VRB-101 for Obesity

Not currently recruiting at 19 trial locations
VB
Overseen ByVerdiva Bio Medical Affairs
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Verdiva Bio Dev Limited
Must be taking: Semaglutide, Tirzepatide
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 Ecnoglutide (VRB-101), a potential weight management drug, to help people maintain their weight. The researchers aim to determine the optimal weekly dose of VRB-101 for participants with a history of obesity or being overweight, particularly those with related health issues. Participants will receive either VRB-101 or a placebo (a harmless substance resembling the treatment but without effect) once a week. This trial may suit individuals who have previously lost weight with certain medications and maintained their weight without significant regain. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it does require that you have been on semaglutide or tirzepatide for at least 6 months before joining. If you are on medications that cause significant weight gain, you must have stopped them at least 3 months before the trial.

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

Research has shown that ecnoglutide (VRB-101) is generally safe and well-tolerated. Previous studies found that participants taking ecnoglutide lost more weight than those on a placebo. The safety record is strong, with most side effects being mild. Common side effects included nausea and diarrhea.

In one study, about 93% of participants taking ecnoglutide reported some side effects, similar to the 84% in the placebo group. Ecnoglutide is already approved for other conditions, indicating that its safety has been thoroughly evaluated for those uses. However, as with any treatment, individual experiences may vary.12345

Why do researchers think this study treatment might be promising?

Ecnoglutide (VRB-101) is unique because it targets obesity through a potentially novel mechanism that sets it apart from standard treatments like lifestyle changes, medications such as orlistat, or GLP-1 receptor agonists like semaglutide. Researchers are excited about VRB-101 because it is designed to be administered once a week, which could simplify treatment regimens and improve patient compliance. Additionally, if VRB-101 shows promising results, it might offer an alternative with fewer side effects or improved efficacy over existing options, providing new hope for those struggling with obesity.

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

Studies have shown that ecnoglutide, also known as VRB-101, helps individuals who are obese or overweight lose a significant amount of weight. Specifically, one study found that 77% to 87% of participants lost at least 5% of their body weight after using ecnoglutide for 40 weeks. This medication targets a part of the body that controls appetite and food intake. Additionally, ecnoglutide is generally well-tolerated, with most people not experiencing serious side effects. These findings suggest that ecnoglutide could effectively manage obesity and related weight issues. Participants in this trial will receive VRB-101 in one of the active arms or a placebo in the comparator arm to further evaluate its effectiveness and safety.12356

Are You a Good Fit for This Trial?

This trial is for people who have lost at least 10% of their body weight after using weekly semaglutide or tirzepatide shots for at least 6 months, and had obesity or were overweight with related health issues before starting those medicines. Participants must not be pregnant or breastfeeding and must use contraception if needed.

Inclusion Criteria

I have used weekly semaglutide or tirzepatide injections for at least 6 months.
I have lost at least 10% of my body weight in the past 6 months and kept it off.
* Participants of childbearing potential (POCBP) must be non-pregnant and non-lactating and must agree to use study-specified contraceptive methods.
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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 doses of VRB-101 or placebo for weight maintenance

16 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Ecnoglutide (VRB-101)

Trial Overview

The study tests a new oral medication called VRB-101 (ecnoglutide) taken once a week to help maintain weight loss, compared to a placebo. Participants are randomly assigned to either the active drug or placebo group.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: VRB-101 (Active Arm 3)Experimental Treatment1 Intervention
Group II: VRB-101 (Active Arm 2)Experimental Treatment1 Intervention
Group III: VRB-101 (Active Arm 1)Experimental Treatment1 Intervention
Group IV: PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Verdiva Bio Dev Limited

Lead Sponsor

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40555243/

Efficacy and safety of a biased GLP-1 receptor agonist ...

We aimed to assess the efficacy and safety of once weekly ecnoglutide versus placebo for the treatment of overweight or obesity in Chinese adults.

NCT07281937 | A Study of Weekly Oral Ecnoglutide (VRB- ...

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 ...

Efficacy and safety of a biased GLP-1 receptor agonist ...

Individuals administered ecnoglutide had superior and sustained reduction in bodyweight versus placebo with a favourable safety profile, supporting its ...

734-P: VRB101 Is a Potent Oral GLP-1 Tablet with Once ...

Here we present pharmacokinetic (PK) analysis of 30 mg daily dose of VRB101 and the modeled PK data supporting the potential of VRB101 as a once ...

Efficacy and safety of cAMP signalling-biased GLP-1 ...

In this work, we show that ecnoglutide monotherapy significantly improved glycaemic control versus placebo and was well-tolerated in this ...

Efficacy and safety of GLP-1 analog ecnoglutide in adults ...

We show that ecnoglutide was generally safe and well tolerated in this population and resulted in significant improvements in blood glucose, ...