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HomeTrials › NCT07553299

Obesity & weight · Phase 2 · Opening soon

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 · Sponsor: Verdiva Bio Dev Limited

What this trial means for you

This study is opening soon at 17 US sites. It's studying VRB-101, Placebo for obesity, overweight, weight maintenance.

Who can joinAll sexes, 18 Years – 80 Years
Healthy volunteersNo — diagnosis required
What you'd takeVRB-101, Placebo
Study length~6 months overall
Planned participants120
TypeInterventional (you receive treatment)

What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.

The study, in the sponsor's words

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.

Can you join? The exact criteria

Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.

Full eligibility criteria (for you and your doctor)

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.

Study sites by state

Alabama

  • Clinical Study Site 202 — Cullman

Arizona

  • Clinical Study Site 203 — Phoenix
  • Clinical Study Site 212 — Tempe

Arkansas

  • Clinical Study Site 201 — Little Rock

California

  • Clinical Study Site 214 — Santa Maria

Connecticut

  • Clinical Study Site 216 — Stamford

Florida

  • Clinical Study Site 204 — Bradenton
  • Clinical Study Site 215 — St. Petersburg

Kansas

  • Clinical Study Site 213 — El Dorado

Mississippi

  • Clinical Study Site 210 — Petal

New York

  • Clinical Study Site 205 — Buffalo

North Carolina

  • Clinical Study Site 206 — Lenoir

Tennessee

  • Clinical Study Site 209 — Jackson

Texas

  • Clinical Study Site 217 — Houston
  • Clinical Study Site 211 — Houston
  • Clinical Study Site 218 — Irving

Virginia

  • Clinical Study Site 207 — Richmond

View the official record on ClinicalTrials.gov →

Verify before you act. Medical disclaimer: content on this site is for informational purposes only and is not medical advice. GLP-1 medications are prescription drugs; always consult a licensed healthcare provider about eligibility, risks, and benefits. Trial details and enrollment status change frequently — always verify on the official registry and talk to your own clinician before contacting a study site. This page was generated from registry data and is not affiliated with the study sponsor.

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