A Study of Weekly Oral Ecnoglutide (VRB-101) in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

NCT07281937 | Active Not Recruiting Phase 2 FDA Drug

• 1 other identifier: VRB-101-201
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 22

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.

Conditions

Obesity; Overweight

Keywords

Hypertension; Weight reduction; Dose Escalation; Glucagon-like peptide-1 (GLP-1)

Outcome Measures

Primary Outcomes (1)

• 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.

  From Baseline (Day 0) up to Week 21

Secondary Outcomes (6)

• 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

Study Arms (6)

Schedule A: VRB-101 (Active Arm 1)

EXPERIMENTAL

Participants will receive VRB-101 once every week.

Drug: VRB-101

Schedule A: VRB-101 (Active Arm 2)

EXPERIMENTAL

Participants will receive VRB-101 once every week.

Drug: VRB-101

Schedule A: VRB-101 (Active Arm 3)

EXPERIMENTAL

Participants will receive VRB-101 once every week.

Drug: VRB-101

Schedule B: VRB-101 (Active Arm 4)

EXPERIMENTAL

Participants will receive VRB-101 once every week.

Drug: VRB-101

Schedule B: VRB-101 (Active Arm 5)

EXPERIMENTAL

Participants will receive VRB-101 once every week.

Drug: VRB-101

Pooled Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo to VRB-101 once every week.

Drug: Placebo

Interventions

VRB-101 DRUG

VRB-101 tablets will be administered orally.

Also known as: Oral Ecnoglutide

Schedule A: VRB-101 (Active Arm 1); Schedule A: VRB-101 (Active Arm 2); Schedule A: VRB-101 (Active Arm 3); Schedule B: VRB-101 (Active Arm 4); Schedule B: VRB-101 (Active Arm 5)

Placebo DRUG

Placebo tablets will be administered orally.

Pooled Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Verdiva Bio Dev Limited: lead

Study Sites (22)

Clinical Study Site 103

Anniston, Alabama, 36207, United States

Location

Clinical Study Site 109

Cullman, Alabama, 35055, United States

Location

Clinical Study Site 110

Phoenix, Arizona, 85028, United States

Location

Clinical Study Site 113

Little Rock, Arkansas, 72205, United States

Location

Clinical Study Site 111

Anaheim, California, 92801, United States

Location

Clinical Study Site 107

Montclair, California, 91763, United States

Location

Clinical Study Site 118

Tarzana, California, 91356, United States

Location

Clinical Study Site 119

Decatur, Georgia, 30030, United States

Location

Clinical Study Site 116

West Des Moines, Iowa, 50266, United States

Location

Clinical Study Site 106

Wichita, Kansas, 67207, United States

Location

Clinical Study Site 122

Southfield, Michigan, 48076, United States

Location

Clinical Study Site 121

Omaha, Nebraska, 68134, United States

Location

Clinical Study Site 117

Binghamton, New York, 13905, United States

Location

Clinical Study Site 101

Rochester, New York, 14609, United States

Location

Clinical Study Site 120

Charlotte, North Carolina, 28210, United States

Location

Clinical Study Site 108

Monroe, North Carolina, 28112, United States

Location

Clinical Study Site 105

Norman, Oklahoma, 73069, United States

Location

Clinical Study Site 114

Duncansville, Pennsylvania, 16635, United States

Location

Clinical Study Site 115

Knoxville, Tennessee, 37909, United States

Location

Clinical Study Site 112

Dallas, Texas, 75251, United States

Location

Clinical Study Site 102

San Antonio, Texas, 78229, United States

Location

Clinical Study Site 104

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Hypertension; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Body Weight Changes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: December 15, 2025
• Study Start: November 25, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (22)