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Once-weekly KAI-9531 injections for people living with obesity without diabetes

A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes

Phase 2 Interventional Kailera · NCT07458269

This trial will test if once-weekly KAI-9531 injections help adults with obesity who do not have diabetes lose more body weight than a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment250 (estimated)
Ages18 Years and up
SexAll
SponsorKailera Industry-sponsored
Locations33 sites (Mesa, Arizona and 32 other locations)
Trial IDNCT07458269 on ClinicalTrials.gov

What this trial studies

This is a Phase 2 interventional trial comparing weekly subcutaneous KAI-9531 injections to placebo in adults with obesity and no diabetes. The main outcome is percent change in body weight with treatment versus placebo. Eligible participants must have a BMI of at least 35 kg/m2 and a recent history of unsuccessful weight-loss attempts with diet and exercise. Key exclusions include current or prior diabetes, recent unstable weight, certain medications that cause weight gain, history of pancreatitis, medullary thyroid cancer risk, and uncontrolled cardiovascular conditions.

Who should consider this trial

Good fit: Ideal candidates are adults with BMI ≥35 kg/m2, no diagnosis of diabetes, and a recent self-reported unsuccessful attempt to lose weight with diet and exercise.

Not a fit: People with any form of diabetes, recent unstable weight change, certain weight-gain–causing medications, a history of pancreatitis, medullary thyroid cancer risk, or uncontrolled cardiovascular disease are unlikely to be eligible or benefit from participation.

Why it matters

Potential benefit: If successful, KAI-9531 could offer a once-weekly medication option to help people with obesity lose a meaningful amount of body weight.

How similar studies have performed: Other drugs targeting GLP-1 and combined GLP-1/GIP pathways have produced substantial weight loss in previous trials, so this approach has precedent.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* BMI ≥35 kilograms per meter squared (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, including type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), history of diabetic ketoacidosis, or hyperosmolar state/coma.
* 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 within 2 years prior to Screening.
* Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1R/glucose-dependent insulinotropic polypeptide receptor (GIPR), or glucagon receptor agonist within 3 months prior to Screening.

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

Where this trial is running

Mesa, Arizona and 32 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-1Glucose-dependent Insulinotropic PeptideGIPObesity Without Diabetes
Last reviewed 2026-06-13 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.