> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-and-safety-of-ribupatide-kai-9531-administered-once-a86e5766-9124-40ef-afba-6c1f7acb7cd2 > Record changed: 2026-11-04 # Efficacy and Safety of Ribupatide (KAI-9531) Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes NCT07458269 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) Participants 264 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) Lead sponsor Kailera Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) Start date 2026-03-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) Number of sites 35 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) **Short title** Efficacy and Safety of Ribupatide (KAI-9531) Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) ## Dates **Completion date** 2027-06-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) **First posted** 2026-03-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) **Registry last updated** 2026-07-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) **Primary completion date** 2027-05-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) **Start date** 2026-03-04 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) ## Size and sites **Actual participants** 264 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) **Participants** 264 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) **Number of sites** 35 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) **Lead sponsor** Kailera Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) ## Identifiers **Registry ID** NCT07458269 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) **ClinicalTrials.gov ID** NCT07458269 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Double masking **Masked roles** Participants, Investigators Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) ## Outcomes ### Primary outcomes 1. Percent Change From Baseline in Body Weight at Week 48 Timeframe: Baseline, Week 48 ### Secondary outcomes 1. Percent of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction From Baseline in Body Weight Timeframe: Baseline, Week 48 2. Change From Baseline in Waist Circumference Timeframe: Baseline, Week 48 3. Change From Baseline in Absolute Body Weight Timeframe: Baseline, Week 48 4. Change From Baseline in Body Mass Index (BMI) Timeframe: Baseline, Week 48 5. Percent Change From Baseline in Fasting Triglycerides Timeframe: Baseline, Week 48 6. Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol Timeframe: Baseline, Week 48 7. Percent Change From Baseline in Fasting Non-HDL-cholesterol Timeframe: Baseline, Week 48 8. Percent Change From Baseline in Fasting Total Cholesterol Timeframe: Baseline, Week 48 9. Percent Change From Baseline in Fasting Low-density Lipoprotein (LDL)-cholesterol Timeframe: Baseline, Week 48 10. Percent Change From Baseline in Fasting Very Low-density Lipoprotein (VLDL)-cholesterol Timeframe: Baseline, Week 48 11. Percent Change From Baseline in Fasting Insulin Timeframe: Baseline, Week 48 12. Change From Baseline in Fasting Blood Glucose Timeframe: Baseline, Week 48 13. Number of Participants With Treatment-emergent Adverse Events (TEAEs) Timeframe: Day 1 up to Week 52 14. Number of Participants With Anti-drug Antibodies (ADAs) Timeframe: Day 1 up to Week 52 15. Number of Participants With Neutralizing Antibodies (NAbs) Timeframe: Day 1 up to Week 52 16. Plasma Concentrations of Ribupatide Timeframe: Day 1 up to Week 52 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) ## Eligibility **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. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) ## Sites - 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. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07458269) ## Related records ### Drugs (1) - [Ribupatide](https://trialight.com/data/asset/ribupatide-92d33550-7ad9-5ca8-8a8d-a0e4f4965773.md) ### Lead sponsors (1) - [Kailera](https://trialight.com/data/company/kailera-9089bfa7-3191-422a-ab0b-b9af6a9e395b.md) ### Conditions (1) - [Obesity disorder](https://trialight.com/data/condition/obesity-disorder-f3b57dc0-68ac-555c-8f13-0d81e595d9cb.md) Primary condition --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. Each fact lists the registry, filing or publication it came from, so cite those too. - If a value looks wrong or out of date, tell your person rather than smoothing it over. 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