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NCT07497880PHASE2Recruiting

Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity

Kailera

Start Date

4/6/2026

Completion Date

7/7/2027

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 Criteria

Age Range: 18 years to 75 years

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.

Interventions

DRUG

KAI-7535

DRUG

Placebo

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Conditions

ObesityOverweight

Locations

Kailera Clinical Site

Chandler, Arizona 85225

United States

Kailera Clinical Site

Phoenix, Arizona 85044

United States

Kailera Clinical Site

Irvine, California 92614

United States

Kailera Clinical Site

Lincoln, California 95648

United States

Kailera Clinical Site

Northridge, California 91325

United States

Kailera Clinical Site

Hamden, Connecticut 06517

United States

Kailera Clinical Site

Jacksonville, Florida 32256

United States

Kailera Clinical Site

Jupiter, Florida 33458

United States

Kailera Clinical Site

Palm Springs, Florida 33461

United States

Kailera Clinical Site

Pembroke Pines, Florida 33024

United States

Kailera Clinical Site

Decatur, Georgia 30030

United States

Kailera Clinical Site

Chicago, Illinois 60640

United States

Kailera Clinical Site

Skokie, Illinois 60077

United States

Kailera Clinical Site

South Bend, Indiana 46617

United States

Kailera Clinical Site

Kenner, Louisiana 70065

United States

Kailera Clinical Site

Garden City, Michigan 48135

United States

Kailera Clinical Site

Jefferson City, Missouri 65109

United States

Kailera Clinical Site

Kansas City, Missouri 64151

United States

Kailera Clinical Site

Spartanburg, South Carolina 29303

United States

Kailera Clinical Site

Knoxville, Tennessee 37909

United States

Kailera Clinical Site

Austin, Texas 78705

United States

Kailera Clinical Site

Austin, Texas 78757

United States

Kailera Clinical Site

Brownsville, Texas 78520

United States

Kailera Clinical Site

Farmers Branch, Texas 75234

United States

Kailera Clinical Site

Fort Worth, Texas 76135

United States

Kailera Clinical Site

Mesquite, Texas 75149

United States

Kailera Clinical Site

San Antonio, Texas 78222

United States

Kailera Clinical Site

San Antonio, Texas 78229

United States

Kailera Clinical Site

San Antonio, Texas 78240

United States

Kailera Clinical Site

Sugar Land, Texas 77479

United States

Kailera Clinical Site

Sandy City, Utah 84093

United States

Kailera Clinical Site

Dee Why, New South Wales 2100

Australia

Kailera Clinical Site

Miranda, New South Wales 2228

Australia

Kailera Clinical Site

Wollongong, New South Wales 2500

Australia

Kailera Clinical Site

Norwood, South Australia 5067

Australia

Kailera Clinical Site

Altona N., Victoria 3025

Australia