RecruitingPhase 3NCT07284979
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
Sponsor
Kailera
Enrollment
1,200 participants
Start Date
Dec 30, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 18 Years
Inclusion Criteria2
- 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.
Exclusion Criteria10
- 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.
- Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer.
- Uncontrolled hypertension or unstable cardiovascular disease.
- History of chronic or acute pancreatitis.
- Known clinically significant gastric-emptying abnormality or chronic treatment with medications that directly affect gastrointestinal motility.
- History of suicide attempt.
- History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder.
- Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1/glucose-dependent insulinotropic polypeptide (GIP), or glucagon receptor agonist within 3 months prior to Screening.
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Interventions
DRUGKAI-9531
SC Injection
DRUGSemaglutide
SC Injection
DRUGPlacebo
SC Injection
Locations(25)
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NCT07284979
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