Enlicitide + Lithium for Healthy Subjects
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment Period 1
Participants receive a single oral dose of lithium carbonate
Treatment Period 2
Participants receive a single oral dose of lithium carbonate coadministered with enlicitide
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Enlicitide
- Lithium
Find a Clinic Near You
Who Is Running the Clinical Trial?
Merck Sharp & Dohme LLC
Lead Sponsor
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