drugset / Trial / NCT05931380

A Study of Once-Daily Oral Orforglipron (LY3502970) in Japanese Adult Participants With Obesity Disease

NCT05931380 ↗

Phase 3 Completed 238 enrolled Eli Lilly and Company
RandomizedParallel-groupDouble-blindTreatment

Summary

The main purpose of this study is to investigate the efficacy and safety of oral orforglipron in participants with obesity disease with obesity-related health problems.

Timeline

Start
2023-07-31
Primary completion
2025-06-19
Completion
2025-06-19

Outcome

Met primary endpoint

registry analysis (superiority test); Placebo QD vs 6 mg Orforglipron QD; p <.001; LS Mean Difference (Final values) -5.28 (95% CI -7.52 to -3.03); ANCOVA NCT05931380 ↗

registry analysis (superiority test); Placebo QD vs 6 mg Orforglipron QD; p <.001; Risk Difference (RD) 30.36 (95% CI 15.09 to 45.62); Regression, Logistic NCT05931380 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Orforglipron Small molecule 6 mg Oral
Subject Orforglipron Small molecule 12 mg Oral
Subject Orforglipron Small molecule 36 mg Oral

Indications