The aim of this study is to evaluate the efficacy of VRB-101 for body weight reduction compared to placebo in participants who have obesity or overweight with weight-related comorbidities.
This is a randomized, double-blind, placebo-controlled study of oral ecnoglutide (VRB-101), with 5 active arms and 1 placebo arm. The study will include a Screening Period of 4 weeks, followed by a 20-week Study Treatment Period and a 4-week Safety Follow-up Period prior to the end of study (EOS) visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
Clinical Study Site 103
Anniston, Alabama, United States
Mean percent change from baseline in body weight
To evaluate the efficacy of VRB-101 for body weight reduction compared to placebo in Schedule A dose regimens.
Time frame: From Baseline (Day 0) up to Week 21
Absolute change from baseline in body weight
To compare the effect of VRB-101 versus placebo on body weight in Schedule A.
Time frame: From Baseline (Day 0) up to Week 21
Percentage of participants who achieve 5% or more body weight reduction
To compare the effect of VRB-101 versus placebo on body weight in Schedule A
Time frame: From Baseline (Day 0) up to Week 21
Change from baseline in body mass index (BMI)
To compare the effect of VRB-101 versus placebo on body weight in Schedule A.
Time frame: From Baseline (Day 0) up to Week 21
Number of study participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
To assess safety and tolerability of study interventions. Adverse events (AEs) reported after first administration of study intervention will be designated as a TEAE.
Time frame: From Baseline (Day 0) up to Week 24
Change from baseline in blood pressure (BP)
To assess safety and tolerability of study interventions.
Time frame: From Baseline (Day 0) up to Week 24
Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
To assess safety and tolerability of study interventions. C-SSRS is a tool to help systematically assess suicidal ideation and behavior in participants during clinical studies of centrally acting drugs. It is composed of 3 questions addressing suicidal behavior and 5 questions addressing suicidal ideation, with sub-questions assessing the severity. The responses to the questions will be recorded as 'yes/no'.
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Clinical Study Site 109
Cullman, Alabama, United States
RECRUITINGClinical Study Site 110
Phoenix, Arizona, United States
RECRUITINGClinical Study Site 113
Little Rock, Arkansas, United States
RECRUITINGClinical Study Site 111
Anaheim, California, United States
RECRUITINGClinical Study Site 107
Montclair, California, United States
RECRUITINGClinical Study Site 118
Tarzana, California, United States
RECRUITINGClinical Study Site 119
Decatur, Georgia, United States
RECRUITINGClinical Study Site 116
West Des Moines, Iowa, United States
RECRUITINGClinical Study Site 106
Wichita, Kansas, United States
RECRUITING...and 12 more locations
Time frame: From Baseline (Day 0) up to Week 21