A Study of Tirzepatide (LY3298176) Compared With Dulaglutide on Major Cardiovascular Events in Participants With Type 2 Diabetes
Summary
The purpose of the trial is to assess the efficacy and safety of tirzepatide to dulaglutide in participants with type 2 diabetes and increased cardiovascular risk.
Timeline
- Start
- 2020-05-29
- Primary completion
- 2025-06-12
- Completion
- 2025-06-12
Outcome
Met primary endpoint
paper hazard ratio, 0.92; 95.3% confidence interval, 0.83 to 1.01; P = 0.003 for noninferiority; P = 0.09 for superiority PMID 41406444 ↗
paper tirzepatide was noninferior to dulaglutide with respect to a composite of death from cardiovascular causes, myocardial infarction, or stroke. PMID 41406444 ↗
release “SURPASS-CVOT: Mounjaro demonstrated non-inferiority vs. Trulicity with an 8% lower risk of MACE-3 events” lilly.com ↗
release “In SURPASS-CVOT, Mounjaro achieved the primary objective by demonstrating a non-inferior rate of major adverse cardiovascular events (MACE-3)” lilly.com ↗
Publications
- Nissen SE, Wolski K, D'Alessio D, Weerakkody G, Kiljanski J, Wiese RJ, Pavo I, Cariou B, Nicholls SJ. Cardiorenal Outcomes With Tirzepatide Compared With Dulaglutide in Patients With Diabetes and Cardiovascular Disease: A Post Hoc Analysis of the SURPASS-CVOT Randomized Clinical Trial. JAMA Cardiol. 2026 Jun 1;11(6):544-552. doi: 10.1001/jamacardio.2026.0767.
- Nicholls SJ, Pavo I, Bhatt DL, Buse JB, Del Prato S, Kahn SE, Lincoff AM, McGuire DK, Miller D, Nauck MA, Nishiyama H, Nissen SE, Sattar N, Weerakkody G, Wiese RJ, Zinman B, Zoungas S, Basile J, Davies MJ, Giorgino F, Kellerer M, Ji L, Varkonyi T, Menon V, Broder JC, Herschtal A, D'Alessio D; SURPASS-CVOT Investigators. Cardiovascular Outcomes with Tirzepatide versus Dulaglutide in Type 2 Diabetes. N Engl J Med. 2025 Dec 18;393(24):2409-2420. doi: 10.1056/NEJMoa2505928.
- Khawaji A, A Jaly A, A Bakri H, Ravi R, Hattan A, Khawaji A, Najmi W. Weight Loss Efficacy of Tirzepatide Compared to Placebo or GLP-1 Receptor Agonists in Adults With Obesity or Overweight: A Meta-Analysis of Randomized Controlled Trials With >/= 20 Weeks Treatment Duration. J Obes. 2025 Jul 24;2025:3442754. doi: 10.1155/jobe/3442754. eCollection 2025.
- Kaneko S. Tirzepatide: A Novel, Once-weekly Dual GIP and GLP-1 Receptor Agonist for the Treatment of Type 2 Diabetes. touchREV Endocrinol. 2022 Jun;18(1):10-19. doi: 10.17925/EE.2022.18.1.10. Epub 2022 Jun 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dulaglutide | Peptide | 1.5 mg | Subcutaneous |
| Subject | Tirzepatide | Peptide | 5 mg | Subcutaneous |
| Subject | Tirzepatide | Peptide | 10 mg | Subcutaneous |
| Subject | Tirzepatide | Peptide | 15 mg | Subcutaneous |