A Study of Weekly Oral Ecnoglutide (VRB-101) in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities
NCT ID: NCT07281937
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
200 participants
INTERVENTIONAL
2025-11-25
2026-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Schedule A: VRB-101 (Active Arm 1)
Participants will receive VRB-101 once every week.
VRB-101
VRB-101 tablets will be administered orally.
Schedule A: VRB-101 (Active Arm 2)
Participants will receive VRB-101 once every week.
VRB-101
VRB-101 tablets will be administered orally.
Schedule A: VRB-101 (Active Arm 3)
Participants will receive VRB-101 once every week.
VRB-101
VRB-101 tablets will be administered orally.
Schedule B: VRB-101 (Active Arm 4)
Participants will receive VRB-101 once every week.
VRB-101
VRB-101 tablets will be administered orally.
Schedule B: VRB-101 (Active Arm 5)
Participants will receive VRB-101 once every week.
VRB-101
VRB-101 tablets will be administered orally.
Pooled Placebo
Participants will receive matching placebo to VRB-101 once every week.
Placebo
Placebo tablets will be administered orally.
Interventions
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VRB-101
VRB-101 tablets will be administered orally.
Placebo
Placebo tablets will be administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
80 Years
ALL
No
Sponsors
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Verdiva Bio Dev Limited
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Central Contacts
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Other Identifiers
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VRB-101-201
Identifier Type: -
Identifier Source: org_study_id