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

April 21, 2026 updated by: Verdiva Bio Dev Limited

A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Identify the Optimal Weekly Oral Dose of Ecnoglutide (VRB-101) for Maintaining Body Weight in Participants With Obesity or Overweight Who Have Weight-Related Comorbidities

The purpose of this study is to identify the weekly oral dose of VRB-101 (oral ecnoglutide) that can effectively maintain body weight in participants with a history of obesity or overweight with weight-related comorbidities.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy of oral ecnoglutide (VRB-101) in participants with a history of obesity or overweight who have achieved weight reduction after 6 months of treatment with injectable semaglutide or tirzepatide. The study comprises three active arms and one placebo arm.

The study will include a Screening Period of approximately 4 weeks, followed by a 16-week Treatment Period and a 4-week Safety Follow-up Period prior to the end of the study.

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Alabama
      • Cullman, Alabama, United States, 35055
        • Clinical Study Site 202
    • Arizona
      • Phoenix, Arizona, United States, 85028
        • Clinical Study Site 203
      • Tempe, Arizona, United States, 85281
        • Clinical Study Site 212
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Clinical Study Site 201
    • California
      • Santa Maria, California, United States, 93454
        • Clinical Study Site 214
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Clinical Study Site 216
    • Florida
      • Bradenton, Florida, United States, 34209
        • Clinical Study Site 204
      • St. Petersburg, Florida, United States, 33704
        • Clinical Study Site 215
    • Kansas
      • El Dorado, Kansas, United States, 67042
        • Clinical Study Site 213
    • Mississippi
      • Petal, Mississippi, United States, 39465
        • Clinical Study Site 210
    • New York
      • Buffalo, New York, United States, 14217
        • Clinical Study Site 205
    • North Carolina
      • Lenoir, North Carolina, United States, 28645
        • Clinical Study Site 206
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Clinical Study Site 209
    • Texas
      • Houston, Texas, United States, 77008
        • Clinical Study Site 217
      • Houston, Texas, United States, 77040
        • Clinical Study Site 211
      • Irving, Texas, United States, 75063
        • Clinical Study Site 218
    • Virginia
      • Richmond, Virginia, United States, 23226
        • Clinical Study Site 207

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Have a history of BMI of ≥30 kg/m2 OR ≥27 kg/m2 and <30 kg/m2 with at least 1 weight-related comorbidity at the time of initiation of subcutaneous (SC) semaglutide and/or tirzepatide treatment.
  • Documented history of having obesity or overweight with weight-related comorbidities per medical records at the time of initiation of SC semaglutide and/or tirzepatide treatment.
  • History of treatment with weekly SC semaglutide and/or tirzepatide for a minimum of 6 months prior to Screening.
  • Documented weight reduction of ≥10% in 6 months and no clinically relevant weight regain.
  • Participants of childbearing potential (POCBP) must be non-pregnant and non-lactating and must agree to use study-specified contraceptive methods.

Exclusion Criteria:

  • Current or past diagnosis of diabetes mellitus [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 HbA1c <6.5% at Screening and is not on medication to lower glucose.
  • 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).
  • Diagnosed with obesity due to endocrinologic disorders (for example, Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (for example, melanocortin 4 receptor deficiency or Prader-Willi syndrome)
  • History of clinically significant gastric emptying abnormality (for example, severe gastroparesis or gastric outlet obstruction).
  • Evidence of uncontrolled hypothyroidism or hyperthyroidism based on an abnormal thyroid-stimulating hormone (TSH).
  • Personal or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma.
  • Evidence of a significant, uncontrolled endocrine abnormality (for example, thyrotoxicosis or adrenal crises)
  • Renal impairment measured as eGFR <30 mL/min/1.73 m2
  • History of acute or chronic pancreatitis or clinically significant gallbladder disease.
  • Triglycerides >500 mg/dL (5.7 mmol/L) at Screening.
  • Poorly controlled hypertension or an elevated resting pulse rate (>100 bpm).
  • Current treatment with or history of treatment with (within 3 months prior to Screening) medications that may cause significant weight gain.
  • Prior or planned surgical treatment for obesity, plan to have endoscopic and/or device-based therapy for obesity or have had device removal within the last 6 months prior to Screening.
  • Known hypersensitivity to any of the study drug ingredients.
  • Are pregnant or lactating at Screening or planning to become pregnant (self or partner) at any time during the study and for at least 60 days after completion of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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: 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: 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
Placebo Comparator: Placebo
Participants will receive matching placebo to VRB-101 once every week.
Drug: Placebo
Placebo tablets will be administered orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To identify the dose of VRB-101 for weight maintenance
Time Frame: Baseline to End of Treatment (Week 17)
Baseline to End of Treatment (Week 17)

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change in body weight from baseline
Time Frame: Baseline to End of Treatment (Week 17)
Baseline to End of Treatment (Week 17)
Absolute change in body weight from baseline
Time Frame: Baseline to End of Treatment (Week 17)
Baseline to End of Treatment (Week 17)
Number of participants with treatment-emergent adverse events (TEAEs), serious adverse events (SAEs) and Adverse events of special interest (AESIs)
Time Frame: Baseline to Week 24
Baseline to Week 24
Change in blood pressure from baseline
Time Frame: Baseline to End of Treatment (Week 17)
Baseline to End of Treatment (Week 17)
Change in Columbia-Suicide Severity Rating Scale (C-SSRS) from baseline
Time Frame: Baseline to End of Treatment (Week 17)
Baseline to End of Treatment (Week 17)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Verdiva Bio Dev Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 28, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VRB-101-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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