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Recruiting Phase 2 NCT07458269

Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes

Phase 2 – studying effectiveness and dosage
Conditions: Obesity

Sponsor: Kailera

trial.available_in: БГ
Overview
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.
Who can participate
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 mood stabilizers. * Unstable weight defined as self-reported change in body weight exceeding 5% within 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 within 2 years prior to Screening. * Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1R/glucose-dependent insulinotropic polypeptide receptor (GIPR), or glucagon receptor agonist within 3 months prior to Screening. Note: Additional inclusion/exclusion criteria may apply, per protocol.
Interventions
KAI-9531
DRUG
Placebo
DRUG
Locations 33
United States (33)
Kailera Clinical Site
Decatur , Georgia
Kailera Clinical Site
DeLand , Florida
Kailera Clinical Site
East Syracuse , New York
Kailera Clinical Site
Greensboro , North Carolina
Kailera Clinical Site
Greenville , South Carolina
Kailera Clinical Site
Indianapolis , Indiana
Kailera Clinical Site
Knoxville , Tennessee
Kailera Clinical Site
Lake Forest , California
Kailera Clinical Site
Lincoln , Nebraska
Kailera Clinical Site
Lomita , California
Kailera Clinical Site
Long Beach , California
Kailera Clinical Site
Louisville , Kentucky
Kailera Clinical Site
Memphis , Tennessee
Kailera Clinical Site
Mesa , Arizona
Kailera Clinical Site
Monroe , North Carolina
Kailera Clinical Site
Montclair , California
Kailera Clinical Site
Morton , Illinois
Kailera Clinical Site
Myrtle Beach , South Carolina
Kailera Clinical Site
Omaha , Nebraska
Kailera Clinical Site
Orlando , Florida
Kailera Clinical Site
Orlando , Florida
Kailera Clinical Site
Raleigh , North Carolina
Kailera Clinical Site
Rockville , Maryland
Kailera Clinical Site
Rolling Hills Estates , California
Kailera Clinical Site
San Antonio , Texas
Kailera Clinical Site
San Diego , California
Kailera Clinical Site
Santa Ana , California
Kailera Clinical Site
St Louis , Missouri
Kailera Clinical Site
Sun City West , Arizona
Kailera Clinical Site
The Villages , Florida
Kailera Clinical Site
Van Nuys , California
Kailera Clinical Site
Winchester , Virginia
Kailera Clinical Site
Woodstock , Georgia
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
04.03.2026
Completion date
01.06.2027
Registry ID
NCT07458269
Source
clinicaltrials.gov
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