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

Last updated: June 1, 2026
Sponsor: Verdiva Bio Dev Limited
Overall Status: Active - Not Recruiting

Phase

2

Condition

Obesity

Circulation Disorders

Stress

Treatment

Placebo

VRB-101

Clinical Study ID

NCT07281937
VRB-101-201
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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-relatedcomorbidity.

  • Have a self-reported history of stable body weight for the 3 months prior torandomization (≤5% body weight change).

  • Participants of childbearing potential must be non-pregnant and non-lactating andmust agree to use study-specified contraceptive methods.

Exclusion

Exclusion Criteria:

  • Have any prior diagnosis of type 1 diabetes mellitus (T1DM) or type 2 diabetesmellitus (T2DM), or other forms of diabetes mellitus. A participant with a historyof 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 orany prior history of known or suspected hypersensitivity/allergies, intolerability,or lack of efficacy to these medications. Have known or suspected hypersensitivityto study intervention(s), to selective GLP-1 receptor agonist (RA) orglucose-dependent insulinotropic peptide (GIP)/GLP-1 or GLP-1/glucagon (GCG) dualreceptor agonists.

  • Pregnant or breastfeeding at Screening or planning to become pregnant (self orpartner) at any time within the dosing period, including follow -up, and for atleast 60 days after the last dose of study intervention.

Study Design

Total Participants: 206
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
November 25, 2025
Estimated Completion Date:
August 31, 2026

Study 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.

Connect with a study center

  • Clinical Study Site 103

    Anniston, Alabama 36207
    United States

    Site Not Available

  • Clinical Study Site 109

    Cullman, Alabama 35055
    United States

    Site Not Available

  • Clinical Study Site 110

    Phoenix, Arizona 85028
    United States

    Site Not Available

  • Clinical Study Site 113

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Clinical Study Site 111

    Anaheim, California 92801
    United States

    Site Not Available

  • Clinical Study Site 107

    Montclair, California 91763
    United States

    Site Not Available

  • Clinical Study Site 118

    Tarzana, California 91356
    United States

    Site Not Available

  • Clinical Study Site 119

    Decatur, Georgia 30030
    United States

    Site Not Available

  • Clinical Study Site 116

    West Des Moines, Iowa 50266
    United States

    Site Not Available

  • Clinical Study Site 106

    Wichita, Kansas 67207
    United States

    Site Not Available

  • Clinical Study Site 122

    Southfield, Michigan 48076
    United States

    Site Not Available

  • Clinical Study Site 121

    Omaha, Nebraska 68134
    United States

    Site Not Available

  • Clinical Study Site 117

    Binghamton, New York 13905
    United States

    Site Not Available

  • Clinical Study Site 101

    Rochester, New York 14609
    United States

    Site Not Available

  • Clinical Study Site 120

    Charlotte, North Carolina 28210
    United States

    Site Not Available

  • Clinical Study Site 108

    Monroe, North Carolina 28112
    United States

    Site Not Available

  • Clinical Study Site 105

    Norman, Oklahoma 73069
    United States

    Site Not Available

  • Clinical Study Site 114

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Clinical Study Site 115

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Clinical Study Site 112

    Dallas, Texas 75251
    United States

    Site Not Available

  • Clinical Study Site 102

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Clinical Study Site 104

    San Antonio, Texas 78240
    United States

    Site Not Available

  • Clinical Study Site 104

    San Antonio 4726206, Texas 4736286 78240
    United States

    Active - Recruiting

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