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

Purpose

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

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Schedule A: VRB-101 (Active Arm 1) 		Participants will receive VRB-101 once every week.
  • Drug: VRB-101
    VRB-101 tablets will be administered orally.
    Other names:
    • Oral Ecnoglutide
Experimental
Schedule A: VRB-101 (Active Arm 2) 		Participants will receive VRB-101 once every week.
  • Drug: VRB-101
    VRB-101 tablets will be administered orally.
    Other names:
    • Oral Ecnoglutide
Experimental
Schedule A: VRB-101 (Active Arm 3) 		Participants will receive VRB-101 once every week.
  • Drug: VRB-101
    VRB-101 tablets will be administered orally.
    Other names:
    • Oral Ecnoglutide
Experimental
Schedule B: VRB-101 (Active Arm 4) 		Participants will receive VRB-101 once every week.
  • Drug: VRB-101
    VRB-101 tablets will be administered orally.
    Other names:
    • Oral Ecnoglutide
Experimental
Schedule B: VRB-101 (Active Arm 5) 		Participants will receive VRB-101 once every week.
  • Drug: VRB-101
    VRB-101 tablets will be administered orally.
    Other names:
    • Oral Ecnoglutide
Placebo Comparator
Pooled Placebo 		Participants will receive matching placebo to VRB-101 once every week.
  • Drug: Placebo
    Placebo tablets will be administered orally.

Recruiting Locations

Clinical Study Site 103
Anniston 4830198, Alabama 4829764 36207

Clinical Study Site 109
Cullman 4057835, Alabama 4829764 35055

Clinical Study Site 110
Phoenix 5308655, Arizona 5551752 85028

Clinical Study Site 113
Little Rock 4119403, Arkansas 4099753 72205

Clinical Study Site 107
Montclair 5374232, California 5332921 91763

Clinical Study Site 119
Decatur 4191124, Georgia 4197000 30030

Clinical Study Site 106
Wichita 4281730, Kansas 4273857 67207

Clinical Study Site 122
Southfield 5010636, Michigan 5001836 48076

Clinical Study Site 117
Binghamton 5109177, New York 5128638 13905

Clinical Study Site 101
Rochester 5134086, New York 5128638 14609

Clinical Study Site 120
Charlotte 4460243, North Carolina 4482348 28210

Clinical Study Site 108
Monroe 4479946, North Carolina 4482348 28112

Clinical Study Site 105
Norman 4543762, Oklahoma 4544379 73069

Clinical Study Site 114
Duncansville 5187508, Pennsylvania 6254927 16635

Clinical Study Site 115
Knoxville 4634946, Tennessee 4662168 37909

Clinical Study Site 112
Dallas 4684888, Texas 4736286 75251

More Details

Status
Recruiting
Sponsor
Verdiva Bio Dev Limited

Study Contact

Khaled Junaidi
+1 (815) 593-2218
khaled.junaidi@verdivabio.com

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.