Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes (KaiNETIC-2)

August 28, 2026 updated by: Kailera

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1156

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • CABA, Argentina, 1061
        • Recruiting
        • Kailera Clinical Site
      • CABA, Argentina, 1056
        • Recruiting
        • Kailera Clinical Site
      • Córdoba, Argentina, 5002
        • Recruiting
        • Kailera Clinical Site
    • Buenos Aires
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1120
        • Recruiting
        • Kailera Clinical Site
      • La Plata, Buenos Aires, Argentina, 1900
        • Recruiting
        • Kailera Clinical Site
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Recruiting
        • Kailera Clinical Site
      • San Nicolás de los Arroyos, Buenos Aires, Argentina, 2900
        • Recruiting
        • Kailera Clinical Site
      • Zárate, Buenos Aires, Argentina, 2800
        • Recruiting
        • Kailera Clinical Site
    • Buenos Aires F.D.
      • Buenos Aires, Buenos Aires F.D., Argentina, 1060
        • Recruiting
        • Kailera Clinical Site
    • Mendoza Province
      • Godoy Cruz, Mendoza Province, Argentina, 5501
        • Recruiting
        • Kailera Clinical Site
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, 2000
        • Recruiting
        • Kailera Clinical Site
    • Sante Fe
      • Rosario, Sante Fe, Argentina, 2000
        • Recruiting
        • Kailera Clinical Site
  • Australia
      • South Brisbane, Australia, 4101
        • Recruiting
        • Kailera Clinical Site
    • Australian Capital Territory
      • Bruce, Australian Capital Territory, Australia, 2617
        • Recruiting
        • Kailera Clinical Site
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Recruiting
        • Kailera Clinical Site
      • Charlestown, New South Wales, Australia, 2290
        • Recruiting
        • Kailera Clinical Site
      • Kanwal, New South Wales, Australia, 2259
        • Recruiting
        • Kailera Clinical Site
      • Leichhardt, New South Wales, Australia, 2040
        • Recruiting
        • Kailera Clinical Site
      • Penrith, New South Wales, Australia, 2750
        • Recruiting
        • Kailera Clinical Site
      • Sydney, New South Wales, Australia, 2228
        • Recruiting
        • Kailera Clinical Site
      • Sydney, New South Wales, Australia, 2100
        • Recruiting
        • Kailera Clinical Site
      • Wollongong, New South Wales, Australia, 2500
        • Recruiting
        • Kailera Clinical Site
    • Queensland
      • Herston, Queensland, Australia, 4006
        • Recruiting
        • Kailera Clinical Site
      • Morayfield, Queensland, Australia, 4506
        • Recruiting
        • Kailera Clinical Site
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Recruiting
        • Kailera Clinical Site
      • Melbourne, Victoria, Australia, 3025
        • Recruiting
        • Kailera Clinical Site
  • Bulgaria
      • Montana, Bulgaria, 3400
        • Recruiting
        • Kailera Clinical Site
    • Kyustendil Province
      • Kyustendil, Kyustendil Province, Bulgaria, 2500
        • Recruiting
        • Kailera Clinical Site
    • Pleven Province
      • Pleven, Pleven Province, Bulgaria, 5800
        • Recruiting
        • Kailera Clinical Site
    • Plovdiv Province
      • Plovdiv, Plovdiv Province, Bulgaria, 4020
        • Recruiting
        • Kailera Clinical Site
    • Ruse Province
      • Rousse, Ruse Province, Bulgaria, 7013
        • Recruiting
        • Kailera Clinical Site
    • Sofia
      • Sofia, Sofia, Bulgaria, 1606
        • Recruiting
        • Kailera Clinical Site
      • Sofia, Sofia, Bulgaria, 1618
        • Recruiting
        • Kailera Clinical Site
      • Sofia, Sofia, Bulgaria, 1527
        • Recruiting
        • Kailera Clinical Site
    • Stara Zagora Province
      • Stara Zagora, Stara Zagora Province, Bulgaria, 6000
        • Recruiting
        • Kailera Clinical Site
    • Varna Province
      • Varna, Varna Province, Bulgaria, 9000
        • Recruiting
        • Kailera Clinical Site
  • Czechia
      • Hodonín, Czechia, 69501
        • Recruiting
        • Kailera Clinical Site
      • Olomouc, Czechia, 77900
        • Recruiting
        • Kailera Clinical Site
      • Pardubice, Czechia, 53002
        • Recruiting
        • Kailera Clinical Site
      • Prague, Czechia, 15000
        • Recruiting
        • Kailera Clinical Site
      • Uherské Hradiště, Czechia, 68601
        • Recruiting
        • Kailera Clinical Site
    • Central Bohemia
      • Brandýs nad Labem, Central Bohemia, Czechia, 25001
        • Recruiting
        • Kailera Clinical Site
    • Hradec Králové Region
      • Náchod, Hradec Králové Region, Czechia, 54701
        • Recruiting
        • Kailera Clinical Site
      • Trutnov, Hradec Králové Region, Czechia, 54101
        • Recruiting
        • Kailera Clinical Site
    • Prague
      • Bohnice, Prague, Czechia, 18100
        • Recruiting
        • Kailera Clinical Site
      • Prague, Prague, Czechia, 14059
        • Recruiting
        • Kailera Clinical Site
    • South Moravian
      • Brno, South Moravian, Czechia, 60200
        • Recruiting
        • Kailera Clinical Site
    • Zlín
      • Holešov, Zlín, Czechia, 76901
        • Recruiting
        • Kailera Clinical Site
  • Germany
      • Schwerin, Germany, 19055
        • Recruiting
        • Kailera Clinical Site
    • Baden-Wurttemberg
      • Tübingen, Baden-Wurttemberg, Germany, 72076
        • Recruiting
        • Kailera Clinical Site
    • Brandenburg
      • Falkensee, Brandenburg, Germany, 14612
        • Recruiting
        • Kailera Clinical Site
    • North Rhine-Westphalia
      • Cologne, North Rhine-Westphalia, Germany, 51069
        • Recruiting
        • Kailera Clinical Site
      • Essen, North Rhine-Westphalia, Germany, 45355
        • Recruiting
        • Kailera Clinical Site
    • Schleswig-Holstein
      • Oldenburg in Holstein, Schleswig-Holstein, Germany, 23758
        • Recruiting
        • Kailera Clinical Site
  • New Zealand
      • Auckland, New Zealand, 1023
        • Recruiting
        • Kailera Clinical Site
      • Hastings, New Zealand, 4120
        • Recruiting
        • Kailera Clinical Site
      • Nelson, New Zealand, 7011
        • Recruiting
        • Kailera Clinical Site
    • Auckland
      • Grafton, Auckland, New Zealand, 1010
        • Recruiting
        • Kailera Clinical Site
      • New Lynn, Auckland, New Zealand, 0610
        • Recruiting
        • Kailera Clinical Site
      • Silverdale, Auckland, New Zealand, 0932
        • Recruiting
        • Kailera Clinical Site
      • Takapuna, Auckland, New Zealand, 0622
        • Recruiting
        • Kailera Clinical Site
    • Hamilton
      • Nawton, Hamilton, New Zealand, 3200
        • Recruiting
        • Kailera Clinical Site
  • Poland
      • Gdynia, Poland, 81-338
        • Recruiting
        • Kailera Clinical Site
      • Krakow, Poland, 30-363
        • Recruiting
        • Kailera Clinical Site
      • Warsaw, Poland, 02-677
        • Recruiting
        • Kailera Clinical Site
        • Contact:
          • Kailera Clinical Site Kailera Clinical Site
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-231
        • Recruiting
        • Kailera Clinical Site
      • Torun, Kuyavian-Pomeranian Voivodeship, Poland, 87-100
        • Recruiting
        • Kailera Clinical Site
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-033
        • Recruiting
        • Kailera Clinical Site
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-718
        • Recruiting
        • Kailera Clinical Site
    • Masovian Voivodeship
      • Siedlce, Masovian Voivodeship, Poland, 08-110
        • Recruiting
        • Kailera Clinical Site
      • Warsaw, Masovian Voivodeship, Poland, 00-872
        • Recruiting
        • Kailera Clinical Site
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-351
        • Recruiting
        • Kailera Clinical Site
    • Pomeranian Voivodeship
      • Gdynia, Pomeranian Voivodeship, Poland, 81-338
        • Recruiting
        • Kailera Clinical Site
    • Silesian Voivodeship
      • Chorzów, Silesian Voivodeship, Poland, 41-500
        • Recruiting
        • Kailera Clinical Site
    • Łódź Voivodeship
      • Skierniewice, Łódź Voivodeship, Poland, 96-100
        • Recruiting
        • Kailera Clinical Site
    • Świętokrzyskie Voivodeship
      • Kielce, Świętokrzyskie Voivodeship, Poland, 25-338
        • Recruiting
        • Kailera Clinical Site
  • Puerto Rico
      • Bayamón, Puerto Rico, 00959
        • Recruiting
        • Kailera Clinical Site
      • Ponce, Puerto Rico, 00716
        • Recruiting
        • Kailera Clinical Site
      • San Juan, Puerto Rico, 00907
        • Recruiting
        • Kailera Clinical Site
      • San Juan, Puerto Rico, 00909
        • Recruiting
        • Kailera Clinical Site
      • Vega Baja, Puerto Rico, 693
        • Recruiting
        • Kailera Clinical Site
  • Spain
      • Madrid, Spain, 28003
        • Recruiting
        • Kailera Clinical Site
      • Seville, Spain, 41003
        • Recruiting
        • Kailera Clinical Site
      • Seville, Spain, 41013
        • Recruiting
        • Kailera Clinical Site
      • Valencia, Spain, 46014
        • Recruiting
        • Kailera Clinical Site
    • A Coruna
      • Ferrol, A Coruna, Spain, 15402
        • Recruiting
        • Kailera Clinical Site
    • Andalusia
      • Seville, Andalusia, Spain, 41010
        • Recruiting
        • Kailera Clinical Site
    • Cadiz
      • Villamartín, Cadiz, Spain, 11650
        • Recruiting
        • Kailera Clinical Site
    • Catalonia
      • Barcelona, Catalonia, Spain, 08035
        • Recruiting
        • Kailera Clinical Site
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Recruiting
        • Kailera Clinical Site
    • Sevilla
      • Castilleja de la Cuesta, Sevilla, Spain, 41950
        • Recruiting
        • Kailera Clinical Site
  • United Kingdom
      • Manchester, United Kingdom, M13 9WL
        • Recruiting
        • Kailera Clinical Site
    • Cornwall
      • Truro, Cornwall, United Kingdom, TR1 3LJ
        • Recruiting
        • Kailera Clinical Site
    • Devon
      • Plymouth, Devon, United Kingdom, PL6 8DH
        • Recruiting
        • Kailera Clinical Site
    • Dorset
      • Bournemouth, Dorset, United Kingdom, BH7 7DW
        • Recruiting
        • Kailera Clinical Site
    • East Yorkshire
      • Hull, East Yorkshire, United Kingdom, HU3 2JZ
        • Recruiting
        • Kailera Clinical Site
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G51 4TF
        • Recruiting
        • Kailera Clinical Site
    • Greater London
      • London, Greater London, United Kingdom, EC1M 6BQ
        • Recruiting
        • Kailera Clinical Site
    • Hertfordshire
      • Stevenage, Hertfordshire, United Kingdom, SG1 4AB
        • Recruiting
        • Kailera Clinical Site
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE5 4PW
        • Recruiting
        • Kailera Clinical Site
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG7 2QW
        • Recruiting
        • Kailera Clinical Site
    • South Gloucestershire
      • Yate, South Gloucestershire, United Kingdom, BS37 4AX
        • Recruiting
        • Kailera Clinical Site
    • Tyne and Wear
      • Newcastle upon Tyne, Tyne and Wear, United Kingdom, NE1 4LP
        • Recruiting
        • Kailera Clinical Site
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD9 6RJ
        • Recruiting
        • Kailera Clinical Site
  • United States
    • Alabama
      • Cullman, Alabama, United States, 35055
        • Recruiting
        • Kailera Clinical Site
    • Arizona
      • Phoenix, Arizona, United States, 85012
        • Recruiting
        • Kailera Clinical Site
      • Sun City, Arizona, United States, 85351
        • Recruiting
        • Kailera Clinical Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • Kailera Clinical Site
    • California
      • Escondido, California, United States, 92025
        • Recruiting
        • Kailera Clinical Site
      • La Mesa, California, United States, 91942
        • Recruiting
        • Kailera Clinical Site
      • Montclair, California, United States, 91763
        • Recruiting
        • Kailera Clinical Site
      • Northridge, California, United States, 91325
        • Recruiting
        • Kailera Clinical Site
      • Oceanside, California, United States, 92058
        • Recruiting
        • Kailera Clinical Site
      • Toluca Lake, California, United States, 91602
        • Recruiting
        • Kailera Clinical Site
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Recruiting
        • Kailera Clinical Site
    • Florida
      • Bradenton, Florida, United States, 34209
        • Recruiting
        • Kailera Clinical Site
      • Jupiter, Florida, United States, 33458
        • Recruiting
        • Kailera Clinical Site
      • Miami, Florida, United States, 33135
        • Recruiting
        • Kailera Clinical Site
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Kailera Clinical Site
      • Orange City, Florida, United States, 32763
        • Recruiting
        • Kailera Clinical Site
      • Orlando, Florida, United States, 32801
        • Recruiting
        • Kailera Clinical Site
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Kailera Clinical Site
      • The Villages, Florida, United States, 32162
        • Recruiting
        • Kailera Clinical Site
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Recruiting
        • Kailera Clinical Site
      • Lilburn, Georgia, United States, 30047
        • Recruiting
        • Kailera Clinical Site
      • Riverdale, Georgia, United States, 30274
        • Recruiting
        • Kailera Clinical Site
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Recruiting
        • Kailera Clinical Site
      • Springfield, Illinois, United States, 62702
        • Active, not recruiting
        • Kailera Clinical Site
    • Kansas
      • Newton, Kansas, United States, 67114
        • Recruiting
        • Kailera Clinical Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71105
        • Recruiting
        • Kailera Clinical Site
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Recruiting
        • Kailera Clinical Site
      • Columbia, Maryland, United States, 21045
        • Recruiting
        • Kailera Clinical Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Kailera Clinical Site
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Kailera Clinical Site
    • Montana
      • Missoula, Montana, United States, 59804
        • Recruiting
        • Kailera Clinical Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Recruiting
        • Kailera Clinical Site
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • Kailera Clinical Site
    • New York
      • Albany, New York, United States, 12203
        • Recruiting
        • Kailera Clinical Site
      • Laurelton, New York, United States, 11413
        • Recruiting
        • Kailera Clinical Site
      • New York, New York, United States, 10016
        • Recruiting
        • Kailera Clinical Site
    • North Carolina
      • Greensboro, North Carolina, United States, 27405
        • Recruiting
        • Kailera Clinical Site
      • Monroe, North Carolina, United States, 28112
        • Recruiting
        • Kailera Clinical Site
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • Kailera Clinical Site
      • Morrisville, North Carolina, United States, 27560
        • Recruiting
        • Kailera Clinical Site
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Recruiting
        • Kailera Clinical Site
    • Oklahoma
      • Chickasha, Oklahoma, United States, 73018
        • Recruiting
        • Kailera Clinical Site
    • Rhode Island
      • East Greenwich, Rhode Island, United States, 02818
        • Recruiting
        • Kailera Clinical Site
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Kailera Clinical Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37405
        • Active, not recruiting
        • Kailera Clinical Site
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • Kailea Clinical Site
    • Texas
      • Amarillo, Texas, United States, 79124
        • Recruiting
        • Kailera Clinical Site
      • Brownsville, Texas, United States, 78526
        • Recruiting
        • Kailera Clinical Site
      • DeSoto, Texas, United States, 75115
        • Recruiting
        • Kailera Clinical Site
      • El Paso, Texas, United States, 79902
        • Recruiting
        • Kailera Clinical Site
      • Farmers Branch, Texas, United States, 75234
        • Recruiting
        • Kailera Clinical Site
      • Kingwood, Texas, United States, 77345
        • Recruiting
        • Kailera Clinical Site
      • Plano, Texas, United States, 75093
        • Recruiting
        • Kailera Clinical Site
      • Tomball, Texas, United States, 77375
        • Recruiting
        • Kailera Clinical Site
    • Utah
      • Pleasant View, Utah, United States, 84404
        • Recruiting
        • Kailera Clinical Site
      • Salt Lake City, Utah, United States, 84117
        • Recruiting
        • Kailera Clinical Site
    • Virginia
      • Manassas, Virginia, United States, 20110
        • Recruiting
        • Kailera Clinical Site
      • Richmond, Virginia, United States, 23236
        • Recruiting
        • Kailera Clinical Site
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Kailera Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ribupatide: Dose 1
Participants will receive Dose 1 of ribupatide once weekly.
Drug: Ribupatide
SC Injection
Other Names:
  • KAI-9531
Experimental: Ribupatide: Dose 2
Participants will receive Dose 2 of ribupatide once weekly.
Drug: Ribupatide
SC Injection
Other Names:
  • KAI-9531
Experimental: Ribupatide: Dose 3
Participants will receive Dose 3 of ribupatide once weekly.
Drug: Ribupatide
SC Injection
Other Names:
  • KAI-9531
Experimental: Ribupatide: Dose 4
Participants will receive Dose 4 of ribupatide once weekly.
Drug: Ribupatide
SC Injection
Other Names:
  • KAI-9531
Placebo Comparator: Placebo
Participants will receive placebo matched to ribupatide once weekly.
Drug: Placebo
SC Injection

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Waist Circumference
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in Absolute Body Weight
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in Systolic Blood Pressure (SBP)
Time Frame: Baseline, Week 76
Baseline, Week 76
Percent Change From Baseline in Fasting Triglycerides
Time Frame: Baseline, Week 76
Baseline, Week 76
Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol
Time Frame: Baseline, Week 76
Baseline, Week 76
Percent Change From Baseline in Fasting Non-HDL-cholesterol
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score
Time Frame: Baseline, Week 76
Baseline, Week 76
Percentage of Participants with ≥30% Reduction in Body Weight
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in Control of Eating Questionnaire (CoEQ) Craving Control Score
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in CoEQ Positive Mood Score
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in CoEQ Craving for Sweets Score
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in CoEQ Craving for Savory Food Score
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in CoEQ Hunger Score
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in CoEQ Satiety Score
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in CoEQ Combined Score
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in Food Noise Questionnaire (FNQ) Score
Time Frame: Baseline, Week 76
Baseline, Week 76
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Day 1 up to Week 80
Day 1 up to Week 80
Number of Participants With Anti-drug Antibodies (ADAs)
Time Frame: Up to Week 80
Up to Week 80
Number of Participants With Neutralizing Antibodies (Nabs)
Time Frame: Up to Week 80
Up to Week 80
Percentage of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in Fasting Blood Glucose
Time Frame: Baseline, Week 76
Baseline, Week 76
Participants with Body Mass Index (BMI) ≥35 Kilograms per Square Meter (kg/m^2): Percent Change From Baseline in Body Weight
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in BMI
Time Frame: Baseline, Week 76
Baseline, Week 76
Percentage of Participants with HbA1c <5.7%
Time Frame: Baseline, Week 76
Baseline, Week 76
Change From Baseline in Diastolic Blood Pressure (DBP)
Time Frame: Baseline, Week 76
Baseline, Week 76
Percent Change From Baseline in Fasting Total Cholesterol
Time Frame: Baseline, Week 76
Baseline, Week 76
Percent Change From Baseline in Fasting Low-density Lipoprotein (LDL)-cholesterol
Time Frame: Baseline, Week 76
Baseline, Week 76
Percent Change From Baseline in Very Low-density Lipoprotein (VLDL)-cholesterol
Time Frame: Baseline, Week 76
Baseline, Week 76
Percent Change From Baseline in Fasting Insulin
Time Frame: Baseline, Week 76
Baseline, Week 76
Doses 1 and 2 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Time Frame: Baseline, Week 76
Baseline, Week 76
Doses 1 and 2 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76
Time Frame: Baseline, Week 76
Baseline, Week 76
Percentage of Participants with HbA1c <7% and ≤6.5%
Time Frame: Baseline, Week 76
Baseline, Week 76
Plasma Concentrations of Ribupatide
Time Frame: Up to Week 76
Up to Week 76

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kailera

Investigators

  • Study Director: Medical Director, Kailera Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 12, 2026

Primary Completion (Estimated)

March 27, 2028

Study Completion (Estimated)

April 24, 2028

Study Registration Dates

First Submitted

December 9, 2025

First Submitted That Met QC Criteria

December 9, 2025

First Posted (Actual)

December 16, 2025

Study Record Updates

Last Update Posted (Actual)

September 1, 2026

Last Update Submitted That Met QC Criteria

August 28, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K9531-3104
  • 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
  • 2025-523510-87-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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