulicity if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). Do not use Trulicity if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use Trulicity if you are allergic to dulaglutide or other ingredients in Trulicity. Ask your healthcare provider how to recognize the serious side effects below and what to do if you think you have one: Inflammation of the pancreas (pancreatitis). Stop using Trulicity and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without nausea or vomiting. Sometimes, you may feel the pain from your abdomen to your back. Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use TRULICITY with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, confusion or drowsiness, headache, blurred vision, slurred speech, fast heartbeat, sweating, hunger, shakiness, feeling jittery, weakness, anxiety, irritability, or mood changes. Serious allergic reactions. Stop using Trulicity and get medical help right away if you have any symptoms of a serious allergic reaction which may include swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting, or feeling dizzy, or very rapid heartbeat. Dehydration leading to kidney problems. Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration. Tell your healthcare provider right away if you have nausea, vomiting, or diarrhea that does not go away. Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Trulicity. Tell your healthcare provider if you have stomach problems that are severe or will not go away. Changes in vision. Tell your healthcare provider if you have changes in your eyesight (vision) during treatment with Trulicity. Gallbladder problems. Gallbladder problems have happened in some people who take Trulicity. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), clay-colored stools. Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Trulicity may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Trulicity before you are scheduled to have surgery or other procedures. Common side effects The most common side effects of Trulicity include nausea, diarrhea, vomiting, abdominal pain and decreased appetite, indigestion, and fatigue. These are not all the possible side effects of Trulicity. Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or . Before using Your healthcare provider should show you how to use Trulicity before you use it for the first time. Before you use Trulicity, talk to your healthcare provider about low blood sugar and how to manage it. Review these questions with your healthcare provider: ❑ Do you have other medical conditions, including problems with your pancreas, kidneys, liver, or stomach, or have a history of diabetic retinopathy (vision problems related to diabetes)? ❑ Do you take other diabetes medicines, such as insulin or sulfonylureas? ❑ Are you scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation)? ❑ Are you pregnant or plan to become pregnant or breastfeeding or plan to breastfeed? ❑ Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements? How to take Read the Instructions for Use that come with Trulicity. Use Trulicity exactly as your healthcare provider says. Inject Trulicity under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm. Do not inject Trulicity into a muscle (intramuscularly) or vein (intravenously). Do not share your Trulicity pen, syringe, or needles with another person. Do not give Trulicity to other people. If you take too much Trulicity, call your healthcare provider or Poison Helpline at 1-800-222-1222 or go to the nearest hospital emergency room right away. Learn more Trulicity is a prescription medicine available as a pre-filled single-dose pen in 0.75 mg,1.5 mg, 3 mg, or 4.5 mg per 0.5 mL injection. For more information, call 1-800-LillyRx (1-800-545-5979) or go to . This summary provides basic information about Trulicity but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Trulicity and how to take it. Your healthcare provider is the best person to help you decide if Trulicity is right for you. DG CON HL BS 25MAR2026 Trulicity® and its delivery device base are registered trademarks owned or licensed by Eli Lilly and Company, its subsidiaries, or affiliates. Endnotes Fang M, Wang D, Tang O, et al. Subclinical cardiovascular disease in US adults with and without diabetes. J Am Heart Assoc. 2023;12(11): e029083. doi:10.1161/JAHA.122.029083. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram, and LinkedIn. P-LLY Trademarks and Trade Names All trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Cautionary Statement Regarding Forward-Looking Statements This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about Mounjaro as a treatment for adults with type 2 diabetes and who are at high risk for cardiovascular events and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that future study results will be consistent with study results to date, that Mounjaro will receive additional regulatory approvals, or that Lilly will execute its strategy as planned. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. CMAT-35000 8/2026 ©Lilly USA, LLC 2026. All rights reserved. SOURCE Eli Lilly and Company 21% more press release views with Request a Demo

Clinical ResultDrug ApprovalPhase 3AHA

28 Aug 2026

·www.biospace.com

Caliway’s CBL-514 Combination Therapy Cleared by U.S. FDA for Phase 2 Trial; Pivotal Phase 3 Trial SUPREME-01 Initiates Enrollment

FDA IND Clearance for CBL-0201WR —Caliway has cleared its Investigational New Drug application for CBL-0201WR, a Phase 2 trial evaluating CBL-514 in combination with tirzepatide. U.S. IRB Approval for Pivotal Phase 3 Trial SUPREME-01 (CBL-0301)— The protocol amendment for the pivotal Phase 3 clinical trial SUPREME-01 has been approved by the North American central Institutional Review Board (IRB) in the US, officially initiating subject enrollment. CBL-514 "Visceral Fat Reduction" Data Selected for EASD Oral Presentation— Breakthrough research demonstrating CBL-514's efficacy in reducing visceral fat has been selected for an oral presentation at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD) on September 30, 2026 (local time). NEW TAIPEI CITY , Aug. 25, 2026 /PRNewswire/ -- Caliway Biopharmaceuticals (TWSE: 6919), a clinical-stage biopharmaceutical company developing innovative small-molecule therapeutics, today announced two major clinical milestones in its new drug development program. The Investigational New Drug application for CBL-0201WR, a Phase 2 clinical trial combining its first-in-class local fat-reducing new drug CBL-514 with Eli Lilly's Zepbound® (Tirzepatide), has been cleared by the U.S. FDA. In addition, the pivotal Phase 3 clinical trial SUPREME-01, evaluating large-area abdominal fat reduction, has received approval from the IRB and has officially initiated enrollment. CBL-0201WR Receives FDA Approval, Targeting Weight Regain and Stubborn Fat Post- GLP-1 Treatment The CBL-0201WR study is a randomized, single-blind, placebo-controlled trial designed to "reduce abdominal subcutaneous fat in overweight or obese adults," with an anticipated enrollment of 120 subjects in the U.S. The trial will use magnetic resonance imaging (MRI) to precisely measure volumetric changes in abdominal subcutaneous fat volume to evaluate the efficacy, safety, and tolerability of CBL-514 combined with Tirzepatide. The exploratory endpoints will also assess key indicators such as body weight, visceral fat, and lean body mass. With the growing popularity of GLP-1 receptor agonists, the global weight management markets are rapidly shifting towards a post-weight management era focused on "post-treatment maintenance," "body composition improvement," and "metabolic health." While current mainstream GLP-1 drugs effectively suppress appetite, they only temporarily shrink fat cells, leading to a high risk of weight regain and an inability to eliminate stubborn localized fat after discontinuation. CBL-514's unique mechanism of "action selectively induces adipocyte apoptosis" fundamentally reduces the number of fat cells. The powerful combination of these two drugs is expected not only to help patients eliminate stubborn localized fat in areas like the abdomen on top of general weight loss but also to address the dual crisis of post-treatment weight rebound, potentially achieving a synergistic effect where 1 + 1 > 2. The clearance of CBL-0201WR IND marks CBL-514's formal expansion from local fat reduction into the post-weight management market centered on "post-treatment maintenance," "body composition improvement," and "metabolic health." SUPREME-01 Initiates Enrollment, Aiming for World's First Non-Surgical Drug Approval for Large-Area Fat Reduction Concurrently, significant progress has been made on the pivotal Phase 3 clinical trial SUPREME-01 which has received IRB approval in the U.S. and enrollment has now commenced. This trial is designed to evaluate the efficacy of CBL-514 for large-area abdominal fat reduction. If the trial successfully meets its endpoints, CBL-514 could become the world's first and only revolutionary drug administered via non-surgical injection to achieve a 2-grade improvement on the Abdominal Fat Rating Scale (AFRS). Academic Breakthrough Research Gains Further International Recognition, with Data on CBL-514's Combined Weight Loss and Visceral Fat Reduction Data Selected for EASD Oral Presentation Beyond its outstanding clinical progress, Caliway's scientific advancements continue to receive top-tier global academic recognition. Integrating preclinical studies on CBL-514 combined GLP-1 drugs and Phase 2 clinical trial analysis "visceral fat reduction" has been selected for an oral presentation at the 62nd Annual Meeting of the European Association for the Study of Diabetes (EASD). The presentation will be delivered on September 30, 2026 (local time) in Italy by W. Timothy Garvey, MD, an international authority in obesity medicine and a scientific advisor to Caliway. The presentation will unveil to the global medical community for the first time how CBL-514 precisely reduces MRI-measured L2-L3 visceral adipose tissue volume while simultaneously reducing subcutaneous fat. Caliway Biopharmaceuticals stated that the concurrent advancement of the two key trials, CBL-0201WR and SUPREME-01, combined with the upcoming presentation of visceral fat data, fully demonstrates the company's strong execution capabilities in global clinical development and scientific validation. Looking ahead, Caliway will continue to deepen CBL-514's global footprint, aiming to provide a safer, more effective, and transformative treatment solution for patients worldwide suffering from obesity and metabolic diseases by leveraging its unique dual advantages of improving subcutaneous fat and metabolic indicators. About CBL-514 CBL-514 is a patented, first-in-class small-molecule 505(b)(1) injection developed by Caliway. It is designed to selectively induce adipocyte apoptosis to precisely reduce subcutaneous fat at the injection site without causing necrosis or damage to surrounding tissues or cells. CBL-514 has demonstrated broad therapeutic potential across multiple indications, including non-surgical subcutaneous fat reduction and moderate-to-severe cellulite. A separate formulation, designated as CBL-514D, is being developed for the treatment of Dercum's Disease, a rare disease. To date, more than 544 subjects have participated in clinical trials related to CBL-514. Across the 10 completed clinical trials with finalized statistical reports, all primary and key secondary efficacy endpoints have been met, demonstrating excellent safety and tolerability. About Caliway Biopharmaceuticals Caliway Biopharmaceuticals Co., Ltd. (TWSE: 6919), founded in 2012, is dedicated to developing breakthrough therapeutics that redefine standards of care and transform clinical practices. Caliway aims to leverage Taiwan's robust pharmaceutical research and development capabilities to serve the global aesthetic medicine and biomedical markets. The company was officially listed on the Taiwan Stock Exchange (TWSE: 6919) on October 2, 2024. Disclaimer This press release and related web pages contain forward-looking statements that are based on the Company's current expectations, forecasts, and assessments. These statements involve risks, uncertainties, and other factors beyond the Company's control. Actual events or results may differ materially from those projected in these forward-looking statements due to various external factors. Caliway undertakes no obligation to update or revise any information in this press release. Media & Investor Relations Contact ir@caliwaybiopharma.com View original content to download multimedia: SOURCE Caliway Biopharmaceuticals

Phase 2Phase 3IND

28 Aug 2026

·healthcare-digital.com

Study: Eli Lilly’s Zepbound Linked To Lower Healthcare Costs

Eli Lilly’s GLP-1 portfolio includes Type 2 diabetes medications Mounjaro and Trulicity, as well as oral GLP-1 pill Foundayo designed to tackle weight management and type 2 diabetes. Credit: Pexels Eli Lilly’s Zepbound has been linked with lower health costs, with CEO David Ricks saying the results show the value of investing in obesity treatment A study of nearly 16,000 adults over 55 with obesity in the US found that individuals using Eli Lilly 's Zepbound weight management drug had lower healthcare costs relative to untreated adults not using a GLP-1 treatment. Zepbound was already the most-prescribed branded weight management medicine in 2025, with Eli Lilly reporting US$4.2bn in Zepbound revenue in Q4 2025 alone. Fewer hospital and emergency department admissions for Zepbound users drove the lower healthcare costs. Alongside Zepbound, Eli Lilly’s GLP-1 portfolio includes Type 2 diabetes medications Mounjaro and Trulicity, as well as oral GLP-1 pill Foundayo designed to tackle weight management and type 2 diabetes. David A. Ricks, chair and CEO of Eli Lilly and Company. Credit: Eli Lilly Discussing the results on LinkedIn, David Ricks, CEO of Eli Lilly, writes, “Real-world evidence demonstrates obesity coverage is an investment that pays off for patients and healthcare systems. As Medicare, states and employers consider expanding access to obesity treatment, this report provides valuable evidence to support those decisions.” “ Real-world evidence demonstrates obesity coverage is an investment that pays off for patients and healthcare systems. ” David Ricks CEO of Eli Lilly Real-world evidence The results, published in the Diabetes, Obesity and Metabolism medical journal, offer a range of real-world results. The study covered a high-risk demographic: more than 40% of participants had at least four weight-related comorbidities, while 21% also had an emergency department visit during the baseline period. A key finding from the analysis was that Zepbound-associated healthcare savings increased the longer patients remained on treatment. Zepbound Study: Key Numbers 40% of participants had four or more weight-related comorbidities 21% had an emergency department visit at baseline 15% lower healthcare costs at six months Up to US$607 monthly savings at 12 months Savings exceeded Medicare’s US$195 monthly treatment cost after 12 months Changes over time At six months, healthcare costs were up to 15% lower, representing savings of as much as US$181 per patient per month compared with those not receiving Zepbound. By 12 months, the gap had widened substantially, with estimated savings reaching US$607 per patient per month – equivalent to healthcare costs up to 38% lower. Lower rates of hospital admissions and emergency department visits across every follow-up period accompanied the reduction. Meanwhile, Zepbound-treated patients recorded numerically higher rates of routine outpatient and office visits, suggesting greater engagement with regular care rather than acute services. Importantly, the estimated savings began to offset the US$195 monthly treatment cost of Zepbound through the Medicare GLP-1 Bridge at six months. From 12 months onwards, estimated healthcare savings exceeded the cost of treatment, pointing to the potential for sustained Zepbound use in an older population to generate net healthcare savings over time. Ilya Yuffa, Executive Vice President and President of Eli Lilly USA and Global Customer Capabilities. Credit: LinkedIn "This compelling real-world evidence highlights the impact that treating obesity with Zepbound can have on older patients and the healthcare system," says Ilya Yuffa, Executive Vice President and President of Eli Lilly USA and Global Customer Capabilities. "This analysis shows treatment costs can be lowered, and in some cases more than covered, by savings elsewhere in care – including for payers and in Medicare. As coverage expands across Medicare, states and employers, these data offer evidence on the cost implications of long-term obesity treatment and should help shape decisions." Medicare’s GLP-1 Bridge programme The study comes at a pivotal moment. The Medicare GLP-1 Bridge began on 1 July 2026, a temporary US government programme designed to give eligible Medicare beneficiaries access to certain GLP-1 medicines specifically for weight management. It is run by the Centers for Medicare & Medicaid Services (CMS) and will run until 31 December 2027. It comes amid a period of declining coverage of GLP-1 treatments among US employers., A Business Group on Health survey published on 25 August 2026 showed fewer employers are covering GLP-1s to treat obesity, with coverage falling from 72% in 2025 to 60% in 2026. Against this backdrop, evidence that Zepbound may reduce wider healthcare costs within 12 months could strengthen the case for sustained access to GLP-1 treatments. Eli Lilly – key partners NVIDIA CEO : Jensen Huang | HQ : Santa Clara, California NVIDIA is a US technology company specialising in accelerated computing and artificial intelligence. Lilly and NVIDIA are investing up to US$1bn over five years in an AI co-innovation lab focused on drug discovery, robotics and physical AI. Insilico Medicine CEO : Alex Zhavoronkov | HQ : Hong Kong Insilico Medicine is an AI-powered drug discovery company. Lilly expanded its partnership with Insilico in 2026 through a deal worth up to US$2.75bn, combining Insilico’s AI platforms with Lilly’s drug development expertise to advance novel oral medicines. CVS Health CEO : David Joyner | HQ : Woonsocket, Rhode Island Eli Lilly is partnering with CVS to expand access to Zepbound and Foundayo, with eligible patients able to view transparent pricing through the CVS Health app and access same-day pickup and pharmacist support at CVS pharmacies. Company portals CVS Health Eli Lilly Insilico Medicine NVIDIA Executives David Ricks Chair and CEO

100 Deals associated with Tirzepatide

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KEGG	Wiki	ATC	Drug Bank
D11360	Tirzepatide	-	DB15171

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Obesity Hypoventilation Syndrome	China	Eli Lilly Suzhou Pharmaceutical Co. Ltd.	30 Jun 2025
Sleep Apnea, Obstructive	United States	Eli Lilly & Co.	20 Dec 2024
Obesity	United States	Eli Lilly & Co.	08 Nov 2023
Overweight	United States	Eli Lilly & Co.	08 Nov 2023
Weight Gain	Australia	Eli Lilly Australia Pty Ltd.	23 Dec 2022
Diabetes Mellitus, Type 2	United States	Eli Lilly & Co.	13 May 2022

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Heart failure with normal ejection fraction	NDA/BLA	China	Eli Lilly & Co.	22 Nov 2024
Reduced ejection fraction co-occurrent and due to chronic heart failure	NDA/BLA	European Union	Eli Lilly & Co.	-
Metabolic dysfunction-associated steatotic liver disease	Phase 3	United States	Eli Lilly & Co.	16 Oct 2025
Colitis, Ulcerative	Phase 3	United States	Eli Lilly & Co.	26 Jun 2025
Colitis, Ulcerative	Phase 3	Austria	Eli Lilly & Co.	26 Jun 2025
Colitis, Ulcerative	Phase 3	Belgium	Eli Lilly & Co.	26 Jun 2025
Colitis, Ulcerative	Phase 3	Brazil	Eli Lilly & Co.	26 Jun 2025
Colitis, Ulcerative	Phase 3	Bulgaria	Eli Lilly & Co.	26 Jun 2025
Colitis, Ulcerative	Phase 3	Canada	Eli Lilly & Co.	26 Jun 2025
Colitis, Ulcerative	Phase 3	Czechia	Eli Lilly & Co.	26 Jun 2025

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05822830 (SURMOUNT-5, Pubmed \| Curr Med Res Opin)	Phase 3	Obesity	383	Tirzepatide 15 mg or maximum tolerated dose (MTD)	qgsxydnoye(rbjwczxurq) = The safety profile was generally consistent with the overall SURMOUNT‐5 population, with gastrointestinal events most common. exwalwseso (xpucwmdzvo ) View more	Positive	11 Jul 2026
				Semaglutide 2.4 mg or MTD
NCT04255433 (SURPASS-CVOT \| SURPASS, CTgov)	Phase 3	Diabetes Mellitus, Type 2	13,299	Dulaglutide	onbjnrfkvu = ygczymczag rsqwyqkuhy (xxmhggweww, qaypyggspu - kboevgktqn) View more	-	08 Jul 2026
NCT05963022 (SURPASS-CN-MONO, Pubmed \| Med)	Phase 3	Early-onset type II diabetes	206	5 mg Tirzepatide	pzrwoeynmi(nqbszllmay) = vawqofgppj xwxchbvxhs (oxdcjwpkcm ) View more	Positive	01 Jul 2026
				10 mg Tirzepatide	pzrwoeynmi(nqbszllmay) = atxqmupqpd xwxchbvxhs (oxdcjwpkcm ) View more
NCT06588283 (Pubmed \| JAMA Dermatol)	Phase 3	Psoriasis	274	Ixekizumab plus Tirzepatide	qqraquhchz(rimirbdlxe) = pynyoqmgge udghmgklrn (uvzwlrjywx ) View more	Positive	01 Jul 2026
				Ixekizumab (Diet and exercise adjunct)	qqraquhchz(rimirbdlxe) = quxpwsakid udghmgklrn (uvzwlrjywx ) View more
NCT05260021 (SURPASS-PEDS, ADA2026)	Phase 3	Diabetes Mellitus, Type 2	99	Tirzepatide 5 mg	gjfjlqiabo(cbojifhtkk) = tvdeatswky wnkilrdqnx (ffgwxbmbwz )	Positive	20 Jun 2026
				Placebo	gjfjlqiabo(cbojifhtkk) = fiojidooaj wnkilrdqnx (ffgwxbmbwz )
ADA2026	Not Applicable	Diabetes Mellitus, Type 2	71	Tirzepatide (Type 2 Diabetes Mellitus)	xfmqcjrnsy(rgmyoosgpo) = Gastrointestinal adverse events were common (59.2%) but predominantly mild to moderate. No severe hypoglycemia or serious adverse events occurred. czvbidxxte (ssxyctddxm )	Positive	20 Jun 2026
ADA2026	Not Applicable	Overweight \| Obesity	181	Tirzepatide	cpfwasqecn(usohakyott) = hnpmmmhscf msftvkipnp (habdgsvxoj, 80.7 - 91.2) View more	Positive	20 Jun 2026
ADA2026	Not Applicable	Diabetes Mellitus, Type 2	12,500	Tirzepatide	fvqwiuxnbk(gvvzfcjgxn): RR = 1.08 (95.0% CI, 0.97 - 1.2)	Positive	20 Jun 2026
				Semaglutide
ADA2026	Not Applicable	Diabetes Mellitus, Type 2 \| Peripheral Arterial Disease	24,374	Tirzepatide	czuxkcrafx(oilysjzpma): RR = 0.65 (95.0% CI, 0.45 - 0.92), P-Value = 0.015	Positive	20 Jun 2026
				Injectable Semaglutide
EULAR2026	Not Applicable	Arthritis, Psoriatic	73	Tirzepatide+biologic	kksjyrxbvt(orslalfunb) = ymemgrnxul lauxvtmtlx (ypmoseiyxp ) View more	Positive	11 Jun 2026
				biologic	vuasvbxfnl(whgawtlxlx) = mwxjzjttlh vmrvmgsfjw (dgjlmxkgcv ) View more

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