CompletedPhase 1

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

United States28 participantsStarted 2024-07-08

Plain-language 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

Who can participate

Age range

19 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Area under the Concentration-Time Curve from Time 0 to 48 hours (AUC0-48hrs) of Levothyroxine (total T4)

Timeframe: At designated timepoints (up to approximately 48 hours postdose)

Maximum Plasma Concentration (Cmax) of Levothyroxine (total T4)

Timeframe: At designated timepoints (up to approximately 48 hours postdose)

Time to Maximum Plasma Concentration (Tmax) of Levothyroxine (total T4)

Timeframe: At designated timepoints (up to approximately 48 hours postdose)

Area under the Concentration-Time Curve from Time 0 to 48 hours (AUC0-48hrs) of Triiodothyronine (total T3)

Timeframe: At designated timepoints (up to approximately 48 hours postdose)

Maximum Plasma Concentration (Cmax) of Triiodothyronine (total T3)

Timeframe: At designated timepoints (up to approximately 48 hours postdose)

Time to Maximum Plasma Concentration (Tmax) of Triiodothyronine (total T3)

Timeframe: At designated timepoints (up to approximately 48 hours postdose)

Trial details

NCT IDNCT06625814

SponsorMerck Sharp & Dohme LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-08-19

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