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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Enlicitide Decanoate; Drug: Levothyroxine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06625814

0616-028

MK-0616-028 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 19 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Levothyroxine

Experimental group

Description:

Participants will receive a single oral dose of levothyroxine.

Treatment:

Drug: Levothyroxine

Levothyroxine Plus Enlicitide Decanoate

Experimental group

Description:

Participants will receive a single oral dose of levothyroxine and a single oral dose of enlicitide decanoate at the same time.

Treatment:

Drug: Enlicitide Decanoate

Drug: Levothyroxine