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Completed

NCT Number: NCT06719544

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

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion ( Site 0002)

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lithium Carbonate

Drug

Oral capsule

Other names: lithium

Enlicitide

Drug

Oral tablet

Other names: enlicitide decanoate, MK-0616/sodium caprate

Primary outcomes

  1. Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) for Lithium in Plasma

    Time frame: At designated timepoints (up to approximately 5 days post dose)

    Blood samples will be collected to determine the AUC0-inf of lithium in plasma.

  2. Area Under the Concentration versus Time Curve From Time Zero to Last Quantifiable Sample (AUC0-last) for Lithium in Plasma

    Time frame: At designated timepoints (up to approximately 5 days post dose)

    Blood samples will be collected to determine the AUC0-last of lithium in plasma.

  3. Cmax (Maximum Concentration) for Lithium in Plasma

    Time frame: At designated timepoints (up to approximately 5 days post dose)

    Blood samples will be collected determine the Cmax of lithium in plasma.

Secondary outcomes

  1. Number of Participants who experience a Treatment Emergent Adverse Event (TEAE)

    Time frame: 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.

  2. Number of Participants Who Discontinue Study Due to a TEAE

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2024
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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