Healthy
Conditions
Brief summary
The goal of this study is to learn about the safety and whether people tolerate a study medicine called efinopegdutide. The study will also measure what happens to efinopegdutide in a healthy person's body over time.
Interventions
DRUGEfinopegdutide
Subcutaneous injection
DRUGPlacebo
placebo matching efinopegdutide
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
The key inclusion criteria include but are not limited to the following: * Is in good health before randomization * Has a body mass index (BMI) ≥25 and ≤35 kg/m\^2
Exclusion criteria
The key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve to the end of the dosing period (AUC 0-tau)of Efinopegdutide- multiple dose | At designated timepoints up to 78 days | Blood samples will be collected to determine the AUC0 to tau of efinopegdutide when multiple doses are administered |
| Minimum Plasma Concentration (Cmin) of Efinopegdutide- multiple dose | At designated time points up to 112 days | Blood samples will be collected to determine the Cmin of efinopegdutide when multiple doses are administered |
| Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide- multiple dose | At designated time points up to 112 days | Blood samples will be collected to determine the Tmax of efinopegdutide when multiple doses are administered |
| Terminal half life (t1/2) of Efinopegdutide- multiple dose | At designated timepoints up to 112 days | Blood samples will be collected to determine the t1/2 of efinopegdutide when multiple doses are administered |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Efinopegdutide-multiple dose | At designated timepoints up to 112 days | Blood samples will be collected to determine the AUC0-last of efinopegdutide when multiple doses are administered |
| Apparent Clearance (CL) of Efinopegdutide- multiple dose | At designated timepoints up to 112 days | Blood samples will be collected to determine the CL of efinopegdutide when multiple doses are administered |
| Volume of Distribution at Steady State (Vss) of Efinopegdutide- multiple dose | At designated timepoints up to 112 days | Blood samples will be collected to determine the Vss of efinopegdutide when multiple doses are administered |
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 112 days | 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. The number of participants who experience an AE will be reported. |
| Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 78 days | 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. The number of participants who discontinue study treatment due to an AE will be reported. |
| Maximum Plasma Concentration (Cmax) of Efinopegdutide- single dose | At designated time points up to 35 days | Blood samples will be collected to determine the Cmax of efinopegdutide when administered as a single dose |
| Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide- single dose | At designated time points up to 35 days | Blood samples will be collected to determine the Tmax of efinopegdutide when administered as a single dose |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Efinopegdutide- single dose | At designated timepoints up to 35 days | Blood samples will be collected to determine the AUC0-last of efinopegdutide when administered as a single dose |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of Efinopegdutide- single dose | At designated timepoints up to 35 days | Blood samples will be collected to determine the AUC0-inf of efinopegdutide when administered as a single dose |
| Terminal half life (t1/2) of Efinopegdutide- single dose | At designated timepoints up to 35 days | Blood samples will be collected to determine the t1/2 of efinopegdutide when administered as a single dose |
| Apparent Clearance (CL) of Efinopegdutide- single dose | At designated timepoints up to 35 days | Blood samples will be collected to determine the CL of efinopegdutide when administered as a single dose |
| Volume of Distribution (Vz) of Efinopegdutide- single dose | At designated timepoints up to 35 days | Blood samples will be collected to determine the Vz of efinopegdutide when administered as a single dose |
| Maximum Plasma Concentration (Cmax) of Efinopegdutide- multiple dose | At designated time points up to 112 days | Blood samples will be collected to determine the Cmax of efinopegdutide when multiple doses are administered |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in HDL Cholesterol | Baseline and day 112 | Change from baseline in HDL cholesterol will be computed for participants who received multiple doses of efinopegdutide |
| Change from Baseline in LDL Cholesterol | Baseline and day 112 | Change from baseline in LDL cholesterol will be computed for participants who received multiple doses of efinopegdutide |
| Change from Baseline in Total Cholesterol | Baseline and day 112 | Change from baseline in total cholesterol will be computed for participants who received multiple doses of efinopegdutide |
| Change from Baseline in Triglycerides | Baseline and day 112 | Change from baseline in triglycerides will be computed for participants who received multiple doses of efinopegdutide |
| Number of participants with anti drug antibodies (ADA) to efinopegdutide | At designated timepoints up to 112 days | Blood samples will be collected to determine the number of participants with ADA to efinopegdutide |
| Change from Baseline in Weight | Baseline and day 112 | Change from baseline in weight will be computed for participants who received multiple doses of efinopegdutide |
Countries
China
Outcome results
None listed