Clinical trial

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

Recruiting now · Phase 2 · 2 countries · Registry ID NCT07497880

Recruiting nowPhase 2Interventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 75 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Overweight

Full registry criteria

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.

Treatments and study arms

KAI-7535

Drug

Oral tablets

Placebo

Drug

Oral tablets

Primary outcomes

Percent Change from Baseline in Body Weight at Week 44 for Participants Without Diabetes MellitusBaseline, Week 44

Study locations

36 locations were listed when this page was built. The first 40 are shown.

Kailera Clinical Site🇦🇺 Altona N., Victoria, Australia
Kailera Clinical Site🇦🇺 Dee Why, New South Wales, Australia
Kailera Clinical Site🇦🇺 Miranda, New South Wales, Australia
Kailera Clinical Site🇦🇺 Norwood, South Australia, Australia
Kailera Clinical Site🇦🇺 Wollongong, New South Wales, Australia
Kailera Clinical Site🇺🇸 Austin, Texas, United States
Kailera Clinical Site🇺🇸 Austin, Texas, United States
Kailera Clinical Site🇺🇸 Brownsville, Texas, United States
Kailera Clinical Site🇺🇸 Chandler, Arizona, United States
Kailera Clinical Site🇺🇸 Chicago, Illinois, United States
Kailera Clinical Site🇺🇸 Decatur, Georgia, United States
Kailera Clinical Site🇺🇸 Farmers Branch, Texas, United States
Kailera Clinical Site🇺🇸 Fort Worth, Texas, United States
Kailera Clinical Site🇺🇸 Garden City, Michigan, United States
Kailera Clinical Site🇺🇸 Hamden, Connecticut, United States
Kailera Clinical Site🇺🇸 Irvine, California, United States
Kailera Clinical Site🇺🇸 Jacksonville, Florida, United States
Kailera Clinical Site🇺🇸 Jefferson City, Missouri, United States
Kailera Clinical Site🇺🇸 Jupiter, Florida, United States
Kailera Clinical Site🇺🇸 Kansas City, Missouri, United States
Kailera Clinical Site🇺🇸 Kenner, Louisiana, United States
Kailera Clinical Site🇺🇸 Knoxville, Tennessee, United States
Kailera Clinical Site🇺🇸 Lincoln, California, United States
Kailera Clinical Site🇺🇸 Mesquite, Texas, United States
Kailera Clinical Site🇺🇸 Northridge, California, United States
Kailera Clinical Site🇺🇸 Palm Springs, Florida, United States
Kailera Clinical Site🇺🇸 Pembroke Pines, Florida, United States
Kailera Clinical Site🇺🇸 Phoenix, Arizona, United States
Kailera Clinical Site🇺🇸 San Antonio, Texas, United States
Kailera Clinical Site🇺🇸 San Antonio, Texas, United States
Kailera Clinical Site🇺🇸 San Antonio, Texas, United States
Kailera Clinical Site🇺🇸 Sandy City, Utah, United States
Kailera Clinical Site🇺🇸 Skokie, Illinois, United States
Kailera Clinical Site🇺🇸 South Bend, Indiana, United States
Kailera Clinical Site🇺🇸 Spartanburg, South Carolina, United States
Kailera Clinical Site🇺🇸 Sugar Land, Texas, United States