> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-and-safety-of-ribupatide-in-participants-living-e722f138-d257-4b15-a824-e84463dc5e0c > Record changed: 2026-11-04 # Efficacy and Safety of Ribupatide in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes NCT07284875 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) Participants 2,530 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) Lead sponsor Kailera Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) Start date 2025-12-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) Number of sites 110 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) ## Title and summary **Summary** The primary objective of the study is to determine the effects of ribupatide (KAI-9531) subcutaneous (SC) injection once weekly compared to placebo on percent change in body weight. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) **Acronym** KaiNETIC-1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) **Short title** Efficacy and Safety of Ribupatide in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) **Official title** A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) ## Dates **Completion date** 2028-03-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) **First posted** 2025-12-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) **Registry last updated** 2026-10-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) **Primary completion date** 2028-02-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) **Start date** 2025-12-18 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) ## Size and sites **Actual participants** 2,530 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) **Participants** 2,530 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) **Number of sites** 110 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) **Lead sponsor** Kailera Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) ## Identifiers **Registry ID** NCT07284875 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) **ClinicalTrials.gov ID** NCT07284875 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) ## 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/NCT07284875) ## Outcomes ### Primary outcomes 1. Dose 3 and 4 versus Placebo: Percent Change From Baseline in Body Weight at Week 76 Timeframe: Baseline, Week 76 ### Secondary outcomes 1. Dose 1 and 2 versus Placebo: Percent Change From Baseline in Body Weight at Week 76 Timeframe: Baseline, Week 76 2. Percentage of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight Timeframe: Baseline, Week 76 3. Change From Baseline in Waist Circumference Timeframe: Baseline, Week 76 4. Change From Baseline in Absolute Body Weight Timeframe: Baseline, Week 76 5. Change From Baseline in Systolic Blood Pressure (SBP) Timeframe: Baseline, Week 76 6. Percent Change From Baseline in Fasting Triglycerides Timeframe: Baseline, Week 76 7. Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol Timeframe: Baseline, Week 76 8. Percent Change From Baseline in Fasting Non-HDL-cholesterol Timeframe: Baseline, Week 76 9. 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 10. Participants with Body Mass Index (BMI) ≥35 Kilograms per Square Meter (kg/m^2): Percent Change From Baseline in Body Weight Timeframe: Baseline, Week 76 11. Percentage of Participants with ≥30% Reduction in Body Weight Timeframe: Baseline, Week 76 12. Change From Baseline in BMI Timeframe: Baseline, Week 76 13. Change From Baseline in Diastolic Blood Pressure (DBP) Timeframe: Baseline, Week 76 14. Percent Change From Baseline in Total Cholesterol Timeframe: Baseline, Week 76 15. Percent Change From Baseline in Low-density Lipoprotein (LDL)-cholesterol Timeframe: Baseline, Week 76 16. Percent Change From Baseline in Very Low-density Lipoprotein (VLDL)-cholesterol Timeframe: Baseline, Week 76 17. Percent Change From Baseline in Fasting Insulin Timeframe: Baseline, Week 76 18. Change From Baseline in Fasting Blood Glucose Timeframe: Baseline, Week 76 19. Change From Baseline in Control of Eating Questionnaire (CoEQ) Craving Control Score Timeframe: Baseline, Week 76 20. Change From Baseline in CoEQ Positive Mood Score Timeframe: Baseline, Week 76 21. Change From Baseline in CoEQ Craving for Sweets Score Timeframe: Baseline, Week 76 22. Change From Baseline in CoEQ Craving for Savory Food Score Timeframe: Baseline, Week 76 23. Change From Baseline in CoEQ Hunger Score Timeframe: Baseline, Week 76 24. Change From Baseline in CoEQ Satiety Score Timeframe: Baseline, Week 76 25. Change From Baseline in CoEQ Combined Score Timeframe: Baseline, Week 76 And 5 more, listed on the interactive page. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No ### Inclusion criteria - BMI ≥30 kg/m^2 or BMI ≥27 kg/m^2 and previously diagnosed with at least 1 of the following: 1. hypertension, 2. dyslipidemia, 3. obstructive sleep apnea, or 4. cardiovascular (CV) disease. - 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, or phentermine. - 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. - Received treatment with semaglutide, tirzepatide, GLP-1 receptor 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) ## Sites - Kailera Clinical SiteAnniston, United States - Kailera Clinical SiteBirmingham, United States - Kailera Clinical SiteCullman, United States - Kailera Clinical SiteSun City, United States - Kailera Clinical SiteEscondido, United States - Kailera Clinical SiteToluca Lake, United States - Kailera Clinical SiteAurora, United States - Kailera Clinical SiteBridgeport, United States - Kailera Clinical SiteJupiter, United States - Kailera Clinical SiteLilburn, United States - Kailera Clinical SiteSpringfield, United States - Kailera Clinical SiteColumbia, United States - Kailera Clinical SiteLas Vegas, United States - Kailera Clinical SiteRochester, United States - Kailera Clinical SiteMorehead City, United States - Kailera Clinical SiteChickasha, United States - Kailera Clinical SiteMauldin, United States - Kailera Clinical SiteChattanooga, United States - Kailera Clinical SiteAmarillo, United States - Kailera Clinical SiteBellaire, United States - Kailera Clinical SiteDeSoto, United States - Kailera Clinical SiteTomball, United States - Kailera Clinical SiteSalt Lake City, United States - Kailera Clinical SiteDanville, United States - Kailera Clinical SiteLa Plata, Argentina And 85 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) ## References ### Other registry identifiers (2) - 2025 - 2025-523486-17-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284875) ## 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. 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