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Once-weekly KAI-9531 versus semaglutide or placebo for weight loss in adults with obesity without diabetes

A Phase 3, Randomized, Active- and Placebo-Controlled, Partially-Blinded Study to Compare the Efficacy and Safety of KAI-9531 Administered Once Weekly Versus Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes

Phase 3 Interventional Kailera · NCT07284979

This test compares a once-weekly injection called KAI-9531 to semaglutide and to placebo to see if it helps adults with obesity (who do not have diabetes) lose more weight.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1200 (estimated)
Ages18 Years and up
SexAll
SponsorKailera Industry-sponsored
Locations32 sites (Glendale, Arizona and 31 other locations)
Trial IDNCT07284979 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial randomizes adults with obesity (BMI ≥35 kg/m^2) and no diabetes to receive once-weekly subcutaneous KAI-9531, semaglutide, or placebo. The primary outcome is percent change in body weight from baseline. Participants must have a recent history of at least one unsuccessful weight-loss attempt with diet and exercise and must meet several safety exclusion criteria (for example, no diabetes, no uncontrolled cardiovascular disease, and no history of certain endocrine or pancreatic conditions). The study is being run at Kailera clinical sites in Arizona and Arkansas.

Who should consider this trial

Good fit: Adults with obesity (BMI ≥35 kg/m^2), without a diagnosis of diabetes, who have tried but not maintained weight loss with diet and exercise are the intended participants.

Not a fit: People with diabetes, recent large weight changes, uncontrolled hypertension or unstable cardiovascular disease, a history of pancreatitis, certain psychiatric or endocrine cancer histories, or recent use of medications that cause weight gain are unlikely to be eligible or benefit from this trial.

Why it matters

Potential benefit: If successful, KAI-9531 could provide greater weight loss than current GLP-1 therapy options and offer a new treatment choice for people with obesity who do not have diabetes.

How similar studies have performed: Other large trials of GLP-1 receptor agonists such as semaglutide have produced substantial weight loss, but KAI-9531 is a newer agent being directly compared in Phase 3 and does not yet have established Phase 3 results.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Glendale, Arizona and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions ObesityKAI-9531Glucagon-like peptide-1GLP-1SemaglutideGlucose-dependent Insulinotropic PeptideGIP
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.