A Study of Weekly Oral Ecnoglutide (VRB-101) in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (EVOLVE-2)

August 14, 2026 updated by: Verdiva Bio Dev Limited

A Randomized, Double-Blind, Placebo-Controlled Phase 2b Study of Weekly Oral Ecnoglutide (VRB-101) in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized, double-blind, placebo-controlled study of oral ecnoglutide (VRB-101), with 5 active arms and 1 placebo arm. The study will include a Screening Period of 4 weeks, followed by a 20-week Study Treatment Period and a 4-week Safety Follow-up Period prior to the end of study (EOS) visit.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
206

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alabama
      • Anniston, Alabama, United States, 36207
        • Clinical Study Site 103
      • Cullman, Alabama, United States, 35055
        • Clinical Study Site 109
    • Arizona
      • Phoenix, Arizona, United States, 85028
        • Clinical Study Site 110
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Clinical Study Site 113
    • California
      • Anaheim, California, United States, 92801
        • Clinical Study Site 111
      • Montclair, California, United States, 91763
        • Clinical Study Site 107
      • Tarzana, California, United States, 91356
        • Clinical Study Site 118
    • Georgia
      • Decatur, Georgia, United States, 30030
        • Clinical Study Site 119
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Clinical Study Site 116
    • Kansas
      • Wichita, Kansas, United States, 67207
        • Clinical Study Site 106
    • Michigan
      • Southfield, Michigan, United States, 48076
        • Clinical Study Site 122
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Clinical Study Site 121
    • New York
      • Binghamton, New York, United States, 13905
        • Clinical Study Site 117
      • Rochester, New York, United States, 14609
        • Clinical Study Site 101
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Clinical Study Site 120
      • Monroe, North Carolina, United States, 28112
        • Clinical Study Site 108
    • Oklahoma
      • Norman, Oklahoma, United States, 73069
        • Clinical Study Site 105
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Clinical Study Site 114
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Clinical Study Site 115
    • Texas
      • Dallas, Texas, United States, 75251
        • Clinical Study Site 112
      • San Antonio, Texas, United States, 78229
        • Clinical Study Site 102
      • San Antonio, Texas, United States, 78240
        • Clinical Study Site 104

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Schedule A: 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: Schedule A: 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: Schedule A: 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
Experimental: Schedule B: VRB-101 (Active Arm 4)
Participants will receive VRB-101 once every week.
Drug: VRB-101
VRB-101 tablets will be administered orally.
Other Names:
  • Oral Ecnoglutide
Experimental: Schedule B: VRB-101 (Active Arm 5)
Participants will receive VRB-101 once every week.
Drug: VRB-101
VRB-101 tablets will be administered orally.
Other Names:
  • Oral Ecnoglutide
Placebo Comparator: Pooled 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean percent change from baseline in body weight
Time Frame: From Baseline (Day 0) up to Week 21
To evaluate the efficacy of VRB-101 for body weight reduction compared to placebo in Schedule A dose regimens.
From Baseline (Day 0) up to Week 21

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Absolute change from baseline in body weight
Time Frame: From Baseline (Day 0) up to Week 21
To compare the effect of VRB-101 versus placebo on body weight in Schedule A.
From Baseline (Day 0) up to Week 21
Percentage of participants who achieve 5% or more body weight reduction
Time Frame: From Baseline (Day 0) up to Week 21
To compare the effect of VRB-101 versus placebo on body weight in Schedule A
From Baseline (Day 0) up to Week 21
Change from baseline in body mass index (BMI)
Time Frame: From Baseline (Day 0) up to Week 21
To compare the effect of VRB-101 versus placebo on body weight in Schedule A.
From Baseline (Day 0) up to Week 21
Number of study participants with treatment emergent adverse events (TEAEs) and serious adverse events (SAEs)
Time Frame: From Baseline (Day 0) up to Week 24
To assess safety and tolerability of study interventions. Adverse events (AEs) reported after first administration of study intervention will be designated as a TEAE.
From Baseline (Day 0) up to Week 24
Change from baseline in blood pressure (BP)
Time Frame: From Baseline (Day 0) up to Week 24
To assess safety and tolerability of study interventions.
From Baseline (Day 0) up to Week 24
Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: From Baseline (Day 0) up to Week 21
The C-SSRS systematically assesses suicidal ideation and behavior using yes/no questions, ordinal severity ratings (0-5), and intensity subscales. Results at End of Study will be compared to Baseline.
From Baseline (Day 0) up to Week 21

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 25, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 23, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 23, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 15, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VRB-101-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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