MK-4082 for Healthy Subjects

Not currently recruiting at 1 trial location
TF
Overseen ByToll Free Number
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: Merck Sharp & Dohme LLC
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 tests a new weight loss pill, MK-4082, to determine a safe and effective dose. Unlike other treatments that require injections, this one is taken orally. The study evaluates how different versions of the pill (Formulations 1, 2, and 4) function in the body and assesses their tolerability. Participants who are generally healthy, have a body mass index (BMI) between 25 and 40, and weigh at least 60 kg may be suitable candidates. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has not yet provided detailed evidence on the safety of MK-4082 Formulation 1, but clearer information exists for the other two versions. A study on MK-4082 Formulation 2 and Formulation 4 examined their safety and side effects, focusing on how the body reacts to these versions. As a phase 1 study, it primarily tests the treatment's safety, with small doses closely monitored for any negative reactions. This stage helps researchers determine if the treatment is generally safe and well-tolerated. For MK-4082 overall, no concerning data has shown serious problems, but this trial is crucial to confirm that all versions are safe for future studies.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about MK-4082 because it offers new formulation options that could improve how treatments are administered and tolerated. Unlike standard treatments that may rely on traditional dosing schedules or delivery methods, the different formulations of MK-4082 (F1, F2, and F4) provide flexibility in dosing over a five-week period. This could potentially enhance patient adherence and optimize therapeutic outcomes. Additionally, the investigational approach of alternating formulations in structured sequences aims to maximize effectiveness while minimizing potential side effects, which is a fresh strategy in this treatment landscape.

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

Research on MK-4082 remains in the early stages, focusing on its safety and mechanism of action. This trial evaluates different formulations of MK-4082—Formulation 1 (F1), Formulation 2 (F2), and Formulation 4 (F4)—to assess their potential as weight loss pills. Participants will receive these formulations in various sequences to evaluate their effects. Although direct evidence on MK-4082's effectiveness for weight loss is limited, the pill form represents a novel approach that could simplify access to weight loss treatments. Scientists believe that improving the pill's design might aid in weight management. Early indications and the mechanism of MK-4082 suggest potential benefits, but further studies are necessary to confirm its effectiveness.13567

Who Is on the Research Team?

MD

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Are You a Good Fit for This Trial?

This trial is for healthy adults who are overweight or obese, with a BMI between 25 and 40 and weighing at least 60 kg. Participants should not have any major health problems.

Inclusion Criteria

Is in good health
Has a body mass index (BMI) between 25 and 40 kg/m^2, inclusive and weighs at least 60 kg

Exclusion Criteria

I or my family have a history of medullary thyroid cancer or MEN2.
I have had surgery or conditions that affect how my body absorbs food.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily oral doses of MK-4082 formulations in a fixed sequence over 5 weeks

5 weeks
Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • MK-4082 Formulation 1 (F1)
  • MK-4082 Formulation 2 (F2)
  • MK-4082 Formulation 4 (F4)

Trial Overview

The study is testing three different pill versions of MK-4082 to see how safe they are, how well people tolerate them, and how the body processes each version. The goal is to find the best formulation for future weight loss studies.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Panel B Sequence 2Experimental Treatment2 Interventions
Group II: Panel B Sequence 1Experimental Treatment2 Interventions
Group III: Panel A Sequence 2Experimental Treatment2 Interventions
Group IV: Panel A Sequence 1Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Citations

Goal 1: No Poverty

For example, it has enabled access to safe drinking water, reduced deaths caused by water-borne diseases, and improved hygiene to reduce health risks related to ...

Taylor Swift - the 1 (Official Lyric Video)

Official lyric video by Taylor Swift performing “the 1” – off her album 'folklore.' Album available here: https://store.taylorswift.com ...

3.

onepercentfortheplanet.org

onepercentfortheplanet.org/

1% for the Planet | Accelerating Environmental Giving

Join a global network of businesses committing 1% of sales to environmental causes. Certified impact, brand differentiation, and collective action.

4.

mail.google.com

mail.google.com/mail/u/1/

1 - Gmail - Google

No information is available for this page.

L-1A Intracompany Transferee Executive or Manager

The following information describes some of the features and requirements of the L-1 nonimmigrant visa program.

the 1 - song and lyrics by Taylor Swift

Listen to the 1 on Spotify. Song · Taylor Swift · 2020.

7.

en.wikipedia.org

en.wikipedia.org/wiki/1

1

1 (one, unit, unity) is a number, numeral, and grapheme. It is the first and smallest positive integer of the infinite sequence of natural numbers.