A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes
Status: Recruiting
Location: See all (93) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The primary objective of the study is to determine the effects of ribupatide (KAI-9531) subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• BMI ≥30 kg/m\^2 or BMI ≥27 kg/m\^2 and previously diagnosed with at least 1 of the following:
‣ hypertension,
⁃ dyslipidemia,
⁃ obstructive sleep apnea, or
⁃ cardiovascular (CV) disease.
• 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
Alabama
Kailera Clinical Site
RECRUITING
Anniston
Kailera Clinical Site
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Birmingham
Kailera Clinical Site
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Cullman
Arizona
Kailera Clinical Site
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Sun City
California
Kailera Clinical Site
RECRUITING
Escondido
Kailera Clinical Site
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Toluca Lake
Colorado
Kailera Clinical Site
RECRUITING
Aurora
Connecticut
Kailera Clinical Site
RECRUITING
Bridgeport
Florida
Kailera Clinical Site
RECRUITING
Jupiter
Georgia
Kailera Clinical Site
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Lilburn
Illinois
Kailera Clinical Site
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Springfield
Maryland
Kailera Clinical Site
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Columbia
North Carolina
Kailera Clinical Site
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Morehead City
Nevada
Kailera Clinical Site
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Las Vegas
New York
Kailera Clinical Site
RECRUITING
Rochester
Oklahoma
Kailera Clinical Site
RECRUITING
Chickasha
South Carolina
Kailera Clinical Site
RECRUITING
Mauldin
Tennessee
Kailera Clinical Site
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Chattanooga
Texas
Kailera Clinical Site
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Amarillo
Kailera Clinical Site
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Bellaire
Kailera Clinical Site
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Desoto
Kailera Clinical Site
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Tomball
Utah
Kailera Clinical Site
RECRUITING
Salt Lake City
Virginia
Kailera Clinical Site
RECRUITING
Danville
Other Locations
Argentina
Kailera Clinical Site
RECRUITING
Buenos Aires
Kailera Clinical Site
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Buenos Aires
Kailera Clinical Site
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Buenos Aires
Kailera Clinical Site
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Caba
Kailera Clinical Site
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Córdoba
Kailera Clinical Site
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Godoy Cruz
Kailera Clinical Site
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La Plata
Kailera Clinical Site
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Rosario
Kailera Clinical Site
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San Nicolás De Los Arroyos
Australia
Kailera Clinical Site
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Charlestown
Kailera Clinical Site
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Heidelberg Heights
Kailera Clinical Site
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Melbourne
Kailera Clinical Site
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Norwood
Kailera Clinical Site
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Sippy Downs
Kailera Clinical Site
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Sydney
Kailera Clinical Site
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Sydney
Kailera Clinical Site
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Sydney
Kailera Clinical Site
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Wollongong
Bulgaria
Kailera Clinical Site
RECRUITING
Kyustendil
Kailera Clinical Site
RECRUITING
Pazardzhik
Kailera Clinical Site
RECRUITING
Plovdiv
Kailera Clinical Site
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Plovdiv
Kailera Clinical Site
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Sofia
Kailera Clinical Site
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Sofia
Kailera Clinical Site
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Sofia
Kailera Clinical Site
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Varna
Kailera Clinical Site
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Yambol
Germany
Kailera Clinical Site
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Cologne
Kailera Clinical Site
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Dresden
Kailera Clinical Site
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Essen
Kailera Clinical Site
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Falkensee
Kailera Clinical Site
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Hamburg
Kailera Clinical Site
RECRUITING
Hamburg
Kailera Clinical Site
RECRUITING
Leipzig
Kailera Clinical Site
RECRUITING
Oldenburg In Holstein
Kailera Clinical Site
RECRUITING
Schwerin
Kailera Clinical Site
RECRUITING
Tübingen
New Zealand
Kailera Clinical Site
RECRUITING
Auckland
Kailera Clinical Site
RECRUITING
Grafton
Kailera Clinical Site
RECRUITING
Hamilton
Kailera Clinical Site
RECRUITING
Nelson
Kailera Clinical Site
RECRUITING
Silverdale
Poland
Kailera Clinical Site
RECRUITING
Krakow
Kailera Clinical Site
RECRUITING
Poznan
Kailera Clinical Site
RECRUITING
Siedlce
Kailera Clinical Site
RECRUITING
Skierniewice
Kailera Clinical Site
RECRUITING
Torun
Kailera Clinical Site
RECRUITING
Warsaw
Kailera Clinical Site
RECRUITING
Zamość
Spain
Kailera Clinical Site
RECRUITING
Barcelona
Kailera Clinical Site
RECRUITING
Barcelona
Kailera Clinical Site
RECRUITING
Castilleja De La Cuesta
Kailera Clinical Site
RECRUITING
Ferrol
Kailera Clinical Site
RECRUITING
Madrid
Kailera Clinical Site
RECRUITING
Oviedo
Kailera Clinical Site
RECRUITING
Seville
Kailera Clinical Site
RECRUITING
Valencia
Kailera Clinical Site
RECRUITING
Villamartín
United Kingdom
Kailera Clinical Site
RECRUITING
Bradford
Kailera Clinical Site
RECRUITING
Hounslow
Kailera Clinical Site
RECRUITING
Hull
Kailera Clinical Site
RECRUITING
Leicester
Kailera Clinical Site
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London
Kailera Clinical Site
RECRUITING
Manchester
Kailera Clinical Site
RECRUITING
Newcastle Upon Tyne
Kailera Clinical Site
RECRUITING
Nottingham
Kailera Clinical Site
RECRUITING
Soham
Kailera Clinical Site
RECRUITING
Stevenage
Kailera Clinical Site
RECRUITING
Torpoint
Contact Information
Primary
Kailera Therapeutics, Inc.
info-clinicalstudies@kailera.com
781-317-0291
Time Frame
Start Date: 2025-12-18
Estimated Completion Date: 2028-03
Participants
Target number of participants: 2340
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.
Experimental: Ribupatide: Dose 3
Participants will receive Dose 3 of ribupatide once weekly.
Experimental: Ribupatide: Dose 4
Participants will receive Dose 4 of ribupatide once weekly.
Placebo_comparator: Placebo
Participants will receive placebo matched to ribupatide once weekly.
Related Therapeutic Areas
Sponsors
Leads: Kailera