Clinical trial

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

Active, not recruiting · Phase 2 · 1 countries · Registry ID NCT07553299

Active, not recruitingPhase 2Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 80 Years
SexAll
Healthy volunteersNot accepted
ConditionObesity, Overweight, Weight Maintenance

Full registry criteria

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.

Treatments and study arms

VRB-101

Drug

VRB-101 tablets will be administered orally.

Placebo

Drug

Placebo tablets will be administered orally.

Primary outcomes

To identify the dose of VRB-101 for weight maintenanceBaseline to End of Treatment (Week 17)

Study locations

20 locations were listed when this page was built. The first 40 are shown.

Clinical Study Site 204🇺🇸 Bradenton, Florida, United States
Clinical Study Site 205🇺🇸 Buffalo, New York, United States
Clinical Study Site 202🇺🇸 Cullman, Alabama, United States
Clinical Study Site 213🇺🇸 El Dorado, Kansas, United States
Clinical Study Site 211🇺🇸 Houston, Texas, United States
Clinical Study Site 217🇺🇸 Houston, Texas, United States
Clinical Study Site 218🇺🇸 Irving, Texas, United States
Clinical Study Site 209🇺🇸 Jackson, Tennessee, United States
Clinical Study Site 206🇺🇸 Lenoir, North Carolina, United States
Clinical Study Site 201🇺🇸 Little Rock, Arkansas, United States
Clinical Study Site 219🇺🇸 Niles, Illinois, United States
Clinical Study Site 220🇺🇸 Oklahoma City, Oklahoma, United States
Clinical Study Site 221🇺🇸 Orange City, Florida, United States
Clinical Study Site 210🇺🇸 Petal, Mississippi, United States
Clinical Study Site 203🇺🇸 Phoenix, Arizona, United States
Clinical Study Site 207🇺🇸 Richmond, Virginia, United States
Clinical Study Site 214🇺🇸 Santa Maria, California, United States
Clinical Study Site 215🇺🇸 St. Petersburg, Florida, United States
Clinical Study Site 216🇺🇸 Stamford, Connecticut, United States
Clinical Study Site 212🇺🇸 Tempe, Arizona, United States