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

NCT07284875 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: K9531-31032025-523486-17-00
• Study Type: interventional
• Target: 2,340
• Locations: 10 countries
• Sites: 88

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Dose 3 and 4 versus Placebo: Percent Change From Baseline in Body Weight at Week 76

  Baseline, Week 76

Secondary Outcomes (30)

• Dose 1 and 2 versus Placebo: Percent Change From Baseline in Body Weight 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

• Change From Baseline in Systolic Blood Pressure (SBP)

  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:

• BMI ≥30 kg/m\^2 or BMI ≥27 kg/m\^2 and previously diagnosed with at least 1 of the following:
• hypertension,
• dyslipidemia,
• obstructive sleep apnea, or
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kailera: lead

Study Sites (88)

Kailera Clinical Site

Anniston, Alabama, 36207, United States

RECRUITING

Kailera Clinical Site

Birmingham, Alabama, 35294, United States

RECRUITING

Kailera Clinical Site

Cullman, Alabama, 35055, United States

RECRUITING

Kailera Clinical Site

Sun City, Arizona, 85351, United States

RECRUITING

Kailera Clinical Site

Escondido, California, 92025, United States

RECRUITING

Kailera Clinical Site

Toluca Lake, California, 91602, United States

RECRUITING

Kailera Clinical Site

Aurora, Colorado, 80012, United States

RECRUITING

Kailera Clinical Site

Bridgeport, Connecticut, 06606, United States

RECRUITING

Kailera Clinical Site

Jupiter, Florida, 33458, United States

RECRUITING

Kailera Clinical Site

Lilburn, Georgia, 30047, United States

RECRUITING

Kailera Clinical Site

Springfield, Illinois, 62072, United States

RECRUITING

Kailera Clinical Site

Columbia, Maryland, 21045, United States

RECRUITING

Kailera Clinical Site

Las Vegas, Nevada, 89119, United States

RECRUITING

Kailera Clinical Site

Rochester, New York, 14609, 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

Mauldin, South Carolina, 29662, United States

RECRUITING

Kailera Clinical Site

Chattanooga, Tennessee, 37405, United States

RECRUITING

Kailera Clinical Site

Amarillo, Texas, 79124, United States

RECRUITING

Kailera Clinical Site

Bellaire, Texas, 77401, United States

RECRUITING

Kailera Clinical Site

DeSoto, Texas, 75115, United States

RECRUITING

Kailera Clinical Site

Tomball, Texas, 77375, United States

RECRUITING

Kailera Clinical Site

Salt Lake City, Utah, 84124, United States

RECRUITING

Kailera Clinical Site

Danville, Virginia, 24541, United States

RECRUITING

Kailera Clinical Site

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

RECRUITING

Kailera Clinical Site

Buenos Aires, Buenos Aires F.D., 1056, Argentina

RECRUITING

Kailera Clinical Site

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

RECRUITING

Kailera Clinical Site

Buenos Aires, Buenos Aires F.D., 1120, Argentina

RECRUITING

Kailera Clinical Site

Godoy Cruz, Mendoza Province, 5501, Argentina

RECRUITING

Kailera Clinical Site

Rosario, Santa Fe Province, 2000, Argentina

RECRUITING

Kailera Clinical Site

CABA, 1061, Argentina

RECRUITING

Kailera Clinical Site

Córdoba, 5000, Argentina

RECRUITING

Kailera Clinical Site

Silverdale, Auckland, 0932, Australia

RECRUITING

Kailera Clinical Site

Charlestown, New South Wales, 2290, Australia

RECRUITING

Kailera Clinical Site

Sydney, New South Wales, 2019, 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

Sippy Downs, Queensland, 4556, Australia

RECRUITING

Kailera Clinical Site

Norwood, South Australia, 5067, Australia

RECRUITING

Kailera Clinical Site

Heidelberg Heights, Victoria, 3081, Australia

RECRUITING

Kailera Clinical Site

Melbourne, Victoria, 3025, Australia

RECRUITING

Kailera Clinical Site

Kyustendil, Kyustendil Province, 2500, Bulgaria

RECRUITING

Kailera Clinical Site

Pazardzhik, 4400, Bulgaria

RECRUITING

Kailera Clinical Site

Plovdiv, 4000, Bulgaria

RECRUITING

Kailera Clinical Site

Plovdiv, 4020, Bulgaria

RECRUITING

Kailera Clinical Site

Sofia, 1431, Bulgaria

RECRUITING

Kailera Clinical Site

Sofia, 1510, Bulgaria

RECRUITING

Kailera Clinical Site

Varna, 9020, Bulgaria

RECRUITING

Kailera Clinical Site

Yambol, 8600, 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

Brno, South Moravian, 61500, Czechia

RECRUITING

Kailera Clinical Site

Hodonín, 69501, 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

Dresden, Saxony, 01069, Germany

RECRUITING

Kailera Clinical Site

Leipzig, Saxony, 04107, Germany

RECRUITING

Kailera Clinical Site

Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany

RECRUITING

Kailera Clinical Site

Hamburg, 22415, Germany

RECRUITING

Kailera Clinical Site

Hamburg, 22607, Germany

RECRUITING

Kailera Clinical Site

Schwerin, 19055, Germany

RECRUITING

Kailera Clinical Site

Grafton, Auckland, 1010, New Zealand

RECRUITING

Kailera Clinical Site

Hamilton, Waikato Region, 3200, New Zealand

RECRUITING

Kailera Clinical Site

Auckland, 0610, 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, 30-363, 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

Skierniewice, 96-100, Poland

RECRUITING

Kailera Clinical Site

Zamość, 22-400, Poland

RECRUITING

Kailera Clinical Site

Ferrol, A Coruna, 15402, Spain

RECRUITING

Kailera Clinical Site

Villamartín, Cadiz, 11650, Spain

RECRUITING

Kailera Clinical Site

Castilleja de la Cuesta, Sevilla, 41950, Spain

RECRUITING

Kailera Clinical Site

Barcelona, 08023, Spain

RECRUITING

Kailera Clinical Site

Madrid, 28003, Spain

RECRUITING

Kailera Clinical Site

Valencia, 46014, Spain

RECRUITING

Kailera Clinical Site

Soham, Cambridgeshire, NG72QW, United Kingdom

RECRUITING

Kailera Clinical Site

Torpoint, Cornwall, PL112TB, United Kingdom

RECRUITING

Kailera Clinical Site

Hull, East Yorkshire, HU32JZ, United Kingdom

RECRUITING

Kailera Clinical Site

Leicester, Leicestershire, LE54PW, United Kingdom

RECRUITING

Kailera Clinical Site

Nottingham, Nottinghamshire, NG72QW, United Kingdom

RECRUITING

Kailera Clinical Site

Hounslow, YW47NJ, United Kingdom

RECRUITING

Kailera Clinical Site

London, EC1M6BQ, United Kingdom

RECRUITING

Kailera Clinical Site

Manchester, M139WL, United Kingdom

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Medical Director

  Kailera Therapeutics, Inc.

  STUDY DIRECTOR

Central Study Contacts

Kailera Therapeutics, Inc.

CONTACT

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: December 18, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 22, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (24); NZ (4); AU (10); GB (8); AR (8); CZ (5); BU (8); DE (9); ES (6); PL (6)