Efficacy and Safety of Ribupatide (KAI-9531) Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes
- 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.
- Short title
- Efficacy and Safety of Ribupatide (KAI-9531) Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Completion date
- 2027-06-01
- First posted
- 2026-03-09
- Registry last updated
- 2026-07-15
- Primary completion date
- 2027-05-01
- Start date
- 2026-03-04
- Actual participants
- Participants
- Participant count basis
- Actual
- Protocol amendments
- Number of sites
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Kailera
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07458269
- ClinicalTrials.gov ID
- NCT07458269
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Percent Change From Baseline in Body Weight at Week 48
Timeframe: Baseline, Week 48
Percent of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction From Baseline in Body Weight
Timeframe: Baseline, Week 48
Change From Baseline in Waist Circumference
Timeframe: Baseline, Week 48
Change From Baseline in Absolute Body Weight
Timeframe: Baseline, Week 48
Change From Baseline in Body Mass Index (BMI)
Timeframe: Baseline, Week 48
Percent Change From Baseline in Fasting Triglycerides
Timeframe: Baseline, Week 48
Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol
Timeframe: Baseline, Week 48
Percent Change From Baseline in Fasting Non-HDL-cholesterol
Timeframe: Baseline, Week 48
Percent Change From Baseline in Fasting Total Cholesterol
Timeframe: Baseline, Week 48
Percent Change From Baseline in Fasting Low-density Lipoprotein (LDL)-cholesterol
Timeframe: Baseline, Week 48
Percent Change From Baseline in Fasting Very Low-density Lipoprotein (VLDL)-cholesterol
Timeframe: Baseline, Week 48
Percent Change From Baseline in Fasting Insulin
Timeframe: Baseline, Week 48
Change From Baseline in Fasting Blood Glucose
Timeframe: Baseline, Week 48
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Timeframe: Day 1 up to Week 52
Number of Participants With Anti-drug Antibodies (ADAs)
Timeframe: Day 1 up to Week 52
Number of Participants With Neutralizing Antibodies (NAbs)
Timeframe: Day 1 up to Week 52
Plasma Concentrations of Ribupatide
Timeframe: Day 1 up to Week 52
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 18 Years
- Healthy volunteers
- No
Key Inclusion Criteria:
- 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:
- 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.
Note: Additional inclusion/exclusion criteria may apply, per protocol.
- Kailera Clinical SiteMesa, United States
- Kailera Clinical SiteSun City West, United States
- Kailera Clinical SiteIrvine, United States
- Kailera Clinical SiteLake Forest, United States
- Kailera Clinical SiteLomita, United States
- Kailera Clinical SiteLong Beach, United States
- Kailera Clinical SiteMontclair, United States
- Kailera Clinical SiteRolling Hills Estates, United States
- Kailera Clinical SiteSan Diego, United States
- Kailera Clinical SiteSanta Ana, United States
- Kailera Clinical SiteVan Nuys, United States
- Kailera Clinical SiteDeLand, United States
- Kailera Clinical SiteOrlando, United States
- Kailera Clinical SiteOrlando, United States
- Kailera Clinical SiteThe Villages, United States
- Kailera Clinical SiteDecatur, United States
- Kailera Clinical SiteWoodstock, United States
- Kailera Clinical SiteMorton, United States
- Kailera Clinical SiteIndianapolis, United States
- Kailera Clinical SiteLouisville, United States
- Kailera Clinical SiteRockville, United States
- Kailera Clinical SiteSt Louis, United States
- Kailera Clinical SiteLincoln, United States
- Kailera Clinical SiteOmaha, United States
- Kailera Clinical SiteEast Syracuse, United States
And 10 more, listed on the interactive page.
Related records
Drugs (1)
Lead sponsors (1)
Conditions (1)
- Obesity disorder Primary condition