Enrolling now · NCT07284979

A study testing whether an investigational medicine (KAI-9531) from Kailera can help with weight.

What this means for you

Who can join
Adults 18+, have obesity, BMI 35+.
What you take
KAI-9531, given as part of the study at no cost to you. Some participants may receive a placebo (an inactive version) instead, decided at random.
How long it lasts
The full study runs about 2.3 years; your own time in it is usually shorter.
What you get
The study medication and study-related care at no cost. Compensation varies by study site; many cover travel and provide the study medication at no cost. The trial coordinator will explain what that site offers before you join.
Phase Phase 3Sponsor KaileraDrug KAI-9531Class GLP-1 RASites 25 USEnrollment target 1,200

What this study is for

Primary condition: Obesity.

Full scientific study title: Efficacy and Safety of KAI-9531 Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do No.

Who can join

Age18 and upSexAnyBMI35 or higher

Adults 18+, have obesity, BMI 35+. A site coordinator confirms whether you qualify during a free screening visit. The exact medical requirements are below.

Full medical eligibility (for you and your doctor)verbatim from the registry

This is the exact wording from ClinicalTrials.gov, including clinical measures (lab values, imaging scores). Bring it to your doctor if any of it is unclear.

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.

Where this study is enrolling

This trial has 25 sites across 19 states. Contact a site coordinator directly to start screening.

Arizona2 sites
  • Kailera Clinical Site
    Glendale, Arizona
  • Kailera Clinical Site
    Phoenix, Arizona
Arkansas1 site
  • Kailera Clinical Site
    Little Rock, Arkansas
California2 sites
  • Kailera Clinical Site
    Northridge, California
  • Kailera Clinical Site
    Oceanside, California
Connecticut2 sites
  • Kailera Clinical Site
    Hamden, Connecticut
  • Kailera Clinical Site
    Stamford, Connecticut
Florida1 site
  • Kailera Clinical Site
    Orange City, Florida
Georgia1 site
  • Kailera Clinical Site
    Albany, Georgia
Illinois1 site
  • Kailera Clinical Site
    Chicago, Illinois
Kansas1 site
  • Kailera Clinical Site
    Newton, Kansas
Louisiana1 site
  • Kailera Clinical Site
    Shreveport, Louisiana
Michigan1 site
  • Kailera Clinical Site
    Farmington Hills, Michigan
Montana1 site
  • Kailera Clinical Site
    Missoula, Montana
Nevada1 site
  • Kailera Clinical Site
    Las Vegas, Nevada
New York1 site
  • Kailera Clinical Site
    Albany, New York
North Carolina1 site
  • Kailera Clinical Site
    Morehead City, North Carolina
Oklahoma1 site
  • Kailera Clinical Site
    Norman, Oklahoma
Rhode Island1 site
  • Kailera Clinical Site
    East Greenwich, Rhode Island
South Carolina2 sites
  • Kailera Clinical Site
    North Charleston, South Carolina
  • Kailera Clinical Site
    Spartanburg, South Carolina
Texas2 sites
  • Kailera Clinical Site
    Brownsville, Texas
  • Kailera Clinical Site
    San Antonio, Texas
Virginia2 sites
  • Kailera Clinical Site
    Manassas, Virginia
  • Kailera Clinical Site
    Richmond, Virginia

Timeline

Started enrolling: 2025-12-30. Expected completion: 2028-04-17. Last updated on ClinicalTrials.gov: 2026-04-30.

Official source

We sync this data quarterly from ClinicalTrials.gov, the federal registry for clinical research. Before contacting a site, verify the trial is still recruiting on the official page:

View on ClinicalTrials.gov →

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