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Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes

RecruitingPhase 3

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Key Inclusion Criteria:

* 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.

Key Exclusion Criteria:

* Current diagnosis or history of type 1 diabetes mellitus (T1DM) or any other type of diabetes except T2DM.
* History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year prior to Screening.
* History of severe hypoglycemia or hypoglycemia unawareness within 1 year prior to Screening.
* 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, or phentermine.
* Unstable weight defined as self-reported change in body weight exceeding 5% within 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 (GI) motility if taken for \>30 days continually within 3 months prior to Screening.
* History of suicide attempt.
* History of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within 2 years prior to Screening.
* Received treatment with semaglutide, tirzepatide, GLP-1 receptor agonists, GLP-1/glucose-dependent insulinotropic polypeptide (GIP) agonists, glucagon receptor agonists, or other weight loss medications or treatments aside from diet and exercise 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 placebo on:

* Percent change in body weight * Change in hemoglobin A1c (HbA1c)

What is being tested

Sponsor: Kailera · Participants: 1,156 · Started: Jan 12, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07284901

Locations in the U.S.

AlabamaKailera Clinical Site, Cullman
ArizonaKailera Clinical Site, Phoenix
Kailera Clinical Site, Sun City
ArkansasKailera Clinical Site, Little Rock
CaliforniaKailera Clinical Site, Escondido
Kailera Clinical Site, La Mesa
Kailera Clinical Site, Montclair
Kailera Clinical Site, Northridge
Kailera Clinical Site, Oceanside
Kailera Clinical Site, Toluca Lake
ConnecticutKailera Clinical Site, Stamford
FloridaKailera Clinical Site, Bradenton
Kailera Clinical Site, Hollywood
Kailera Clinical Site, Jupiter
Kailera Clinical Site, Miami
Kailera Clinical Site, Miami Lakes
Kailera Clinical Site, Orange City
Kailera Clinical Site, Orlando
Kailera Clinical Site, Orlando
Kailera Clinical Site, The Villages
GeorgiaKailera Clinical Site, Decatur
Kailera Clinical Site, Lilburn
Kailera Clinical Site, Marietta
Kailera Clinical Site, Riverdale
IllinoisKailera Clinical Site, Skokie
KansasKailera Clinical Site, Newton
LouisianaKailera Clinical Site, Shreveport
MarylandKailera Clinical Site, Annapolis
Kailera Clinical Site, Columbia
MassachusettsKailera Clinical Site, Boston
MichiganKailera Clinical Site, Farmington Hills
MontanaKailera Clinical Site, Missoula
NebraskaKailera Clinical Site, Lincoln
NevadaKailera Clinical Site, Las Vegas
New YorkKailera Clinical Site, Albany
Kailera Clinical Site, Laurelton
Kailera Clinical Site, New York
North CarolinaKailera Clinical Site, Greensboro
Kailera Clinical Site, Monroe
Kailera Clinical Site, Morehead City
Kailera Clinical Site, Morrisville
OhioKailera Clinical Site, Cleveland
OklahomaKailera Clinical Site, Chickasha
Rhode IslandKailera Clinical Site, East Greenwich
South CarolinaKailera Clinical Site, Spartanburg
TennesseeKailea Clinical Site, Memphis
TexasKailera Clinical Site, Amarillo
Kailera Clinical Site, Brownsville
Kailera Clinical Site, DeSoto
Kailera Clinical Site, El Paso
Kailera Clinical Site, Farmers Branch
Kailera Clinical Site, Kingwood
Kailera Clinical Site, Plano
Kailera Clinical Site, Tomball
UtahKailera Clinical Site, Pleasant View
Kailera Clinical Site, Salt Lake City
VirginiaKailera Clinical Site, Manassas
Kailera Clinical Site, Richmond
WashingtonKailera Clinical Site, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.