HealthyPhase 1NCT06719544
A Study of Lithium and Enlicitide in Healthy Adult Participants (MK-0616-034)
A Phase 1 study testing lithium carbonate and enlicitide in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- lithium carbonate and enlicitide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jan 2025to 6 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study to Evaluate the Effect of Enlicitide on the Pharmacokinetics of Lithium in Healthy Adult Participants
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
- Conditions
- Healthy
- Being tested
- lithium carbonate, enlicitide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lithium carbonateDrug
Also called lithium
Oral capsule
enlicitideDrug
Also called enlicitide decanoate, MK-0616/sodium caprate
Oral tablet
| Study group | Role | What they receive |
|---|---|---|
| Lithium Carbonate | Experimental | On Day 1 of Period 1, a single oral dose of lithium carbonate will be administered. Receives: Drug: lithium carbonate |
| Enlicitide with Lithium Carbonate | Experimental | On Day 1 of Period 2, a single oral dose of lithium carbonate will be coadministered with a single oral dose of enlicitide. Receives: Drug: lithium carbonate; Drug: enlicitide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) for Lithium in Plasma
Blood samples will be collected to determine the AUC0-inf of lithium in plasma.
Measured: At designated timepoints (up to approximately 5 days post dose)
Area Under the Concentration versus Time Curve From Time Zero to Last Quantifiable Sample (AUC0-last) for Lithium in Plasma
Blood samples will be collected to determine the AUC0-last of lithium in plasma.
Measured: At designated timepoints (up to approximately 5 days post dose)
Cmax (Maximum Concentration) for Lithium in Plasma
Blood samples will be collected determine the Cmax of lithium in plasma.
Measured: At designated timepoints (up to approximately 5 days post dose)
Secondary outcomes (2)
Number of Participants who experience a Treatment Emergent Adverse Event (TEAE)
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.
Measured: Up to approximately 3 weeks
Number of Participants Who Discontinue Study Due to a TEAE
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.
Measured: Up to approximately 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start2 Jan 2025
- Primary completion27 Jan 2025
- Study completion6 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06719544
- Sponsor's protocol ID
- 0616-034
- Other IDs
- MK-0616-034
- Status last verified
- Feb 2025
- First submitted
- 2 Dec 2024
- Last updated
- 17 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Effect of Enlicitide on the Pharmacokinetics of Lithium in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06719544
- Acronym / sponsor ID
- 0616-034
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 2 Jan 2025 (actual)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 6 Feb 2025 (actual)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lithium Carbonate | Experimental | Drug: lithium carbonateOn Day 1 of Period 1, a single oral dose of lithium carbonate will be administered. |
| Enlicitide with Lithium Carbonate | Experimental | Drug: lithium carbonate, Drug: enlicitideOn Day 1 of Period 2, a single oral dose of lithium carbonate will be coadministered with a single oral dose of enlicitide. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Has a history or presence of clinically significant medical or psychiatric condition or disease
- Has a history of cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lithium carbonateAlso: lithiumOral capsule | Drug | Enlicitide with Lithium Carbonate, Lithium Carbonate |
| enlicitideAlso: enlicitide decanoate, MK-0616/sodium caprateOral tablet | Drug | Enlicitide with Lithium Carbonate |
Primary outcome
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.
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.
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.
2 secondary outcomes
Number of Participants who experience a Treatment Emergent Adverse Event (TEAE)
Time frame: Up to approximately 3 weeks
Number of Participants Who Discontinue Study Due to a TEAE
Time frame: Up to approximately 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2025.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Merck Sharp & Dohme LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing lithium carbonate and enlicitide in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2025; AzTrials last refreshed its copy on 8 Nov 2026.