Insulin Glargine(Boehringer Ingelheim)

In ACHIEVE-3, Foundayo 17.2 mg drove 57.1% greater relative reduction in A1C and 73.6% greater relative weight loss compared to oral semaglutide 14 mg In ACHIEVE-2 and ACHIEVE-5, Foundayo delivered significant improvements in blood sugar and weight, with up to 68.6% and 69.1% of participants reaching an A1C goal of ≤6.5% respectively Lilly plans to submit Foundayo for type 2 diabetes to the U.S. Food and Drug Administration by the end of the second quarter INDIANAPOLIS, June 8, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY), the maker of Zepbound (tirzepatide), today announced detailed results from three Phase 3 trials in the ACHIEVE program evaluating Foundayo (orforglipron), a small molecule oral GLP-1 taken without food or water restrictions, in adults with type 2 diabetes. In the landmark head-to-head ACHIEVE-3 trial, Foundayo outperformed oral semaglutide across the primary and all key secondary endpoints. In ACHIEVE-2 and ACHIEVE-5, Foundayo met the primary endpoint and key secondary endpoints, delivering superior A1C reduction and weight loss versus dapagliflozin and placebo added to insulin glargine respectively.1,2 Results from ACHIEVE-3, ACHIEVE-2 and ACHIEVE-5 were presented at the American Diabetes Association (ADA) 86th Scientific Sessions. ACHIEVE-3 was previously published in The Lancet, while ACHIEVE-2 and ACHIEVE-5 were published in The Lancet and JAMA, respectively. "ACHIEVE-3 provides the first head-to-head data on oral GLP-1s in type 2 diabetes, with orforglipron showing greater A1C and weight reductions than oral semaglutide, which was tested at approved diabetes doses," said Dr. Julio Rosenstock, clinical professor of medicine at the University of Texas Southwestern Medical Center and ACHIEVE-3 lead investigator. "That level of efficacy is reinforced in ACHIEVE-2 and ACHIEVE-5, demonstrating a consistent and robust treatment effect across a wide spectrum of patient populations. These results support a potential shift toward using oral GLP-1 receptor agonist therapies like orforglipron earlier as a foundation of type 2 diabetes care." In ACHIEVE-3, Foundayo 9 mg and 17.2 mg outperformed oral semaglutide 7 mg and 14 mg in the first and only head-to-head Phase 3 trial of two oral GLP-1 receptor agonists for type 2 diabetes.3 Foundayo lowered A1C by an average of 1.9% (9 mg) and 2.2% (17.2 mg) compared to 1.1% (7 mg) and 1.4% (14 mg) with oral semaglutide at 52 weeks, a 57.1% greater relative reduction at the highest dose comparison. More patients taking the highest dose of Foundayo achieved an A1C <5.7% (37.1% vs 12.5%), the threshold for normal blood sugar levels. Foundayo also delivered greater weight loss, with patients losing an average of 14.6 lbs (6.7%; 9 mg) and 19.7 lbs (9.2%; 17.2 mg) compared to 7.9 lbs (3.7%; 7 mg) and 11.0 lbs (5.3%; 14 mg) with oral semaglutide, a 73.6% greater relative weight loss at the highest dose comparison. ACHIEVE-3 Efficacy Estimand Results 4 ip<0.001 vs. oral semaglutide 7 mg iip<0.001 vs. oral semaglutide 14 mg iiip<0.01 vs. oral semaglutide 14 mg ivBody weight for Foundayo 9 mg vs. oral semaglutide 14 mg and percentage of participants achieving A1C <5.7% were not controlled for family-wise type 1 error. In ACHIEVE-2, Foundayo delivered superior results, lowering A1C by up to an average of 1.7% compared to 0.8% with dapagliflozin at 40 weeks from an average baseline of 8.1%. Up to 68.6% of patients taking the highest dose of Foundayo achieved an A1C ≤6.5%, the level recommended for more intensive blood sugar control, compared to 21.6% with dapagliflozin. Participants taking Foundayo lost an average of 7.1 lbs (3.5%; 2.5 mg), 12.8 lbs (6.3%; 9 mg), and 15.0 lbs (7.3%; 17.2 mg) versus 6.0 lbs (3.0%) with dapagliflozin. In ACHIEVE-5, Foundayo demonstrated significant improvements compared to placebo added to titrated insulin glargine. Foundayo lowered A1C by up to an average of 2.1% compared to 0.8% with placebo at 40 weeks from an average baseline of 8.5%. Up to 69.1% of patients taking Foundayo 9 mg achieved an A1C ≤6.5% compared to 11.1% with placebo. Participants taking Foundayo lost an average of 4.9 lbs (2.7%; 2.5 mg), 11.0 lbs (5.8%; 9 mg), and 11.5 lbs (6.1%; 17.2 mg) compared to a 1.1 lb (0.6%) gain with placebo. "When we look across the ACHIEVE program, Foundayo consistently demonstrated superior A1C control and weight loss, giving us real confidence in what it could deliver for patients," said Thomas Seck, M.D., senior vice president of product development, Lilly Cardiometabolic Health. "ACHIEVE-3 marks the first time two oral GLP-1 therapies have been tested head-to-head in a Phase 3 study, and Foundayo clearly outperformed oral semaglutide on the outcomes that matter most to patients with type 2 diabetes. For the millions of people with type 2 diabetes who want an oral treatment they can take any time of day, Foundayo has the potential to be an attractive first-line therapy option in primary care." Across all three trials, Foundayo showed clinically meaningful improvements from baseline across key cardiovascular risk factors, including non-HDL cholesterol, HDL cholesterol, VLDL cholesterol, total cholesterol, systolic blood pressure and triglycerides. The overall safety and tolerability profile of Foundayo, including treatment discontinuation rates, was consistent with previous studies. Across the three trials, the most common adverse events were gastrointestinal, including nausea, diarrhea, vomiting, dyspepsia and decreased appetite. Treatment discontinuation rates due to adverse events were 8.7% and 9.7% with Foundayo 9 mg and 17.2 mg vs. 4.5% and 4.9% with oral semaglutide in ACHIEVE-3; 9.2%, 10.8%, and 12.4% with 2.5 mg, 9 mg, and 17.2 mg vs. 1.2% with dapagliflozin in ACHIEVE-2; and 3.6%, 7.6%, and 9.6% with 2.5 mg, 9 mg, and 17.2 mg vs. 3.6% with placebo in ACHIEVE-5. Based on these findings, as well as those from ACHIEVE-1 and ACHIEVE-4, Lilly plans to submit Foundayo for the treatment of type 2 diabetes to the U.S. FDA by the end of the second quarter under the Commissioner's National Priority Review Voucher. About Foundayo Foundayo (orforglipron) is FDA-approved for adults with obesity, or some adults with overweight who also have weight-related medical problems to reduce excess body weight and maintain weight reduction long term, alongside a reduced-calorie diet and increased physical activity. Foundayo is a once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist that can be taken any time of the day without restrictions on food and water intake. Orforglipron was discovered by Chugai Pharmaceutical Co., Ltd. and licensed by Lilly in 2018. In addition to chronic weight management, orforglipron is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence. About ACHIEVE-2, ACHIEVE-3, ACHIEVE-5 and the ACHIEVE clinical trial program ACHIEVE-2 (NCT06192108) is a Phase 3, 40-week, randomized, active-controlled, open-label study comparing the efficacy and safety of Foundayo 2.5 mg, 9 mg and 17.2 mg to dapagliflozin 10 mg in participants with type 2 diabetes and inadequate glycemic control with metformin. The study randomized 962 participants in a 1:1:1:1 ratio to receive either Foundayo 2.5 mg, 9 mg or 17.2 mg, or dapagliflozin 10 mg once daily, in addition to background metformin therapy. The objective of the study was to demonstrate that Foundayo is non-inferior in A1C reduction from baseline after 40 weeks, compared to dapagliflozin. ACHIEVE-3 (NCT06045221) is a Phase 3, 52-week, randomized, open-label trial evaluating the efficacy and safety of Foundayo compared with oral semaglutide in adults with type 2 diabetes inadequately controlled with metformin. The trial randomized 1,698 participants across the U.S., Argentina, China, Japan, Mexico and Puerto Rico to receive either 9 mg or 17.2 mg Foundayo or 7 mg or 14 mg oral semaglutide in a 1:1:1:1 ratio. The primary objective of the study was to demonstrate that Foundayo is non-inferior in A1C reduction from baseline after 52 weeks compared with oral semaglutide when comparing the lower and higher doses. ACHIEVE-5 (NCT06109311) is a Phase 3, 40-week, randomized, double-blind, placebo-controlled study assessing the efficacy and safety of Foundayo 2.5 mg, 9 mg and 17.2 mg in participants with type 2 diabetes and inadequate glycemic control with insulin glargine, with or without metformin and/or SGLT-2 inhibitors. The study randomized 546 participants in a 1:1:1:1 ratio to receive either Foundayo 2.5 mg, 9 mg or 17.2 mg, or placebo with background therapy of titrated insulin glargine alone or in combination with metformin and/or SGLT-2 inhibitors. The objective of the study was to demonstrate that Foundayo is superior in A1C reduction from baseline after 40 weeks, compared to placebo. Study participants had an A1C between ≥7.0% and ≤10.5% and a BMI of ≥23 kg/m2. All participants in the Foundayo treatment arms started the study at a dose of Foundayo 0.8 mg once-daily and then increased the dose in a step-wise approach at four-week intervals until reaching their randomized maintenance dose of 2.5 mg (via one step at 0.8 mg), 9 mg (via steps at 0.8 mg, 2.5 mg and 5.5 mg) or 17.2 mg (via steps at 0.8 mg, 2.5 mg, 5.5 mg, 9 mg and 14.5 mg). These trials were conducted using an investigational formulation of Foundayo at dosages equivalent to Foundayo tablets. Endnotes and References Data in this press release are based on the efficacy estimand. Foundayo achieved statistical superiority in weight loss across all comparisons, except Foundayo 2.5 mg vs. dapagliflozin 10 mg which was not controlled for family-wise error rate and did not achieve statistical significance. All measures except for body weight for Foundayo 9 mg vs. oral semaglutide 14 mg and percentage of participants achieving A1C <5.7% were controlled for family-wise type 1 error using the efficacy estimand and treatment-regimen estimand. Body weight for Foundayo 9 mg vs. oral semaglutide 14 mg and percentage of participants achieving A1C <5.7% were prespecified secondary endpoints and showed nominal statistical significance using the efficacy estimand and treatment-regimen estimand. The efficacy estimand represents efficacy had all randomized participants remained on study intervention (with possible dose interruptions and/or dose modifications) without initiating additional antihyperglycemic medications (>14 days of use). INDICATION AND SAFETY SUMMARY WITH WARNINGS Foundayo (fown-DAY-oh) is a prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off. Foundayo should not be used with other GLP-1 receptor agonist medicines. It is not known if Foundayo is safe and effective for use in children. Warnings – Foundayo 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 Foundayo if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). Do not use Foundayo if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use Foundayo if you have had a serious allergic reaction to orforglipron or any of the ingredients in Foundayo. Foundayo may cause serious side effects, including: Inflammation of the pancreas (pancreatitis). Stop taking Foundayo 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. Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Foundayo. Tell your healthcare provider if you have stomach problems that are severe or will not go away. 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. Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Foundayo with medicines that can cause low blood sugar, such as an insulin or sulfonylurea. 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, mood changes, hunger, weakness, or feeling jittery. Serious allergic reactions. Stop using Foundayo 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, or very rapid heartbeat. Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Foundayo. Gallbladder problems. Gallbladder problems have happened in some people who use Foundayo. 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), or clay-colored stools. Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Foundayo may increase the chance of food getting into your lungs during surgery or other procedures. Tell your healthcare providers that you are taking Foundayo before you are scheduled to have surgery or other procedures. Common side effects The most common side effects of Foundayo include nausea, constipation, diarrhea, vomiting, indigestion, stomach (abdominal) pain, headache, swollen belly, feeling tired, belching, heartburn, gas, and hair loss. These are not all the possible side effects of Foundayo. Talk to your healthcare provider about any side effect that bothers you or doesn't go away. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or . Before taking Foundayo Tell your healthcare provider about all the medicines you take. Foundayo may affect the way some medicines work, and some medicines may affect the way Foundayo works. Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Foundayo during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979). If you take birth control pills by mouth, talk to your healthcare provider before you take Foundayo. Birth control pills may not work as well while taking Foundayo. Your healthcare provider may recommend another type of birth control for 30 days after starting Foundayo and for 30 days after each dose increase of Foundayo. Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea. Review these questions with your healthcare provider: ❑ Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your liver, severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food? ❑ 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 or plan to become pregnant? Foundayo may harm your unborn baby. ❑ Are you breastfeeding or plan to breastfeed? Breastfeeding is not recommended during treatment with Foundayo. ❑ Do you take any other prescriptions or over-the-counter medicines, vitamins, or herbal supplements? How to take Take Foundayo exactly as your healthcare provider tells you to. Use Foundayo with a reduced-calorie diet and increased physical activity. Take Foundayo by mouth 1 time each day, with or without food. Swallow tablets whole. Do not break, crush, or chew the tablet. If you miss a dose, take it as soon as possible. Do not take 2 doses of Foundayo in the same day. Do not take more than 1 tablet per day. If you miss taking Foundayo for 7 or more days in a row, call your healthcare provider to talk about how to restart your treatment. If you take too much Foundayo, 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 Foundayo is a prescription medicine available in 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, or 17.2 mg oral tablets. For more information, call 1-800-545-5979 or go to foundayo.lilly.com. This summary provides basic information about Foundayo 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 doctor. Be sure to talk to your doctor or other healthcare provider about Foundayo and how to take it. Your doctor is the best person to help you decide if Foundayo is right for you. OG CON BS APR2026 ZEPBOUND INDICATIONS AND SAFETY SUMMARY WITH WARNINGS Zepbound® (ZEHP-bownd) is an injectable prescription medicine used with a reduced-calorie diet and increased physical activity to help adults with: obesity, or some adults with overweight who also have weight-related medical problems, to lose excess body weight and keep the weight off. moderate-to-severe obstructive sleep apnea (OSA) and obesity to improve their OSA. Zepbound contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective for use in children. Warnings - Zepbound 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 Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC). Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound. KwikPen® : Do not share your KwikPen with other people, even if the pen needle has been changed. You may give other people a serious infection or get a serious infection from them. Zepbound may cause serious side effects, including: Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away. 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. Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound. 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), or clay-colored stools. Inflammation of the pancreas (pancreatitis). Stop using Zepbound 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. You may feel the pain from your abdomen to your back. Serious allergic reactions. Stop using Zepbound 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, or very rapid heartbeat. Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound with medicines 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, mood changes, hunger, weakness or feeling jittery. Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound. Food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Zepbound may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Zepbound before you are scheduled to have surgery or other procedures. Common side effects The most common side effects of Zepbound include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn't go away. Tell your doctor if you have any side effects. You can report side effects at 1-800-FDA-1088 or . Before using Zepbound Your healthcare provider should show you how to use Zepbound before you use it for the first time. Talk to your healthcare provider about low blood sugar and how to manage it. Tell your healthcare provider if you are taking medicines to treat diabetes including an insulin or sulfonylurea. If you take birth control pills by mouth, talk to your healthcare provider before you use Zepbound. Birth control pills may not work as well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound and for 4 weeks after each increase in your dose of Zepbound. 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 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)? ❑ Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements? ❑ Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Zepbound. Zepbound may pass into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound. Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Zepbound during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Lilly at 1-800-LillyRx (1-800-545-5979). How to take Read the Instructions for Use that come with Zepbound. Use Zepbound exactly as your healthcare provider says. Use Zepbound with a reduced-calorie diet and increased physical activity. Inject Zepbound under the skin (subcutaneously) of your stomach (abdomen), thigh, or have another person inject in the back of the upper arm. Do not inject ZEPBOUND into a muscle (intramuscularly) or vein (intravenously). Use Zepbound 1 time each week, at any time of the day. Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection. If you take too much Zepbound, call your healthcare provider, call the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. Zepbound is approved as a 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, and 15 mg injection. Learn more Zepbound is a prescription medicine. For more information, call 1-800-LillyRx (1-800-545-5979) or go to . This summary provides basic information about Zepbound 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 Zepbound and how to take it. Your healthcare provider is the best person to help you decide if Zepbound is right for you. ZP CON BS 25FEB2026 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 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 Foundayo (orforglipron) as a potential treatment for adults with type 2 diabetes and/or obesity or overweight with weight-related medical problems 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 planned or ongoing studies will be completed as planned or that future study results will be consistent with study results to date, that Foundayo will prove to be a safe and effective treatment for adults with type 2 diabetes or other potential indications, that Foundayo will receive additional regulatory approvals, or that Lilly will execute its strategy as expected. 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. 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. SOURCE Eli Lilly and Company 21% more press release views with Request a Demo

With safety and efficacy successes in hand, Lilly says it will now submit Foundayo to the FDA for review in type 2 diabetes by the end of the second quarter. Eli Lilly is wasting no time in pursuit of the next indication for its newly christened obesity pill Foundayo, presenting new data in diabetes Thursday that also serve to address the FDA’s desire for more safety info on the oral GLP-1. The results seen with Foundayo, also known as orforglipron, enabled Lilly’s late-stage Achieve-4 study to hit its primary endpoint. Specifically, the drug demonstrated non-inferiority to insulin glargine in adults with Type 2 diabetes and obesity, or who are overweight, who are at increased cardiovascular risk. The risk of major adverse cardiovascular events (MACE)—including cardiovascular death, heart attack, stroke or hospitalization for unstable and sudden chest paint—was 16% lower in the trial’s Foundayo cohort compared to the insulin arm, Lilly said in an April 16 press release. Meanwhile, Foundayo also proved superior to insulin glargine at improving blood sugar levels and helping patients reduce body weight at the one-year mark, with those benefits persisting through 104 weeks of treatment, according to Lilly. With safety and efficacy successes in hand, the company says it will now submit the drug to the FDA for an approval verdict Type 2 diabetes by the end of the second quarter, with plans to once again leverage the new Commissioner’s National Priority Review Voucher program.  That lower MACE risk for Foundayo, which was the study’s prime non-inferiority goal, may help appease the FDA’s desire for additional safety information on the drug, as laid out in the approval letter (PDF) for Foundayo issued at the top of the month, when it was greenlit in obesity. In that letter, the regulator called on Lilly specifically to accrue more data on the med’s potential link to MACE and drug-induced liver injury, plus further information about delayed gastric emptying associated with Foundayo, as well as its potential effects in lactating women. The agency singled out the Achieve-4 study as an appropriate vehicle to furnish the necessary MACE data. Lilly noted that while its trial didn’t control for multiplicity, the risk of all-cause death was “significantly lower” for patients on Foundayo versus insulin glargine, too. Moreover, the company said its study included a “thorough analysis of potential drug-induced liver injury,” with its analyses confirming “no hepatic safety signal, consistent with all prior studies in the ACHIEVE and ATTAIN programs.” Lilly boasted that Achieve-4 marks its “largest and longest study” of Foundayo for Type 2 diabetes thus far. The trial enrolled more than 2,700 patients across 15 countries. "Across seven Phase 3 studies enrolling more than 11,000 patients, Foundayo has demonstrated a consistent safety and efficacy profile," Thomas Seck, M.D., SVP of product development for Lilly Cardiometabolic Health, said in a statement Thursday. He continued, “ACHIEVE-4 adds a new dimension to that evidence—cardiovascular safety and a lower observed risk of all-cause death in patients who carry elevated cardiovascular risk.”Aside from the lower MACE risk observed with Foundayo, Lilly’s med also showed clinically meaningful improvements from baseline on multiple cardiovascular risk factors, such as non-HDL cholesterol, systolic blood pressure, triglycerides and high-sensitivity C-reactive protein (hsCRP)—a marker of inflammation. Foundayo’s FDA nod on April 1 formalized the opening of a new front in the obesity and broader GLP-1 commercial contest playing out between Lilly and Novo Nordisk. Until now, that competition had been waged between the company’s respective injectables for diabetes and obesity: Mounjaro and Zepbound in Lilly’s case, and Ozempic and Wegovy for Novo.  Novo got a leg up on Lilly with the approval of its own oral weight loss med, the Wegovy pill, at the tail end of 2025, which it followed up with a January 5 launch that has so far posted impressive results. Lilly is hoping the fact that its pill can be taken at any time of day and without food or water restrictions could give Foundayo a convenience edge over oral Wegovy, which must be taken on an empty stomach in the morning with up to 4 ounces of water, and not any other liquids.