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In adults with type 2 diabetes, retatrutide lowered A1C by an average of 2.2% vs. 1.8% with Ozempic 2 mg at 80 weeks
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Participants taking retatrutide lost an average of 44 lbs to 47 lbs (20% to 21%) vs. 21 lbs (9%) with Ozempic 2 mg at 80 weeks
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TRANSCEND-T2D-2 marks the sixth Phase 3 trial in which retatrutide has delivered powerful efficacy, reinforcing its potential to transform cardiometabolic care
INDIANAPOLIS, Oct 28, 2026 /PRNewswire/ --Eli Lilly and Company(NYSE: LLY), the maker of Mounjaro (tirzepatide) and Foundayo (orforglipron), today announced positive topline results from TRANSCEND-T2D-2, a head-to-head Phase 3 trial comparing retatrutide with injectable Ozempic 2 mg in adults with type 2 diabetes. At 80 weeks, retatrutide met the primary and all key secondary endpoints, delivering greater A1C reduction and substantially more weight loss than Ozempic.1,2
Kenneth Custer, Ph.D., Executive Vice President and President ofLilly Cardiometabolic Health: "Head-to-head trials show patients and physicians how a potential new medicine compares with treatments that are available and reimbursed today. In TRANSCEND-T2D-2, the first Phase 3 trial comparing retatrutide with another incretin medicine, retatrutide delivered greater A1C reduction and more than double the weight loss of the highest approved dose of Ozempic for type 2 diabetes. Based on these results and those from across our Phase 3 program, we believe retatrutide, if approved, could shift the treatment paradigm for people living with type 2 diabetes, obesity and related cardiometabolic conditions."
In the TRANSCEND-T2D-2 trial, both doses of retatrutide lowered A1C by an average of 2.2% compared to 1.8% with Ozempic at 80 weeks. Participants taking retatrutide lost an average of 44.3 lbs (19.5%; 9 mg) and 47.4 lbs (20.9%; 12 mg) compared to 20.9 lbs (9.4%) with Ozempic. Retatrutide also delivered greater improvements than Ozempic across certain cardiovascular risk factors, including non-HDL cholesterol, triglycerides and systolic blood pressure.1
TRANSCEND-T2D-2 Efficacy Estimand Results at 80 Weeks
iNominal p<0.001 vs. Ozempic 2 mg
iiNoninferiority for change in A1C with retatrutide 9 mg vs. Ozempic 2 mg was a key secondary endpoint.
iiip<0.001 vs. Ozempic 2 mg; family-wise type 1 error controlled for superiority.
In TRANSCEND-T2D-2, the most common adverse events with retatrutide (9 mg, 12 mg vs. Ozempic) were diarrhea (28.3%, 32.7% vs. 26.4%), nausea (21.2%, 23.8% vs. 21.3%), constipation (14.2%, 13.1% vs. 19.8%), vomiting (10.2%, 15.0% vs. 13.2%) and dyspepsia (10.4%, 8.5% vs. 11.6%). The incidence of dysesthesia with retatrutide (9 mg, 12 mg vs. Ozempic) was 4.8%, 6.5% vs. 2.7%, while the incidence of urinary tract infections was 5.8%, 4.2% vs. 5.8%. The majority of these events were mild-to-moderate and typically resolved during treatment. Treatment discontinuation rates due to adverse events were 4.8%, 7.9% vs. 2.7% with retatrutide 9 mg and 12 mg vs. Ozempic, respectively.
Detailed results from TRANSCEND-T2D-2 will be presented at a future medical meeting and published in a peer-reviewed journal.
About retatrutide
Retatrutide is an investigational, once-weekly, triple hormone receptor agonist. Retatrutide is a single molecule that activates the body's receptors for glucose-dependent insulinotropic polypeptide (GIP), glucagon-like peptide-1 (GLP-1), and glucagon. Lilly is studying retatrutide in several Phase 3 clinical trials to evaluate its potential efficacy and safety in obesity and overweight with at least one weight-related medical problem, type 2 diabetes, knee osteoarthritis pain, moderate-to-severe obstructive sleep apnea, chronic low back pain, cardiovascular outcomes, and metabolic dysfunction-associated steatotic liver disease. Retatrutide is an investigational molecule that cannot be legally sold or marketed for human use.
About TRANSCEND-T2D-2 and TRANSCEND clinical trial program
TRANSCEND-T2D-2 (NCT06260722) is a Phase 3, randomized, open-label trial comparing once-weekly retatrutide (9 mg and 12 mg) with once-weekly Ozempic 2 mg in 1,298 adults with type 2 diabetes inadequately controlled with metformin, with or without an SGLT2 inhibitor. Participants with a baseline A1C of 7.0% to 10.5% were randomized 2:2:1 to retatrutide 9 mg, retatrutide 12 mg or Ozempic 2 mg. The primary objective was to demonstrate that retatrutide 12 mg is noninferior to Ozempic 2 mg in A1C reduction at 80 weeks. Retatrutide was initiated at 2 mg and increased every four weeks to the 9 mg or 12 mg target dose. TRANSCEND-T2D-2 also includes an extension period in which approximately 650 participants continue treatment with retatrutide for an additional 24 weeks to evaluate long-term efficacy and safety.
The TRANSCEND-T2D Phase 3 clinical trial program is evaluating the safety and efficacy of retatrutide for the treatment of adults with type 2 diabetes across three global registrational trials. The program, which began in 2024, has enrolled more than 2,050 participants.
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.
Endnotes and References:
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All comparisons of retatrutide vs. Ozempic 2 mg were controlled for family-wise type 1 error, except superiority of retatrutide 9 mg vs. Ozempic 2 mg in change in A1C and in systolic blood pressure, which were prespecified secondary endpoints and showed nominal statistical significance. A1C noninferiority for retatrutide 9 mg vs. Ozempic 2 mg was met under family-wise type 1 error control as a key secondary endpoint.
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All data included in this press release are for the efficacy estimand. The efficacy estimand represents efficacy had all randomized participants remained on study intervention (with possible dose interruptions and modifications) for 80 weeks without initiating additional antihyperglycemic medication (>14 days of use).