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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 and Diabetes

Status: Recruiting
Location: See all (154) 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 placebo on: * Percent change in body weight * Change in hemoglobin A1c (HbA1c)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Diagnosis of type 2 diabetes mellitus (T2DM).

• Receiving stable therapy for T2DM for 3 months prior to Screening. This includes diet and/or exercise alone or in combination with any oral medication for T2DM treatment except for DPP-4 inhibitors. Participants can be treatment naïve if they have an HbA1c of 6.5% to 7.5%, inclusive.

• BMI ≥27 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
Alabama
Kailera Clinical Site
RECRUITING
Cullman
Arkansas
Kailera Clinical Site
RECRUITING
Little Rock
Arizona
Kailera Clinical Site
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Phoenix
Kailera Clinical Site
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Sun City
California
Kailera Clinical Site
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Escondido
Kailera Clinical Site
RECRUITING
La Mesa
Kailera Clinical Site
RECRUITING
Montclair
Kailera Clinical Site
RECRUITING
Northridge
Kailera Clinical Site
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Oceanside
Kailera Clinical Site
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Toluca Lake
Connecticut
Kailera Clinical Site
RECRUITING
Stamford
Florida
Kailera Clinical Site
RECRUITING
Bradenton
Kailera Clinical Site
RECRUITING
Hollywood
Kailera Clinical Site
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Jupiter
Kailera Clinical Site
RECRUITING
Miami
Kailera Clinical Site
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Miami Lakes
Kailera Clinical Site
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Orange City
Kailera Clinical Site
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Orlando
Kailera Clinical Site
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Orlando
Kailera Clinical Site
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The Villages
Georgia
Kailera Clinical Site
RECRUITING
Decatur
Kailera Clinical Site
RECRUITING
Lilburn
Kailera Clinical Site
RECRUITING
Marietta
Kailera Clinical Site
RECRUITING
Riverdale
Illinois
Kailera Clinical Site
RECRUITING
Skokie
Kailera Clinical Site
ACTIVE_NOT_RECRUITING
Springfield
Kansas
Kailera Clinical Site
RECRUITING
Newton
Louisiana
Kailera Clinical Site
RECRUITING
Shreveport
Massachusetts
Kailera Clinical Site
RECRUITING
Boston
Maryland
Kailera Clinical Site
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Annapolis
Kailera Clinical Site
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Columbia
Michigan
Kailera Clinical Site
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Farmington Hills
Montana
Kailera Clinical Site
RECRUITING
Missoula
North Carolina
Kailera Clinical Site
RECRUITING
Greensboro
Kailera Clinical Site
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Monroe
Kailera Clinical Site
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Morehead City
Kailera Clinical Site
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Morrisville
Nebraska
Kailera Clinical Site
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Lincoln
Nevada
Kailera Clinical Site
RECRUITING
Las Vegas
New York
Kailera Clinical Site
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Albany
Kailera Clinical Site
RECRUITING
Laurelton
Kailera Clinical Site
RECRUITING
New York
Ohio
Kailera Clinical Site
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Cleveland
Oklahoma
Kailera Clinical Site
RECRUITING
Chickasha
Rhode Island
Kailera Clinical Site
RECRUITING
East Greenwich
South Carolina
Kailera Clinical Site
RECRUITING
Spartanburg
Tennessee
Kailera Clinical Site
ACTIVE_NOT_RECRUITING
Chattanooga
Kailea Clinical Site
RECRUITING
Memphis
Texas
Kailera Clinical Site
RECRUITING
Amarillo
Kailera Clinical Site
RECRUITING
Brownsville
Kailera Clinical Site
RECRUITING
Desoto
Kailera Clinical Site
RECRUITING
El Paso
Kailera Clinical Site
RECRUITING
Farmers Branch
Kailera Clinical Site
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Kingwood
Kailera Clinical Site
RECRUITING
Plano
Kailera Clinical Site
RECRUITING
Tomball
Utah
Kailera Clinical Site
RECRUITING
Pleasant View
Kailera Clinical Site
RECRUITING
Salt Lake City
Virginia
Kailera Clinical Site
RECRUITING
Manassas
Kailera Clinical Site
RECRUITING
Richmond
Washington
Kailera Clinical Site
RECRUITING
Seattle
Other Locations
Argentina
Kailera Clinical Site
RECRUITING
Buenos Aires
Kailera Clinical Site
RECRUITING
Buenos Aires
Kailera Clinical Site
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Buenos Aires
Kailera Clinical Site
RECRUITING
Buenos Aires
Kailera Clinical Site
RECRUITING
Ciudad Autonoma De Buenos Aires
Kailera Clinical Site
RECRUITING
Córdoba
Kailera Clinical Site
RECRUITING
Córdoba
Kailera Clinical Site
RECRUITING
Godoy Cruz
Kailera Clinical Site
RECRUITING
La Plata
Kailera Clinical Site
RECRUITING
Mar Del Plata
Kailera Clinical Site
RECRUITING
Rosario
Kailera Clinical Site
RECRUITING
San Nicolás De Los Arroyos
Kailera Clinical Site
RECRUITING
Zárate
Australia
Kailera Clinical Site
RECRUITING
Blacktown
Kailera Clinical Site
RECRUITING
Bruce
Kailera Clinical Site
RECRUITING
Camberwell
Kailera Clinical Site
RECRUITING
Charlestown
Kailera Clinical Site
RECRUITING
Herston
Kailera Clinical Site
RECRUITING
Kanwal
Kailera Clinical Site
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Leichhardt
Kailera Clinical Site
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Melbourne
Kailera Clinical Site
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Morayfield
Kailera Clinical Site
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Penrith
Kailera Clinical Site
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South Brisbane
Kailera Clinical Site
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Sydney
Kailera Clinical Site
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Sydney
Kailera Clinical Site
RECRUITING
Wollongong
Bulgaria
Kailera Clinical Site
RECRUITING
Kyustendil
Kailera Clinical Site
RECRUITING
Montana
Kailera Clinical Site
RECRUITING
Pleven
Kailera Clinical Site
RECRUITING
Plovdiv
Kailera Clinical Site
RECRUITING
Rousse
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
Germany
Kailera Clinical Site
RECRUITING
Cologne
Kailera Clinical Site
RECRUITING
Essen
Kailera Clinical Site
RECRUITING
Falkensee
Kailera Clinical Site
RECRUITING
Oldenburg In Holstein
Kailera Clinical Site
RECRUITING
Schwerin
Kailera Clinical Site
RECRUITING
Tübingen
New Zealand
Kailera Clinical Site
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Auckland
Kailera Clinical Site
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Grafton
Kailera Clinical Site
RECRUITING
Hastings
Kailera Clinical Site
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Nawton
Kailera Clinical Site
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Nelson
Kailera Clinical Site
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New Lynn
Kailera Clinical Site
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Silverdale
Kailera Clinical Site
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Takapuna
Poland
Kailera Clinical Site
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Bialystok
Kailera Clinical Site
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Bydgoszcz
Kailera Clinical Site
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Chorzów
Kailera Clinical Site
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Gdynia
Kailera Clinical Site
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Gdynia
Kailera Clinical Site
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Kielce
Kailera Clinical Site
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Krakow
Kailera Clinical Site
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Krakow
Kailera Clinical Site
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Lublin
Kailera Clinical Site
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Siedlce
Kailera Clinical Site
RECRUITING
Skierniewice
Kailera Clinical Site
RECRUITING
Torun
Kailera Clinical Site
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Warsaw
Kailera Clinical Site
RECRUITING
Warsaw
Puerto Rico
Kailera Clinical Site
RECRUITING
Bayamón
Kailera Clinical Site
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Ponce
Kailera Clinical Site
RECRUITING
San Juan
Kailera Clinical Site
RECRUITING
San Juan
Kailera Clinical Site
RECRUITING
Vega Baja
Spain
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
Seville
Kailera Clinical Site
RECRUITING
Seville
Kailera Clinical Site
RECRUITING
Valencia
Kailera Clinical Site
RECRUITING
Villamartín
United Kingdom
Kailera Clinical Site
RECRUITING
Bournemouth
Kailera Clinical Site
RECRUITING
Bradford
Kailera Clinical Site
RECRUITING
Glasgow
Kailera Clinical Site
RECRUITING
Hull
Kailera Clinical Site
RECRUITING
Leicester
Kailera Clinical Site
RECRUITING
London
Kailera Clinical Site
RECRUITING
Manchester
Kailera Clinical Site
RECRUITING
Newcastle Upon Tyne
Kailera Clinical Site
RECRUITING
Nottingham
Kailera Clinical Site
RECRUITING
Plymouth
Kailera Clinical Site
RECRUITING
Stevenage
Kailera Clinical Site
RECRUITING
Truro
Kailera Clinical Site
RECRUITING
Yate
Contact Information
Primary
Kailera Therapeutics, Inc.
info-clinicalstudies@kailera.com
1-781-317-0291
Time Frame
Start Date: 2026-01-12
Estimated Completion Date: 2028-04-24
Participants
Target number of participants: 1156
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

This content was sourced from clinicaltrials.gov