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Clinical Trials in the USA / NCT07497880
Active, not recruiting Phase 2

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

NCT07497880 · tracked via the Priya Life Science USA tracker
Sponsor
Kailera
Phase
Phase 2
Started
2026-04-06
Last updated
2026-09-09

Condition(s) studied

ObesityOverweight

Investigational drug(s) / intervention(s)

KAI-7535Placebo

KAI-7535: Oral tablets

Placebo: Oral tablets

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. Safety and tolerability and other weight-related outcomes will also be evaluated.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (36)

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

More Kailera trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07497880 on ClinicalTrials.gov ↗ ← All trials in the USA