Actively Recruiting
Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity
Led by Kailera · Updated on 2026-05-13
320
Participants Needed
10
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 75 years
- For participants without diabetes: BMI of 30 kg/m2 or higher, or BMI of 27 kg/m2 or higher with at least one of the following: hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease
- For participants with type 2 diabetes: BMI of 27 kg/m2 or higher
- Diagnosis of type 2 diabetes mellitus for participants with diabetes
- Stable therapy for type 2 diabetes for at least 3 months prior to screening
You will not qualify if you...
- For participants without diabetes: laboratory evidence of diabetes
- For participants without diabetes: taking medication for glycemic control
- For participants with type 2 diabetes: history of diabetic ketoacidosis or hyperosmolar state/coma within 1 year prior to screening
- For participants with type 2 diabetes: history of severe hypoglycemia or hypoglycemia unawareness within 1 year prior to screening
- For participants with type 2 diabetes: history of proliferative diabetic retinopathy, diabetic maculopathy, or nonproliferative diabetic retinopathy requiring acute treatment
- Started medications causing significant weight change within 3 months prior to screening, including tricyclic antidepressants, atypical antipsychotics, and mood stabilizers
- Unstable weight defined as self-reported body weight change exceeding 5% within 3 months prior to screening
- Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid carcinoma
- Uncontrolled hypertension or unstable cardiovascular disease
- History of chronic or acute pancreatitis
- Known significant gastric-emptying abnormality or chronic treatment with medications affecting gastrointestinal motility
- History of suicide attempt
- History of significant active or unstable major depressive disorder or other severe psychiatric disorder
- Treatment with semaglutide, tirzepatide, GLP-1 receptor agonists, GLP-1/GIP receptor agonists, or glucagon receptor agonists within 3 months prior to screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Kailera Clinical Site
Chandler, Arizona, United States, 85225
Actively Recruiting
2
Kailera Clinical Site
Irvine, California, United States, 92614
Actively Recruiting
3
Kailera Clinical Site
Lincoln, California, United States, 95648
Actively Recruiting
4
Kailera Clinical Site
Northridge, California, United States, 91325
Actively Recruiting
5
Kailera Clinical Site
Hamden, Connecticut, United States, 06517
Actively Recruiting
6
Kailera Clinical Site
Jupiter, Florida, United States, 33458
Actively Recruiting
7
Kailera Clinical Site
Decatur, Georgia, United States, 30030
Actively Recruiting
8
Kailera Clinical Site
South Bend, Indiana, United States, 46617
Actively Recruiting
9
Kailera Clinical Site
Kenner, Louisiana, United States, 70065
Actively Recruiting
10
Kailera Clinical Site
San Antonio, Texas, United States, 78229
Actively Recruiting
Research Team
K
Kailera Therapeutics, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
5
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