Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With… (NCT07497880) | Clinical Trial Compass
RecruitingPhase 2
Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity
United States320 participantsStarted 2026-04-06
Plain-language summary
The primary objective of this study is to determine the efficacy of oral KAI-7535 once daily compared with placebo on percent change in body weight in participants living with obesity or overweight, with at least 1 weight-related comorbidity, without diabetes mellitus. Efficacy in participants with type 2 diabetes mellitus will be evaluated. Safety and tolerability and other weight-related outcomes will be evaluated in both types of participants.
Who can participate
Age range
18 Years – 75 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:
* For participants without diabetes mellitus at screening and on Day 1, BMI ≥30 kilograms/square meter (kg/m\^2) or BMI ≥27 kg/m\^2 and a previous diagnosis of at least 1 of the following:
* Hypertension
* Dyslipidemia
* Obstructive sleep apnea
* Cardiovascular disease
* For participants living with type 2 diabetes mellitus and BMI ≥27 kg/m\^2 only:
* Diagnosis of type 2 diabetes mellitus
* On stable therapy for type 2 diabetes mellitus for at least 3 months prior to screening
Key Exclusion Criteria:
* For participants without diabetes:
* Laboratory evidence of diabetes
* Taking a concomitant medication for the indication of glycemic control
* For participants living with type 2 diabetes mellitus only:
* History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year of screening
* History of severe hypoglycemia or hypoglycemia unawareness within 1 year of screening
* History of proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy that required acute treatment
* Started medications that may cause significant weight change within 3 months prior to screening, including 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 carcinoma
* Uncontrolled hyperte…
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
Percent Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus