Recruiting

Phase 3

KAI-9531Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes

Sponsor:

Kailera

Code:

NCT07284901

Conditions

Obesity With Diabetes

Overweight With Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ribupatide

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 placebo on:

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

Conditions

Obesity With Diabetes

Overweight With Diabetes

Study ID

NCT07284901

Start date

Jan 12, 2026

Status verified date

Sep, 2026

Completion date

Apr 24, 2028

Anticipated

Primary completion date

Mar 27, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1156 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

Doses 3 and 4 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76 [ Time Frame: Baseline, Week 76 ]
Doses 3 and 4 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76 [ Time Frame: Baseline, Week 76 ]

Central Contacts and Locations

Central contacts

Kailera Therapeutics, Inc.

1-781-317-0291 info-clinicalstudies@kailera.com

Locations

Kailera Clinical Site

Recruiting

Cullman, Alabama, United States, 35055

Kailera Clinical Site

Recruiting

Phoenix, Arizona, United States, 85012

Kailera Clinical Site

Recruiting

Sun City, Arizona, United States, 85351

Kailera Clinical Site

Recruiting

Little Rock, Arkansas, United States, 72205

Kailera Clinical Site

Recruiting

Escondido, California, United States, 92025

Kailera Clinical Site

Recruiting

La Mesa, California, United States, 91942

Kailera Clinical Site

Recruiting

Montclair, California, United States, 91763

Kailera Clinical Site

Recruiting

Northridge, California, United States, 91325

Kailera Clinical Site

Recruiting

Oceanside, California, United States, 92058

Kailera Clinical Site

Recruiting

Toluca Lake, California, United States, 91602

Kailera Clinical Site

Recruiting

Stamford, Connecticut, United States, 06905

Kailera Clinical Site

Recruiting

Bradenton, Florida, United States, 34209

Kailera Clinical Site

Recruiting

Hollywood, Florida, United States, 33024

Kailera Clinical Site

Recruiting

Jupiter, Florida, United States, 33458

Kailera Clinical Site

Recruiting

Miami, Florida, United States, 33135

Kailera Clinical Site

Recruiting

Miami Lakes, Florida, United States, 33016

Kailera Clinical Site

Recruiting

Orange City, Florida, United States, 32763

Kailera Clinical Site

Recruiting

Orlando, Florida, United States, 32801

Kailera Clinical Site

Recruiting

Orlando, Florida, United States, 32803

Kailera Clinical Site

Recruiting

The Villages, Florida, United States, 32162

Kailera Clinical Site

Recruiting

Decatur, Georgia, United States, 30030

Kailera Clinical Site

Recruiting

Lilburn, Georgia, United States, 30047

Kailera Clinical Site

Recruiting

Marietta, Georgia, United States, 30060

Kailera Clinical Site

Recruiting

Riverdale, Georgia, United States, 30274

Kailera Clinical Site

Recruiting

Skokie, Illinois, United States, 60077

Kailera Clinical Site

Recruiting

Newton, Kansas, United States, 67114

Kailera Clinical Site

Recruiting

Shreveport, Louisiana, United States, 71105

Kailera Clinical Site

Recruiting

Annapolis, Maryland, United States, 21401

Kailera Clinical Site

Recruiting

Columbia, Maryland, United States, 21045

Kailera Clinical Site

Recruiting

Boston, Massachusetts, United States, 02115

Kailera Clinical Site

Recruiting

Farmington Hills, Michigan, United States, 48334

Kailera Clinical Site

Recruiting

Missoula, Montana, United States, 59804

Kailera Clinical Site

Recruiting

Lincoln, Nebraska, United States, 68516

Kailera Clinical Site

Recruiting

Las Vegas, Nevada, United States, 89148

Kailera Clinical Site

Recruiting

Albany, New York, United States, 12203

Kailera Clinical Site

Recruiting

Laurelton, New York, United States, 11413

Kailera Clinical Site

Recruiting

New York, New York, United States, 10016

Kailera Clinical Site

Recruiting

Greensboro, North Carolina, United States, 27405

Kailera Clinical Site

Recruiting

Monroe, North Carolina, United States, 28112

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

Cleveland, Ohio, United States, 44122

Kailera Clinical Site

Recruiting

Chickasha, Oklahoma, United States, 73018

Kailera Clinical Site

Recruiting

East Greenwich, Rhode Island, United States, 02818

Kailera Clinical Site

Recruiting

Spartanburg, South Carolina, United States, 29303

Kailea Clinical Site

Recruiting

Memphis, Tennessee, United States, 38119

Kailera Clinical Site

Recruiting

Amarillo, Texas, United States, 79124

Kailera Clinical Site

Recruiting

Brownsville, Texas, United States, 78526

Kailera Clinical Site

Recruiting

DeSoto, Texas, United States, 75115

Kailera Clinical Site

Recruiting

El Paso, Texas, United States, 79902

Kailera Clinical Site

Recruiting

Farmers Branch, Texas, United States, 75234

Kailera Clinical Site

Recruiting

Kingwood, Texas, United States, 77345

Kailera Clinical Site

Recruiting

Plano, Texas, United States, 75093

Kailera Clinical Site

Recruiting

Tomball, Texas, United States, 77375

Kailera Clinical Site

Recruiting

Pleasant View, Utah, United States, 84404

Kailera Clinical Site

Recruiting

Salt Lake City, Utah, United States, 84117

Kailera Clinical Site

Recruiting

Manassas, Virginia, United States, 20110

Kailera Clinical Site

Recruiting

Richmond, Virginia, United States, 23236

Kailera Clinical Site

Recruiting

Seattle, Washington, United States, 98104

More Information

Sponsor

Kailera

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Kailera on 2026-09-03.