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Once-weekly KAI-9531 injections for adults with overweight or obesity and type 2 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 and Diabetes

Phase 3 Interventional Kailera · NCT07284901

This trial will test whether a once-weekly KAI-9531 injection helps adults with type 2 diabetes and overweight or obesity lose weight and lower their HbA1c compared with placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1700 (estimated)
Ages18 Years and up
SexAll
SponsorKailera Industry-sponsored
Locations46 sites (Cullman, Alabama and 45 other locations)
Trial IDNCT07284901 on ClinicalTrials.gov

What this trial studies

KAI-9531 is being tested as a once-weekly subcutaneous injection in adults with type 2 diabetes and a BMI of 27 kg/m² or higher who report prior unsuccessful weight loss attempts. This Phase 3, randomized, placebo-controlled trial compares percent change in body weight and change in hemoglobin A1c (HbA1c) between KAI-9531 and placebo. Key inclusion criteria include stable diabetes therapy for at least 3 months and exclusion criteria include type 1 diabetes, recent diabetic ketoacidosis, severe hypoglycemia, and recent use of GLP‑1R or GLP‑1R/GIPR agonists or DPP‑4 inhibitors. The trial is being conducted at Kailera clinical sites in Alabama and Arizona.

Who should consider this trial

Good fit: Adults with type 2 diabetes who have a BMI ≥27 kg/m², have been on stable diabetes therapy for at least 3 months, and have tried but not succeeded in losing weight with diet and exercise are the intended participants.

Not a fit: People with type 1 diabetes, a recent history of diabetic ketoacidosis or severe hypoglycemia, or those currently using GLP‑1/GIP agonists or DPP‑4 inhibitors are unlikely to be eligible or to benefit from this treatment.

Why it matters

Potential benefit: If successful, KAI-9531 could help people with type 2 diabetes and excess weight lose significant weight and improve blood sugar control.

How similar studies have performed: Other GLP‑1 receptor agonists and GLP‑1/GIP agonists have shown substantial weight loss and HbA1c reductions in similar populations, but KAI‑9531's effects are being confirmed in this Phase 3 trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus (T2DM).
* Receiving stable therapy for T2DM for 3 months prior to Screening. This includes diet/exercise alone and any oral medication for T2DM treatment except for glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1R/glucose-dependent insulinotropic polypeptide receptor (GIPR) dual agonist, or dipeptidyl peptidase-4 (DPP-4) inhibitors.
* BMI ≥27 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 type 1 diabetes mellitus (T1DM) or any other type of diabetes except T2DM.
* History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year prior to Screening.
* History of severe hypoglycemia or hypoglycemia unawareness within 1 year prior to Screening.
* 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 (GI) motility if taken for \>30 days continually within 3 months prior to Screening.
* 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, GLP-1 receptor agonists, GLP-1/glucose-dependent insulinotropic polypeptide (GIP) agonists, glucagon receptor agonists, or other weight loss medications or treatments aside from diet and exercise within 3 months prior to Screening.

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

Where this trial is running

Cullman, Alabama and 45 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 Obesity With DiabetesOverweight With DiabetesObesityOverweightKAI-9531Glucagon-like peptide-1GLP-1Diabetes
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.