Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity
Kailera
320 participants
Apr 6, 2026
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria8
- 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
Exclusion Criteria16
- 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 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 motility
- History of suicide attempt
- History of significant active or unstable major depressive disorder or other severe psychiatric disorder
- Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 (GLP-1) receptor agonist, GLP-1/glucose-dependent insulinotropic polypeptide receptor agonist, or glucagon receptor agonist within the last 3 months prior to screening
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Oral tablets
Oral tablets
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07497880