Obesity, Overweight
Conditions
Keywords
Hypertension, Weight reduction, Dose Escalation, Glucagon-like peptide-1 (GLP-1)
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.
Interventions
DRUGVRB-101
VRB-101 tablets will be administered orally.
DRUGPlacebo
Placebo tablets will be administered orally.
Sponsors
Verdiva Bio Dev Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean percent change from baseline in body weight | 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
| Measure | Time frame | Description |
|---|---|---|
| Absolute change from baseline in body weight | From Baseline (Day 0) up to Week 21 | To compare the effect of VRB-101 versus placebo on body weight in Schedule A. |
| Percentage of participants who achieve 5% or more body weight reduction | From Baseline (Day 0) up to Week 21 | To compare the effect of VRB-101 versus placebo on body weight in Schedule A |
| Change from baseline in body mass index (BMI) | From Baseline (Day 0) up to Week 21 | To compare the effect of VRB-101 versus placebo on body weight in Schedule A. |
| Number of study participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) | From Baseline (Day 0) up to Week 24 | To assess safety and tolerability of study interventions. Adverse events (AEs) reported after first administration of study intervention will be designated as a TEAE. |
| Change from baseline in blood pressure (BP) | From Baseline (Day 0) up to Week 24 | To assess safety and tolerability of study interventions. |
| Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) | From Baseline (Day 0) up to Week 21 | 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. |
Countries
United States
Outcome results
None listed