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MK-4082 for Healthy Subjects

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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 pill, MK-4082, to assess its safety and effects in the body. It targets healthy individuals seeking weight loss support, particularly those with higher body weight. Participants will take varying doses to determine the optimal amount for future studies. Suitable candidates are healthy individuals with a body mass index (BMI) between 25 and 40, indicating higher body weight. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that MK-4082 is likely to be safe for humans?

Research has shown that MK-4082, a new weight loss pill, is under study to assess its safety and tolerability. This study is in the early stages, focusing primarily on the drug's safety in healthy volunteers.

Currently, detailed safety information from past studies on MK-4082 is unavailable. As a Phase 1 trial, this marks the first time the drug is tested in humans. These trials typically involve a small group of participants and aim to identify the most common and serious side effects.

Testing MK-4082 in healthy individuals suggests that researchers consider it safe enough to proceed. However, as an experimental treatment, further studies are necessary to fully understand its safety profile.12345

Why do researchers think this study treatment might be promising?

Researchers are excited about MK-4082 because it offers a potentially novel approach to treatment through its unique dose-escalation strategy. Unlike traditional treatments, which often rely on fixed dosages, MK-4082 allows for a personalized escalation to determine the most effective maintenance dose. This method could optimize therapeutic outcomes and minimize side effects by tailoring the dosage to individual needs. Additionally, the oral delivery of MK-4082 provides a convenient alternative to more invasive administration methods, enhancing patient comfort and adherence.

What evidence suggests that MK-4082 might be an effective treatment for weight loss?

Studies have shown that MK-4082 can aid weight loss by increasing feelings of fullness and reducing appetite. Unlike similar medications often administered as injections, MK-4082 is taken as a pill. Early research has focused on its safety and metabolism, crucial steps before assessing its effectiveness in individuals with higher body weight. Although specific data on weight loss with MK-4082 is not yet available, it functions similarly to other effective weight loss drugs. This similarity suggests that MK-4082 could potentially aid weight loss once further studies are completed.12467

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 have obesity, with a BMI between 25 and 40, and weigh at least 60 kg. Participants should not have major health problems.

Inclusion Criteria

* Is in good health
My BMI is between 25 and 40, and I weigh at least 60 kg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dose Escalation

Participants receive escalating doses of oral MK-4082 once daily or a dose-matched placebo to reach maintenance doses

Up to 84 days
Regular visits for dose adjustments and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

14 days
1-2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • MK-4082

Trial Overview

The study is testing different doses of an experimental weight loss pill called MK-4082 compared to a placebo (a dummy pill) in healthy overweight people to see how safe it is and how the body processes it.

How Is the Trial Designed?

5

Treatment groups

Experimental Treatment

Group I: Panel E: Dose Escalation to Dosage 5Experimental Treatment2 Interventions
Group II: Panel D: Dose Escalation to Dosage 4Experimental Treatment2 Interventions
Group III: Panel C: Dose Escalation to Dosage 3Experimental Treatment2 Interventions
Group IV: Panel B: Dose Escalation to Dosage 2Experimental Treatment2 Interventions
Group V: Panel A: Dose Escalation to Dosage 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

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