A Study of Weekly Oral Ecnoglutide (VRB-101) in Participants Who Have Obesity or Overweight With Weight-Related Comorbidities (EVOLVE-2)

Verdiva Bio Dev Limited

Status and phase: Enrolling; Phase 2

Conditions: Overweight; Obesity

Treatments: Drug: VRB-101; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07281937

VRB-101-201

Details and patient eligibility

About

The aim of this study is to evaluate the efficacy of VRB-101 for body weight reduction compared to placebo in participants who have obesity or overweight with weight-related comorbidities.

Full description

This is a randomized, double-blind, placebo-controlled study of oral ecnoglutide (VRB-101), with 5 active arms and 1 placebo arm. The study will include a Screening Period of 4 weeks, followed by a 20-week Study Treatment Period and a 4-week Safety Follow-up Period prior to the end of study (EOS) visit.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have hemoglobin A1c (HbA1c) <6.5%.
• Have a BMI of ≥30 kg/m2 OR ≥27 kg/m2 and <30 kg/m2 with at least 1 weight-related comorbidity.
• Have a self-reported history of stable body weight for the 3 months prior to randomization (≤5% body weight change).
• Participants of childbearing potential must be non-pregnant and non-lactating and must agree to use study-specified contraceptive methods.

Exclusion criteria

• Have any prior diagnosis of 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 an HbA1c < 6.5% at Screening.
• Have 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).
• Have had exposure to glucagon-like peptide -1 (GLP-1) 6 months prior to Screening or any prior history of known or suspected hypersensitivity/allergies, intolerability, or lack of efficacy to these medications. Have known or suspected hypersensitivity to study intervention(s), to selective GLP-1 receptor agonist (RA) or glucose-dependent insulinotropic peptide (GIP)/GLP-1 or GLP-1/glucagon (GCG) dual receptor agonists.
• Pregnant or breastfeeding at Screening or planning to become pregnant (self or partner) at any time within the dosing period, including follow -up, and for at least 60 days after the last dose of study intervention.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 6 patient groups, including a placebo group

Schedule A: VRB-101 (Active Arm 1)

Experimental group

Description:

Participants will receive VRB-101 once every week.

Treatment:

Drug: VRB-101

Schedule A: VRB-101 (Active Arm 2)

Experimental group

Description:

Participants will receive VRB-101 once every week.

Treatment:

Drug: VRB-101

Schedule A: VRB-101 (Active Arm 3)

Experimental group

Description:

Participants will receive VRB-101 once every week.

Treatment:

Drug: VRB-101

Schedule B: VRB-101 (Active Arm 4)

Experimental group

Description:

Participants will receive VRB-101 once every week.

Treatment:

Drug: VRB-101

Schedule B: VRB-101 (Active Arm 5)

Experimental group

Description:

Participants will receive VRB-101 once every week.

Treatment:

Drug: VRB-101

Pooled Placebo

Placebo Comparator group

Description:

Participants will receive matching placebo to VRB-101 once every week.

Treatment:

Drug: Placebo