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 States, Argentina, Australia1,700 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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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