Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes
- 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)
- Acronym
- KaiNETIC-2
- Short title
- Efficacy and Safety of Ribupatide Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes
- 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
- Control arm
- Placebo
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Active, not recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2028-04-24
- First posted
- 2025-12-16
- Registry last updated
- 2026-10-06
- Primary completion date
- 2028-03-27
- Start date
- 2026-01-12
- Actual participants
- 1,270
- Participants
- 1,270
- 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
- NCT07284901
- ClinicalTrials.gov ID
- NCT07284901
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- Double masking
- Masked roles
- Participants, Investigators
Doses 3 and 4 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Timeframe: Baseline, Week 76
Doses 3 and 4 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76
Timeframe: Baseline, Week 76
Doses 1 and 2 of Ribupatide Versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Timeframe: Baseline, Week 76
Doses 1 and 2 of Ribupatide Versus Placebo: Change From Baseline in HbA1c at Week 76
Timeframe: Baseline, Week 76
Percentage of Participants with ≥5%, ≥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 HbA1c <7% and ≤6.5%
Timeframe: Baseline, Week 76
Change From Baseline in Fasting Blood Glucose
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
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
Percentage of Participants with ≥30% Reduction in Body Weight
Timeframe: Baseline, Week 76
Change From Baseline in BMI
Timeframe: Baseline, Week 76
Percentage of Participants with HbA1c <5.7%
Timeframe: Baseline, Week 76
Change From Baseline in Diastolic Blood Pressure (DBP)
Timeframe: Baseline, Week 76
Percent Change From Baseline in Fasting Total Cholesterol
Timeframe: Baseline, Week 76
Percent Change From Baseline in Fasting Low-density Lipoprotein (LDL)-cholesterol
Timeframe: Baseline, Week 76
Percent Change From Baseline in Very Low-density Lipoprotein (VLDL)-cholesterol
Timeframe: Baseline, Week 76
Percent Change From Baseline in Fasting Insulin
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
And 8 more, listed on the interactive page.
- 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.
- 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.
- 2025
- 2025-523510-87-00
Related records
Drugs (1)
Lead sponsors (1)
Conditions (2)
- Diabetes mellitus Primary condition
- Obesity disorder Primary condition