A Study of Lithium and Enlicitide in Healthy Adult Participants (MK-0616-034)

A Clinical Study to Evaluate the Effect of Enlicitide on the Pharmacokinetics of Lithium in Healthy Adult Participants

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: lithium carbonate; Drug: enlicitide

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Celerion ( Site 0002)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

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

• Is medically healthy with no clinically significant medical history
• Is a continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing

Exclusion Criteria:

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

• Has a history or presence of clinically significant medical or psychiatric condition or disease
• Has a history of cancer

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lithium Carbonate; On Day 1 of Period 1, a single oral dose of lithium carbonate will be administered.	Drug: lithium carbonate; Oral capsule; Other Names: lithium
Experimental: Enlicitide with Lithium Carbonate; On Day 1 of Period 2, a single oral dose of lithium carbonate will be coadministered with a single oral dose of enlicitide.	Drug: lithium carbonate; Oral capsule; Other Names: lithium; Drug: enlicitide; Oral tablet; Other Names: enlicitide decanoate; MK-0616/sodium caprate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) for Lithium in Plasma	Blood samples will be collected to determine the AUC0-inf of lithium in plasma.	At designated timepoints (up to approximately 5 days post dose)
Area Under the Concentration versus Time Curve From Time Zero to Last Quantifiable Sample (AUC0-last) for Lithium in Plasma	Blood samples will be collected to determine the AUC0-last of lithium in plasma.	At designated timepoints (up to approximately 5 days post dose)
Cmax (Maximum Concentration) for Lithium in Plasma	Blood samples will be collected determine the Cmax of lithium in plasma.	At designated timepoints (up to approximately 5 days post dose)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants who experience a Treatment Emergent Adverse Event (TEAE)	An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE will be considered treatment-emergent if the onset date and time is at the time of or after the first study drug administration. The number of participants who experience a TEAE will be reported.	Up to approximately 3 weeks
Number of Participants Who Discontinue Study Due to a TEAE	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE will be considered treatment-emergent if the onset date and time is at the time of or after the first study drug administration. The number of participants who discontinue study due to a TEAE will be reported.	Up to approximately 3 weeks

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2025
• Primary Completion (Actual): January 27, 2025
• Study Completion (Actual): February 6, 2025

Study Registration Dates

• First Submitted: December 2, 2024
• First Submitted That Met QC Criteria: December 2, 2024
• First Posted (Actual): December 6, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 14, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Central Nervous System Depressants; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Antimanic Agents; Lithium Carbonate
• Other Study ID Numbers: 0616-034; MK-0616-034 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No