What this trial means for you
This study is active, not recruiting. It is not currently taking new participants, but its results may matter for treatments you're considering. It's studying VRB-101, Placebo for obesity, overweight.
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study, ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry. Bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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 sites by state
Alabama
- Clinical Study Site 103, Anniston
- Clinical Study Site 109, Cullman
Arizona
- Clinical Study Site 110, Phoenix
Arkansas
- Clinical Study Site 113, Little Rock
California
- Clinical Study Site 111, Anaheim
- Clinical Study Site 107, Montclair
- Clinical Study Site 118, Tarzana
Georgia
- Clinical Study Site 119, Decatur
Iowa
- Clinical Study Site 116, West Des Moines
Kansas
- Clinical Study Site 106, Wichita
Michigan
- Clinical Study Site 122, Southfield
Nebraska
- Clinical Study Site 121, Omaha
New York
- Clinical Study Site 117, Binghamton
- Clinical Study Site 101, Rochester
North Carolina
- Clinical Study Site 120, Charlotte
- Clinical Study Site 108, Monroe
Oklahoma
- Clinical Study Site 105, Norman
Pennsylvania
- Clinical Study Site 114, Duncansville
Tennessee
- Clinical Study Site 115, Knoxville
Texas
- Clinical Study Site 112, Dallas
- Clinical Study Site 102, San Antonio
- Clinical Study Site 104, San Antonio
View the official record on ClinicalTrials.gov →
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