A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Identify the Optimal Weekly Oral Dose of Ecnoglutide (VRB-101) for Maintaining Body Weight in Participants With Obesity or Overweight Who Have Weight-Related Comorbidities
Verdiva Bio Dev Limited
Summary
The purpose of this study is to identify the weekly oral dose of VRB-101 (oral ecnoglutide) that can effectively maintain body weight in participants with a history of obesity or overweight with weight-related comorbidities.
Description
This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy of oral ecnoglutide (VRB-101) in participants with a history of obesity or overweight who have achieved weight reduction after 6 months of treatment with injectable semaglutide or tirzepatide. The study comprises three active arms and one placebo arm. The study will include a Screening Period of approximately 4 weeks, followed by a 16-week Treatment Period and a 4-week Safety Follow-up Period prior to the end of the study.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Have a history of BMI of ≥30 kg/m2 OR ≥27 kg/m2 and \<30 kg/m2 with at least 1 weight-related comorbidity at the time of initiation of subcutaneous (SC) semaglutide and/or tirzepatide treatment. * Documented history of having obesity or overweight with weight-related comorbidities per medical records at the time of initiation of SC semaglutide and/or tirzepatide treatment. * History of treatment with weekly SC semaglutide and/or tirzepatide for a minimum of 6 months prior to Screening. * Documented weight reduction of ≥10% in 6 months and no clinically relevant weight re…
Interventions
- DrugVRB-101
VRB-101 tablets will be administered orally.
- DrugPlacebo
Placebo tablets will be administered orally.
Locations (17)
- Clinical Study Site 202Cullman, Alabama
- Clinical Study Site 203Phoenix, Arizona
- Clinical Study Site 212Tempe, Arizona
- Clinical Study Site 201Little Rock, Arkansas
- Clinical Study Site 214Santa Maria, California
- Clinical Study Site 216Stamford, Connecticut