Recruiting

Phase 3

KAI-9531Efficacy and Safety of Ribupatide in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

Sponsor:

Kailera

Code:

NCT07284875

Conditions

Obesity

Overweight

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ribupatide

Placebo

Study Details

Brief summary:

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.

Conditions

Obesity

Overweight

Study ID

NCT07284875

Start date

Dec 18, 2025

Status verified date

Sep, 2026

Completion date

Mar, 2028

Anticipated

Primary completion date

Feb, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

2340 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.

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.

Interventions

Ribupatide

SC Injection

Placebo

SC Injection

Primary outcome measure

Dose 3 and 4 versus Placebo: 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

Anniston, Alabama, United States, 36207

Kailera Clinical Site

Recruiting

Birmingham, Alabama, United States, 35294

Kailera Clinical Site

Recruiting

Cullman, Alabama, United States, 35055

Kailera Clinical Site

Recruiting

Sun City, Arizona, United States, 85351

Kailera Clinical Site

Recruiting

Escondido, California, United States, 92025

Kailera Clinical Site

Recruiting

Toluca Lake, California, United States, 91602

Kailera Clinical Site

Recruiting

Aurora, Colorado, United States, 80012

Kailera Clinical Site

Recruiting

Bridgeport, Connecticut, United States, 06606

Kailera Clinical Site

Recruiting

Jupiter, Florida, United States, 33458

Kailera Clinical Site

Recruiting

Lilburn, Georgia, United States, 30047

Kailera Clinical Site

Recruiting

Springfield, Illinois, United States, 62072

Kailera Clinical Site

Recruiting

Columbia, Maryland, United States, 21045

Kailera Clinical Site

Recruiting

Las Vegas, Nevada, United States, 89119

Kailera Clinical Site

Recruiting

Rochester, New York, United States, 14609

Kailera Clinical Site

Recruiting

Morehead City, North Carolina, United States, 28557

Kailera Clinical Site

Recruiting

Chickasha, Oklahoma, United States, 73018

Kailera Clinical Site

Recruiting

Mauldin, South Carolina, United States, 29662

Kailera Clinical Site

Recruiting

Chattanooga, Tennessee, United States, 37405

Kailera Clinical Site

Recruiting

Amarillo, Texas, United States, 79124

Kailera Clinical Site

Recruiting

Bellaire, Texas, United States, 77401

Kailera Clinical Site

Recruiting

DeSoto, Texas, United States, 75115

Kailera Clinical Site

Recruiting

Tomball, Texas, United States, 77375

Kailera Clinical Site

Recruiting

Salt Lake City, Utah, United States, 84124

Kailera Clinical Site

Recruiting

Danville, Virginia, United States, 24541

More Information

Sponsor

Kailera

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

Overweight
Obesity
Ribupatide
KAI-9531
Glucagon-like Peptide-1
GLP-1
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 2026-09-03.