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Efficacy and Safety of Ribupatide Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Key Inclusion Criteria:

* 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.

Key Exclusion Criteria:

* Current diagnosis or history of diabetes mellitus.
* Started medications within 3 months prior to Screening that may cause significant weight change, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, mood stabilizers, and phentermine.
* Unstable weight defined as self-reported change in body weight exceeding 5% within the 3 months prior to Screening.
* Family or personal history of multiple endocrine neoplasia Type 2 or medullary thyroid cancer.
* 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 (MDD) or other severe psychiatric disorder.
* Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1/glucose-dependent insulinotropic polypeptide (GIP), or glucagon receptor agonist within 3 months prior to Screening.

Note: Additional inclusion/exclusion criteria may apply, per protocol.

About the study

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.

What is being tested

Sponsor: Kailera · Participants: 1,200 · Started: Dec 30, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07284979

Locations in the U.S.

ArizonaKailera Clinical Site, Glendale
Kailera Clinical Site, Phoenix
ArkansasKailera Clinical Site, Little Rock
CaliforniaKailera Clinical Site, Northridge
Kailera Clinical Site, Oceanside
ConnecticutKailera Clinical Site, Hamden
Kailera Clinical Site, Stamford
FloridaKailera Clinical Site, Orange City
GeorgiaKailera Clinical Site, Albany
IllinoisKailera Clinical Site, Chicago
Kailera Clinical Site, Skokie
KansasKailera Clinical Site, Newton
LouisianaKailera Clinical Site, Shreveport
MichiganKailera Clinical Site, Farmington Hills
MontanaKailera Clinical Site, Missoula
NevadaKailera Clinical Site, Las Vegas
New YorkKailera Clinical Site, Albany
North CarolinaKailera Clinical Site, Morehead City
Kailera Clinical Site, Morrisville
OklahomaKailera Clinical Site, Norman
Rhode IslandKailera Clinical Site, East Greenwich
South CarolinaKailera Clinical Site, North Charleston
Kailera Clinical Site, Spartanburg
TexasKailera Clinical Site, Brownsville
Kailera Clinical Site, San Antonio
VirginiaKailera Clinical Site, Manassas
Kailera Clinical Site, Richmond

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.