Recruiting NCT07284979
Efficacy and Safety of Ribupatide Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ribupatide, Semaglutide, Placebo.
- Who it may be relevant to
- Registry conditions: Obesity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Bulgaria, Poland, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug Ribupatide
SC Injection - Drug Semaglutide
SC Injection - Drug Placebo
SC Injection
Primary outcome measures
- Percent Change From Baseline in Body Weight at Week 76 [Time frame: Baseline, Week 76]
Secondary outcome measures (12)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 27 centers
- Kailera Clinical Site — Glendale
- Kailera Clinical Site — Phoenix
- Kailera Clinical Site — Little Rock
- Kailera Clinical Site — Northridge
- Kailera Clinical Site — Oceanside
- Kailera Clinical Site — Hamden
- Kailera Clinical Site — Stamford
- Kailera Clinical Site — Orange City
- … and 19 more centers
Poland · 8 centers
- Kailera Clinical Site — Krakow
- Kailera Clinical Site — Wroclaw
- Kailera Clinical Site — Warsaw
- Kailera Clinical Site — Gdynia
- Kailera Clinical Site — Chorzów
- Kailera Clinical Site — Gdynia
- Kailera Clinical Site — Wroclaw
- Kailera Clinical Site — Kielce
Australia · 7 centers
- Kailera Clinical Site — Bruce
- Kailera Clinical Site — Blacktown
- Kailera Clinical Site — Kanwal
- Kailera Clinical Site — Herston
- Kailera Clinical Site — Morayfield
- Kailera Clinical Site — South Brisbane
- Kailera Clinical Site — Camberwell
Bulgaria · 7 centers
- Kailera Clinical Site — Pleven
- Kailera Clinical Site — Plovdiv
- Kailera Clinical Site — Sofia
- Kailera Clinical Site — Sofia
- Kailera Clinical Site — Montana
- Kailera Clinical Site — Sofia
- Kailera Clinical Site — Sofia
United Kingdom · 4 centers
- Kailera Clinical Site — Exeter
- Kailera Clinical Site — London
- Kailera Clinical Site — Leicester
- Kailera Clinical Site — Rotherham
Identifiers
NCT: NCT07284979 · K9531-3107 · 2025-523511-11-00