DRUG
KAI-7535
Oral tablets
Status
Recruiting
Phase
Phase 2
Enrollment
320
Locations
36
Results
Not posted
Publications
0
Study 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.
Interventions
DRUG
Oral tablets
DRUG
Oral tablets
Timeline
First posted
Mar 27, 2026
Study start
Apr 6, 2026
Primary completion
Jul 7, 2027
Study completion
Jul 7, 2027
Results posted
Not reported
Registry updated
Jul 28, 2026
Outcomes
Percent Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus
Time frame · Baseline, Week 44
Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes Mellitus
Time frame · Baseline, Week 44
Change from Baseline in Body Mass Index (BMI) at Week 44 for Participants Without Diabetes Mellitus
Time frame · Baseline, Week 44
Percentage of Participants at Week 44 with ≥5% and ≥10% Reduction in Body Weight for Participants Without Diabetes Mellitus
Time frame · Week 44
Percent Change from Baseline in Body Weight at Week 44 for Participants Living with Type 2 Diabetes Mellitus
Time frame · Baseline, Week 44
Change from Baseline in Body Weight at Week 44 for Participants Living with Type 2 Diabetes Mellitus
Time frame · Baseline, Week 44
Change from Baseline in BMI at Week 44 for Participants Living with Type 2 Diabetes Mellitus
Time frame · Baseline, Week 44
Percentage of Participants at Week 44 with ≥5% and ≥10% Reduction in Body Weight for Participants Living with Type 2 Diabetes Mellitus
Time frame · Week 44
Eligibility
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 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 Note: Additional inclusion/exclusion criteria may apply, per protocol.
Study locations
Australia · United States. Showing up to 24 locations stored in the fast local snapshot.
Kailera Clinical Site
Chandler, Arizona, United States
Kailera Clinical Site
Phoenix, Arizona, United States
Kailera Clinical Site
Irvine, California, United States
Kailera Clinical Site
Lincoln, California, United States
Kailera Clinical Site
Northridge, California, United States
Kailera Clinical Site
Hamden, Connecticut, United States
Kailera Clinical Site
Jacksonville, Florida, United States
Kailera Clinical Site
Jupiter, Florida, United States
Kailera Clinical Site
Palm Springs, Florida, United States
Kailera Clinical Site
Pembroke Pines, Florida, United States
Kailera Clinical Site
Decatur, Georgia, United States
Kailera Clinical Site
Chicago, Illinois, United States
Kailera Clinical Site
Skokie, Illinois, United States
Kailera Clinical Site
South Bend, Indiana, United States
Kailera Clinical Site
Kenner, Louisiana, United States
Kailera Clinical Site
Garden City, Michigan, United States
Kailera Clinical Site
Jefferson City, Missouri, United States
Kailera Clinical Site
Kansas City, Missouri, United States
Kailera Clinical Site
Spartanburg, South Carolina, United States
Kailera Clinical Site
Knoxville, Tennessee, United States
Kailera Clinical Site
Austin, Texas, United States
Kailera Clinical Site
Austin, Texas, United States
Kailera Clinical Site
Brownsville, Texas, United States
Kailera Clinical Site
Farmers Branch, Texas, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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