A Randomized, Double-Blind, Placebo-Controlled Phase 2b Study of Weekly Oral Ecnoglutide (VRB-101) in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
Overview
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- Verdiva Bio Dev Limited
- Enrollment
- 206
- Locations
- 22
- Primary Endpoint
- Mean percent change from baseline in body weight
Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Have hemoglobin A1c (HbA1c) \<6.5%.
- •Have a BMI of ≥30 kg/m2 OR ≥27 kg/m2 and \<30 kg/m2 with at least 1 weight-related comorbidity.
- •Have a self-reported history of stable body weight for the 3 months prior to randomization (≤5% body weight change).
- •Participants of childbearing potential must be non-pregnant and non-lactating and must agree to use study-specified contraceptive methods.
Exclusion Criteria
- •Have any prior diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetes mellitus (T2DM), or other forms of diabetes mellitus. A participant with a history of gestational diabetes may be included in the study if the participant has an HbA1c \< 6.5% at Screening.
- •Have at least 1 laboratory value suggestive of diabetes during Screening, including 1 or more of HbA1c ≥6.5% (48 mmol/mol) or random glucose ≥200 mg/dL (11.1 mmol/L).
- •Have had exposure to glucagon-like peptide -1 (GLP-1) 6 months prior to Screening or any prior history of known or suspected hypersensitivity/allergies, intolerability, or lack of efficacy to these medications. Have known or suspected hypersensitivity to study intervention(s), to selective GLP-1 receptor agonist (RA) or glucose-dependent insulinotropic peptide (GIP)/GLP-1 or GLP-1/glucagon (GCG) dual receptor agonists.
- •Pregnant or breastfeeding at Screening or planning to become pregnant (self or partner) at any time within the dosing period, including follow -up, and for at least 60 days after the last dose of study intervention.
Arms & Interventions
Schedule A: VRB-101 (Active Arm 1)
Participants will receive VRB-101 once every week.
Intervention: VRB-101 (Drug)
Schedule A: VRB-101 (Active Arm 2)
Participants will receive VRB-101 once every week.
Intervention: VRB-101 (Drug)
Schedule A: VRB-101 (Active Arm 3)
Participants will receive VRB-101 once every week.
Intervention: VRB-101 (Drug)
Schedule B: VRB-101 (Active Arm 4)
Participants will receive VRB-101 once every week.
Intervention: VRB-101 (Drug)
Schedule B: VRB-101 (Active Arm 5)
Participants will receive VRB-101 once every week.
Intervention: VRB-101 (Drug)
Pooled Placebo
Participants will receive matching placebo to VRB-101 once every week.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Mean percent change from baseline in body weight
Time Frame: From Baseline (Day 0) up to Week 21
To evaluate the efficacy of VRB-101 for body weight reduction compared to placebo in Schedule A dose regimens.
Secondary Outcomes
- Absolute change from baseline in body weight(From Baseline (Day 0) up to Week 21)
- Percentage of participants who achieve 5% or more body weight reduction(From Baseline (Day 0) up to Week 21)
- Change from baseline in body mass index (BMI)(From Baseline (Day 0) up to Week 21)
- Number of study participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)(From Baseline (Day 0) up to Week 24)
- Change from baseline in blood pressure (BP)(From Baseline (Day 0) up to Week 24)
- Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)(From Baseline (Day 0) up to Week 21)