Find Type 2 Diabetes (T2D) Clinical Trials Near You
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Oral KAI-7535 in Adult Participants Living With Obesity or Overweight With at Least 1 Weight-Related Comorbidity
Status: Recruiting
Location: See all (23) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• 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
Locations
United States
Arizona
Kailera Clinical Site
RECRUITING
Chandler
California
Kailera Clinical Site
RECRUITING
Irvine
Kailera Clinical Site
RECRUITING
Lincoln
Kailera Clinical Site
RECRUITING
Northridge
Connecticut
Kailera Clinical Site
RECRUITING
Hamden
Florida
Kailera Clinical Site
RECRUITING
Jacksonville
Kailera Clinical Site
RECRUITING
Jupiter
Kailera Clinical Site
RECRUITING
Pembroke Pines
Georgia
Kailera Clinical Site
RECRUITING
Decatur
Illinois
Kailera Clinical Site
RECRUITING
Skokie
Indiana
Kailera Clinical Site
RECRUITING
South Bend
Louisiana
Kailera Clinical Site
RECRUITING
Kenner
Michigan
Kailera Clinical Site
RECRUITING
Garden City
Missouri
Kailera Clinical Site
RECRUITING
Jefferson City
Kailera Clinical Site
RECRUITING
Kansas City
South Carolina
Kailera Clinical Site
RECRUITING
Spartanburg
Tennessee
Kailera Clinical Site
RECRUITING
Knoxville
Texas
Kailera Clinical Site
RECRUITING
Austin
Kailera Clinical Site
RECRUITING
Brownsville
Kailera Clinical Site
RECRUITING
Farmers Branch
Kailera Clinical Site
RECRUITING
San Antonio
Kailera Clinical Site
RECRUITING
San Antonio
Kailera Clinical Site
RECRUITING
Sugar Land
Contact Information
Primary
Kailera Therapeutics, Inc.
info-clinicalstudies@kailera.com
1-781-317-0291
Time Frame
Start Date:2026-04-06
Estimated Completion Date:2027-07-07
Participants
Target number of participants:320
Treatments
Experimental: KAI-7535: Dose Schedule 1
Participants will receive KAI-7535 once daily.
Experimental: KAI-7535: Dose Schedule 2
Participants will receive KAI-7535 once daily.
Experimental: KAI-7535: Dose Schedule 3
Participants will receive KAI-7535 once daily.
Experimental: KAI-7535: Dose Schedule 4
Participants will receive KAI-7535 once daily.
Placebo_comparator: Placebo
Participants will receive placebo matched to KAI-7535 once daily.