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HomeTrials › NCT07284875

Obesity & weight · Phase 3 · Recruiting now

Efficacy and Safety of KAI-9531 in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

NCT07284875 · Sponsor: Kailera

What this trial means for you

This study is recruiting now at 23 US sites. It's studying KAI-9531, Placebo for obesity, overweight.

Who can joinAll sexes, 18 Years and older
Healthy volunteersNo — diagnosis required
What you'd takeKAI-9531, Placebo
Study length~2.2 years overall
Planned participants1,800
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 the study is to determine the effects of KAI-9531 subcutaneous (SC) injection once weekly compared to placebo 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)

Inclusion Criteria: * BMI ≥30 kg/m\^2 or BMI ≥27 kg/m\^2 and previously diagnosed with at least 1 of the following: 1. hypertension, 2. dyslipidemia, 3. obstructive sleep apnea, or 4. cardiovascular (CV) disease. * History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months. 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 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, GLP-1 receptor 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

Alabama

  • Kailera Clinical Site — Anniston · Recruiting now
  • Kailera Clinical Site — Birmingham · Recruiting now
  • Kailera Clinical Site — Cullman · Recruiting now

Arizona

  • Kailera Clinical Site — Sun City · Recruiting now

California

  • Kailera Clinical Site — Escondido · Recruiting now
  • Kailera Clinical Site — Toluca Lake · Recruiting now

Colorado

  • Kailera Clinical Site — Aurora · Recruiting now

Connecticut

  • Kailera Clinical Site — Bridgeport · Recruiting now

Florida

  • Kailera Clinical Site — Jupiter · Recruiting now

Georgia

  • Kailera Clinical Site — Lilburn · Recruiting now

Illinois

  • Kailera Clinical Site — Springfield · Recruiting now

Maryland

  • Kailera Clinical Site — Columbia · Recruiting now

Nevada

  • Kailera Clinical Site — Las Vegas · Recruiting now

New York

  • Kailera Clinical Site — Rochester · Recruiting now

North Carolina

  • Kailera Clinical Site — Morehead City · Recruiting now

Oklahoma

  • Kailera Clinical Site — Chickasha · Recruiting now

South Carolina

  • Kailera Clinical Site — Mauldin · Recruiting now

Tennessee

  • Kailera Clinical Site — Chattanooga · Recruiting now

Texas

  • Kailera Clinical Site — Amarillo · Recruiting now
  • Kailera Clinical Site — DeSoto · Recruiting now
  • Kailera Clinical Site — Tomball · Recruiting now

Utah

  • Kailera Clinical Site — Salt Lake City · Recruiting now

Virginia

  • Kailera Clinical Site — Danville · 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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