DelfaGLP-1 Atlas

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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

Asset

Ecnoglutide (VRB-101)

Oral · GLP-1 agonist

Listed sites

22

Recruiting sites

—

Enrollment

206

actual

Study population

Obesity / overweight

Key I/E criteria

•BMI 27-30•HbA1c ≤6.5%

Primary endpoint

•Body weight, % change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. 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)

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

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
4
Safety / tolerability / PK
2
Cardiometabolic biomarkers
1

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 1, 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 1, 2026 snapshot.