A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease
Summary
The main purpose of this study is to learn more about tirzepatide in participants with obesity disease. The study will also measure how Tirzepatide affects body weight with a low-calorie diet and increased physical activity. The study will last around 72 Weeks.
Timeline
- Start
- 2021-05-10
- Primary completion
- 2023-06-24
- Completion
- 2023-06-24
Outcome
Met primary endpoint
registry analysis (superiority test); 10 mg Tirzepatide vs Placebo; p <0.001; LS Mean Difference -16.1 (95% CI -18.7 to -13.5); Mixed Models Analysis NCT04844918 ↗
registry analysis (superiority test); 15 mg Tirzepatide vs Placebo; p <0.001; LS Mean Difference -21.1 (95% CI -23.6 to -18.5); Mixed Models Analysis NCT04844918 ↗
registry analysis (superiority test); 10 mg Tirzepatide vs Placebo; p <0.001; Odds Ratio (OR) 119.65 (95% CI 29.06 to 492.67); Mixed Models Analysis NCT04844918 ↗
registry analysis (superiority test); 15 mg Tirzepatide vs Placebo; p <0.001; Odds Ratio (OR) 153.57 (95% CI 36.03 to 654.53); Mixed Models Analysis NCT04844918 ↗
Publications
- Node K, Batterham RL, Liu-Seifert H, Li R, Yoshino M, Oura T, Tanizawa Y, Komuro I. Post hoc analysis of SURMOUNT-J: tirzepatide versus placebo and predicted 10-year cardiovascular disease risk in Japanese adults with obesity disease. Curr Med Res Opin. 2026 Apr;42(4):751-763. doi: 10.1080/03007995.2026.2686052. Epub 2026 Jun 13.
- Masuzaki H, Nagashima H, Shingaki T, Oura T, Tatsuno I. Effect of Tirzepatide on Health-Related Quality of Life in Japanese Patients With Obesity Disease: Patient-Reported Outcomes From the SURMOUNT-J Study. Diabetes Obes Metab. 2026 Aug;28(8):6639-6648. doi: 10.1111/dom.70850. Epub 2026 May 10.
- Yokote K, Fukushima Y, Shingaki T, Oura T, Ogawa W. Association of baseline characteristics with clinical outcomes of tirzepatide treatment in Japanese patients with obesity disease: A subgroup analysis of the SURMOUNT-J trial. Diabetes Obes Metab. 2026 Feb;28(2):1278-1287. doi: 10.1111/dom.70315. Epub 2025 Nov 25.
- Kadowaki T, Kiyosue A, Shingaki T, Oura T, Yokote K. Efficacy and safety of once-weekly tirzepatide in Japanese patients with obesity disease (SURMOUNT-J): a multicentre, randomised, double-blind, placebo-controlled phase 3 trial. Lancet Diabetes Endocrinol. 2025 May;13(5):384-396. doi: 10.1016/S2213-8587(24)00377-2. Epub 2025 Feb 28.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tirzepatide | Peptide | 10 mg | Subcutaneous |
| Subject | Tirzepatide | Peptide | 15 mg | Subcutaneous |