Efficacy and Safety of Ribupatide Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes

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.
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Acronym: KaiNETIC-3
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Short title: Efficacy and Safety of Ribupatide Administered Once Weekly Compared With Semaglutide and Placebo in Participants Living With Obesity Who Do Not Have Diabetes
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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
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Control arm: Placebo
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Registry reports results: No
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Listing at source: Listed
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Recruitment status: Recruiting
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Phase: Phase 3
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Study type: Interventional
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Completion date: 2028-04-01
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First posted: 2025-12-16
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Registry last updated: 2026-07-22
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Primary completion date: 2028-03-01
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Start date: 2025-12-30
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Participants: 1,200
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Participant count basis: Estimated
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Planned participants: 1,200
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Protocol amendments: 2
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Number of sites: 53
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Data monitoring committee: Yes
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Registry sponsor category: Industry
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Lead sponsor: Kailera
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Source registry: ClinicalTrials.gov
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Registry ID: NCT07284979
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ClinicalTrials.gov ID: NCT07284979
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Registry record: Open registry record
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Allocation: Randomised
Model: Parallel groups
Purpose: Treatment
Masking: Double masking
Masking description: The participant and investigator will be blinded for participants randomized to ribupatide or placebo until the study is complete. Semaglutide will be provided open label.
Masked roles: Participants, Investigators

Sources for study design

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Percent Change From Baseline in Body Weight at Week 76
Timeframe: Baseline, Week 76

Percentage of Participants with ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight
Timeframe: Baseline, Week 76
Change From Baseline in Waist Circumference
Timeframe: Baseline, Week 76
Change From Baseline in Absolute Body Weight
Timeframe: Baseline, Week 76
Percentage of Participants with ≥5% Reduction in Body Weight
Timeframe: Baseline, Week 76
Change From Baseline in Systolic Blood Pressure (SBP)
Timeframe: Baseline, Week 76
Percent Change From Baseline in Fasting Triglycerides
Timeframe: Baseline, Week 76
Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol
Timeframe: Baseline, Week 76
Percent Change From Baseline in Fasting Non-HDL-cholesterol
Timeframe: 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
Timeframe: Baseline, Week 76
Percentage of Participants with ≥30% Reduction in Body Weight
Timeframe: Baseline, Week 76
Change From Baseline in Body Mass Index (BMI)
Timeframe: Baseline, Week 76
Change From Baseline in Control of Eating Questionnaire (CoEQ) Craving Control Score
Timeframe: Baseline, Week 76
Change From Baseline in CoEQ Positive Mood Score
Timeframe: Baseline, Week 76
Change From Baseline in CoEQ Craving for Sweets Score
Timeframe: Baseline, Week 76
Change From Baseline in CoEQ Craving for Savory Food Score
Timeframe: Baseline, Week 76
Change From Baseline in CoEQ Hunger Score
Timeframe: Baseline, Week 76
Change From Baseline in CoEQ Satiety Score
Timeframe: Baseline, Week 76
Change From Baseline in CoEQ Combined Score
Timeframe: Baseline, Week 76
Change From Baseline in Food Noise Questionnaire (FNQ) Score
Timeframe: Baseline, Week 76
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timeframe: Day 1 up to Week 80
Number of Participants With Anti-drug Antibodies (ADAs)
Timeframe: Up to Week 80
Number of Participants With Neutralizing Antibodies (Nabs)
Timeframe: Up to Week 80
Plasma Concentrations of Ribupatide
Timeframe: Up to Week 76

Sources for outcomes

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Sex: All
Age groups: Adults, Older adults
Minimum age: 18 Years
Healthy volunteers: No

Key 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.

Key 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.

Sources for eligibility

clinicaltrials.gov