Efficacy and Safety of Ribupatide (KAI-9531) Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes
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
1 other identifier
interventional
264
1 country
35
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 obesity
Started Mar 2026
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2026
CompletedStudy Start
First participant enrolled
March 4, 2026
CompletedFirst Posted
Study publicly available on registry
March 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2027
July 15, 2026
July 1, 2026
1.2 years
March 3, 2026
July 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Change From Baseline in Body Weight at Week 48
Baseline, Week 48
Secondary Outcomes (16)
Percent of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction From Baseline in Body Weight
Baseline, Week 48
Change From Baseline in Waist Circumference
Baseline, Week 48
Change From Baseline in Absolute Body Weight
Baseline, Week 48
Change From Baseline in Body Mass Index (BMI)
Baseline, Week 48
Percent Change From Baseline in Fasting Triglycerides
Baseline, Week 48
- +11 more secondary outcomes
Study Arms (5)
Ribupatide: Dose 1
EXPERIMENTALParticipants will receive Dose 1 of ribupatide once weekly.
Ribupatide: Dose 2
EXPERIMENTALParticipants will receive Dose 2 of ribupatide once weekly.
Ribupatide: Dose 3
EXPERIMENTALParticipants will receive Dose 3 of ribupatide once weekly.
Ribupatide: Dose 4
EXPERIMENTALParticipants will receive Dose 4 of ribupatide once weekly.
Placebo
PLACEBO COMPARATORParticipants will receive placebo matched to ribupatide once weekly.
Interventions
SC Injection
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kaileralead
Study Sites (35)
Kailera Clinical Site
Mesa, Arizona, 85213, United States
Kailera Clinical Site
Sun City West, Arizona, 85375, United States
Kailera Clinical Site
Irvine, California, 92614, United States
Kailera Clinical Site
Lake Forest, California, 92630, United States
Kailera Clinical Site
Lomita, California, 90717, United States
Kailera Clinical Site
Long Beach, California, 90815, United States
Kailera Clinical Site
Montclair, California, 91763, United States
Kailera Clinical Site
Rolling Hills Estates, California, 90274, United States
Kailera Clinical Site
San Diego, California, 92103, United States
Kailera Clinical Site
Santa Ana, California, 92704, United States
Kailera Clinical Site
Van Nuys, California, 91405, United States
Kailera Clinical Site
DeLand, Florida, 32720, United States
Kailera Clinical Site
Orlando, Florida, 32801, United States
Kailera Clinical Site
Orlando, Florida, 32803, United States
Kailera Clinical Site
The Villages, Florida, 32162, United States
Kailera Clinical Site
Decatur, Georgia, 30030, United States
Kailera Clinical Site
Woodstock, Georgia, 30189, United States
Kailera Clinical Site
Morton, Illinois, 61550, United States
Kailera Clinical Site
Indianapolis, Indiana, 46254, United States
Kailera Clinical Site
Louisville, Kentucky, 40213, United States
Kailera Clinical Site
Rockville, Maryland, 20852, United States
Kailera Clinical Site
St Louis, Missouri, 63141, United States
Kailera Clinical Site
Lincoln, Nebraska, 68516, United States
Kailera Clinical Site
Omaha, Nebraska, 68144, United States
Kailera Clinical Site
East Syracuse, New York, 13057, United States
Kailera Clinical Site
Greensboro, North Carolina, 27405, United States
Kailera Clinical Site
Monroe, North Carolina, 28112, United States
Kailera Clinical Site
Raleigh, North Carolina, 27612, United States
Kailera Clinical Site
Greenville, South Carolina, 29607, United States
Kailera Clinical Site
Myrtle Beach, South Carolina, 29572, United States
Kailera Clinical Site
Knoxville, Tennessee, 37909, United States
Kailera Clinical Site
Memphis, Tennessee, 38119, United States
Kailera Clinical Site
Garland, Texas, 75043, United States
Kailera Clinical Site
San Antonio, Texas, 78215, United States
Kailera Clinical Site
Winchester, Virginia, 22601, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2026
First Posted
March 9, 2026
Study Start
March 4, 2026
Primary Completion (Estimated)
May 1, 2027
Study Completion (Estimated)
June 1, 2027
Last Updated
July 15, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share