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HomeTrials › NCT07284979

Obesity & weight · Phase 3 · Recruiting now

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

NCT07284979 · Sponsor: Kailera

What this trial means for you

This study is recruiting now at 26 US sites. It's studying KAI-9531, Semaglutide, Placebo for obesity.

Who can joinAll sexes, 18 Years and older
Healthy volunteersNo — diagnosis required
What you'd takeKAI-9531, Semaglutide, Placebo
Study length~2.3 years overall
Planned participants1,200
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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. * 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. Note: Additional inclusion/exclusion criteria may apply, per protocol.

Study sites by state

Arizona

  • Kailera Clinical Site — Glendale · Recruiting now
  • Kailera Clinical Site — Phoenix · Recruiting now

Arkansas

  • Kailera Clinical Site — Little Rock · Recruiting now

California

  • Kailera Clinical Site — Northridge · Recruiting now
  • Kailera Clinical Site — Oceanside · Recruiting now

Connecticut

  • Kailera Clinical Site — Hamden · Recruiting now
  • Kailera Clinical Site — Stamford · Recruiting now

Florida

  • Kailera Clinical Site — Orange City · Recruiting now

Georgia

  • Kailera Clinical Site — Albany · Recruiting now

Illinois

  • Kailera Clinical Site — Chicago · Recruiting now
  • Kailera Clinical Site — Skokie · Recruiting now

Kansas

  • Kailera Clinical Site — Newton · Recruiting now

Louisiana

  • Kailera Clinical Site — Shreveport · Recruiting now

Michigan

  • Kailera Clinical Site — Farmington Hills · Recruiting now

Montana

  • Kailera Clinical Site — Missoula · Recruiting now

Nevada

  • Kailera Clinical Site — Las Vegas · Recruiting now

New York

  • Kailera Clinical Site — Albany · Recruiting now

North Carolina

  • Kailera Clinical Site — Morehead City · Recruiting now

Oklahoma

  • Kailera Clinical Site — Norman · Recruiting now

Rhode Island

  • Kailera Clinical Site — East Greenwich · Recruiting now

South Carolina

  • Kailera Clinical Site — North Charleston · Recruiting now
  • Kailera Clinical Site — Spartanburg · Recruiting now

Texas

  • Kailera Clinical Site — Brownsville · Recruiting now
  • Kailera Clinical Site — San Antonio · Recruiting now

Virginia

  • Kailera Clinical Site — Manassas · Recruiting now
  • Kailera Clinical Site — Richmond · Recruiting now

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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