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

Running, not enrolling · Phase 2 · Has a placebo group

Conditions studied: Obesity, Overweight

In brief

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.

Key facts

Study ID

NCT07281937

Run by

Verdiva Bio Dev Limited

People needed

206

Starts

2025-11-25

Expected to finish

2026-08-01

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Clinical Study Site 103 — Anniston, Alabama, United States
• Clinical Study Site 109 — Cullman, Alabama, United States
• Clinical Study Site 110 — Phoenix, Arizona, United States
• Clinical Study Site 113 — Little Rock, Arkansas, United States
• Clinical Study Site 111 — Anaheim, California, United States
• Clinical Study Site 107 — Montclair, California, United States
• Clinical Study Site 118 — Tarzana, California, United States
• Clinical Study Site 119 — Decatur, Georgia, United States
• Clinical Study Site 116 — West Des Moines, Iowa, United States
• Clinical Study Site 106 — Wichita, Kansas, United States
• Clinical Study Site 122 — Southfield, Michigan, United States
• Clinical Study Site 121 — Omaha, Nebraska, United States
• Clinical Study Site 117 — Binghamton, New York, United States
• Clinical Study Site 101 — Rochester, New York, United States
• Clinical Study Site 120 — Charlotte, North Carolina, United States
• Clinical Study Site 108 — Monroe, North Carolina, United States
• Clinical Study Site 105 — Norman, Oklahoma, United States
• Clinical Study Site 114 — Duncansville, Pennsylvania, United States
• Clinical Study Site 115 — Knoxville, Tennessee, United States
• Clinical Study Site 112 — Dallas, Texas, United States
• Clinical Study Site 102 — San Antonio, Texas, United States
• Clinical Study Site 104 — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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