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

Last updated: March 12, 2026
Sponsor: Kailera
Overall Status: Active - Recruiting

Phase

3

Condition

Obesity

Diabetes Prevention

Treatment

KAI-9531

Placebo

Semaglutide

Clinical Study ID

NCT07284979
K9531-3107
2025-523511-11-00
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

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 andexercise within the prior 6 months.

Exclusion

Key Exclusion Criteria:

  • Current diagnosis or history of diabetes mellitus.

  • Started medications within 3 months prior to Screening that may cause significantweight gain, including, but not limited to, tricyclic antidepressants, atypicalantipsychotics, and mood stabilizers.

  • Unstable weight defined as self-reported change in body weight exceeding 5% withinthe 3 months prior to Screening.

  • Family or personal history of multiple endocrine neoplasia Type 2 or medullarythyroid cancer.

  • Uncontrolled hypertension or unstable cardiovascular disease.

  • History of chronic or acute pancreatitis.

  • Known clinically significant gastric-emptying abnormality or chronic treatment withmedications that directly affect gastrointestinal motility.

  • History of suicide attempt.

  • History of significant active or unstable Major Depressive Disorder (MDD) or othersevere psychiatric disorder.

  • Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1/glucose-dependent insulinotropic polypeptide (GIP), orglucagon receptor agonist within 3 months prior to Screening.

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

Study Design

Total Participants: 1200
Treatment Group(s): 3
Primary Treatment: KAI-9531
Phase: 3
Study Start date:
December 30, 2025
Estimated Completion Date:
April 17, 2028

Connect with a study center

  • Kailera Clinical Site

    Glendale, Arizona 85308
    United States

    Active - Recruiting

  • Kailera Clinical Site

    Phoenix, Arizona 85012
    United States

    Active - Recruiting

  • Kailera Clinical Site

    Glendale 5295985, Arizona 5551752 85308
    United States

    Site Not Available

  • Kailera Clinical Site

    Phoenix 5308655, Arizona 5551752 85012
    United States

    Site Not Available

  • Kailera Clinical Site

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • Kailera Clinical Site

    Little Rock 4119403, Arkansas 4099753 72205
    United States

    Site Not Available

  • Kailera Clinical Site

    Northridge, California 91325
    United States

    Active - Recruiting

  • Kailera Clinical Site

    Oceanside, California 92058
    United States

    Active - Recruiting

  • Kailera Clinical Site

    Northridge 5377985, California 5332921 91325
    United States

    Site Not Available

  • Kailera Clinical Site

    Oceanside 5378771, California 5332921 92058
    United States

    Site Not Available

  • Kailera Clinical Site

    Hamden, Connecticut 06517
    United States

    Active - Recruiting

  • Kailera Clinical Site

    Stamford, Connecticut 06905
    United States

    Active - Recruiting

  • Kailera Clinical Site

    Stamford 4843564, Connecticut 4831725 06905
    United States

    Site Not Available

  • Kailera Clinical Site

    Orange City, Florida 32763
    United States

    Active - Recruiting

  • Kailera Clinical Site

    Orange City 4167055, Florida 4155751 32763
    United States

    Site Not Available

  • Kailera Clinical Site

    Albany 4179320, Georgia 4197000 31707
    United States

    Site Not Available

  • Kailera Clinical Site

    Chicago, Illinois 60640
    United States

    Active - Recruiting

  • Kailera Clinical Site

    Chicago 4887398, Illinois 4896861 60640
    United States

    Site Not Available

  • Kailera Clinical Site

    Newton, Kansas 67114
    United States

    Active - Recruiting

  • Kailera Clinical Site

    Shreveport, Louisiana 71105
    United States

    Active - Recruiting

  • Kailera Clinical Site

    Shreveport 4341513, Louisiana 4331987 71105
    United States

    Site Not Available

  • Kailera Clinical Site

    Farmington Hills, Michigan 48334
    United States

    Active - Recruiting

  • Kailera Clinical Site

    Farmington Hills 4992523, Michigan 5001836 48334
    United States

    Site Not Available

  • Kailera Clinical Site

    Missoula, Montana 59804
    United States

    Active - Recruiting

  • Kailera Clinical Site

    Missoula 5666639, Montana 5667009 59804
    United States

    Site Not Available

  • Kailera Clinical Site

    Las Vegas, Nevada 89148
    United States

    Active - Recruiting

  • Kailera Clinical Site

    Albany, New York 12203
    United States

    Active - Recruiting

  • Kailera Clinical Site

    Morehead City, North Carolina 28557
    United States

    Active - Recruiting

  • Kailera Clinical Site

    Morehead City 4480153, North Carolina 4482348 28557
    United States

    Site Not Available

  • Kailera Clinical Site

    Norman, Oklahoma 73069
    United States

    Active - Recruiting

  • Kailera Clinical Site

    Norman 4543762, Oklahoma 4544379 73069
    United States

    Site Not Available

  • Kailera Clinical Site

    East Greenwich, Rhode Island 02818
    United States

    Active - Recruiting

  • Kailera Clinical Site

    East Greenwich 5221875, Rhode Island 5224323 02818
    United States

    Site Not Available

  • Kailera Clinical Site

    North Charleston, South Carolina 29405
    United States

    Active - Recruiting

  • Kailera Clinical Site

    Spartanburg, South Carolina 29303
    United States

    Active - Recruiting

  • Kailera Clinical Site

    Spartanburg 4597200, South Carolina 4597040 29303
    United States

    Site Not Available

  • Kailera Clinical Site

    Brownsville, Texas 78526
    United States

    Active - Recruiting

  • Kailera Clinical Site

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • Kailera Clinical Site

    Brownsville 4676740, Texas 4736286 78526
    United States

    Site Not Available

  • Kailera Clinical Site

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • Kailera Clinical Site

    Manassas, Virginia 20110
    United States

    Active - Recruiting

  • Kailera Clinical Site

    Richmond, Virginia 23236
    United States

    Active - Recruiting

  • Kailera Clinical Site

    Manassas 4771401, Virginia 6254928 20110
    United States

    Site Not Available

  • Kailera Clinical Site

    Richmond 4781708, Virginia 6254928 23236
    United States

    Site Not Available

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