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

NCT07553299 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: VRB-101-202
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Obesity; Overweight; Weight Maintenance

Keywords

Weight reduction; Glucagon-like peptide-1 (GLP-1); Chronic Weight Management

Outcome Measures

Primary Outcomes (1)

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

  Baseline to End of Treatment (Week 17)

Secondary Outcomes (5)

• Percent change in body weight from baseline

  Baseline to End of Treatment (Week 17)

• Absolute change in body weight from baseline

  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)

  Baseline to Week 24

• Change in blood pressure from baseline

  Baseline to End of Treatment (Week 17)

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

  Baseline to End of Treatment (Week 17)

Study Arms (4)

VRB-101 (Active Arm 1)

EXPERIMENTAL

Participants will receive VRB-101 once every week.

Drug: VRB-101

VRB-101 (Active Arm 2)

EXPERIMENTAL

Participants will receive VRB-101 once every week.

Drug: VRB-101

VRB-101 (Active Arm 3)

EXPERIMENTAL

Participants will receive VRB-101 once every week.

Drug: VRB-101

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo to VRB-101 once every week.

Drug: Placebo

Interventions

VRB-101 DRUG

VRB-101 tablets will be administered orally.

Also known as: Oral ecnoglutide

VRB-101 (Active Arm 1); VRB-101 (Active Arm 2); VRB-101 (Active Arm 3)

Placebo DRUG

Placebo tablets will be administered orally.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Verdiva Bio Dev Limited: lead

Study Sites (17)

Clinical Study Site 202

Cullman, Alabama, 35055, United States

Location

Clinical Study Site 203

Phoenix, Arizona, 85028, United States

Location

Clinical Study Site 212

Tempe, Arizona, 85281, United States

Location

Clinical Study Site 201

Little Rock, Arkansas, 72205, United States

Location

Clinical Study Site 214

Santa Maria, California, 93454, United States

Location

Clinical Study Site 216

Stamford, Connecticut, 06905, United States

Location

Clinical Study Site 204

Bradenton, Florida, 34209, United States

Location

Clinical Study Site 215

St. Petersburg, Florida, 33704, United States

Location

Clinical Study Site 213

El Dorado, Kansas, 67042, United States

Location

Clinical Study Site 210

Petal, Mississippi, 39465, United States

Location

Clinical Study Site 205

Buffalo, New York, 14217, United States

Location

Clinical Study Site 206

Lenoir, North Carolina, 28645, United States

Location

Clinical Study Site 209

Jackson, Tennessee, 38305, United States

Location

Clinical Study Site 217

Houston, Texas, 77008, United States

Location

Clinical Study Site 211

Houston, Texas, 77040, United States

Location

Clinical Study Site 218

Irving, Texas, 75063, United States

Location

Clinical Study Site 207

Richmond, Virginia, 23226, United States

Location

MeSH Terms

Conditions

Obesity; Overweight; Weight Loss

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Central Study Contacts

Verdiva Bio Medical Affairs

CONTACT

medical.affairs@verdivabio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 28, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

US (17)