VRB-101 for Obesity
(EVOLVE-2 Trial)

Recruiting at 21 trial locations

Overseen ByKhaled Junaidi

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Verdiva Bio Dev Limited

Must not be taking: GLP-1 agonists

Disqualifiers: Diabetes, Pregnancy, Breastfeeding, others

Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called VRB-101 to determine its effectiveness in helping people with obesity lose weight. It compares VRB-101 to a placebo (a non-active treatment) to evaluate its efficacy. Participants will receive VRB-101 once a week. Suitable candidates for this trial have a body mass index (BMI) of 30 or higher, or a BMI between 27 and 30 with other weight-related health issues, and have maintained a stable weight for the past 3 months. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you have been using glucagon-like peptide-1 (GLP-1) medications, you must not have used them in the 6 months before the trial.

Is there any evidence suggesting that VRB-101 is likely to be safe for humans?

Research has shown that VRB-101 has been tested in other studies, focusing on its safety for people with obesity. In these studies, participants generally tolerated VRB-101 well, with most experiencing no serious side effects. Some common, mild side effects included nausea and headaches.

VRB-101 is a pill taken once a week, which simplifies adherence to the treatment plan. Earlier studies also demonstrated that the drug levels in the body were safe and comparable to other approved treatments already in use.

While these results are promising, more research is underway to confirm long-term safety. Always consult a healthcare provider if there are concerns about joining a trial.¹ ² ³ ⁴ ⁵

Why do researchers think this study treatment might be promising for obesity?

VRB-101 is unique because it offers a fresh approach to tackling obesity by possibly targeting different pathways than traditional treatments like lifestyle changes, medications, and bariatric surgery. Researchers are excited about VRB-101 because it might involve a new mechanism of action or active ingredient that sets it apart from current options. This potential innovation could lead to more effective weight management with a once-a-week administration, making it a convenient and promising alternative for people struggling with obesity.

What evidence suggests that VRB-101 might be an effective treatment for obesity?

Research shows that VRB-101 could be a promising treatment for weight loss in people with obesity. Early studies indicate that taking VRB-101 as a weekly pill achieves drug levels comparable to or better than current weekly weight loss treatments. This trial will evaluate VRB-101, administered weekly, across various treatment arms. The medication helps control appetite and manage weight. Initial findings suggest it has strong potential to effectively reduce body weight, making VRB-101 a strong candidate for managing obesity.¹ ² ⁴ ⁶ ⁷

Are You a Good Fit for This Trial?

This trial is for individuals who are overweight or have obesity, particularly those with weight-related health issues like high blood pressure. Participants should be seeking treatment for weight reduction.

Inclusion Criteria

Have hemoglobin A1c (HbA1c) <6.5%

Participants of childbearing potential must be non-pregnant and non-lactating and must agree to use study-specified contraceptive methods

My BMI is 27 or higher, and I have a weight-related health issue.

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Exclusion Criteria

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)

I have diabetes or had gestational diabetes with an HbA1c below 6.5%.

I am not pregnant, breastfeeding, nor planning to become pregnant soon.

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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive weekly oral ecnoglutide (VRB-101) or placebo for body weight reduction

20 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

VRB-101

Trial Overview

The study tests the effectiveness of a weekly oral medication called Ecnoglutide (VRB-101) in reducing body weight, compared to a placebo (a pill without active ingredients).

How Is the Trial Designed?

Treatment groups

Experimental Treatment

Placebo Group

Group I: Schedule B: VRB-101 (Active Arm 5)Experimental Treatment1 Intervention