ObesityPhase 3KaiNETIC-3NCT07284979
Efficacy and Safety of Ribupatide Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes
A Phase 3 study testing Ribupatide and Semaglutide in people with Obesity, run by Kailera at 60 sites in 5 countries.
Trial summary
The primary objective of this study is to demonstrate that ribupatide (KAI-9531) subcutaneous (SC) injection once weekly is superior to semaglutide SC once weekly and to placebo SC once weekly on percent change in body weight. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- Ribupatide and Semaglutide
- 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
- 60 sitesin 5 countries
- Study dates
- 30 Dec 2025to 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
- BMI ≥35 kilograms per square meter (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 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, and phentermine.
- Unstable weight defined as self-reported change in body weight exceeding 5% within the 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.
Show all 11Show fewer
- 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, glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1/glucose-dependent insulinotropic polypeptide (GIP), or glucagon receptor agonist within 3 months prior to Screening.
- Note: Additional inclusion/exclusion criteria may apply, per protocol.
Trial locations and contacts
60 sites in 5 countries.
60 sites in 5 countries
United States28 sites
Kailera Clinical Site
Albany, Georgia, 31707
Kailera Clinical Site
Albany, New York, 12203
Kailera Clinical Site
Brownsville, Texas, 78526
Kailera Clinical Site
Chicago, Illinois, 60640
Kailera Clinical Site
East Greenwich, Rhode Island, 02818
Kailera Clinical Site
Farmington Hills, Michigan, 48334
Kailera Clinical Site
Glendale, Arizona, 85308
Kailera Clinical Site
Hamden, Connecticut, 06517
Kailera Clinical Site
Las Vegas, Nevada, 89148
Kailera Clinical Site
Little Rock, Arkansas, 72205
Kailera Clinical Site
Manassas, Virginia, 20110
Kailera Clinical Site
Missoula, Montana, 59804
Kailera Clinical Site
Morehead City, North Carolina, 28557
Kailera Clinical Site
Morrisville, North Carolina, 27560
Kailera Clinical Site
Newton, Kansas, 67114
Kailera Clinical Site
Norman, Oklahoma, 73069
Kailera Clinical Site
North Charleston, South Carolina, 29405
Kailera Clinical Site
Northridge, California, 91325
Kailera Clinical Site
Oceanside, California, 92058
Kailera Clinical Site
Orange City, Florida, 32763
Kailera Clinical Site
Phoenix, Arizona, 85012
Kailera Clinical Site
Richmond, Virginia, 23236
Kailera Clinical Site #1
San Antonio, Texas, 78229
Kailera Clinical Site #2
San Antonio, Texas, 78229
Kailera Clinical Site
Shreveport, Louisiana, 71105
Kailera Clinical Site
Skokie, Illinois, 60077
Kailera Clinical Site
Spartanburg, South Carolina, 29303
Kailera Clinical Site
Stamford, Connecticut, 06905
Bulgaria9 sites
Kailera Clinical Site
Montana, 3400
Kailera Clinical Site
Pleven, Pleven Province, 5800
Kailera Clinical Site
Plovdiv, Plovdiv Province, 4000
Kailera Clinical Site
Sofia, Sofia, 1606
Kailera Clinical Site
Sofia, Sofia, 1618
Kailera Clinical Site
Sofia, 1606
Kailera Clinical Site
Sofia, 1616
Kailera Clinical Site
Stara Zagora, 6000
Kailera Clinical Site
Varna, Varna Province, 9000
Poland8 sites
Kailera Clinical Site
Bydgoszcz, 85-231
Kailera Clinical Site
Chorzów, Silesian Voivodeship, 41-500
Kailera Clinical Site
Gdynia, Pomeranian Voivodeship, 81-384
Kailera Clinical Site
Gdynia, 81-338
Kailera Clinical Site
Kielce, Świętokrzyskie Voivodeship, 25-338
Kailera Clinical Site
Krakow, Lesser Poland Voivodeship, 30-033
Kailera Clinical Site
Warsaw, Masovian Voivodeship, 01-696
Kailera Clinical Site
Wroclaw, 51-162
United Kingdom8 sites
Kailera Clinical Site
Exeter, Devon, EX2 5DW
Kailera Clinical Site
Glasgow, Glasgow City, G51 4TF
Kailera Clinical Site
Leicester, Leicestershire, LE5 4PW
Kailera Clinical Site
London, Greater London, SE1 9RT
Kailera Clinical Site
London, Greater London, SW1P 2PF
Kailera Clinical Site
Rotherham, South Yorkshire, S65 1DA
Kailera Clinical Site
Torquay, Devon, TQ2 7AA
Kailera Clinical Site
Weymouth, Dorset, DT4 0QE
Australia7 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
Herston, Queensland, 4006
Kailera Clinical Site
Kanwal, New South Wales, 2259
Kailera Clinical Site
Morayfield, Queensland, 4506
Kailera Clinical Site
South Brisbane, Queensland, 4101
About this study
Official title: A Phase 3, Randomized, Active- and Placebo-Controlled, Partially-Blinded Study to Compare the Efficacy and Safety of KAI-9531 Administered Once Weekly Versus Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes
The primary objective of this study is to demonstrate that ribupatide (KAI-9531) subcutaneous (SC) injection once weekly is superior to semaglutide SC once weekly and to placebo SC once weekly on percent change in body weight.
- Conditions
- Obesity
- Being tested
- Ribupatide, Semaglutide, Placebo
- Keywords
- Obesity, Ribupatide, KAI-9531, Glucagon-like peptide-1, GLP-1, Semaglutide, Glucose-dependent Insulinotropic Peptide, GIP
- Medical subject headings
- Obesity
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
SemaglutideDrug
Also called Wegovy
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 |
| Semaglutide | Active comparator | Participants will receive semaglutide once weekly. Receives: Drug: Semaglutide |
| 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.
Percent Change From Baseline in Body Weight at Week 76
Measured: Baseline, Week 76
Secondary outcomes (23)
Percentage of Participants with ≥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 ≥5% Reduction in Body Weight
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
Percentage of Participants with ≥30% Reduction in Body Weight
Measured: Baseline, Week 76
Change From Baseline in Body Mass Index (BMI)
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 start30 Dec 2025
- Primary completionMar 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- NCT07284979
- Sponsor's protocol ID
- K9531-3107
- Other IDs
- 2025-523511-11-00, 2025
- Acronym
- KaiNETIC-3
- 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, Active- and Placebo-Controlled, Partially-Blinded Study to Compare the Efficacy and Safety of KAI-9531 Administered Once Weekly Versus Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes
- ClinicalTrials.gov ID
- NCT07284979
- Acronym / sponsor ID
- KaiNETIC-3 / K9531-3107
- Conditions
- Obesity
- Keywords
- Obesity, Ribupatide, KAI-9531, Glucagon-like peptide-1, GLP-1, Semaglutide, Glucose-dependent Insulinotropic Peptide, GIP
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,270 participants (actual)
- Lead sponsor
- KaileraIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- 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 semaglutide SC once weekly and to placebo SC once weekly on percent change in body weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| 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. |
| Semaglutide | Active comparator | Drug: SemaglutideParticipants will receive semaglutide 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 (2 listed)
- BMI ≥35 kilograms per square meter (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 (11 listed)
- 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, and phentermine.
- Unstable weight defined as self-reported change in body weight exceeding 5% within the 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.
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 |
| SemaglutideAlso: WegovySC Injection | Drug | Semaglutide |
| PlaceboSC Injection | Drug | Placebo |
Primary outcome
Percent Change From Baseline in Body Weight at Week 76
Time frame: Baseline, Week 76
23 secondary outcomes
Percentage of Participants with ≥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 ≥5% Reduction in Body Weight
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
Percentage of Participants with ≥30% Reduction in Body Weight
Time frame: Baseline, Week 76
Change From Baseline in Body Mass Index (BMI)
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.
60 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ribupatide and Semaglutide in people with Obesity, run by Kailera at 60 sites in 5 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 2 inclusion and 11 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 60 sites in United States, Bulgaria, Poland, United Kingdom, Australia. 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?
Percent Change From Baseline in Body Weight at Week 76 (time frame: Baseline, Week 76). 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.