NCT07553299
Not yet recruiting
Phase 2
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study to Identify the Optimal Weekly Oral Dose of Ecnoglutide (VRB-101) for Maintaining Body Weight in Participants With Obesity or Overweight Who Have Weight-Related Comorbidities
Verdiva Bio Dev Limited17 sites in 1 country120 target enrollmentStarted: May 1, 2026Last updated:
Overview
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Verdiva Bio Dev Limited
- Enrollment
- 120
- Locations
- 17
- Primary Endpoint
- To identify the dose of VRB-101 for weight maintenance
Overview
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.
Detailed Description
This is a randomized, double-blind, placebo-controlled study to evaluate the efficacy of oral ecnoglutide (VRB-101) in participants with a history of obesity or overweight who have achieved weight reduction after 6 months of treatment with injectable semaglutide or tirzepatide. The study comprises three active arms and one placebo arm.
The study will include a Screening Period of approximately 4 weeks, followed by a 16-week Treatment Period and a 4-week Safety Follow-up Period prior to the end of the study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
VRB-101 (Active Arm 1)
Experimental
Participants will receive VRB-101 once every week.
Intervention: VRB-101 (Drug)
VRB-101 (Active Arm 2)
Experimental
Participants will receive VRB-101 once every week.
Intervention: VRB-101 (Drug)
VRB-101 (Active Arm 3)
Experimental
Participants will receive VRB-101 once every week.
Intervention: VRB-101 (Drug)
Placebo
Placebo Comparator
Participants will receive matching placebo to VRB-101 once every week.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
To identify the dose of VRB-101 for weight maintenance
Time Frame: Baseline to End of Treatment (Week 17)
Secondary Outcomes
- 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))
Investigators
Study Sites (17)
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