A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes
Kailera
Summary
The primary objective of this study is to demonstrate that KAI-9531 subcutaneous (SC) injection once weekly is superior to placebo on: * Percent change in body weight * Change in hemoglobin A1c (HbA1c)
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Diagnosis of type 2 diabetes mellitus (T2DM). * Receiving stable therapy for T2DM for 3 months prior to Screening. This includes diet/exercise alone and any oral medication for T2DM treatment except for glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1R/glucose-dependent insulinotropic polypeptide receptor (GIPR) dual agonist, or dipeptidyl peptidase-4 (DPP-4) inhibitors. * BMI ≥27 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…
Interventions
- DrugKAI-9531
SC Injection
- DrugPlacebo
SC Injection
Locations (44)
- Kailera Clinical SiteCullman, Alabama
- Kailera Clinical SitePhoenix, Arizona
- Kailera Clinical SiteSun City, Arizona
- Kailera Clinical SiteLittle Rock, Arkansas
- Kailera Clinical SiteEscondido, California
- Kailera Clinical SiteNorthridge, California