Study of Oral Ecnoglutide (VRB-101) for Weight Maintenance
This study is testing a new oral medication called VRB-101 (ecnoglutide) to see if it can help people maintain their weight. You might be able to join if you are 18 to 80 years old and have a history of obesity or being overweight with other health problems related to weight. You also need to have already lost weight after taking injectable semaglutide or tirzepatide for at least 6 months. The main goal is to find the right weekly dose of VRB-101 that helps keep weight stable over 17 weeks. This study is currently looking for 120 participants, but its overall status is unclear.
- Study design
- This is a randomized, double-blind, placebo-controlled study, meaning participants are randomly assigned to receive VRB-101 or a placebo (an inactive pill), and neither you nor your doctors will know which you are receiving. It will include 120 participants.
- What's involved
- The study involves a screening period of about 4 weeks, followed by a 16-week treatment period where you would take VRB-101 or placebo tablets orally.
- Compensation
- Not stated in the trial record.
- Follow-up
- After the 16-week treatment, there will be a 4-week safety follow-up period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07553299
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
PHASE2Ages 18–80InterventionalTreatmentVerdiva Bio Dev Limited
~120 participants
Updated 2026-08-04 on ClinicalTrials.gov
What's tested:VRB-101Placebo
At a glance
Recruiting sites
0 of 20 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To identify the dose of VRB-101 for weight maintenance
Measured over Baseline to End of Treatment (Week 17)
Conditions
Where it's being run
20 sites across 15 statesFlorida3
Texas3
Arizona2
Alabama1
Arkansas1
California1
Connecticut1
Illinois1
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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
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.
What this trial measures
- To identify the dose of VRB-101 for weight maintenanceBaseline to End of Treatment (Week 17)