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

NCT07281937

CompletedPhase 2

Sponsor: Verdiva Bio Dev Limited

Conditions: Obesity, Overweight

Interventions: VRB-101, Placebo

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (22)

Anniston, Alabama, United States
Cullman, Alabama, United States
Phoenix, Arizona, United States
Little Rock, Arkansas, United States
Anaheim, California, United States
Montclair, California, United States
Tarzana, California, United States
Decatur, Georgia, United States
West Des Moines, Iowa, United States
Wichita, Kansas, United States
Southfield, Michigan, United States
Omaha, Nebraska, United States
Binghamton, New York, United States
Rochester, New York, United States
Charlotte, North Carolina, United States
Monroe, North Carolina, United States
Norman, Oklahoma, United States
Duncansville, Pennsylvania, United States
Knoxville, Tennessee, United States
Dallas, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States