> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/efficacy-and-safety-of-ribupatide-administered-once-weekly-3ce7a6fb-be37-4ac3-871a-69d8495f241b > Record changed: 2026-11-04 # Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes NCT07284901 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) Participants 1,270 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) Lead sponsor Kailera Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) Start date 2026-01-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) Number of sites 173 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) ## Title and summary **Summary** The primary objective of this study is to demonstrate that ribupatide (KAI-9531) subcutaneous (SC) injection once weekly is superior to placebo on: \* Percent change in body weight \* Change in hemoglobin A1c (HbA1c) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) **Acronym** KaiNETIC-2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) **Short title** Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) **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 and Diabetes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) ## Dates **Completion date** 2028-04-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) **First posted** 2025-12-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) **Registry last updated** 2026-10-06 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) **Primary completion date** 2028-03-27 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) **Start date** 2026-01-12 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) ## Size and sites **Actual participants** 1,270 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) **Participants** 1,270 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) **Protocol amendments** 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) **Number of sites** 173 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) **Lead sponsor** Kailera Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) ## Identifiers **Registry ID** NCT07284901 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) **ClinicalTrials.gov ID** NCT07284901 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) ## 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/NCT07284901) ## Outcomes ### Primary outcomes 1. Doses 3 and 4 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76 Timeframe: Baseline, Week 76 2. Doses 3 and 4 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76 Timeframe: Baseline, Week 76 ### Secondary outcomes 1. Doses 1 and 2 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76 Timeframe: Baseline, Week 76 2. Doses 1 and 2 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76 Timeframe: Baseline, Week 76 3. Percentage of Participants with ≥5%, ≥10%, ≥15%, ≥20% and ≥25% Reduction in Body Weight Timeframe: Baseline, Week 76 4. Change From Baseline in Waist Circumference Timeframe: Baseline, Week 76 5. Change From Baseline in Absolute Body Weight Timeframe: Baseline, Week 76 6. Percentage of Participants with HbA1c <7% and ≤6.5% Timeframe: Baseline, Week 76 7. Change From Baseline in Fasting Blood Glucose Timeframe: Baseline, Week 76 8. Change From Baseline in Systolic Blood Pressure (SBP) Timeframe: Baseline, Week 76 9. Percent Change From Baseline in Fasting Triglycerides Timeframe: Baseline, Week 76 10. Percent Change From Baseline in Fasting High-density Lipoprotein (HDL)-cholesterol Timeframe: Baseline, Week 76 11. Percent Change From Baseline in Fasting Non-HDL-cholesterol Timeframe: Baseline, Week 76 12. 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 13. 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 14. Percentage of Participants with ≥30% Reduction in Body Weight Timeframe: Baseline, Week 76 15. Change From Baseline in BMI Timeframe: Baseline, Week 76 16. Percentage of Participants with HbA1c <5.7% Timeframe: Baseline, Week 76 17. Change From Baseline in Diastolic Blood Pressure (DBP) Timeframe: Baseline, Week 76 18. Percent Change From Baseline in Fasting Total Cholesterol Timeframe: Baseline, Week 76 19. Percent Change From Baseline in Fasting Low-density Lipoprotein (LDL)-cholesterol Timeframe: Baseline, Week 76 20. Percent Change From Baseline in Very Low-density Lipoprotein (VLDL)-cholesterol Timeframe: Baseline, Week 76 21. Percent Change From Baseline in Fasting Insulin Timeframe: Baseline, Week 76 22. Change From Baseline in Control of Eating Questionnaire (CoEQ) Craving Control Score Timeframe: Baseline, Week 76 23. Change From Baseline in CoEQ Positive Mood Score Timeframe: Baseline, Week 76 24. Change From Baseline in CoEQ Craving for Sweets Score Timeframe: Baseline, Week 76 25. Change From Baseline in CoEQ Craving for Savory Food Score Timeframe: Baseline, Week 76 And 8 more, listed on the interactive page. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key Inclusion Criteria: - Diagnosis of type 2 diabetes mellitus (T2DM). - Receiving stable therapy for T2DM for 3 months prior to Screening. This includes diet and/or exercise alone or in combination with any oral medication for T2DM treatment except for DPP-4 inhibitors. Participants can be treatment naïve if they have an HbA1c of 6.5% to 7.5%, inclusive. - BMI ≥27 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 type 1 diabetes mellitus (T1DM) or any other type of diabetes except T2DM. - History of diabetic ketoacidosis or hyperosmolar state/coma within 1 year prior to Screening. - History of severe hypoglycemia or hypoglycemia unawareness within 1 year prior to Screening. - 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 (GI) motility if taken for >30 days continually within 3 months prior to Screening. - 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, GLP-1 receptor agonists, GLP-1/glucose-dependent insulinotropic polypeptide (GIP) agonists, glucagon receptor agonists, or other weight loss medications or treatments aside from diet and exercise 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/NCT07284901) ## Sites - Kailera Clinical SiteCullman, United States - Kailera Clinical SitePhoenix, United States - Kailera Clinical SiteSun City, United States - Kailera Clinical SiteLittle Rock, United States - Kailera Clinical SiteEscondido, United States - Kailera Clinical SiteLa Mesa, United States - Kailera Clinical SiteMontclair, United States - Kailera Clinical SiteNorthridge, United States - Kailera Clinical SiteOceanside, United States - Kailera Clinical SiteToluca Lake, United States - Kailera Clinical SiteStamford, United States - Kailera Clinical SiteBradenton, United States - Kailera Clinical SiteHollywood, United States - Kailera Clinical SiteJupiter, United States - Kailera Clinical SiteMiami, United States - Kailera Clinical SiteMiami Lakes, United States - Kailera Clinical SiteOrange City, 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 SiteLilburn, United States - Kailera Clinical SiteMarietta, United States - Kailera Clinical SiteRiverdale, United States - Kailera Clinical SiteSkokie, United States And 148 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) ## References ### Other registry identifiers (2) - 2025 - 2025-523510-87-00 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07284901) ## 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 (2) - [Diabetes mellitus](https://trialight.com/data/condition/diabetes-mellitus-1a0391a8-9f84-5600-a2bf-ec97c2229de4.md) Primary condition - [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. 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