A Study of Levothyroxine and Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-028)

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Levothyroxine; Drug: Enlicitide Decanoate

• Registration Number: NCT06625814
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

Levothyroxine (T4) is a man-made thyroid hormone used to treat certain thyroid conditions. After taking levothyroxine, a person's body changes it to triiodothyronine (T3). The amount of levothyroxine in a person's blood must be carefully controlled to maintain proper function. Enlicitide decanoate was designed to lower the amount of cholesterol in a person's blood.

Researchers want to learn about levothyroxine when taken at the same time with enlicitide decanoate. They want to:

* Measure a person's blood to find out if the amount of levothyroxine in the blood is the same when levothyroxine is taken alone or with enlicitide decanoate

* Learn about the safety of levothyroxine when taken alone or with enlicitide decanoate and if people tolerate it

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-08
• Primary Completion: 2024-08-19
• Status Verified: 2024-09
• Study Completion: 2024-09-11
• Study First Submitted: 2024-10-01
• Study First Submitted QC: 2024-10-01
• Last Update Submitted: 2024-10-01
• Study First Posted: 2024-10-03
• Last Update Posted: 2024-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

• Medically healthy with no clinically significant medical history
• 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:

• History of cardiovascular disease or diabetes mellitus
• History of cancer

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Levothyroxine	Levothyroxine	Participants will receive a single oral dose of levothyroxine.
Levothyroxine Plus Enlicitide Decanoate	Levothyroxine	Participants will receive a single oral dose of levothyroxine and a single oral dose of enlicitide decanoate at the same time.
Levothyroxine Plus Enlicitide Decanoate	Enlicitide Decanoate	Participants will receive a single oral dose of levothyroxine and a single oral dose of enlicitide decanoate at the same time.

Primary Outcome Measures

Name	Time	Method
Area under the Concentration-Time Curve from Time 0 to 48 hours (AUC0-48hrs) of Levothyroxine (total T4)	At designated timepoints (up to approximately 48 hours postdose)	Blood samples will be collected to determine the AUC0-48hr of Levothyroxine (T4).
Maximum Plasma Concentration (Cmax) of Levothyroxine (total T4)	At designated timepoints (up to approximately 48 hours postdose)	Blood samples will be collected to determine the Cmax of Levothyroxine (T4).
Time to Maximum Plasma Concentration (Tmax) of Levothyroxine (total T4)	At designated timepoints (up to approximately 48 hours postdose)	Blood samples will be collected to determine the Tmax of Levothyroxine (T4).
Area under the Concentration-Time Curve from Time 0 to 48 hours (AUC0-48hrs) of Triiodothyronine (total T3)	At designated timepoints (up to approximately 48 hours postdose)	Blood samples will be collected to determine the AUC0-48hr of triiodothyronine (T3).
Maximum Plasma Concentration (Cmax) of Triiodothyronine (total T3)	At designated timepoints (up to approximately 48 hours postdose)	Blood samples will be collected to determine the Cmax of triiodothyronine (T3).
Time to Maximum Plasma Concentration (Tmax) of Triiodothyronine (total T3)	At designated timepoints (up to approximately 48 hours postdose)	Blood samples will be collected to determine the Tmax of triiodothyronine (T3).

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE)	Up to approximately 7 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 7 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 0001); 🇺🇸 Lincoln, Nebraska, United States