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Efficacy and Safety of Ribupatide in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have 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 With Weight-Related Comorbidities Who Do Not Have Diabetes

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* BMI ≥30 kg/m\^2 or BMI ≥27 kg/m\^2 and previously diagnosed with at least 1 of the following:

  1. hypertension,
  2. dyslipidemia,
  3. obstructive sleep apnea, or
  4. 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.

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, 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 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, GLP-1 receptor 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 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.

What is being tested

Sponsor: Kailera · Participants: 2,340 · Started: Dec 18, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT07284875

Locations in the U.S.

AlabamaKailera Clinical Site, Anniston
Kailera Clinical Site, Birmingham
Kailera Clinical Site, Cullman
ArizonaKailera Clinical Site, Sun City
CaliforniaKailera Clinical Site, Escondido
Kailera Clinical Site, Toluca Lake
ColoradoKailera Clinical Site, Aurora
ConnecticutKailera Clinical Site, Bridgeport
FloridaKailera Clinical Site, Jupiter
GeorgiaKailera Clinical Site, Lilburn
IllinoisKailera Clinical Site, Springfield
MarylandKailera Clinical Site, Columbia
NevadaKailera Clinical Site, Las Vegas
New YorkKailera Clinical Site, Rochester
North CarolinaKailera Clinical Site, Morehead City
OklahomaKailera Clinical Site, Chickasha
South CarolinaKailera Clinical Site, Mauldin
TennesseeKailera Clinical Site, Chattanooga
TexasKailera Clinical Site, Amarillo
Kailera Clinical Site, Bellaire
Kailera Clinical Site, DeSoto
Kailera Clinical Site, Tomball
UtahKailera Clinical Site, Salt Lake City
VirginiaKailera Clinical Site, Danville

Conditions

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