A Phase 1 interventional study of Enlicitide Chloride and Placebo in Healthy, sponsored by Merck Sharp & Dohme LLC. Completed at 1 site in China. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-07.
Sponsored by Merck Sharp & Dohme LLC · Phase 1, Interventional, and Basic science
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.
Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.
Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria include, but are not limited to:
Exclusion Criteria:
Exclusion criteria include, but are not limited to:
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.
Drug: Enlicitide Chloride · Drug: Placebo
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).
Drug: Enlicitide Chloride · Drug: Placebo
Participants will receive enlicitide chloride dose 2 or placebo once daily for 14 days on an empty stomach (after a ≥8-hour overnight fast).
Drug: Enlicitide Chloride · Drug: Placebo
Oral Capsule
Also known as: MK-0616
Placebo oral capsule matching enlicitide chloride
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
Time frame: 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
Time frame: Up to approximately 2 months
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
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
Blood samples will be collected to determine the 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
Blood samples will be collected to determine the 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
Blood samples will be collected to determine the 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
Blood samples will be collected to determine the 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
Blood samples will be collected to determine the C24 of enlicitide chloride
Time frame: 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
Time frame: 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
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
Blood samples will be collected to determine the 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)
Blood samples will be collected to determine the percent of reduction of serum LDL-C
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Predose and at designated timepoints (up to 14 days postdose)
Plan to share: Yes — http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
This study is completed, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Merck Sharp & Dohme LLC