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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
120
Clinical Study Site 202
Cullman, Alabama, United States
Clinical Study Site 203
Phoenix, Arizona, United States
To identify the dose of VRB-101 for weight maintenance
Time frame: Baseline to End of Treatment (Week 17)
Percent change in body weight from baseline
Time frame: Baseline to End of Treatment (Week 17)
Absolute change in body weight from baseline
Time frame: Baseline to End of Treatment (Week 17)
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and Adverse events of special interest (AESIs)
Time frame: Baseline to Week 24
Change in blood pressure from baseline
Time frame: Baseline to End of Treatment (Week 17)
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) from baseline
The C-SSRS systematically assesses suicidal ideation and behavior using yes/no questions, ordinal severity ratings (0-5), and intensity subscales. Results at End of Study will be compared to Baseline.
Time frame: Baseline to End of Treatment (Week 17)
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Clinical Study Site 212
Tempe, Arizona, United States
Clinical Study Site 201
Little Rock, Arkansas, United States
Clinical Study Site 214
Santa Maria, California, United States
Clinical Study Site 216
Stamford, Connecticut, United States
Clinical Study Site 204
Bradenton, Florida, United States
Clinical Study Site 215
St. Petersburg, Florida, United States
Clinical Study Site 213
El Dorado, Kansas, United States
Clinical Study Site 210
Petal, Mississippi, United States
...and 7 more locations