Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or O… (NCT07284901) | Clinical Trial Compass
RecruitingPhase 3
Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes
United States1,700 participantsStarted 2026-01-12
Plain-language summary
The primary objective of this study is to demonstrate that KAI-9531 subcutaneous (SC) injection once weekly is superior to placebo on:
* Percent change in body weight
* Change in hemoglobin A1c (HbA1c)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Doses 3 and 4 KAI-9531 Versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Timeframe: Baseline, Week 76
2
Doses 3 and 4 KAI-9531 Versus Placebo: Change From Baseline in HbA1c at Week 76