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RECRUITINGPHASE3

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

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

NCT07284875•Kailera

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (22)

Kailera Clinical Site

Anniston, Alabama, United States

Kailera Clinical Site

Cullman, Alabama, United States

Kailera Clinical Site

Sun City, Arizona, United States

Kailera Clinical Site

Escondido, California, United States

Kailera Clinical Site

Toluca Lake, California, United States

Kailera Clinical Site

Aurora, Colorado, United States

Kailera Clinical Site

Bridgeport, Connecticut, United States

Kailera Clinical Site

Jupiter, Florida, United States

Kailera Clinical Site

Lilburn, Georgia, United States

Kailera Clinical Site

Springfield, Illinois, United States

Key Dates

Start Date

December 18, 2025

Primary Completion Date

February 28, 2028

Completion Date

March 27, 2028

Last Updated

March 2, 2026

Enrollment

1,800

ESTIMATED participants

Conditions

ObesityOverweight

Interventions

KAI-9531

DRUG

Placebo

DRUG

Contacts

Kailera Therapeutics, Inc.

CONTACT

781-317-0291 info-clinicalstudies@kailera.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 2, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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