HealthyPhase 1NCT06814106
A Single- and Multiple-Dose Study of Enlicitide Chloride (MK-0616) in Healthy Chinese Adult Participants (MK 0616-010)
A Phase 1 study testing Enlicitide Chloride in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in China.
Trial summary
The purpose of this study is to learn about the safety of enlicitide chloride and how well people tolerate it. Researchers also want to learn what happens to different amounts of enlicitide chloride in a healthy person's body over time. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Enlicitide Chloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2023to 8 May 2023
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Is in good health
- Has a body mass index ≥19.0 and ≤26.0 kg/m^2, inclusive
Who cannot join
- Has a history of gastrointestinal disease
- Has a history of cancer (malignancy)
Trial locations and contacts
1 site in 1 country.
China1 site
Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 0001)
Shanghai, Shanghai Municipality, 200032
About this study
Official title: A Single- and Multiple-Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-0616 in Healthy Chinese Adult Participants.
The purpose of this study is to learn about the safety of enlicitide chloride and how well people tolerate it. Researchers also want to learn what happens to different amounts of enlicitide chloride in a healthy person's body over time.
- Conditions
- Healthy
- Being tested
- Enlicitide Chloride, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enlicitide ChlorideDrug
Also called MK-0616
Oral Capsule
PlaceboDrug
Placebo oral capsule matching enlicitide chloride
| Study group | Role | What they receive |
|---|---|---|
| Enlicitide Chloride Panel A | Experimental | Period 1: Participants will receive a single dose of enlicitide chloride dose 1 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast).
Period 2: Participants will receive a single dose of enlicitide chloride dose 1 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast) followed by a standard breakfast. Receives: Drug: Enlicitide Chloride; Drug: Placebo |
| Enlicitide Chloride Panel B | Experimental | Period 1: Participants will receive a single dose of enlicitide chloride dose 2 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast).
Period 2: Participants will receive a single dose of enlicitide chloride dose 3 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast). Receives: Drug: Enlicitide Chloride; Drug: Placebo |
| Enlicitide Chloride Panel C | Experimental | Participants will receive enlicitide chloride dose 2 or placebo once daily for 14 days on an empty stomach (after a ≥8-hour overnight fast). Receives: Drug: Enlicitide Chloride; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Experience an Adverse Event (AE)
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
Measured: Up to approximately 2 months
Number of Participants Who Discontinue the Study Treatment Due to an AE
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
Measured: Up to approximately 2 months
Secondary outcomes (19)
Panels A and B: Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of Enlicitide Chloride
Blood samples will be collected to determine the AUC0-inf of enlicitide chloride
Measured: Predose and at designated timepoints (up to 8 days postdose)
Panels A and B: Area Under the Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of Enlicitide Chloride
Blood samples will be collected to determine the AUC0-24 of enlicitide chloride
Measured: Predose and at designated timepoints (up to 24 hours postdose)
Panels A and B: Area Under the Concentration-Time Curve from 0 to Last Measurable Concentration (AUC0-last) of Enlicitide Chloride
Blood samples will be collected to determine the AUC0-last of enlicitide chloride
Measured: Predose and at designated timepoints (up to 8 days postdose)
Panels A and B: Maximum Plasma Concentration (Cmax) of Enlicitide Chloride
Blood samples will be collected to determine the Cmax of enlicitide chloride
Measured: Predose and at designated timepoints (up to 8 days postdose)
Panels A and B: Time to Maximum Plasma Concentration (Tmax) of Enlicitide Chloride
Blood samples will be collected to determine the Tmax of enlicitide chloride
Measured: Predose and at designated timepoints (up to 8 days postdose)
Panels A and B: Concentration at 24 Hours Postdose (C24) of Enlicitide Chloride
Blood samples will be collected to determine the C24 of enlicitide chloride
Measured: 24 hours postdose
Panels A and B: Apparent Terminal Half-Life (t1/2) of Enlicitide Chloride
Blood samples will be collected to determine the apparent terminal t1/2 of enlicitide chloride
Measured: Predose and at designated timepoints (up to 8 days postdose)
Panels A and B: Apparent Clearance (CL/F) of Enlicitide Chloride
Blood samples will be collected to determine the CL/F of enlicitide chloride
Measured: Predose and at designated timepoints (up to 8 days postdose)
Panels A and B: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide Chloride
Blood samples will be collected to determine the Vz/F of enlicitide chloride
Measured: Predose and at designated timepoints (up to 8 days postdose)
Panels A and B: Percent of Reduction of Serum Low Density Lipoprotein Cholesterol (LDL-C)
Blood samples will be collected to determine the percent of reduction of serum LDL-C
Measured: Predose and at designated timepoints (up to 8 days postdose)
Panel C: AUC0-24 of Enlicitide Chloride
Blood samples will be collected to determine the AUC0-24 of enlicitide chloride
Measured: Predose and at designated timepoints (up to 24 hours postdose)
Panel C: Cmax of Enlicitide Chloride
Blood samples will be collected to determine the Cmax of enlicitide chloride
Measured: Predose and at designated timepoints (up to 14 days postdose)
Panel C: Tmax of Enlicitide Chloride
Blood samples will be collected to determine the Tmax of enlicitide chloride
Measured: Predose and at designated timepoints (up to 14 days postdose)
Panel C: C24 of Enlicitide Chloride
Blood samples will be collected to determine the C24 of enlicitide chloride
Measured: 24 hours postdose
Panel C: Apparent Terminal t1/2 of Enlicitide Chloride
Blood samples will be collected to determine the apparent terminal t/2 of enlicitide chloride
Measured: Predose and at designated timepoints (up to 14 days postdose)
Panel C: CL/F of Enlicitide Chloride
Blood samples will be collected to determine the CL/F of enlicitide chloride
Measured: Predose and at designated timepoints (up to 14 days postdose)
Panel C: Vz/F of Enlicitide Chloride
Blood samples will be collected to determine the Vz/F of enlicitide chloride
Measured: Predose and at designated timepoints (up to 14 days postdose)
Panel C: Accumulation Ratio of Enlicitide Chloride
Blood samples will be collected to determine the accumulation ratio of enlicitide chloride
Measured: Predose and at designated timepoints (up to 14 days postdose)
Panel C: Percent of Reduction of Serum LDL-C
Blood samples will be collected to determine the percent of reduction of serum LDL-C
Measured: Predose and at designated timepoints (up to 14 days postdose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start6 Mar 2023
- Primary completion8 May 2023
- Study completion8 May 2023
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
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 37 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 Sharpe & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814106
- Sponsor's protocol ID
- 0616-010
- Other IDs
- MK-0616-010
- Status last verified
- Feb 2025
- First submitted
- 3 Feb 2025
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single- and Multiple-Dose Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-0616 in Healthy Chinese Adult Participants.
- ClinicalTrials.gov ID
- NCT06814106
- Acronym / sponsor ID
- 0616-010
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 8 May 2023 (actual)
- Study completion
- 8 May 2023 (actual)
- First posted
- 7 Feb 2025 (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.
The purpose of this study is to learn about the safety of enlicitide chloride and how well people tolerate it. Researchers also want to learn what happens to different amounts of enlicitide chloride in a healthy person's body over time.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Enlicitide Chloride Panel A | Experimental | Drug: Enlicitide Chloride, Drug: PlaceboPeriod 1: Participants will receive a single dose of enlicitide chloride dose 1 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast). Period 2: Participants will receive a single dose of enlicitide chloride dose 1 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast) followed by a standard breakfast. |
| Enlicitide Chloride Panel B | Experimental | Drug: Enlicitide Chloride, Drug: PlaceboPeriod 1: Participants will receive a single dose of enlicitide chloride dose 2 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast). Period 2: Participants will receive a single dose of enlicitide chloride dose 3 or a single dose of placebo on Day 1 on an empty stomach (after a ≥8-hour overnight fast). |
| Enlicitide Chloride Panel C | Experimental | Drug: Enlicitide Chloride, Drug: PlaceboParticipants will receive enlicitide chloride dose 2 or placebo once daily for 14 days on an empty stomach (after a ≥8-hour overnight fast). |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Is in good health
- Has a body mass index ≥19.0 and ≤26.0 kg/m^2, inclusive
Key exclusion criteria (2 listed)
- Has a history of gastrointestinal disease
- Has a history of cancer (malignancy)
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 |
|---|---|---|
| Enlicitide ChlorideAlso: MK-0616Oral Capsule | Drug | Enlicitide Chloride Panel A, Enlicitide Chloride Panel B, Enlicitide Chloride Panel C |
| PlaceboPlacebo oral capsule matching enlicitide chloride | Drug | Enlicitide Chloride Panel A, Enlicitide Chloride Panel B, Enlicitide Chloride Panel C |
Primary outcome
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 2 months
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
Number of Participants Who Discontinue the Study Treatment Due to an AE
Time frame: Up to approximately 2 months
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
19 secondary outcomes
Panels A and B: Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of Enlicitide Chloride
Time frame: Predose and at designated timepoints (up to 8 days postdose)
Panels A and B: Area Under the Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of Enlicitide Chloride
Time frame: Predose and at designated timepoints (up to 24 hours postdose)
Panels A and B: Area Under the Concentration-Time Curve from 0 to Last Measurable Concentration (AUC0-last) of Enlicitide Chloride
Time frame: Predose and at designated timepoints (up to 8 days postdose)
Panels A and B: Maximum Plasma Concentration (Cmax) of Enlicitide Chloride
Time frame: Predose and at designated timepoints (up to 8 days postdose)
Panels A and B: Time to Maximum Plasma Concentration (Tmax) of Enlicitide Chloride
Time frame: Predose and at designated timepoints (up to 8 days postdose)
Panels A and B: Concentration at 24 Hours Postdose (C24) of Enlicitide Chloride
Time frame: 24 hours postdose
Panels A and B: Apparent Terminal Half-Life (t1/2) of Enlicitide Chloride
Time frame: Predose and at designated timepoints (up to 8 days postdose)
Panels A and B: Apparent Clearance (CL/F) of Enlicitide Chloride
Time frame: Predose and at designated timepoints (up to 8 days postdose)
Panels A and B: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide Chloride
Time frame: Predose and at designated timepoints (up to 8 days postdose)
Panels A and B: Percent of Reduction of Serum Low Density Lipoprotein Cholesterol (LDL-C)
Time frame: Predose and at designated timepoints (up to 8 days postdose)
Panel C: AUC0-24 of Enlicitide Chloride
Time frame: Predose and at designated timepoints (up to 24 hours postdose)
Panel C: Cmax of Enlicitide Chloride
Time frame: Predose and at designated timepoints (up to 14 days postdose)
Panel C: Tmax of Enlicitide Chloride
Time frame: Predose and at designated timepoints (up to 14 days postdose)
Panel C: C24 of Enlicitide Chloride
Time frame: 24 hours postdose
Panel C: Apparent Terminal t1/2 of Enlicitide Chloride
Time frame: Predose and at designated timepoints (up to 14 days postdose)
Panel C: CL/F of Enlicitide Chloride
Time frame: Predose and at designated timepoints (up to 14 days postdose)
Panel C: Vz/F of Enlicitide Chloride
Time frame: Predose and at designated timepoints (up to 14 days postdose)
Panel C: Accumulation Ratio of Enlicitide Chloride
Time frame: Predose and at designated timepoints (up to 14 days postdose)
Panel C: Percent of Reduction of Serum LDL-C
Time frame: Predose and at designated timepoints (up to 14 days postdose)
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 7 Feb 2025.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/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 Sharpe & 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 Enlicitide Chloride in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in China.
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 2 inclusion and 2 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 7 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 China. 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?
Number of Participants Who Experience an Adverse Event (AE) (time frame: Up to approximately 2 months). The study lists 2 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 7 Feb 2025.