ObesityPhase 2NCT07458269
Efficacy and Safety of Ribupatide (KAI-9531) Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes
A Phase 2 study testing Ribupatide in people with Obesity, run by Kailera at 35 sites in United States.
Trial summary
The primary objective of this study is to determine the effects of ribupatide administered by subcutaneous (SC) injection once weekly compared to placebo 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
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 264 participants
- Where
- 35 sitesUnited States
- Study dates
- 4 Mar 2026to Jun 2027
- Phase
- Phase 2
- 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 meter squared (kg/m^2).
- History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months.
Who cannot join
- Current diagnosis or history of diabetes mellitus, including type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), history of diabetic ketoacidosis, or hyperosmolar state/coma.
- Started medications within 3 months prior to Screening that may cause significant weight gain, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, and mood stabilizers.
- 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.
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 within 2 years prior to Screening.
- Received treatment with semaglutide, tirzepatide, glucagon-like peptide-1 receptor (GLP-1R) agonist, GLP-1R/glucose-dependent insulinotropic polypeptide receptor (GIPR), or glucagon receptor agonist within 3 months prior to Screening.
- Note: Additional inclusion/exclusion criteria may apply, per protocol.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Kailera Clinical Site
Decatur, Georgia, 30030
Kailera Clinical Site
DeLand, Florida, 32720
Kailera Clinical Site
East Syracuse, New York, 13057
Kailera Clinical Site
Garland, Texas, 75043
Kailera Clinical Site
Greensboro, North Carolina, 27405
Kailera Clinical Site
Greenville, South Carolina, 29607
Kailera Clinical Site
Indianapolis, Indiana, 46254
Kailera Clinical Site
Irvine, California, 92614
Kailera Clinical Site
Knoxville, Tennessee, 37909
Kailera Clinical Site
Lake Forest, California, 92630
Kailera Clinical Site
Lincoln, Nebraska, 68516
Kailera Clinical Site
Lomita, California, 90717
Kailera Clinical Site
Long Beach, California, 90815
Kailera Clinical Site
Louisville, Kentucky, 40213
Kailera Clinical Site
Memphis, Tennessee, 38119
Kailera Clinical Site
Mesa, Arizona, 85213
Kailera Clinical Site
Monroe, North Carolina, 28112
Kailera Clinical Site
Montclair, California, 91763
Kailera Clinical Site
Morton, Illinois, 61550
Kailera Clinical Site
Myrtle Beach, South Carolina, 29572
Kailera Clinical Site
Omaha, Nebraska, 68144
Kailera Clinical Site
Orlando, Florida, 32801
Kailera Clinical Site
Orlando, Florida, 32803
Kailera Clinical Site
Raleigh, North Carolina, 27612
Kailera Clinical Site
Rockville, Maryland, 20852
Kailera Clinical Site
Rolling Hills Estates, California, 90274
Kailera Clinical Site
San Antonio, Texas, 78215
Kailera Clinical Site
San Diego, California, 92103
Kailera Clinical Site
Santa Ana, California, 92704
Kailera Clinical Site
St Louis, Missouri, 63141
Kailera Clinical Site
Sun City West, Arizona, 85375
Kailera Clinical Site
The Villages, Florida, 32162
Kailera Clinical Site
Van Nuys, California, 91405
Kailera Clinical Site
Winchester, Virginia, 22601
Kailera Clinical Site
Woodstock, Georgia, 30189
About this study
Official title: A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes
The primary objective of this study is to determine the effects of ribupatide administered by subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight.
- Conditions
- Obesity
- Being tested
- Ribupatide, Placebo
- Keywords
- Obesity, Ribupatide, KAI-9531, Glucagon-like peptide-1, GLP-1, Glucose-dependent Insulinotropic Peptide, GIP, Obesity Without Diabetes
- 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
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.
Percent Change From Baseline in Body Weight at Week 48
Measured: Baseline, Week 48
Secondary outcomes (16)
Percent of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction From Baseline in Body Weight
Measured: Baseline, Week 48
Change From Baseline in Waist Circumference
Measured: Baseline, Week 48
Change From Baseline in Absolute Body Weight
Measured: Baseline, Week 48
Change From Baseline in Body Mass Index (BMI)
Measured: Baseline, Week 48
Percent Change From Baseline in Fasting Triglycerides
Measured: Baseline, Week 48
Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol
Measured: Baseline, Week 48
Percent Change From Baseline in Fasting Non-HDL-cholesterol
Measured: Baseline, Week 48
Percent Change From Baseline in Fasting Total Cholesterol
Measured: Baseline, Week 48
Percent Change From Baseline in Fasting Low-density Lipoprotein (LDL)-cholesterol
Measured: Baseline, Week 48
Percent Change From Baseline in Fasting Very Low-density Lipoprotein (VLDL)-cholesterol
Measured: Baseline, Week 48
Percent Change From Baseline in Fasting Insulin
Measured: Baseline, Week 48
Change From Baseline in Fasting Blood Glucose
Measured: Baseline, Week 48
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Measured: Day 1 up to Week 52
Number of Participants With Anti-drug Antibodies (ADAs)
Measured: Day 1 up to Week 52
Number of Participants With Neutralizing Antibodies (NAbs)
Measured: Day 1 up to Week 52
Plasma Concentrations of Ribupatide
Measured: Day 1 up to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2026
- Study start4 Mar 2026
- Primary completionMay 2027 (estimated)
- Study completionJun 2027 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kailera
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07458269
- Sponsor's protocol ID
- K9531-2110
- Status last verified
- Jul 2026
- First submitted
- 3 Mar 2026
- Last updated
- 15 Jul 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 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes
- ClinicalTrials.gov ID
- NCT07458269
- Acronym / sponsor ID
- K9531-2110
- Conditions
- Obesity
- Keywords
- Obesity, Ribupatide, KAI-9531, Glucagon-like peptide-1, GLP-1, Glucose-dependent Insulinotropic Peptide, GIP, Obesity Without Diabetes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 264 participants (actual)
- Lead sponsor
- KaileraIndustry (pharma, biotech, devices)
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Mar 2026 (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 determine the effects of ribupatide administered by subcutaneous (SC) injection once weekly compared to placebo 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
- 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 (2 listed)
- BMI ≥35 kilograms per meter squared (kg/m^2).
- History of at least 1 self-reported unsuccessful effort to lose weight with diet and exercise within the prior 6 months.
Key exclusion criteria (11 listed)
- Current diagnosis or history of diabetes mellitus, including type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), history of diabetic ketoacidosis, or hyperosmolar state/coma.
- Started medications within 3 months prior to Screening that may cause significant weight gain, including, but not limited to, tricyclic antidepressants, atypical antipsychotics, and mood stabilizers.
- 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.
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
Percent Change From Baseline in Body Weight at Week 48
Time frame: Baseline, Week 48
16 secondary outcomes
Percent of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction From Baseline in Body Weight
Time frame: Baseline, Week 48
Change From Baseline in Waist Circumference
Time frame: Baseline, Week 48
Change From Baseline in Absolute Body Weight
Time frame: Baseline, Week 48
Change From Baseline in Body Mass Index (BMI)
Time frame: Baseline, Week 48
Percent Change From Baseline in Fasting Triglycerides
Time frame: Baseline, Week 48
Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol
Time frame: Baseline, Week 48
Percent Change From Baseline in Fasting Non-HDL-cholesterol
Time frame: Baseline, Week 48
Percent Change From Baseline in Fasting Total Cholesterol
Time frame: Baseline, Week 48
Percent Change From Baseline in Fasting Low-density Lipoprotein (LDL)-cholesterol
Time frame: Baseline, Week 48
Percent Change From Baseline in Fasting Very Low-density Lipoprotein (VLDL)-cholesterol
Time frame: Baseline, Week 48
Percent Change From Baseline in Fasting Insulin
Time frame: Baseline, Week 48
Change From Baseline in Fasting Blood Glucose
Time frame: Baseline, Week 48
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time frame: Day 1 up to Week 52
Number of Participants With Anti-drug Antibodies (ADAs)
Time frame: Day 1 up to Week 52
Number of Participants With Neutralizing Antibodies (NAbs)
Time frame: Day 1 up to Week 52
Plasma Concentrations of Ribupatide
Time frame: Day 1 up to Week 52
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 15 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ribupatide in people with Obesity, run by Kailera at 35 sites in United States.
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 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 48 (time frame: Baseline, Week 48). 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 15 Jul 2026.