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

NCT07284901 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: K9531-31042025-523510-87-00
• Study Type: interventional
• Target: 1,156
• Locations: 11 countries
• Sites: 116

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Doses 3 and 4 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76

  Baseline, Week 76

• Doses 3 and 4 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76

  Baseline, Week 76

Secondary Outcomes (33)

• Doses 1 and 2 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76

  Baseline, Week 76

• Doses 1 and 2 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76

  Baseline, Week 76

• Percentage of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight

  Baseline, Week 76

• Change From Baseline in Waist Circumference

  Baseline, Week 76

• Change From Baseline in Absolute Body Weight

  Baseline, Week 76

Study Arms (5)

Ribupatide: Dose 1

EXPERIMENTAL

Participants will receive Dose 1 of ribupatide once weekly.

Drug: Ribupatide

Ribupatide: Dose 2

EXPERIMENTAL

Participants will receive Dose 2 of ribupatide once weekly.

Drug: Ribupatide

Ribupatide: Dose 3

EXPERIMENTAL

Participants will receive Dose 3 of ribupatide once weekly.

Drug: Ribupatide

Ribupatide: Dose 4

EXPERIMENTAL

Participants will receive Dose 4 of ribupatide once weekly.

Drug: Ribupatide

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matched to ribupatide once weekly.

Drug: Placebo

Interventions

Placebo DRUG

SC Injection

Placebo

Ribupatide DRUG

SC Injection

Also known as: KAI-9531

Ribupatide: Dose 1; Ribupatide: Dose 2; Ribupatide: Dose 3; Ribupatide: Dose 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kailera: lead

Study Sites (116)

Kailera Clinical Site

Cullman, Alabama, 35055, United States

RECRUITING

Kailera Clinical Site

Phoenix, Arizona, 85012, United States

RECRUITING

Kailera Clinical Site

Sun City, Arizona, 85351, United States

RECRUITING

Kailera Clinical Site

Little Rock, Arkansas, 72205, United States

RECRUITING

Kailera Clinical Site

Escondido, California, 92025, United States

RECRUITING

Kailera Clinical Site

Montclair, California, 91763, United States

RECRUITING

Kailera Clinical Site

Northridge, California, 91325, United States

RECRUITING

Kailera Clinical Site

Oceanside, California, 92058, United States

RECRUITING

Kailera Clinical Site

Toluca Lake, California, 91602, United States

RECRUITING

Kailera Clinical Site

Stamford, Connecticut, 06905, United States

RECRUITING

Kailera Clinical Site

Jupiter, Florida, 33458, United States

RECRUITING

Kailera Clinical Site

Miami, Florida, 33135, United States

RECRUITING

Kailera Clinical Site

Orange City, Florida, 32763, United States

RECRUITING

Kailera Clinical Site

Orlando, Florida, 32801, United States

RECRUITING

Kailera Clinical Site

Orlando, Florida, 32803, United States

RECRUITING

Kailera Clinical Site

The Villages, Florida, 32162, United States

RECRUITING

Kailera Clinical Site

Lilburn, Georgia, 30047, United States

RECRUITING

Kailera Clinical Site

Skokie, Illinois, 60077, United States

RECRUITING

Kailera Clinical Site

Springfield, Illinois, 62702, United States

ACTIVE NOT RECRUITING

Kailera Clinical Site

Newton, Kansas, 67114, United States

RECRUITING

Kailera Clinical Site

Shreveport, Louisiana, 71105, United States

RECRUITING

Kailera Clinical Site

Columbia, Maryland, 21045, United States

RECRUITING

Kailera Clinical Site

Farmington Hills, Michigan, 48334, United States

RECRUITING

Kailera Clinical Site

Missoula, Montana, 59804, United States

RECRUITING

Kailera Clinical Site

Lincoln, Nebraska, 68516, United States

RECRUITING

Kailera Clinical Site

Las Vegas, Nevada, 89148, United States

RECRUITING

Kailera Clinical Site

Albany, New York, 12203, United States

RECRUITING

Kailera Clinical Site

Laurelton, New York, 11413, United States

RECRUITING

Kailera Clinical Site

Greensboro, North Carolina, 27405, United States

RECRUITING

Kailera Clinical Site

Morehead City, North Carolina, 28557, United States

RECRUITING

Kailera Clinical Site

Chickasha, Oklahoma, 73018, United States

RECRUITING

Kailera Clinical Site

Spartanburg, South Carolina, 29303, United States

RECRUITING

Kailera Clinical Site

Chattanooga, Tennessee, 37405, United States

ACTIVE NOT RECRUITING

Kailera Clinical Site

Amarillo, Texas, 79124, United States

RECRUITING

Kailera Clinical Site

Brownsville, Texas, 78526, United States

RECRUITING

Kailera Clinical Site

DeSoto, Texas, 75115, United States

RECRUITING

Kailera Clinical Site

Tomball, Texas, 77375, United States

RECRUITING

Kailera Clinical Site

Pleasant View, Utah, 84404, United States

RECRUITING

Kailera Clinical Site

Salt Lake City, Utah, 84117, United States

RECRUITING

Kailera Clinical Site

Manassas, Virginia, 20110, United States

RECRUITING

Kailera Clinical Site

Richmond, Virginia, 23236, United States

RECRUITING

Kailera Clinical Site

Ciudad Autonoma de Buenos Aires, Buenos Aires, 1120, Argentina

RECRUITING

Kailera Clinical Site

Mar del Plata, Buenos Aires, 7600, Argentina

RECRUITING

Kailera Clinical Site

San Nicolás de los Arroyos, Buenos Aires, 2900, Argentina

RECRUITING

Kailera Clinical Site

Zárate, Buenos Aires, 2800, Argentina

RECRUITING

Kailera Clinical Site

Buenos Aires, Buenos Aires F.D., 1060, Argentina

RECRUITING

Kailera Clinical Site

Godoy Cruz, Mendoza Province, 5501, Argentina

RECRUITING

Kailera Clinical Site

Rosario, Sante Fe, 2000, Argentina

RECRUITING

Kailera Clinical Site

CABA, 1061, Argentina

RECRUITING

Kailera Clinical Site

Córdoba, 5002, Argentina

RECRUITING

Kailera Clinical Site

Bruce, Australian Capital Territory, 2617, Australia

RECRUITING

Kailera Clinical Site

Blacktown, New South Wales, 2148, Australia

RECRUITING

Kailera Clinical Site

Kanwal, New South Wales, 2259, Australia

RECRUITING

Kailera Clinical Site

Leichhardt, New South Wales, 2040, Australia

RECRUITING

Kailera Clinical Site

Sydney, New South Wales, 2100, Australia

RECRUITING

Kailera Clinical Site

Sydney, New South Wales, 2228, Australia

RECRUITING

Kailera Clinical Site

Wollongong, New South Wales, 2500, Australia

RECRUITING

Kailera Clinical Site

Herston, Queensland, 4006, Australia

RECRUITING

Kailera Clinical Site

Morayfield, Queensland, 4506, Australia

RECRUITING

Kailera Clinical Site

Camberwell, Victoria, 3124, Australia

RECRUITING

Kailera Clinical Site

Melbourne, Victoria, 3025, Australia

RECRUITING

Kailera Clinical Site

South Brisbane, 4101, Australia

RECRUITING

Kailera Clinical Site

Kyustendil, Kyustendil Province, 2500, Bulgaria

RECRUITING

Kailera Clinical Site

Pleven, Pleven Province, 5800, Bulgaria

RECRUITING

Kailera Clinical Site

Plovdiv, Plovdiv Province, 4020, Bulgaria

RECRUITING

Kailera Clinical Site

Rousse, Ruse Province, 7013, Bulgaria

RECRUITING

Kailera Clinical Site

Sofia, Sofia, 1606, Bulgaria

RECRUITING

Kailera Clinical Site

Sofia, Sofia, 1618, Bulgaria

RECRUITING

Kailera Clinical Site

Stara Zagora, Stara Zagora Province, 6000, Bulgaria

RECRUITING

Kailera Clinical Site

Varna, Varna Province, 9000, Bulgaria

RECRUITING

Kailera Clinical Site

Montana, 3400, Bulgaria

RECRUITING

Kailera Clinical Site

Brandýs nad Labem, Central Bohemia, 25001, Czechia

RECRUITING

Kailera Clinical Site

Náchod, Hradec Králové Region, 54701, Czechia

RECRUITING

Kailera Clinical Site

Trutnov, Hradec Králové Region, 54101, Czechia

RECRUITING

Kailera Clinical Site

Brno, South Moravian, 60200, Czechia

RECRUITING

Kailera Clinical Site

Holešov, Zlín, 76901, Czechia

RECRUITING

Kailera Clinical Site

Hodonín, 69501, Czechia

RECRUITING

Kailera Clinical Site

Pardubice, 53002, Czechia

RECRUITING

Kailera Clinical Site

Uherské Hradiště, 68601, Czechia

RECRUITING

Kailera Clinical Site

Falkensee, Brandenburg, 14612, Germany

RECRUITING

Kailera Clinical Site

Cologne, North Rhine-Westphalia, 51069, Germany

RECRUITING

Kailera Clinical Site

Essen, North Rhine-Westphalia, 45355, Germany

RECRUITING

Kailera Clinical Site

Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany

RECRUITING

Kailera Clinical Site

Schwerin, 19055, Germany

RECRUITING

Kailera Clinical Site

Grafton, Auckland, 1010, New Zealand

RECRUITING

Kailera Clinical Site

New Lynn, Auckland, 0610, New Zealand

RECRUITING

Kailera Clinical Site

Silverdale, Auckland, 0932, New Zealand

RECRUITING

Kailera Clinical Site

Takapuna, Auckland, 0622, New Zealand

RECRUITING

Kailera Clinical Site

Nawton, Hamilton, 3200, New Zealand

RECRUITING

Kailera Clinical Site

Auckland, 1023, New Zealand

RECRUITING

Kailera Clinical Site

Hastings, 4120, New Zealand

RECRUITING

Kailera Clinical Site

Nelson, 7011, New Zealand

RECRUITING

Kailera Clinical Site

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

RECRUITING

Kailera Clinical Site

Krakow, Lesser Poland Voivodeship, 30-033, Poland

RECRUITING

Kailera Clinical Site

Siedlce, Masovian Voivodeship, 08-110, Poland

RECRUITING

Kailera Clinical Site

Warsaw, Masovian Voivodeship, 00-872, Poland

RECRUITING

Kailera Clinical Site

Gdynia, Pomeranian Voivodeship, 81-338, Poland

RECRUITING

Kailera Clinical Site

Chorzów, Silesian Voivodeship, 41-500, Poland

RECRUITING

Kailera Clinical Site

Gdynia, 81-338, Poland

RECRUITING

Kailera Clinical Site

Krakow, 30-363, Poland

RECRUITING

Kailera Clinical Site

Warsaw, 02-677, Poland

RECRUITING

Kailera Clinical Site

Skierniewice, Łódź Voivodeship, 96-100, Poland

RECRUITING

Kailera Clinical Site

Kielce, Świętokrzyskie Voivodeship, 25-338, Poland

RECRUITING

Kailera Clinical Site

San Juan, 00907, Puerto Rico

RECRUITING

Kailera Clinical Site

Ferrol, A Coruna, 15402, Spain

RECRUITING

Kailera Clinical Site

Villamartín, Cadiz, 11650, Spain

RECRUITING

Kailera Clinical Site

Madrid, 28003, Spain

RECRUITING

Kailera Clinical Site

Valencia, 46014, Spain

RECRUITING

Kailera Clinical Site

Truro, Cornwall, TR13LJ, United Kingdom

RECRUITING

Kailera Clinical Site

Hull, East Yorkshire, HU32JZ, United Kingdom

RECRUITING

Kailera Clinical Site

London, Greater London, EC1M6BQ, United Kingdom

RECRUITING

Kailera Clinical Site

Leicester, Leicestershire, LE54PW, United Kingdom

RECRUITING

Kailera Clinical Site

Nottingham, Nottinghamshire, NG72QW, United Kingdom

RECRUITING

Kailera Clinical Site

Yate, South Gloucestershire, BS374AX, United Kingdom

RECRUITING

Kailera Clinical Site

Bradford, West Yorkshire, BD96RJ, United Kingdom

RECRUITING

Kailera Clinical Site

Manchester, M139WL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Medical Director

  Kailera Therapeutics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Kailera Therapeutics, Inc.

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2025
• First Posted: December 16, 2025
• Study Start: January 12, 2026
• Primary Completion (Estimated): March 27, 2028
• Study Completion (Estimated): April 24, 2028
• Last Updated: July 15, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (12); AR (9); NZ (8); US (41); CZ (8); DE (5); PL (11); PR (1); BU (9); ES (4); GB (8)