A Phase 3, Randomized, Active- and Placebo-Controlled, Partially-Blinded Study to Compare the Efficacy and Safety of KAI-9531 Administered Once Weekly Versus Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes
Status: Recruiting
Location: See all (59) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The primary objective of this study is to demonstrate that ribupatide (KAI-9531) subcutaneous (SC) injection once weekly is superior to semaglutide SC once weekly and to placebo SC once weekly on percent change in body weight.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• BMI ≥35 kilograms per square meter (kg/m\^2).
• History of being unresponsive to at least 1 self-reported effort to lose weight with diet and/or exercise in the last 6 months.
Locations
United States
Arkansas
Kailera Clinical Site
RECRUITING
Little Rock
Arizona
Kailera Clinical Site
RECRUITING
Glendale
Kailera Clinical Site
RECRUITING
Phoenix
California
Kailera Clinical Site
RECRUITING
Northridge
Kailera Clinical Site
RECRUITING
Oceanside
Connecticut
Kailera Clinical Site
RECRUITING
Hamden
Kailera Clinical Site
RECRUITING
Stamford
Florida
Kailera Clinical Site
RECRUITING
Orange City
Georgia
Kailera Clinical Site
RECRUITING
Albany
Illinois
Kailera Clinical Site
RECRUITING
Chicago
Kailera Clinical Site
RECRUITING
Skokie
Kansas
Kailera Clinical Site
RECRUITING
Newton
Louisiana
Kailera Clinical Site
RECRUITING
Shreveport
Michigan
Kailera Clinical Site
RECRUITING
Farmington Hills
Montana
Kailera Clinical Site
RECRUITING
Missoula
North Carolina
Kailera Clinical Site
RECRUITING
Morehead City
Kailera Clinical Site
RECRUITING
Morrisville
Nevada
Kailera Clinical Site
RECRUITING
Las Vegas
New York
Kailera Clinical Site
RECRUITING
Albany
Oklahoma
Kailera Clinical Site
RECRUITING
Norman
Rhode Island
Kailera Clinical Site
RECRUITING
East Greenwich
South Carolina
Kailera Clinical Site
RECRUITING
North Charleston
Kailera Clinical Site
RECRUITING
Spartanburg
Texas
Kailera Clinical Site
RECRUITING
Brownsville
Kailera Clinical Site
RECRUITING
San Antonio
Virginia
Kailera Clinical Site
RECRUITING
Manassas
Kailera Clinical Site
RECRUITING
Richmond
Other Locations
Australia
Kailera Clinical Site
RECRUITING
Blacktown
Kailera Clinical Site
RECRUITING
Bruce
Kailera Clinical Site
RECRUITING
Camberwell
Kailera Clinical Site
RECRUITING
Herston
Kailera Clinical Site
RECRUITING
Kanwal
Kailera Clinical Site
RECRUITING
Morayfield
Kailera Clinical Site
RECRUITING
South Brisbane
Bulgaria
Kailera Clinical Site
RECRUITING
Montana
Kailera Clinical Site
RECRUITING
Pleven
Kailera Clinical Site
RECRUITING
Plovdiv
Kailera Clinical Site
RECRUITING
Sofia
Kailera Clinical Site
RECRUITING
Sofia
Kailera Clinical Site
RECRUITING
Sofia
Kailera Clinical Site
RECRUITING
Sofia
Kailera Clinical Site
RECRUITING
Stara Zagora
Kailera Clinical Site
RECRUITING
Varna
Poland
Kailera Clinical Site
RECRUITING
Bydgoszcz
Kailera Clinical Site
RECRUITING
Chorzów
Kailera Clinical Site
RECRUITING
Gdynia
Kailera Clinical Site
RECRUITING
Gdynia
Kailera Clinical Site
RECRUITING
Kielce
Kailera Clinical Site
RECRUITING
Krakow
Kailera Clinical Site
RECRUITING
Warsaw
Kailera Clinical Site
RECRUITING
Wroclaw
United Kingdom
Kailera Clinical Site
RECRUITING
Exeter
Kailera Clinical Site
RECRUITING
Glasgow
Kailera Clinical Site
RECRUITING
Leicester
Kailera Clinical Site
RECRUITING
London
Kailera Clinical Site
RECRUITING
London
Kailera Clinical Site
RECRUITING
Rotherham
Kailera Clinical Site
RECRUITING
Torquay
Kailera Clinical Site
RECRUITING
Weymouth
Contact Information
Primary
Kailera Therapeutics, Inc.
info-clinicalstudies@kailera.com
781-317-0291
Time Frame
Start Date: 2025-12-30
Estimated Completion Date: 2028-04
Participants
Target number of participants: 1200
Treatments
Experimental: Ribupatide: Dose 1
Participants will receive Dose 1 of ribupatide once weekly.
Experimental: Ribupatide: Dose 2
Participants will receive Dose 2 of ribupatide once weekly.
Active_comparator: Semaglutide
Participants will receive semaglutide once weekly.
Placebo_comparator: Placebo
Participants will receive placebo matched to ribupatide once weekly.
Related Therapeutic Areas
Sponsors
Leads: Kailera