Efficacy and Safety of Ribupatide (KAI-9531) Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes

Phase
Recruitment status
Active, not recruiting
Participants
Lead sponsor
Start date
Number of sites

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.
Short title
Efficacy and Safety of Ribupatide (KAI-9531) Administered Once Weekly in Participants Living With Obesity Who Do Not Have Diabetes
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

Control arm
Registry reports results
Listing at source
Recruitment status
Active, not recruiting
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Actual participants
Participants
Participant count basis
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design

  1. Percent Change From Baseline in Body Weight at Week 48

    Timeframe: Baseline, Week 48

  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

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

  • 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

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)