A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities

Summary

The main purpose of this phase 3b study is to evaluate the efficacy and safety of tirzepatide compared with semaglutide in adult participants who have obesity or overweight with weight related comorbidities without Type 2 Diabetes. The study will last around 74 weeks.

Timeline

Start

2023-04-21

Primary completion

2024-11-13

Completion

2024-11-13

Outcome

Met primary endpoint

registry analysis (superiority test); 15 mg or MTD - Tirzepatide vs 2.4 mg or MTD - Semaglutide; LS Mean Difference -6.5 (95% CI -8.1 to -4.9) NCT05822830 ↗

release “In the SURMOUNT-5 trial, Zepbound demonstrated a significantly higher magnitude of weight reduction compared to Wegovy across all comparisons” lilly.com ↗

Publications

• Kitamoto T, Yoshino M, Shingaki T, Oura T, Gomez Valderas E, Dunn JP. Tirzepatide compared with semaglutide in obesity disease: a subpopulation analysis applying Japan Society for the Study of Obesity criteria in the global SURMOUNT-5 trial. Curr Med Res Opin. 2026 Jul 11:1-13. doi: 10.1080/03007995.2026.2695047. Online ahead of print.
• Aronne LJ, Horn DB, Kokkinos AD, Falcon BL, Wang H, Hoffmann HT, Lee CJ, Dunn JP. Relationship of early rapid weight loss to efficacy and safety of tirzepatide and semaglutide for obesity: SURMOUNT-5 post hoc analysis. Am J Med. 2026 Jul;139(7):913-921. doi: 10.1016/j.amjmed.2026.03.010. Epub 2026 Mar 20.
• Mamas MA, Bays H, Li R, Upadhyay N, Irani T, Senyucel C, Dunn JP, Liu-Seifert H. Tirzepatide compared with semaglutide and 10-year cardiovascular disease risk reduction in obesity: post-hoc analysis of the SURMOUNT-5 trial. Eur Heart J Open. 2025 Sep 2;5(5):oeaf117. doi: 10.1093/ehjopen/oeaf117. eCollection 2025 Sep.
• Aronne LJ, Horn DB, le Roux CW, Ho W, Falcon BL, Gomez Valderas E, Das S, Lee CJ, Glass LC, Senyucel C, Dunn JP; SURMOUNT-5 Trial Investigators. Tirzepatide as Compared with Semaglutide for the Treatment of Obesity. N Engl J Med. 2025 Jul 3;393(1):26-36. doi: 10.1056/NEJMoa2416394. Epub 2025 May 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Semaglutide	Peptide	1.7 mg	Subcutaneous
Comparator	Semaglutide	Peptide	2.4 mg	Subcutaneous
Subject	Tirzepatide	Peptide	10 mg	Subcutaneous
Subject	Tirzepatide	Peptide	15 mg	Subcutaneous

Indications