Trials / Recruiting
RecruitingNCT07284979
Efficacy and Safety of KAI-9531 Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes
A Phase 3, Randomized, Active- and Placebo-Controlled, Partially-Blinded Study to Compare the Efficacy and Safety of KAI-9531 Administered Once Weekly Versus Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes
- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,200 (estimated)
- Sponsor
- Kailera · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to demonstrate that KAI-9531 subcutaneous (SC) injection once weekly is superior to semaglutide SC once weekly and to placebo SC once weekly on percent change in body weight.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KAI-9531 | SC Injection |
| DRUG | Semaglutide | SC Injection |
| DRUG | Placebo | SC Injection |
Timeline
- Start date
- 2025-12-30
- Primary completion
- 2028-03-20
- Completion
- 2028-04-17
- First posted
- 2025-12-16
- Last updated
- 2026-03-13
Locations
25 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07284979. Inclusion in this directory is not an endorsement.