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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: lithium carbonate; Drug: enlicitide

• Registration Number: NCT06719544
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-02
• Study First Submitted QC: 2024-12-02
• Study First Posted: 2024-12-06
• Study Start: 2025-01-02
• Primary Completion: 2025-01-27
• Status Verified: 2025-02
• Study Completion: 2025-02-06
• Last Update Submitted: 2025-02-14
• Last Update Posted: 2025-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lithium Carbonate	lithium carbonate	On Day 1 of Period 1, a single oral dose of lithium carbonate will be administered.
Enlicitide with Lithium Carbonate	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.
Enlicitide with Lithium Carbonate	enlicitide	On Day 1 of Period 2, a single oral dose of lithium carbonate will be coadministered with a single oral dose of enlicitide.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Participants who experience a Treatment Emergent Adverse Event (TEAE)	Up to approximately 3 weeks	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.
Number of Participants Who Discontinue Study Due to a TEAE	Up to approximately 3 weeks	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.

Trial Locations

Locations (1)

Celerion ( Site 0002); 🇺🇸 Tempe, Arizona, United States