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KAI-9531 for weight loss in adults with overweight or obesity without 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

Phase 3 Interventional Kailera · NCT07284875

This study will test whether a once-weekly KAI-9531 injection helps adults who are overweight or have obesity (and do not have diabetes) lose more weight than a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1800 (estimated)
Ages18 Years and up
SexAll
SponsorKailera Industry-sponsored
Locations36 sites (Anniston, Alabama and 35 other locations)
Trial IDNCT07284875 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial compares once-weekly subcutaneous KAI-9531 injections to matching placebo to measure percent change in body weight. Eligible adults have BMI ≥30 kg/m2 or BMI ≥27 kg/m2 with at least one weight-related comorbidity and a recent unsuccessful diet-and-exercise weight-loss attempt, while people with diabetes, certain thyroid or pancreatitis histories, unstable cardiovascular disease, or recent use of weight-gain medications are excluded. Participants receive KAI-9531 or placebo and body weight and safety measures are monitored over the treatment period to determine effects and tolerability. The trial is conducted at Kailera clinical sites in Alabama and uses scheduled clinic visits for dosing and assessments.

Who should consider this trial

Good fit: Adults without diabetes with BMI ≥30 kg/m2, or BMI ≥27 kg/m2 plus at least one weight-related comorbidity (hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease) and a recent unsuccessful attempt to lose weight with diet and exercise are ideal candidates.

Not a fit: People with diabetes, uncontrolled or unstable cardiovascular disease, a history of pancreatitis, personal or family history of medullary thyroid cancer or MEN2, recent use of medications that cause weight gain, or unstable weight changes are unlikely to qualify or benefit.

Why it matters

Potential benefit: If successful, KAI-9531 could provide a once-weekly medication that produces clinically meaningful weight loss for people with overweight or obesity who do not have diabetes.

How similar studies have performed: Other drugs acting on the GLP-1 pathway (for example, semaglutide and tirzepatide) have produced substantial weight loss, so similar mechanisms have shown success in prior trials.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

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

Where this trial is running

Anniston, Alabama and 35 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 ObesityOverweightKAI-9531Glucagon-like Peptide-1GLP-1Glucose-dependent Insulinotropic PeptideGIP
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.