A Single- and Multiple-Dose Study of Enlicitide Chloride (MK-0616) in Healthy Chinese Adult Participants (MK 0616-010)

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Enlicitide Chloride; Drug: Placebo

• Registration Number: NCT06814106
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-03-06
• Primary Completion: 2023-05-08
• Study Completion: 2023-05-08
• Status Verified: 2025-02
• Study First Submitted: 2025-02-03
• Study First Submitted QC: 2025-02-03
• Last Update Submitted: 2025-02-03
• Study First Posted: 2025-02-07
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 37

Inclusion Criteria

Inclusion criteria include, but are not limited to:

• Is in good health
• Has a body mass index ≥19.0 and ≤26.0 kg/m^2, inclusive

Exclusion Criteria

Exclusion criteria include, but are not limited to:

• Has a history of gastrointestinal disease
• Has a history of cancer (malignancy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Enlicitide Chloride Panel A	Enlicitide Chloride	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.
Enlicitide Chloride Panel A	Placebo	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.
Enlicitide Chloride Panel B	Enlicitide Chloride	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).
Enlicitide Chloride Panel B	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).
Enlicitide Chloride Panel C	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).
Enlicitide Chloride Panel C	Enlicitide Chloride	Participants will receive enlicitide chloride dose 2 or placebo once daily for 14 days on an empty stomach (after a ≥8-hour overnight fast).

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experience an Adverse Event (AE)	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	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

Secondary Outcome Measures

Name	Time	Method
Panels A and B: Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of Enlicitide Chloride	Predose and at designated timepoints (up to 8 days postdose)	Blood samples will be collected to determine the AUC0-inf of enlicitide chloride
Panels A and B: Area Under the Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of Enlicitide Chloride	Predose and at designated timepoints (up to 24 hours postdose)	Blood samples will be collected to determine the AUC0-24 of enlicitide chloride
Panels A and B: Area Under the Concentration-Time Curve from 0 to Last Measurable Concentration (AUC0-last) of Enlicitide Chloride	Predose and at designated timepoints (up to 8 days postdose)	Blood samples will be collected to determine the AUC0-last of enlicitide chloride
Panels A and B: Maximum Plasma Concentration (Cmax) of Enlicitide Chloride	Predose and at designated timepoints (up to 8 days postdose)	Blood samples will be collected to determine the Cmax of enlicitide chloride
Panels A and B: Time to Maximum Plasma Concentration (Tmax) of Enlicitide Chloride	Predose and at designated timepoints (up to 8 days postdose)	Blood samples will be collected to determine the Tmax of enlicitide chloride
Panels A and B: Concentration at 24 Hours Postdose (C24) of Enlicitide Chloride	24 hours postdose	Blood samples will be collected to determine the C24 of enlicitide chloride
Panels A and B: Apparent Terminal Half-Life (t1/2) of Enlicitide Chloride	Predose and at designated timepoints (up to 8 days postdose)	Blood samples will be collected to determine the apparent terminal t1/2 of enlicitide chloride
Panels A and B: Apparent Clearance (CL/F) of Enlicitide Chloride	Predose and at designated timepoints (up to 8 days postdose)	Blood samples will be collected to determine the CL/F of enlicitide chloride
Panels A and B: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide Chloride	Predose and at designated timepoints (up to 8 days postdose)	Blood samples will be collected to determine the Vz/F of enlicitide chloride
Panels A and B: Percent of Reduction of Serum Low Density Lipoprotein Cholesterol (LDL-C)	Predose and at designated timepoints (up to 8 days postdose)	Blood samples will be collected to determine the percent of reduction of serum LDL-C
Panel C: AUC0-24 of Enlicitide Chloride	Predose and at designated timepoints (up to 24 hours postdose)	Blood samples will be collected to determine the AUC0-24 of enlicitide chloride
Panel C: Cmax of Enlicitide Chloride	Predose and at designated timepoints (up to 14 days postdose)	Blood samples will be collected to determine the Cmax of enlicitide chloride
Panel C: Tmax of Enlicitide Chloride	Predose and at designated timepoints (up to 14 days postdose)	Blood samples will be collected to determine the Tmax of enlicitide chloride
Panel C: C24 of Enlicitide Chloride	24 hours postdose	Blood samples will be collected to determine the C24 of enlicitide chloride
Panel C: Apparent Terminal t1/2 of Enlicitide Chloride	Predose and at designated timepoints (up to 14 days postdose)	Blood samples will be collected to determine the apparent terminal t/2 of enlicitide chloride
Panel C: CL/F of Enlicitide Chloride	Predose and at designated timepoints (up to 14 days postdose)	Blood samples will be collected to determine the CL/F of enlicitide chloride
Panel C: Vz/F of Enlicitide Chloride	Predose and at designated timepoints (up to 14 days postdose)	Blood samples will be collected to determine the Vz/F of enlicitide chloride
Panel C: Accumulation Ratio of Enlicitide Chloride	Predose and at designated timepoints (up to 14 days postdose)	Blood samples will be collected to determine the accumulation ratio of enlicitide chloride
Panel C: Percent of Reduction of Serum LDL-C	Predose and at designated timepoints (up to 14 days postdose)	Blood samples will be collected to determine the percent of reduction of serum LDL-C

Trial Locations

Locations (1)

Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 0001); 🇨🇳 Shanghai, Shanghai, China