Obesity With DiabetesPhase 3KaiNETIC-2NCT07284901
Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes
A Phase 3 study testing Ribupatide in people with Obesity With Diabetes and Overweight With Diabetes, run by Kailera at 173 sites in 11 countries.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity With Diabetes, Overweight With Diabetes
- What is being tested?
- Ribupatide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,270 participants
- Where
- 173 sitesin 11 countries
- Study dates
- 12 Jan 2026to 24 Apr 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 13Show fewer
- 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.
Trial locations and contacts
173 sites in 11 countries.
173 sites in 11 countries
United States62 sites
Kailera Clinical Site
Albany, New York, 12203
Kailera Clinical Site
Amarillo, Texas, 79124
Kailera Clinical Site
Annapolis, Maryland, 21401
Kailera Clinical Site
Boston, Massachusetts, 02115
Kailera Clinical Site
Bradenton, Florida, 34209
Kailera Clinical Site
Brownsville, Texas, 78526
Kailera Clinical Site
Chattanooga, Tennessee, 37405
Kailera Clinical Site
Chickasha, Oklahoma, 73018
Kailera Clinical Site
Cleveland, Ohio, 44122
Kailera Clinical Site
Columbia, Maryland, 21045
Kailera Clinical Site
Cullman, Alabama, 35055
Kailera Clinical Site
Decatur, Georgia, 30030
Kailera Clinical Site
DeSoto, Texas, 75115
Kailera Clinical Site
East Greenwich, Rhode Island, 02818
Kailera Clinical Site
El Paso, Texas, 79902
Kailera Clinical Site
Escondido, California, 92025
Kailera Clinical Site
Farmers Branch, Texas, 75234
Kailera Clinical Site
Farmington Hills, Michigan, 48334
Kailera Clinical Site
Greensboro, North Carolina, 27405
Kailera Clinical Site
Hollywood, Florida, 33024
Kailera Clinical Site
Jupiter, Florida, 33458
Kailera Clinical Site
Kingwood, Texas, 77345
Kailera Clinical Site
La Mesa, California, 91942
Kailera Clinical Site
Las Vegas, Nevada, 89148
Kailera Clinical Site
Laurelton, New York, 11413
Kailera Clinical Site
Lilburn, Georgia, 30047
Kailera Clinical Site
Lincoln, Nebraska, 68516
Kailera Clinical Site
Little Rock, Arkansas, 72205
Kailera Clinical Site
Manassas, Virginia, 20110
Kailera Clinical Site
Marietta, Georgia, 30060
Kailera Clinical Site
Memphis, Tennessee, 38119
Kailera Clinical Site
Miami, Florida, 33135
Kailera Clinical Site
Miami Lakes, Florida, 33016
Kailera Clinical Site
Missoula, Montana, 59804
Kailera Clinical Site
Monroe, North Carolina, 28112
Kailera Clinical Site
Montclair, California, 91763
Kailera Clinical Site #1
Morehead City, North Carolina, 28557
Kailera Clinical Site #2
Morehead City, North Carolina, 28557
Kailera Clinical Site
Morrisville, North Carolina, 27560
Kailera Clinical Site
New York, New York, 10016
Kailera Clinical Site
Newton, Kansas, 67114
Kailera Clinical Site
Northridge, California, 91325
Kailera Clinical Site
Oceanside, California, 92058
Kailera Clinical Site
Orange City, Florida, 32763
Kailera Clinical Site
Orlando, Florida, 32801
Kailera Clinical Site
Orlando, Florida, 32803
Kailera Clinical Site
Phoenix, Arizona, 85012
Kailera Clinical Site
Plano, Texas, 75093
Kailera Clinical Site
Pleasant View, Utah, 84404
Kailera Clinical Site
Richmond, Virginia, 23236
Kailera Clinical Site
Riverdale, Georgia, 30274
Kailera Clinical Site
Salt Lake City, Utah, 84117
Kailera Clinical Site
Seattle, Washington, 98104
Kailera Clinical Site
Shreveport, Louisiana, 71105
Kailera Clinical Site
Skokie, Illinois, 60077
Kailera Clinical Site
Spartanburg, South Carolina, 29303
Kailera Clinical Site
Springfield, Illinois, 62702
Kailera Clinical Site
Stamford, Connecticut, 06905
Kailera Clinical Site
Sun City, Arizona, 85351
Kailera Clinical Site
The Villages, Florida, 32162
Kailera Clinical Site
Toluca Lake, California, 91602
Kailera Clinical Site
Tomball, Texas, 77375
Argentina17 sites
Kailera Clinical Site #1
Buenos Aires, 1056
Kailera Clinical Site #2
Buenos Aires, 1056
Kailera Clinical Site
Buenos Aires, 1060
Kailera Clinical Site
Buenos Aires, 1061
Kailera Clinical Site
Buenos Aires, 1128
Kailera Clinical Site
Ciudad Autonoma de Buenos Aires, Buenos Aires, 1120
Kailera Clinical Site
Córdoba, 5000
Kailera Clinical Site
Córdoba, 5002
Kailera Clinical Site
Godoy Cruz, Mendoza Province, 5501
Kailera Clinical Site
La Plata, Buenos Aires, 1900
Kailera Clinical Site
Mar del Plata, Buenos Aires, 7600
Kailera Clinical Site #1
Rosario, Santa Fe Province, 2000
Kailera Clinical Site #2
Rosario, Santa Fe Province, 2000
Kailera Clinical Site #3
Rosario, Santa Fe Province, 2000
Kailera Clinical Site #4
Rosario, Sante Fe, 2000
Kailera Clinical Site
San Nicolás de los Arroyos, Buenos Aires, 2900
Kailera Clinical Site
Zárate, Buenos Aires, 2800
Australia14 sites
Kailera Clinical Site
Blacktown, New South Wales, 2148
Kailera Clinical Site
Bruce, Australian Capital Territory, 2617
Kailera Clinical Site
Camberwell, Victoria, 3124
Kailera Clinical Site
Charlestown, New South Wales, 2290
Kailera Clinical Site
Herston, Queensland, 4006
Kailera Clinical Site
Kanwal, New South Wales, 2259
Kailera Clinical Site
Leichhardt, New South Wales, 2040
Kailera Clinical Site
Melbourne, Victoria, 3025
Kailera Clinical Site
Morayfield, Queensland, 4506
Kailera Clinical Site
Penrith, New South Wales, 2750
Kailera Clinical Site
South Brisbane, 4101
Kailera Clinical Site
Sydney, New South Wales, 2100
Kailera Clinical Site
Sydney, New South Wales, 2228
Kailera Clinical Site
Wollongong, New South Wales, 2500
Poland14 sites
Kailera Clinical Site
Bialystok, Podlaskie Voivodeship, 15-351
Kailera Clinical Site
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-231
Kailera Clinical Site
Chorzów, Silesian Voivodeship, 41-500
Kailera Clinical Site #1
Gdynia, Pomeranian Voivodeship, 81-338
Kailera Clinical Site #2
Gdynia, Pomeranian Voivodeship, 81-338
Kailera Clinical Site
Kielce, Świętokrzyskie Voivodeship, 25-338
Kailera Clinical Site
Krakow, Lesser Poland Voivodeship, 30-033
Kailera Clinical Site
Krakow, 30-363
Kailera Clinical Site
Lublin, Lublin Voivodeship, 20-718
Kailera Clinical Site
Siedlce, Masovian Voivodeship, 08-110
Kailera Clinical Site
Skierniewice, Łódź Voivodeship, 96-100
Kailera Clinical Site
Torun, Kuyavian-Pomeranian Voivodeship, 87-100
Kailera Clinical Site
Warsaw, Masovian Voivodeship, 00-872
Kailera Clinical Site
Warsaw, 02-677
United Kingdom13 sites
Kailera Clinical Site
Bournemouth, Dorset, BH7 7DW
Kailera Clinical Site
Bradford, West Yorkshire, BD9 6RJ
Kailera Clinical Site
Glasgow, Glasgow City, G51 4TF
Kailera Clinical Site
Hull, East Yorkshire, HU3 2JZ
Kailera Clinical Site
Leicester, Leicestershire, LE5 4PW
Kailera Clinical Site
London, Greater London, EC1M 6BQ
Kailera Clinical Site
Manchester, M13 9WL
Kailera Clinical Site
Newcastle upon Tyne, Tyne and Wear, NE1 4LP
Kailera Clinical Site
Nottingham, Nottinghamshire, NG7 2QW
Kailera Clinical Site
Plymouth, Devon, PL6 8DH
Kailera Clinical Site
Stevenage, Hertfordshire, SG1 4AB
Kailera Clinical Site
Truro, Cornwall, TR1 3LJ
Kailera Clinical Site
Yate, South Gloucestershire, BS37 4AX
Czechia12 sites
Kailera Clinical Site
Bohnice, Prague, 18100
Kailera Clinical Site
Brandýs nad Labem, Central Bohemia, 25001
Kailera Clinical Site
Brno, South Moravian, 60200
Kailera Clinical Site
Hodonín, 69501
Kailera Clinical Site
Holešov, Zlín, 76901
Kailera Clinical Site
Náchod, Hradec Králové Region, 54701
Kailera Clinical Site
Olomouc, 77900
Kailera Clinical Site
Pardubice, 53002
Kailera Clinical Site
Prague, Prague, 14059
Kailera Clinical Site
Prague, 15000
Kailera Clinical Site
Trutnov, Hradec Králové Region, 54101
Kailera Clinical Site
Uherské Hradiště, 68601
Bulgaria10 sites
Kailera Clinical Site
Kyustendil, Kyustendil Province, 2500
Kailera Clinical Site
Montana, 3400
Kailera Clinical Site
Pleven, Pleven Province, 5800
Kailera Clinical Site
Plovdiv, Plovdiv Province, 4020
Kailera Clinical Site
Rousse, Ruse Province, 7013
Kailera Clinical Site
Sofia, Sofia, 1527
Kailera Clinical Site
Sofia, Sofia, 1606
Kailera Clinical Site
Sofia, Sofia, 1618
Kailera Clinical Site
Stara Zagora, Stara Zagora Province, 6000
Kailera Clinical Site
Varna, Varna Province, 9000
Spain10 sites
Kailera Clinical Site
Barcelona, Catalonia, 08035
Kailera Clinical Site
Castilleja de la Cuesta, Sevilla, 41950
Kailera Clinical Site
Ferrol, A Coruna, 15402
Kailera Clinical Site
Madrid, 28003
Kailera Clinical Site
Oviedo, Principality of Asturias, 33011
Kailera Clinical Site
Seville, Andalusia, 41010
Kailera Clinical Site
Seville, 41003
Kailera Clinical Site
Seville, 41013
Kailera Clinical Site
Valencia, 46014
Kailera Clinical Site
Villamartín, Cadiz, 11650
New Zealand8 sites
Kailera Clinical Site
Auckland, 1023
Kailera Clinical Site
Grafton, Auckland, 1010
Kailera Clinical Site
Hastings, 4120
Kailera Clinical Site
Nawton, Hamilton, 3200
Kailera Clinical Site
Nelson, 7011
Kailera Clinical Site
New Lynn, Auckland, 0610
Kailera Clinical Site
Silverdale, Auckland, 0932
Kailera Clinical Site
Takapuna, Auckland, 0622
Germany7 sites
Kailera Clinical Site
Cologne, North Rhine-Westphalia, 51069
Kailera Clinical Site #1
Essen, North Rhine-Westphalia, 45355
Kailera Clinical Site #2
Essen, North Rhine-Westphalia, 45355
Kailera Clinical Site
Falkensee, Brandenburg, 14612
Kailera Clinical Site
Oldenburg in Holstein, Schleswig-Holstein, 23758
Kailera Clinical Site
Schwerin, 19055
Kailera Clinical Site
Tübingen, Baden-Wurttemberg, 72076
Puerto Rico6 sites
Kailera Clinical Site #1
Bayamón, 00959
Kailera Clinical Site #2
Bayamón, 00959
Kailera Clinical Site
Ponce, 00716
Kailera Clinical Site
San Juan, 00907
Kailera Clinical Site
San Juan, 00909
Kailera Clinical Site
Vega Baja, 693
About this study
Official title: 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)
- Conditions
- Obesity With Diabetes, Overweight With Diabetes
- Being tested
- Ribupatide, Placebo
- Keywords
- Obesity, Overweight, Ribupatide, KAI-9531, Glucagon-like peptide-1, GLP-1, Diabetes, Glucose-dependent Insulinotropic Peptide, GIP
- Medical subject headings
- Obesity, Overweight, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibupatideDrug
Also called KAI-9531
SC Injection
PlaceboDrug
SC Injection
| Study group | Role | What they receive |
|---|---|---|
| Ribupatide: Dose 1 | Experimental | Participants will receive Dose 1 of ribupatide once weekly. Receives: Drug: Ribupatide |
| Ribupatide: Dose 2 | Experimental | Participants will receive Dose 2 of ribupatide once weekly. Receives: Drug: Ribupatide |
| Ribupatide: Dose 3 | Experimental | Participants will receive Dose 3 of ribupatide once weekly. Receives: Drug: Ribupatide |
| Ribupatide: Dose 4 | Experimental | Participants will receive Dose 4 of ribupatide once weekly. Receives: Drug: Ribupatide |
| Placebo | Placebo comparator | Participants will receive placebo matched to ribupatide once weekly. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Doses 3 and 4 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Measured: Baseline, Week 76
Doses 3 and 4 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76
Measured: Baseline, Week 76
Secondary outcomes (33)
Doses 1 and 2 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Measured: Baseline, Week 76
Doses 1 and 2 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76
Measured: Baseline, Week 76
Percentage of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight
Measured: Baseline, Week 76
Change From Baseline in Waist Circumference
Measured: Baseline, Week 76
Change From Baseline in Absolute Body Weight
Measured: Baseline, Week 76
Percentage of Participants with HbA1c <7% and ≤6.5%
Measured: Baseline, Week 76
Change From Baseline in Fasting Blood Glucose
Measured: Baseline, Week 76
Change From Baseline in Systolic Blood Pressure (SBP)
Measured: Baseline, Week 76
Percent Change From Baseline in Fasting Triglycerides
Measured: Baseline, Week 76
Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol
Measured: Baseline, Week 76
Percent Change From Baseline in Fasting Non-HDL-cholesterol
Measured: 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
Measured: Baseline, Week 76
Participants with Body Mass Index (BMI) ≥35 Kilograms per Square Meter (kg/m^2): Percent Change From Baseline in Body Weight
Measured: Baseline, Week 76
Percentage of Participants with ≥30% Reduction in Body Weight
Measured: Baseline, Week 76
Change From Baseline in BMI
Measured: Baseline, Week 76
Percentage of Participants with HbA1c <5.7%
Measured: Baseline, Week 76
Change From Baseline in Diastolic Blood Pressure (DBP)
Measured: Baseline, Week 76
Percent Change From Baseline in Fasting Total Cholesterol
Measured: Baseline, Week 76
Percent Change From Baseline in Fasting Low-density Lipoprotein (LDL)-cholesterol
Measured: Baseline, Week 76
Percent Change From Baseline in Very Low-density Lipoprotein (VLDL)-cholesterol
Measured: Baseline, Week 76
Percent Change From Baseline in Fasting Insulin
Measured: Baseline, Week 76
Change From Baseline in Control of Eating Questionnaire (CoEQ) Craving Control Score
Measured: Baseline, Week 76
Change From Baseline in CoEQ Positive Mood Score
Measured: Baseline, Week 76
Change From Baseline in CoEQ Craving for Sweets Score
Measured: Baseline, Week 76
Change From Baseline in CoEQ Craving for Savory Food Score
Measured: Baseline, Week 76
Change From Baseline in CoEQ Hunger Score
Measured: Baseline, Week 76
Change From Baseline in CoEQ Satiety Score
Measured: Baseline, Week 76
Change From Baseline in CoEQ Combined Score
Measured: Baseline, Week 76
Change From Baseline in Food Noise Questionnaire (FNQ) Score
Measured: Baseline, Week 76
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Day 1 up to Week 80
Number of Participants With Anti-drug Antibodies (ADAs)
Measured: Up to Week 80
Number of Participants With Neutralizing Antibodies (Nabs)
Measured: Up to Week 80
Plasma Concentrations of Ribupatide
Measured: Up to Week 76
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start12 Jan 2026
- Primary completion27 Mar 2028 (estimated)
- Study completion24 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity With DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kailera
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Kailera Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07284901
- Sponsor's protocol ID
- K9531-3104
- Other IDs
- 2025-523510-87-00, 2025
- Acronym
- KaiNETIC-2
- Status last verified
- Oct 2026
- First submitted
- 9 Dec 2025
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07284901
- Acronym / sponsor ID
- KaiNETIC-2 / K9531-3104
- Conditions
- Obesity With Diabetes, Overweight With Diabetes
- Keywords
- Obesity, Overweight, Ribupatide, KAI-9531, Glucagon-like peptide-1, GLP-1, Diabetes, Glucose-dependent Insulinotropic Peptide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,270 participants (actual)
- Lead sponsor
- KaileraIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2026 (actual)
- Primary completion
- 27 Mar 2028 (estimated)
- Study completion
- 24 Apr 2028 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Ribupatide: Dose 1 | Experimental | Drug: RibupatideParticipants will receive Dose 1 of ribupatide once weekly. |
| Ribupatide: Dose 2 | Experimental | Drug: RibupatideParticipants will receive Dose 2 of ribupatide once weekly. |
| Ribupatide: Dose 3 | Experimental | Drug: RibupatideParticipants will receive Dose 3 of ribupatide once weekly. |
| Ribupatide: Dose 4 | Experimental | Drug: RibupatideParticipants will receive Dose 4 of ribupatide once weekly. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive placebo matched to ribupatide once weekly. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RibupatideAlso: KAI-9531SC Injection | Drug | Ribupatide: Dose 1, Ribupatide: Dose 2, Ribupatide: Dose 3, Ribupatide: Dose 4 |
| PlaceboSC Injection | Drug | Placebo |
Primary outcome
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
33 secondary outcomes
Doses 1 and 2 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Time frame: Baseline, Week 76
Doses 1 and 2 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76
Time frame: Baseline, Week 76
Percentage of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight
Time frame: Baseline, Week 76
Change From Baseline in Waist Circumference
Time frame: Baseline, Week 76
Change From Baseline in Absolute Body Weight
Time frame: Baseline, Week 76
Percentage of Participants with HbA1c <7% and ≤6.5%
Time frame: Baseline, Week 76
Change From Baseline in Fasting Blood Glucose
Time frame: Baseline, Week 76
Change From Baseline in Systolic Blood Pressure (SBP)
Time frame: Baseline, Week 76
Percent Change From Baseline in Fasting Triglycerides
Time frame: Baseline, Week 76
Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol
Time frame: Baseline, Week 76
Percent Change From Baseline in Fasting Non-HDL-cholesterol
Time frame: 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
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
Percentage of Participants with ≥30% Reduction in Body Weight
Time frame: Baseline, Week 76
Change From Baseline in BMI
Time frame: Baseline, Week 76
Percentage of Participants with HbA1c <5.7%
Time frame: Baseline, Week 76
Change From Baseline in Diastolic Blood Pressure (DBP)
Time frame: Baseline, Week 76
Percent Change From Baseline in Fasting Total Cholesterol
Time frame: Baseline, Week 76
Percent Change From Baseline in Fasting Low-density Lipoprotein (LDL)-cholesterol
Time frame: Baseline, Week 76
Percent Change From Baseline in Very Low-density Lipoprotein (VLDL)-cholesterol
Time frame: Baseline, Week 76
Percent Change From Baseline in Fasting Insulin
Time frame: Baseline, Week 76
Change From Baseline in Control of Eating Questionnaire (CoEQ) Craving Control Score
Time frame: Baseline, Week 76
Change From Baseline in CoEQ Positive Mood Score
Time frame: Baseline, Week 76
Change From Baseline in CoEQ Craving for Sweets Score
Time frame: Baseline, Week 76
Change From Baseline in CoEQ Craving for Savory Food Score
Time frame: Baseline, Week 76
Change From Baseline in CoEQ Hunger Score
Time frame: Baseline, Week 76
Change From Baseline in CoEQ Satiety Score
Time frame: Baseline, Week 76
Change From Baseline in CoEQ Combined Score
Time frame: Baseline, Week 76
Change From Baseline in Food Noise Questionnaire (FNQ) Score
Time frame: Baseline, Week 76
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 up to Week 80
Number of Participants With Anti-drug Antibodies (ADAs)
Time frame: Up to Week 80
Number of Participants With Neutralizing Antibodies (Nabs)
Time frame: Up to Week 80
Plasma Concentrations of Ribupatide
Time frame: Up to Week 76
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Kailera Therapeutics, Inc.
173 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ribupatide in people with Obesity With Diabetes and Overweight With Diabetes, run by Kailera at 173 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 173 sites in United States, Argentina, Australia, Poland, United Kingdom and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.