A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes
Kailera
Summary
The primary objective of this study is to determine the effects of KAI-9531 administered by subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * BMI ≥35 kilograms per meter squared (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, including type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), history of diabetic ketoacidosis, or hyperosmolar state/coma. * Started medications within 3 months prior to Screening that may cause significant weight gain, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, and…
Interventions
- DrugKAI-9531
SC Injection
- DrugPlacebo
SC Injection
Locations (33)
- Kailera Clinical SiteMesa, Arizona
- Kailera Clinical SiteSun City West, Arizona
- Kailera Clinical SiteLake Forest, California
- Kailera Clinical SiteLomita, California
- Kailera Clinical SiteLong Beach, California
- Kailera Clinical SiteMontclair, California