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Clinical Trials in the USA / NCT07553299
Active, not recruiting Phase 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

NCT07553299 · tracked via the Priya Life Science USA tracker
Sponsor
Verdiva Bio Dev Limited
Phase
Phase 2
Started
2026-06-12
Last updated
2026-08-04

Condition(s) studied

ObesityOverweightWeight Maintenance

Investigational drug(s) / intervention(s)

VRB-101Placebo

VRB-101: VRB-101 tablets will be administered orally.

Placebo: Placebo tablets will be administered orally.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (20)

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

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07553299 on ClinicalTrials.gov ↗ ← All trials in the USA