Efficacy, Safety, and Pharmacokinetics of Orforglipron Once Daily Oral Versus Placebo in Adolescent Participants Who Have Obesity, or Overweight With Weight-Related Comorbidities: A Randomized, Double-Blind Trial (ADVANCE-ATTAIN-ADOLESCENTS)

The main purpose of this study, performed under Master Protocol J4M-MC-PWMP, is to evaluate the efficacy, safety, and pharmacokinetics of orforglipron once daily oral versus Placebo in adolescent participants with obesity, or overweight with related comorbidities. Participation in the study will last about 18 months.

Start Date01 Dec 2024

Sponsor / Collaborator

Eli Lilly & Co.

NCT06672549 / Not yet recruitingPhase 3

A Master Protocol for a Randomized, Controlled, Clinical Platform Trial to Investigate the Efficacy and Safety of Interventions for Chronic Weight Management in Pediatric Participants With Obesity or Overweight

The purpose of this pediatric, chronic weight management, Phase 3 Master Protocol (PWMP) is to create a framework to evaluate the safety and efficacy of pharmacologic agents for the treatment of obesity or overweight in pediatric participants.

Start Date01 Dec 2024

Sponsor / Collaborator

Eli Lilly & Co.

NCT06649045 / RecruitingPhase 3

A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Once Daily in Participants Who Have Obstructive Sleep Apnea and Obesity or Overweight: A Randomized, Double-Blind, Placebo-Controlled Trial

Study GZRA is a master protocol that will support 2 independent studies, GZ01 and GZ02. Participants will be assigned to the appropriate study prior to randomization. The purpose of the studies is to evaluate the efficacy and safety of orforglipron in participants who have moderate-to-severe OSA and obesity or overweight. Study GZ01 will include participants who are unable or are unwilling to use PAP therapy. Study GZ02 will include participants who are on PAP therapy for at least 3 months at time of screening and plan to continue PAP therapy during the study.

Start Date22 Oct 2024

Sponsor / Collaborator

Eli Lilly & Co.

100 Clinical Results associated with Orforglipron

100 Translational Medicine associated with Orforglipron

100 Patents (Medical) associated with Orforglipron

Literatures (Medical) associated with Orforglipron

01 Dec 2024·METABOLISM-CLINICAL AND EXPERIMENTAL

Seven glucagon-like peptide-1 receptor agonists and polyagonists for weight loss in patients with obesity or overweight: an updated systematic review and network meta-analysis of randomized controlled trials

Article

Author: Li, Mengting ; Cao, Weiling ; Zheng, Guimei ; Deng, Weishang ; Xie, Zeyu ; Liang, Zhuoru

PURPOSE:

This study aimed to provide evidence-based support and a reference for the efficacy and safety of seven glucagon-like peptide-1 (GLP-1) receptor agonists and polyagonists for weight loss in patients with obesity or overweight through a network meta-analysis.

METHODS:

Relevant randomized controlled trials (RCTs) with an intervention duration of at least 16 weeks assessing seven GLP-1 receptor agonists and polyagonists (mazdutide, 6 or 4.5 mg; retatrutide, 12 or 8 mg; tirzepatide, 15 or 10 mg; liraglutide, 3.0 mg; semaglutide, 2.4 mg; orforglipron, 45 or 36 mg; and beinaglutide, 0.2 mg) in patient with obesity or overweight was searched using three databases (Cochrane Library, PubMed, and Embase) from creation to August 30, 2024. The primary outcome was the percentage change in body weight from baseline. Secondary outcomes included changes in waist circumference, hemoglobin A1c, and fasting plasma glucose level from baseline; adverse events, serious adverse events, adverse event withdrawal, and hypoglycemic events. We conducted a frequentist random-effects network meta-analysis to analyze the data extracted from the RCTs using Stata 16.1 software.

RESULTS:

Twenty-seven RCTs of seven GLP-1 receptor agonists and polyagonists and 15,584 patients were included in the network meta-analysis. In terms of efficacy, compared with placebo, retatrutide 12 mg (-22.10 % in body weight and - 17.00 cm in waist circumference), retatrutide 8 mg (-20.70 % and - 15.90 cm), and tirzepatide 15 mg (-16.53 % and - 13.23 cm) were the three most efficacious treatments for reducing body weight and waist circumference. However, these treatments were less effective in patients with type 2 diabetes mellitus (T2DM). In addition, patients with a high body mass index (BMI) or longer treatment cycles exhibited significantly greater weight loss than those with a low BMI or shorter treatment cycles. In terms of safety, patients without T2DM had a higher incidence of adverse events than those with T2DM. None of the interventions increased the incidence of serious adverse or hypoglycemic events (˂54 mg/dL). There was no significant difference in the incidence of adverse event withdrawal for all interventions in head-to-head comparisons. In addition, disparities in race, BMI, and treatment cycles did not significantly increase the incidence of adverse events. Finally, the sensitivity and publication bias analyses indicated that the basic analysis results were reliable.

CONCLUSION:

Retatrutide (both doses) and tirzepatide exhibited superior efficacy compared to other GLP-1 receptor agonists and polyagonists in reducing body weight and waist circumference. Patients without T2DM, those with a high BMI, and individuals undergoing longer treatment cycles demonstrated significantly greater weight loss and reductions in waist circumference. Dual or triple receptor agonists (GLP-1 plus glucose-dependent insulinotropic polypeptide and/or Glucagon receptor) are more effective for weight loss than GLP-1 receptor agonists.

01 Oct 2024·Current diabetes reviews

Future is Brighter: New Potential Paradigm-Shifting Medications and Regimens for Diabetes and Obesity

Review

Author: Aliter, Hashem F. ; Al-Horani, Rami A. ; Aliter, Kholoud F.

Abstract::

Diabetes is a chronic illness that can become debilitating owing to its microvascular and macrovascular complications. Its prevalence is increasing and so is its cost. Diabetes, particularly type 2, appears to have a very close relationship with obesity. While lifestyle modifications, exercises, and current therapeutics have substantially improved clinical outcomes, the need for new therapeutics and regimens continue to exist. Several new medications and regimens for diabetes, obesity, and diabesity are showing promising results in advanced clinical trials. For type 1 diabetes mellitus (T1DM), they include teplizumab, ustekinumab, jakinibs, and cell therapies, whereas for type 2 diabetes mellitus (T2DM), they include once-weakly insulin, tirzepatide, high oral dose of semaglutide, orforglipron, retatrutide, CagriSema, and survodutide. Given their structural and mechanistic diversity as well as their substantial efficacy and safety profiles, these medications and regimens are paradigm shifting and promise a brighter future. They will likely enable better disease prevention and management. This review will provide details about each of the above strategies to keep the scientific community up to date about progress in the fields of diabetes and obesity

11 Sep 2024·Archives of Endocrinology Metabolism

Effects of once-daily oral orforglipron on weight and metabolic markers: a systematic review and meta-analysis of randomized controlled trials

Review

Author: Sande-Lee, Simone van de ; van de Sande-Lee, Simone ; Hohl, Alexandre ; Chavez, Matheus Pedrotti ; Ferreira, Rafael Oliva Morgado ; Pasqualotto, Eric ; Dos Santos, Henrique Vilar ; Ronsoni, Marcelo Fernando ; Petris, Ilmar ; Santos, Henrique Vilar dos ; Wille, Julia Murbach ; Lütkemeyer, Carine

The aim of this study is to assess the effects of once-daily oral orforglipron on weight and metabolic markers in adult patients. PubMed, Embase, Cochrane Library, and ClinicalTrials.gov databases were systematically searched until February 2024 for randomized controlled trials (RCTs) comparing orforglipron versus placebo or other anti-obesity medications in adult patients. Weighted mean differences (WMDs) for continuous outcomes and risk ratios (RRs) or risk differences for binary endpoints were computed, with 95% confidence intervals (CIs). Heterogeneity and risk of bias were assessed with I² statistics and Rob-2, respectively. Statistical analyses were performed using R, version 4.2.2. A total of four studies were included, comprising 815 patients, of whom 620 (76.1%) were prescribed orforglipron. Compared with placebo, orforglipron reduced body weight (WMD -6.14 kg, 95% CI -9.62 to -2.66 kg), body mass index (WMD -2.87 kg/m², 95% CI -4.65 to -1.10 kg/m²), and waist circumference (WMD -5.32 cm, 95% CI -9.13 to -1.51 cm). More patients treated with orforglipron than placebo achieved a weight loss of ≥ 5% (RR 3.31, 95% CI 2.23-4.93), ≥ 10% (RR 5.24, 95% CI 2.07-13.31), and ≥ 15% (RR 9.53, 95% CI 1.26-71.89). The most common adverse events were related to the gastrointestinal tract. In this meta-analysis, the use of once-daily oral orforglipron by adult patients was associated with a significant decrease in body weight, as compared with placebo, with an increase in non-severe gastrointestinal adverse events. Phase 3 RCTs are expected to shed further light on the efficacy and safety of once-daily oral orforglipron over the long term.

News (Medical) associated with Orforglipron

04 Nov 2024

·www.globenewswire.com

Biomea Fusion Presents Preclinical Data Showing Icovamenib (BMF-219) Enhanced Effectiveness of GLP-1-Based Therapies and Introduces BMF-650, a Next-Generation, Oral Small-Molecule GLP-1 Receptor Agonist Candidate

Preclinical data from ex vivo human islet experiments showed that icovamenib (BMF-219) was able to enhance the activity of glucagon-like peptide-1 (GLP-1)-based therapies, potentially leading to increased insulin secretion and improved glycemic control in patients with diabetes Phase II study (COVALENT-211), combining icovamenib with a GLP-1-based therapy, planned to begin in 2025 BMF-650, an investigational next-generation, oral small-molecule GLP-1 receptor agonist (GLP-1 RA), demonstrated positive early preclinical activity, including improved glucose-stimulated insulin secretion, reduction in blood glucose concentration, and appetite suppression in cynomolgus monkeys Oct. 30, 2024 -- Biomea Fusion, Inc. (“Biomea” or “the Company”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to improve the lives of patients with diabetes, obesity, and genetically defined cancers, today presented preclinical data showing icovamenib enhanced the activity of GLP-1-based therapies, along with early preclinical efficacy and pharmacokinetic data for BMF-650, a next-generation, oral small-molecule GLP-1 RA candidate. “Menin plays a central role in the pancreas, not only impacting the proliferation of beta cells but also the expression of GLP-1 receptors. We observed that icovamenib, when combined with either of the two most commonly used GLP-1-based therapies, tirzepatide or semaglutide, enhanced the responsiveness of human islets to the GLP-1-based therapy, leading to substantial insulin secretion under hyperglycemic conditions. The dose-dependent improvements, where glucose-stimulated insulin secretion more than doubled, are highly promising,” stated Juan Pablo Frias, MD, Biomea Fusion’s Chief Medical Officer. “Additionally, we believe the results we’ve seen with our own GLP-1 RA product candidate, BMF-650, highlight a strong potential as a next-generation, oral GLP-1 RA for both diabetes and obesity. We believe these findings open exciting new avenues for treatment.” Icovamenib (BMF-219) in Combination with a GLP-1-Based Therapy Key Highlights: Preclinical studies evaluated insulin secretion by GLP-1-based therapies (tirzepatide and semaglutide) using human islets cultured ex vivo under hyperglycemic conditions, with and without icovamenib treatment. We hypothesized that menin inhibition would enhance the effectiveness of GLP-1-based therapies and showcased functional data, indicating stronger insulin responses with both tirzepatide and semaglutide when combined with icovamenib treatment. Further studies with orforglipron also indicated that icovamenib pretreatment improved insulin secretion, approximately doubling the effect-size depending on the dose. Additionally, BMF-650, Biomea’s next-generation, oral small molecule GLP-1 RA product candidate, used alone or in combination with icovamenib, yielded even further improved results supporting the potential for therapeutic benefits. The initiation of a Phase II study, COVALENT-211, to evaluate the combination of icovamenib with a GLP-1-based therapy, is planned for 2025. In addition, the Company announced additional details about its investigational, next-generation, oral small-molecule GLP-1 RA candidate, BMF-650. BMF-650 - an Investigational, Next-Generation, Oral Small Molecule GLP-1 Receptor Agonist - Key Highlights: We conducted preclinical studies to evaluate the properties of BMF-650 in comparison to a leading oral GLP-1 RA. BMF-650 exhibited higher bioavailability and a less variable pharmacokinetic profile, which may translate to improved tolerability and support successful dose escalation in patients. The estimated human dose will be approximately 100 mg once daily. In human donor islet studies, BMF-650 significantly enhanced glucose-stimulated insulin secretion. In cynomolgus monkey studies, BMF-650 showed significant improvements in glucose stimulated insulin secretion, in line with findings from the human donor islet experiments. BMF-650 also demonstrated superior glucose control. Appetite suppression studies revealed that daily oral BMF-650 dosing significantly reduced food intake during peak drug concentration, with sustained effects throughout the day for a six-day study period. These findings highlight BMF-650’s potential as an oral treatment for diabetes and obesity. “Our preclinical findings about the inhibition of menin in the GLP-1 pathway, announced today, may support the profile of icovamenib as a potential combination agent for GLP-1-based therapies. With the combination of icovamenib, less GLP-1 RA dosing may be required, which may support the overall benefits of these therapeutics. We believe, icovamenib may contribute to improved efficacy, tolerability and adherence, which ultimately will lead to more patients having longer benefits from these agents. We plan to clinically evaluate icovamenib as an adjunct to GLP-1-based therapies,” stated Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board. “We are equally excited with the early results of our newest asset, BMF-650, which demonstrated clear advantages, including when compared to a leading GLP-1 RA in our preclinical studies. BMF-650 has shown superior insulin secretion, better glucose control, a smoother pharmacokinetic profile and higher bioavailability; all of which point to the potential for a greater therapeutic window and support our plans to evaluate BMF-650 as a next-generation oral treatment for diabetes. The appetite suppression results were particularly exciting, as they signal a new and impactful profile which we believe may support an impact on obesity.” Obesity is a chronic disease necessitating long-term management, associated with diminished life expectancy and a spectrum of severe health complications. These include metabolic disorders such as type 2 diabetes and non-alcoholic fatty liver disease; cardiovascular diseases like heart attack, stroke, and hypertension; and increased risks of chronic kidney disease, certain cancers, and chronic inflammation. The CDC estimates that over 40% of adults in the U.S. are considered obese, contributing to a significant burden on public health and healthcare systems. Globally, over 650 million adults are living with obesity, and these numbers are steadily rising. Glucagon-like peptide-1 (GLP-1) is a naturally occurring incretin hormone that plays a vital role in glucose homeostasis and appetite regulation. GLP-1 receptor agonists (GLP-1 RAs) are a class of medications that bind to and activate GLP-1 receptors, mimicking the effects of native GLP-1. These agents have demonstrated robust clinical efficacy in improving glycemic control, promoting weight loss, and enhancing insulin sensitivity in individuals with type 2 diabetes and obesity. Biomea Fusion is a clinical-stage biopharmaceutical company focused on the discovery and development of oral covalent small molecules to improve the lives of patients with diabetes, obesity, and genetically defined cancers. A covalent small molecule is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional non-covalent drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response. We are utilizing our proprietary FUSION™ System to discover, design and develop a pipeline of next-generation covalent-binding small-molecule medicines designed to maximize clinical benefit for patients. We aim to have an outsized impact on the treatment of disease for the patients we serve. We aim to cure. The content above comes from the network. if any infringement, please contact us to modify.

Clinical Result

30 Oct 2024

·www.biopharmadive.com

Lilly shares fall as obesity drug sales miss forecasts

Eli Lillys seemingly inexorable growth hit a speed bump Wednesday, when the Indianapolis drugmaker reported earnings for the third quarter that missed Wall Street expectations and sent shares down sharply.Overall, revenue reached $11.4 billion between July and September, up 20% from the same period last year but higher by only 1% versus the second quarter and well below the consensus forecast of about $12.1 billion.Lillys sales and stock price have swelled on surging demand for the companys GLP-1 medicines Mounjaro and Zepbound, which it respectively sells for diabetes and obesity.The company has had difficulty meeting that demand, though, leading to shortages that have hampered the drugs availability. (In October, the Food and Drug Administration officially removed Mounjaro and Zepbound from its shortage list, but is now reconsidering that decision.)Compared to the third quarter last year, sales of the two drugs are significantly higher, respectively reaching $3.1 billion and $1.26 billion during the period. But both totals were lower than analysts expected and roughly flat compared to the second quarter.Lilly said wholesalers purchasing fewer doses negatively impacted U.S. sales of Mounjaro and Zepbound by mid-single digits as a percent of total sales in the country. Wholesalers had previously stocked up toward the end of the second quarter, according to Lilly.Shares were down by double digits early Wednesday, dragging down a market capitalization that had ballooned beyond $900 billion previously. The stocks of other obesity drugmakers were affected, too, with rival Novo Nordisk falling by more than 3%.Lilly also trimmed its guidance for the year, shaving $600 million off the top end of its estimated revenue range, which it now puts between $45.4 billion and $46 billion.Lucas Montarce, the companys new CFO, said the guidance update was done to reflect Lillys balancing of demand creation activities and new market launches with its production. This is the driver for lowering the top end of the range, he said on an earnings call Wednesday.The company also cut its earnings per share guidance to between $12.05 and $12.55 on a reported basis to reflect both the lowered revenue forecast and accounting charges taken in association with Lillys acquisition of Morphic Therapeuticearlier this year.David Risinger, an analyst at Leerink Partners, described Lillys GLP-1 drug sales as a big miss versus expectations but, writing in a client note Wednesday, said his team views the investment thesis as unchanged since the company is just getting started in commercializing obesity products globally.Company executives said something similar, noting how, after accounting for the wholesaler impacts, underlying demand continues to grow.We do see acceleration of both brands in [the third quarter]over [the second quarter]in actual consumption, said company CEO David Ricks, who noted he expects that to continue as Lilly begins advertising for Zepbound.Along with Novo, Lilly has led the pharmaceutical industrys charge into obesity treatment. Zepbound, which contains the same active ingredient as Mounjaro, can help clinical trial participants lose as much as one-fifth of their body weight. Further testing has shown it holds benefits for people with heart failure and sleep apnea, too.A more recent study found that weekly injections also reduced the risk of developing diabetes, and Lilly is testing the drugs effects on heart and kidney disease as well.Novos drugs Ozempic and Wegovy have proved similarly potent in curbing weight, diabetes and heart risk.In response to that success, pharma and biotechnology companies are racing to develop their own competitors, testing new twists on targeting GLP-1 or attempting to replicate the drugs effects in a pill, rather than injection.Both Lilly and Novo have successors of their own, though. Two of Lillys, retatrutide and orforglipron, are now in Phase 3 testing, with data expected next year and in 2026. Novo, meanwhile, is awaiting a major readout for its combination drug cagrisema later this year.Editors note: This story has been updated with executive commentary. '

AcquisitionPhase 3

24 Sep 2024

·www.biospace.com

Deep Dive: Obesity and Diabetes Markets Explode

A scale and fat cells Taylor Tieden for BioSpace In this deep dive BioSpace dissects the global obesity and diabetes markets along with the growing pipelines that aim to serve them. The global obesity market is forecasted to reach between $100 billion and $160 billion in the next decade. Meanwhile, the market for type 2 diabetes, which is closely related, is predicted to exceed $70 billion by 2032. There is thus considerable opportunity for Novo Nordisk, Eli Lilly, Pfizer and the multitude of other biopharma companies vying for a piece of the lucrative pie. Weight-Loss Market Estimates and Projections Source: IQVIA, Reuters, Goldman Sachs Taylor Tieden for BioSpace While exceedingly successful, many suspect the current GLP-1 injection therapies for obesity will ultimately be replaced by oral GLP-1 drugs, and several companies, including Lilly, Novo and Pfizer, are racing to bring their versions to the market. In addition, the space is not limiting itself to GLP-1s but is also exploring novel mechanisms to tackle these widespread diseases. Here, BioSpace examines the current obesity and diabetes markets along with the growing pipelines that aim to serve them. Weight Loss: A Two-Horse Race The obesity market is currently dominated by two companies: Novo Nordisk and Eli Lilly. While Novo’s obesity drug Wegovy had a two-year head start on Lilly’s Zepbound, the latter is making up ground . On August 7, Novo reported its second-quarter earnings , revealing profits of $1.7 billion for Wegovy and $4.23 billion for diabetes drug Ozempic. Despite growth rates of 53% and 30%, respectively, for the drugs, investors were not impressed because analyst forecasts were missed. Lilly, on the other hand, beat Q2 expectations , bringing in $1.24 billion for Zepbound and $3.1 billion for diabetes treatment Mounjaro. But the future is much more than a two-horse race. Several companies, including Pfizer , Roche , Viking Therapeutics , and Rivus Pharmaceuticals, are developing obesity therapeutics. Some leverage the GLP-1 pathway, while others commit to different mechanisms, including amylin analogs and mitochondrial uncoupling. Other players in the space include Veru Pharmaceuticals, Regeneron, Altimmune, Amgen, and Amylyx. Approval Timeline The obesity space truly caught fire with the clinical success of Wegovy and Zepbound, but these products follow several other treatments for obesity and diabetes approved over the past two-plus decades. Here is a sampling of noteworthy products. November 2023 Eli Lilly, Zepbound Generic name: Tirzepatide Treatment: Weight management June 2022 Vivus, Qsymia Generic names: Phentermine and topiramate Treatment: Weight management in pediatric patients May 2022 Eli Lilly, Mounjaro Generic name: Tirzepatide Treatment: Type 2 diabetes June 2021 Novo Nordisk, Wegovy Generic name: Semaglutide Treatment: Obesity December 2020 Novo Nordisk, Saxenda Generic name: Liraglutide Treatment: Obesity in adolescents September 2019 Novo Nordisk, Rybelsus Generic name: Semaglutide Treatment: Type 2 diabetes (pill form) December 2017 Novo Nordisk, Ozempic Generic Name: semaglutide Treatment: Type 2 diabetes September 2014 Takeda, Contrave Generic names: Naltrexone and bupropion Treatment: Weight loss July 2012 Vivus, Qsymia Generic names: Phentermine and topiramate Treatment: Weight management in adult patients January 2010 Novo Nordisk, Victoza Generic name: Liraglutide Treatment: Type 2 diabetes April 2005 Amylin Pharmaceuticals, Byetta Generic name: Exenatide Treatment: Type 2 diabetes The Highly Sought Weight-Loss Pill In 2019, the FDA approved Novo’s Rybelsus as the first oral GLP-1 for type 2 diabetes. Considered by many to be the next frontier in obesity treatment, oral medicines are under development by a number of companies, including Novo, whose amycretin is in Phase I trials, and Lilly, which has a Phase III trial underway for orforglipron. Brazilian owned multinational company Eurofarma also has a Phase III study underway for its oral candidate sibutramine/topiramate XR. Meanwhile, a host of companies have oral assets in earlier-stage trials. Pfizer recently announced that it would move forward with a modified-release formulation of its candidate danuglipron, and in December 2023, San Francisco–based Structure Therapeutics announced positive results from a Phase IIa trial of its weight-loss pill GSBR-1290. Note: Not all companies with oral medicines in Phase I and II trials are included. Taylor Tieden for BioSpace Widely hailed as “the next big thing” in the obesity space, several companies—including Eli Lilly, Novo Nordisk and Pfizer—are developing oral GLP-1 candidates. How long before oral GLP-1s take majority share of the market? Source: BioSpace LinkedIn poll , August 2024 Taylor Tieden for BioSpace This deep dive was originally published as a special edition of ClinicaSpace. Subscribe here .

Phase 2Clinical ResultPhase 3Phase 1Drug Approval

100 Deals associated with Orforglipron

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Sleep Apnea, Obstructive	Phase 3	US	Eli Lilly & Co.	22 Oct 2024
Cardiovascular Diseases	Phase 3	US	Eli Lilly & Co.	03 Apr 2023
Cardiovascular Diseases	Phase 3	AR	Eli Lilly & Co.	03 Apr 2023
Cardiovascular Diseases	Phase 3	AT	Eli Lilly & Co.	03 Apr 2023
Cardiovascular Diseases	Phase 3	BR	Eli Lilly & Co.	03 Apr 2023
Cardiovascular Diseases	Phase 3	CZ	Eli Lilly & Co.	03 Apr 2023
Cardiovascular Diseases	Phase 3	DE	Eli Lilly & Co.	03 Apr 2023
Cardiovascular Diseases	Phase 3	GR	Eli Lilly & Co.	03 Apr 2023
Cardiovascular Diseases	Phase 3	IN	Eli Lilly & Co.	03 Apr 2023
Cardiovascular Diseases	Phase 3	IT	Eli Lilly & Co.	03 Apr 2023

Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05051579 (EASD2023)	Phase 2	Overweight \| Obesity	272	Orforglipron (OFG) 12 mg	gmmmktxtwj(twgqefehmh) = qukhntjdxd ghqnxnipub (vknxzhsrio ) View more	Positive	03 Oct 2023
				Orforglipron (OFG) 24 mg	gmmmktxtwj(twgqefehmh) = aybboicrre ghqnxnipub (vknxzhsrio ) View more
NCT05051579 (GZGI, CTgov)	Phase 2	Obesity	272	LY3502970 (24 mg LY3502970)	ascpizxobl(uzhzdibcnm) = kqdzdyusrn kbvlzhismz (jenvspotuz, rmeamkaeef - tbsxjbbdsg) View more	-	13 Sep 2023
				Placebo (Placebo)	ascpizxobl(uzhzdibcnm) = tkoaurexwg kbvlzhismz (jenvspotuz, vblhkkspxf - whchkxwgzb) View more
NCT05048719 (ADA2023) Manual	Phase 2	Diabetes Mellitus, Type 2	383	Orforglipron 3 mg	iklhiobpuq(ppcfwuqyoi) = qatyzqlpat ntzabaikws (ptcyikizfq ) View more	Positive	25 Jun 2023
				Orforglipron 12 mg	iklhiobpuq(ppcfwuqyoi) = rlzfwqbeii ntzabaikws (ptcyikizfq ) View more
NCT05051579 (ADA2023) Manual	Phase 2	Overweight \| Obesity	272	Orforglipron 12 mg	wantchwtgg(bkebpfbbvk) = bhzgvpvpiw aodmmouqrr (xlcwoubuyi ) View more	Positive	23 Jun 2023
				Orforglipron 24 mg	wantchwtgg(bkebpfbbvk) = yvtgfajelo aodmmouqrr (xlcwoubuyi ) View more
NCT05048719 (Literature) Manual	Phase 2	Diabetes Mellitus, Type 2	303	orforglipron	hqrisgytvg(rxpfmjbbrz) = kyrdyufrmh lbykoqmbyi (tnplszyypi ) View more	Positive	23 Jun 2023
				Dulaglutide	hqrisgytvg(rxpfmjbbrz) = fexksqlhpg lbykoqmbyi (tnplszyypi ) View more
NCT05051579 (GZGI, Pubmed)	Phase 2	Obesity	272	Orforglipron 12 mg	fyaghwmpcb(dojcekibbf) = pjgazfzwkr wlroiwjklt (brnkaumslm )	-	23 Jun 2023
				Orforglipron 24 mg	fyaghwmpcb(dojcekibbf) = lszvpfmtta wlroiwjklt (brnkaumslm )
ADA2023 Manual	Phase 1	-	46	Orforglipron 3mg (fasted)	pgbjgipeyi(gixxomhceh) = qgvahtdqik gdsukercol (ytzmzixweg ) View more	Positive	20 Jun 2023
				Orforglipron 3mg (fed)	pgbjgipeyi(gixxomhceh) = ovqdarwyxb gdsukercol (ytzmzixweg ) View more
NCT04426474 (NEWS) Manual	Phase 1	Diabetes Mellitus, Type 2	68	LY3502970	spjehucuhe(jfbxujambh) = edqkjzybbo lvtdutyniv (drershwydb ) View more	Positive	13 Oct 2022
				Placebo	aogqnktwin(khsztzoprh) = brrscvnfgl lfxtcstetj (lvakglumlr ) View more
NCT04426474 (EASD2022)	Phase 1	Diabetes Mellitus, Type 2 HbA1c	51	LY3502970	hqdacvruep(yauzcvijgp) = One patient reported 2 severe gastrointestinal events (1 each of nausea and vomiting); all other events were mild or moderate hvlneaikwq (hoswchavay )	Positive	20 Sep 2022
				Placebo
NCT03929744 (ADA2022)	Phase 1	-	133	LY3502970	qfxmqccjvr(zrcdyzmjic) = occurring in ≥3 subjects huhlglhcls (ahjgcpxjom ) View more	-	01 Jun 2022

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