Efficacy and Safety of Ribupatide in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

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.
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Acronym: KaiNETIC-1
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Short title: Efficacy and Safety of Ribupatide in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes
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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
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Control arm: Placebo
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Registry reports results: No
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Listing at source: Listed
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Recruitment status: Active, not recruiting
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Phase: Phase 3
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Study type: Interventional
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Completion date: 2028-03-01
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First posted: 2025-12-16
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Registry last updated: 2026-10-06
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Primary completion date: 2028-02-01
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Start date: 2025-12-18
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Actual participants: 2,530
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Participants: 2,530
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Participant count basis: Actual
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Protocol amendments: 1
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Number of sites: 110
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Data monitoring committee: Yes
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Registry sponsor category: Industry
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Lead sponsor: Kailera
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Source registry: ClinicalTrials.gov
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Registry ID: NCT07284875
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ClinicalTrials.gov ID: NCT07284875
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Registry record: Open registry record
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Allocation: Randomised
Model: Parallel groups
Purpose: Treatment
Masking: Double masking
Masked roles: Participants, Investigators

Sources for study design

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Dose 3 and 4 versus Placebo: Percent Change From Baseline in Body Weight at Week 76
Timeframe: Baseline, Week 76

Dose 1 and 2 versus Placebo: Percent Change From Baseline in Body Weight 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
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
Change From Baseline in Diastolic Blood Pressure (DBP)
Timeframe: Baseline, Week 76
Percent Change From Baseline in Total Cholesterol
Timeframe: Baseline, Week 76
Percent Change From Baseline in 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 Fasting Blood Glucose
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
Change From Baseline in CoEQ Hunger Score
Timeframe: Baseline, Week 76
Change From Baseline in CoEQ Satiety Score
Timeframe: Baseline, Week 76
Change From Baseline in CoEQ Combined Score
Timeframe: Baseline, Week 76

And 5 more, listed on the interactive page.

Sources for outcomes

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Sex: All
Age groups: Adults, Older adults
Minimum age: 18 Years
Healthy volunteers: No

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.

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

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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

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2025
2025-523486-17-00

Sources for references

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Related records

Drugs (1)

Ribupatide

Lead sponsors (1)

Kailera

Conditions (1)

Obesity disorder Primary condition

Efficacy and Safety of Ribupatide in Participants Living With Obesity or Overweight With Weight-Related Comorbidities Who Do Not Have Diabetes

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