EVOLVE-2

Active not recruitingPhase 2

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

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

Lead sponsor

Verdiva Bio Dev Limited

Asset

Ecnoglutide (VRB-101)

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

206

Study population

Obesity / overweight

Eligibility highlights

•BMI 27-30•HbA1c ≤6.5%

Primary endpoint

•Body weight, % change

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07281937

Org study IDVRB-101-201

Timeline

Milestones

Study start2025-11-25actual

Study first posted2025-12-15actual

Last update posted2026-05-08actual

Primary completion2026-07estimated (month precision)

Study completion2026-08estimated (month precision)

Assets

Investigational agents

Ecnoglutide (VRB-101)

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Safety / tolerability / PK

Cardiometabolic biomarkers

Weight & body composition

4 endpoints

Primary/protocol endpoint

Mean percent change from baseline in body weight

Time frame:From Baseline (Day 0) up to Week 21

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute change from baseline in body weight

Time frame:From Baseline (Day 0) up to Week 21

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of participants who achieve 5% or more body weight reduction

Time frame:From Baseline (Day 0) up to Week 21

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change from baseline in body mass index (BMI)

Time frame:From Baseline (Day 0) up to Week 21

BMI, change

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Change from baseline in blood pressure (BP)

Time frame:From Baseline (Day 0) up to Week 24

change from baseline, descriptive

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

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

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Secondary/protocol endpoint

Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)

Time frame:From Baseline (Day 0) up to Week 21

change from baseline, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.