DelfaGLP-1 Atlas

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Not yet recruitingPhase 2

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

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

Asset

Ecnoglutide (VRB-101)

Oral · GLP-1 agonist

Listed sites

17

Recruiting sites

—

Enrollment

120

estimated

Study population

Obesity / overweight

Key I/E criterion

•BMI 27-30

Primary endpoint

•To identify the dose of VRB-101 for weight maintenance

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 IDNCT07553299
Org study IDVRB-101-202

Timeline

Milestones

Study first posted2026-04-28actual
Last update posted2026-04-28actual
Primary completion2026-11-30estimated
Study completion2026-12-31estimated
Study start2026-05estimated (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 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.

Endpoints (6)

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
2
Safety / tolerability / PK
2
Cardiometabolic biomarkers
1
Other (unclassified)
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Percent change in body weight from baseline

Time frame:Baseline to End of Treatment (Week 17)

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Absolute change in body weight from baseline

Time frame:Baseline to End of Treatment (Week 17)

Body weight, absolute change (kg)

change from baseline, improvement

Cardiometabolic biomarkers

1 endpoint
Secondary/protocol endpoint

Change in blood pressure from baseline

Time frame:Baseline to End of Treatment (Week 17)

change from baseline, improvement

Safety / tolerability / PK

2 endpoints
Secondary/protocol endpoint

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

Treatment-emergent AEs (any)

event count, event

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

Secondary/protocol endpoint

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

Time frame:Baseline to End of Treatment (Week 17)

change from baseline, event

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

To identify the dose of VRB-101 for weight maintenance

Time frame:Baseline to End of Treatment (Week 17)

descriptive

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.