62 Participants NeededMy employer runs this trial

Microneedle Patch Semaglutide for Obesity

LG
Overseen ByLynda G Tussey, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method of delivering semaglutide, a medication commonly used for weight loss, via a microneedle patch instead of regular injections. The researchers aim to compare the effectiveness of the microneedle patch to traditional injection methods in medically healthy individuals. The study includes different groups receiving various doses to evaluate effectiveness and safety. It suits individuals with a body mass index (BMI) between 25 and 40, who have not recently used weight loss treatments and are free of significant health issues. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to experience this innovative delivery method.

What prior data suggests that this microneedle patch is safe for delivering semaglutide?

Previous studies have shown that semaglutide is safe for humans. The FDA has already approved it for weight loss in adults when combined with diet and exercise, indicating it is generally well-tolerated. Most people experience only mild side effects, such as nausea or diarrhea.

The new treatment, VX-201, uses a microneedle patch to deliver semaglutide without traditional needles. Since this is the first human test of VX-201, the main goal is to ensure its safety. Although specific data on VX-201 is not yet available, its testing in humans suggests it is not expected to be unsafe. The trial will focus on whether people can tolerate the patch and if any side effects occur.

Overall, based on existing data for semaglutide, the treatment appears safe. However, as with any new treatment, this trial will provide more specific information about how well people tolerate VX-201.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the microneedle patch for delivering semaglutide because it offers a novel method of administering medication for obesity. Unlike traditional injections, this patch could make taking semaglutide more comfortable and accessible for patients. Additionally, the trial is exploring VX-201, a new compound, which could offer another effective option for weight management. These advancements could lead to more convenient and potentially more effective treatments for obesity compared to the current standard injections.

What evidence suggests that this trial's treatments could be effective for obesity?

Research has shown that semaglutide aids in weight loss. Studies have found that individuals taking semaglutide can lose significant weight, with some losing about 21% of their body weight over time. This marks a substantial improvement compared to those not taking the drug. In this trial, participants will receive either semaglutide or VX-201, a new microneedle patch designed to deliver semaglutide without injections, simplifying its use. Although the patch remains under testing, strong evidence supports semaglutide's effectiveness for weight loss.16789

Who Is on the Research Team?

BB

Bridgette Blazek, MD

Principal Investigator

Celerion

Are You a Good Fit for This Trial?

This trial is for healthy adults who are overweight or obese. Participants should not have serious health problems and must meet specific weight and health requirements set by the study.

Inclusion Criteria

Body mass index ≥25 to <35 kg/m2 if participating in the SAD phase or ≥27 to <40 kg/m2 if participating in the MD phase, at the time of Screening
I am between 18 and 60 years old.
Medically healthy with no clinically significant medical history, vital sign, or coagulation results at Screening; chemistry, hematology, or urinalysis at Screening and Day -1 (SAD)/Day 0 (MD) as deemed by the Investigator
See 1 more

Exclusion Criteria

A self-reported change in body weight > 5 kg (11 lb) within 90 days before screening irrespective of medical records
HbA1c ≥ 6.5% as measured at screening
Estimated glomerular filtration rate <80 mL/min as determined by the Mosteller body surface area correction equation at Screening
See 20 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Single Dose Assessment

Participants receive a single dose of either 0.25 mg or 0.5 mg of VX-201 or semaglutide SC

1 week
1 visit (in-person)

Multiple Dose Assessment

Participants receive four weekly doses of 1.7 mg followed by four weekly doses of 2.4 mg of either VX-201 or semaglutide SC

8 weeks
8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • semaglutide SC
  • VX-201

Trial Overview

The study compares two ways of giving semaglutide, a medication used for weight loss: one group uses a new needle-free skin patch (VX-201), while the other gets standard under-the-skin injections. The goal is to see how safe and effective the patch is compared to injections.

How Is the Trial Designed?

6

Treatment groups

Experimental Treatment

Active Control

Group I: VX-201 0.25 mg SAD PhaseExperimental Treatment1 Intervention
Group II: Single VX-201 0.5 mg doseExperimental Treatment1 Intervention
Group III: Multiple VX-201 1.7 and 2.5 mg doseExperimental Treatment1 Intervention
Group IV: Single 0.25 mg semaglutide SC doseActive Control1 Intervention
Group V: Multiple semaglutide SC 1.7 and 2.5 mg doseActive Control1 Intervention
Group VI: Single semaglutide SC 0.5 mg doseActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Terrestrial Bio, Inc.

Lead Sponsor

Celerion

Industry Sponsor

Trials
85
Recruited
7,600+

Dr. Susan Thornton

Celerion

Chief Executive Officer since 2010

PhD in Molecular Biology from the University of Pennsylvania

Dr. Lorraine M. Rusch

Celerion

Chief Medical Officer since 2020

MD from an unspecified institution

Citations

Aardvark Therapeutics Announces ARD-201 Preclinical ...

In a gold-standard model of obesity, treatment with ARD-201 resulted in approximately 19% body weight reduction after 30 days of treatment.

Real‐world evidence on the utilization, clinical and ... - PMC

The observed weight reduction in clinical practice overall tends to be lower than pancreatitis or pancreatic cancer, thyroid disorders, or ...

Semaglutide and Tirzepatide for Obesity: Effectiveness and ...

For oral semaglutide, no CV outcome data exists for patients with obesity without diabetes; range of obesity-related outcomes on CV outcomes, ...

Tirzepatide Once Weekly for the Treatment of Obesity

The mean reduction in total body fat mass was 33.9% with tirzepatide, as compared with 8.2% with placebo, for an estimated treatment difference ...

ARD-201 shows promise in obesity treatment, advancing to ...

ARD-201 attenuated weight gain “rebound” after GLP-1RA therapy withdrawal, achieved significant weight loss as a monotherapy, had lower risks ...

Safety and tolerability of new-generation anti-obesity ... - PMC

This review presents detailed safety profiles for orlistat, phentermine/topiramate, lorcaserin, naltrexone/bupropion and liraglutide 3.0 mg, and discusses the ...

Study Details | NCT07673900 | Semaglutide Delivered Epi ...

VX-201 is a needle free, shelf-stable, microneedle array patch (MAP) for delivery of semaglutide epi/intra-dermally · Other Names: Sema MAP.

Aardvark Therapeutics Announces ARD-201 Preclinical ...

In a gold-standard model of obesity, treatment with ARD-201 resulted in approximately 19% body weight reduction after 30 days of treatment.

Efficacy and safety of bofanglutide, a GLP-1 receptor ...

We evaluated the efficacy and safety of bofanglutide in Chinese adults with overweight or obesity. The safety data were summarized ...