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HomeTrials › NCT07497880

Obesity & weight · Phase 2 · Recruiting now

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

NCT07497880 · Sponsor: Kailera

What this trial means for you

This study is recruiting now at 19 US sites. It's studying KAI-7535, Placebo for obesity, overweight.

Who can joinAll sexes, 18 Years – 75 Years
Healthy volunteersNo — diagnosis required
What you'd takeKAI-7535, Placebo
Study length~15 months overall
Planned participants320
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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 sites by state

Arizona

  • Kailera Clinical Site — Chandler · Recruiting now

California

  • Kailera Clinical Site — Irvine · Recruiting now
  • Kailera Clinical Site — Lincoln · Recruiting now
  • Kailera Clinical Site — Northridge · Recruiting now

Connecticut

  • Kailera Clinical Site — Hamden · Recruiting now

Florida

  • Kailera Clinical Site — Jupiter · Recruiting now
  • Kailera Clinical Site — Pembroke Pines · Recruiting now

Georgia

  • Kailera Clinical Site — Decatur · Recruiting now

Illinois

  • Kailera Clinical Site — Skokie · Recruiting now

Indiana

  • Kailera Clinical Site — South Bend · Recruiting now

Louisiana

  • Kailera Clinical Site — Kenner · Recruiting now

Michigan

  • Kailera Clinical Site — Garden City · Recruiting now

Missouri

  • Kailera Clinical Site — Jefferson City · Recruiting now
  • Kailera Clinical Site — Kansas City · Recruiting now

Tennessee

  • Kailera Clinical Site — Knoxville · Recruiting now

Texas

  • Kailera Clinical Site — Austin · Recruiting now
  • Kailera Clinical Site — Brownsville · Recruiting now
  • Kailera Clinical Site — Farmers Branch · Recruiting now
  • Kailera Clinical Site — San Antonio · Recruiting now

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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