Recruiting

Phase 3

KAI-9531 vs. SemaglutideEfficacy and Safety of Ribupatide Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes

Sponsor:

Kailera

Code:

NCT07284979

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ribupatide

Semaglutide

Placebo

Study Details

Brief summary:

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.

Conditions

Obesity

Study ID

NCT07284979

Start date

Dec 30, 2025

Status verified date

Aug, 2026

Completion date

Apr, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

active comparator: Semaglutide

Participants will receive semaglutide once weekly.

placebo comparator: Placebo

Participants will receive placebo matched to ribupatide once weekly.

Interventions

Ribupatide

SC Injection

Semaglutide

SC Injection

Placebo

SC Injection

Primary outcome measure

Percent Change From Baseline in Body Weight at Week 76 [ Time Frame: Baseline, Week 76 ]

Central Contacts and Locations

Central contacts

Kailera Therapeutics, Inc.

781-317-0291 info-clinicalstudies@kailera.com

Locations

Kailera Clinical Site

Recruiting

Glendale, Arizona, United States, 85308

Kailera Clinical Site

Recruiting

Phoenix, Arizona, United States, 85012

Kailera Clinical Site

Recruiting

Little Rock, Arkansas, United States, 72205

Kailera Clinical Site

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Northridge, California, United States, 91325

Kailera Clinical Site

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Oceanside, California, United States, 92058

Kailera Clinical Site

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Hamden, Connecticut, United States, 06517

Kailera Clinical Site

Recruiting

Stamford, Connecticut, United States, 06905

Kailera Clinical Site

Recruiting

Orange City, Florida, United States, 32763

Kailera Clinical Site

Recruiting

Albany, Georgia, United States, 31707

Kailera Clinical Site

Recruiting

Chicago, Illinois, United States, 60640

Kailera Clinical Site

Recruiting

Skokie, Illinois, United States, 60077

Kailera Clinical Site

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Newton, Kansas, United States, 67114

Kailera Clinical Site

Recruiting

Shreveport, Louisiana, United States, 71105

Kailera Clinical Site

Recruiting

Farmington Hills, Michigan, United States, 48334

Kailera Clinical Site

Recruiting

Missoula, Montana, United States, 59804

Kailera Clinical Site

Recruiting

Las Vegas, Nevada, United States, 89148

Kailera Clinical Site

Recruiting

Albany, New York, United States, 12203

Kailera Clinical Site

Recruiting

Morehead City, North Carolina, United States, 28557

Kailera Clinical Site

Recruiting

Morrisville, North Carolina, United States, 27560

Kailera Clinical Site

Recruiting

Norman, Oklahoma, United States, 73069

Kailera Clinical Site

Recruiting

East Greenwich, Rhode Island, United States, 02818

Kailera Clinical Site

Recruiting

North Charleston, South Carolina, United States, 29405

Kailera Clinical Site

Recruiting

Spartanburg, South Carolina, United States, 29303

Kailera Clinical Site

Recruiting

Brownsville, Texas, United States, 78526

Kailera Clinical Site

Recruiting

San Antonio, Texas, United States, 78229

Kailera Clinical Site

Recruiting

Manassas, Virginia, United States, 20110

Kailera Clinical Site

Recruiting

Richmond, Virginia, United States, 23236

More Information

Sponsor

Kailera

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

Obesity
Ribupatide
KAI-9531
Glucagon-like peptide-1
GLP-1
Semaglutide
Glucose-dependent Insulinotropic Peptide
GIP

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Kailera on 2026-09-01.