Enlicitide + Lithium for Healthy Subjects

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Merck Sharp & Dohme LLC

Must be taking: Lithium

Disqualifiers: Cancer, Psychiatric condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

16 Participants Needed

Trial Summary

What is the purpose of this trial?

Researchers have designed a new study medicine called enlicitide decanoate (MK-0616) as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood. Enlicitide decanoate will be called "enlicitide" from this point forward. Lithium (also called lithium carbonate) is a medicine used in bipolar disorder. Researchers want to learn about lithium when taken at the same time with enlicitide. They want to: * Measure a person's blood to find out if the amount of lithium in the blood is the same when lithium is taken alone or with enlicitide * Learn about the safety of lithium when taken alone or with enlicitide and if people tolerate it

Research Team

Medical Director

Principal Investigator

Merck Sharp & Dohme LLC

Eligibility Criteria

This trial is for healthy adults with no significant medical history, who haven't smoked or used nicotine/tobacco products in the last 3 months. It's designed to see how a new cholesterol-lowering medicine, enlicitide, interacts with lithium.

Inclusion Criteria

I haven't smoked or used nicotine products for at least 3 months.

I am generally healthy with no major medical issues.

Exclusion Criteria

I have a significant health or mental health condition.

I have had cancer in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment Period 1

Participants receive a single oral dose of lithium carbonate

1 day

1 visit (in-person)

Treatment Period 2

Participants receive a single oral dose of lithium carbonate coadministered with enlicitide

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 weeks

Treatment Details

Interventions

• Enlicitide
• Lithium

Trial Overview The study is testing the effects of taking enlicitide and lithium carbonate together. Researchers will measure blood levels of lithium when taken alone versus alongside enlicitide to assess any differences and overall safety.

Participant Groups

Group I: Lithium Carbonate Experimental Treatment 1 Intervention

On Day 1 of Period 1, a single oral dose of lithium carbonate will be administered.

Group II: Enlicitide with Lithium Carbonate Experimental Treatment 2 Interventions

On Day 1 of Period 2, a single oral dose of lithium carbonate will be coadministered with a single oral dose of enlicitide.

Who Is Running the Clinical Trial?

Merck Sharp & Dohme LLC

Lead Sponsor

Trials

4,096

Recruited

5,232,000+

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

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