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
Kailera
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * BMI ≥35 kilograms per square meter (kg/m\^2). * History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months. Key Exclusion Criteria: * Current diagnosis or history of diabetes mellitus. * Started medications within 3 months prior to Screening that may cause significant weight gain, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, and mood stabilizers. * Unstable weight defined as self-reported change in body weight exceeding 5% within the 3 months prior to Screening. * Fam…
Interventions
- DrugKAI-9531
SC Injection
- DrugSemaglutide
SC Injection
- DrugPlacebo
SC Injection
Locations (32)
- Kailera Clinical SiteGlendale, Arizona
- Kailera Clinical SitePhoenix, Arizona
- Kailera Clinical SiteLittle Rock, Arkansas
- Kailera Clinical SiteNorthridge, California
- Kailera Clinical SiteOceanside, California
- Kailera Clinical SiteHamden, Connecticut