A Clinical Study of MK-4082 in Healthy Overweight Participants (MK-4082-002)

Merck Sharp & Dohme (MSD)

Status and phase: Begins enrollment this month; Phase 1

Conditions: Healthy

Treatments: Drug: MK-4082; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07388667

MK-4082-002 (Other Identifier)

4082-002

Details and patient eligibility

About

Researchers are looking for new weight loss medicines for people with higher body weight. The study medicine, MK-4082, is different from similar weight loss medicines because people take it as a pill instead of an injection. Before giving a study medicine to people with a health condition, researchers first do studies to find a safe dose level (amount) of the study medicine that can be used in future studies.

The goals of this study are to learn about:

• The safety of MK-4082 and if people tolerate it
• What happens to different MK-4082 dose levels in a person's body over time

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

• Is in good health
• Has body mass index (BMI) between 25 and 40 kg/m^2, inclusive. Participants must weigh at least 60 kg

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

• has a history of previous surgical treatment for obesity (bariatric surgery, gastric banding, etc.) or any other gastrointestinal (GI) surgery that may induce malabsorption, history of bowel resection >20 cm, any malabsorption disorder, severe gastroparesis, or any GI procedure for weight loss (including LAP-BAND®), as well as clinically significant GI disorders (eg, peptic ulcers, severe gastroesophageal reflux disease)
• has an individual or family history of medullary thyroid carcinoma or multiple endocrine neoplasia 2

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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120 participants in 5 patient groups

Panel A: Dose Escalation to Dosage 1

Experimental group

Description:

Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 1.

Treatment:

Drug: Placebo

Drug: MK-4082

Panel B: Dose Escalation to Dosage 2

Experimental group

Description:

Participants receive escalating doses of oral MK-4082 QD or a dose-matched placebo to reach maintenance dose 2.

Treatment:

Drug: Placebo

Drug: MK-4082

Panel C: Dose Escalation to Dosage 3

Experimental group

Description:

Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 3.

Treatment:

Drug: Placebo

Drug: MK-4082

Panel D: Dose Escalation to Dosage 4

Experimental group

Description:

Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 4.

Treatment:

Drug: Placebo

Drug: MK-4082

Panel E: Dose Escalation to Dosage 5

Experimental group

Description:

Participants receive escalating doses of oral MK-4082 once daily (QD) or a dose-matched placebo to reach maintenance dose 5.

Treatment:

Drug: Placebo

Drug: MK-4082