HealthyPhase 1NCT06836037
A Clinical Study of Efinopegdutide (MK-6024) in Healthy Chinese Volunteers (MK-6024-011)
A Phase 1 study testing Efinopegdutide in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Efinopegdutide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteChina
- Study dates
- 5 Sep 2022to 2 Feb 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 20 to 60 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 in good health before randomization
- Has a body mass index (BMI) ≥25 and ≤35 kg/m^2
Who cannot join
- The key exclusion criteria include but are not limited to the following:
- Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Had major surgery, donated or lost approximately 400 mL blood within 4 weeks prior to entering the study
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 of MK-6024 in Healthy Chinese Participants
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.
- Conditions
- Healthy
- Being tested
- Efinopegdutide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfinopegdutideDrug
Also called MK-6024, HM12525A, JNJ-64565111,
Subcutaneous injection
PlaceboDrug
placebo matching efinopegdutide
| Study group | Role | What they receive |
|---|---|---|
| Efinopegdutide Low Dose | Experimental | Participants receive low dose efinopegdutide at a single dose on day 1 Receives: Drug: Efinopegdutide |
| Efinopegdutide Medium dose | Experimental | Participants receive medium dose efinopegdutide at a single dose on day 1 Receives: Drug: Efinopegdutide |
| Efinopegdutide High Dose | Experimental | Participants receive high dose efinopegdutide at a single dose on day 1 Receives: Drug: Efinopegdutide |
| Efinopegdutide Multiple Dose | Experimental | Participants receive multiple doses of efinopegdutide over 78 days Receives: Drug: Efinopegdutide |
| Placebo | Placebo comparator | Participants receive placebo to match efinopegdutide dose and regimen Receives: 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. The number of participants who experience an AE will be reported.
Measured: Up to approximately 112 days
Number of Participants Who Discontinue 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. The number of participants who discontinue study treatment due to an AE will be reported.
Measured: Up to approximately 78 days
Maximum Plasma Concentration (Cmax) of Efinopegdutide- single dose
Blood samples will be collected to determine the Cmax of efinopegdutide when administered as a single dose
Measured: At designated time points up to 35 days
Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide- single dose
Blood samples will be collected to determine the Tmax of efinopegdutide when administered as a single dose
Measured: At designated time points up to 35 days
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Efinopegdutide- single dose
Blood samples will be collected to determine the AUC0-last of efinopegdutide when administered as a single dose
Measured: At designated timepoints up to 35 days
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of Efinopegdutide- single dose
Blood samples will be collected to determine the AUC0-inf of efinopegdutide when administered as a single dose
Measured: At designated timepoints up to 35 days
Terminal half life (t1/2) of Efinopegdutide- single dose
Blood samples will be collected to determine the t1/2 of efinopegdutide when administered as a single dose
Measured: At designated timepoints up to 35 days
Apparent Clearance (CL) of Efinopegdutide- single dose
Blood samples will be collected to determine the CL of efinopegdutide when administered as a single dose
Measured: At designated timepoints up to 35 days
Volume of Distribution (Vz) of Efinopegdutide- single dose
Blood samples will be collected to determine the Vz of efinopegdutide when administered as a single dose
Measured: At designated timepoints up to 35 days
Maximum Plasma Concentration (Cmax) of Efinopegdutide- multiple dose
Blood samples will be collected to determine the Cmax of efinopegdutide when multiple doses are administered
Measured: At designated time points up to 112 days
Minimum Plasma Concentration (Cmin) of Efinopegdutide- multiple dose
Blood samples will be collected to determine the Cmin of efinopegdutide when multiple doses are administered
Measured: At designated time points up to 112 days
Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide- multiple dose
Blood samples will be collected to determine the Tmax of efinopegdutide when multiple doses are administered
Measured: At designated time points up to 112 days
Terminal half life (t1/2) of Efinopegdutide- multiple dose
Blood samples will be collected to determine the t1/2 of efinopegdutide when multiple doses are administered
Measured: At designated timepoints up to 112 days
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Efinopegdutide-multiple dose
Blood samples will be collected to determine the AUC0-last of efinopegdutide when multiple doses are administered
Measured: At designated timepoints up to 112 days
Apparent Clearance (CL) of Efinopegdutide- multiple dose
Blood samples will be collected to determine the CL of efinopegdutide when multiple doses are administered
Measured: At designated timepoints up to 112 days
Volume of Distribution at Steady State (Vss) of Efinopegdutide- multiple dose
Blood samples will be collected to determine the Vss of efinopegdutide when multiple doses are administered
Measured: At designated timepoints up to 112 days
Area Under the Concentration-Time Curve to the end of the dosing period (AUC 0-tau)of Efinopegdutide- multiple dose
Blood samples will be collected to determine the AUC0 to tau of efinopegdutide when multiple doses are administered
Measured: At designated timepoints up to 78 days
Secondary outcomes (6)
Change from Baseline in Weight
Change from baseline in weight will be computed for participants who received multiple doses of efinopegdutide
Measured: Baseline and day 112
Change from Baseline in HDL Cholesterol
Change from baseline in HDL cholesterol will be computed for participants who received multiple doses of efinopegdutide
Measured: Baseline and day 112
Change from Baseline in LDL Cholesterol
Change from baseline in LDL cholesterol will be computed for participants who received multiple doses of efinopegdutide
Measured: Baseline and day 112
Change from Baseline in Total Cholesterol
Change from baseline in total cholesterol will be computed for participants who received multiple doses of efinopegdutide
Measured: Baseline and day 112
Change from Baseline in Triglycerides
Change from baseline in triglycerides will be computed for participants who received multiple doses of efinopegdutide
Measured: Baseline and day 112
Number of participants with anti drug antibodies (ADA) to efinopegdutide
Blood samples will be collected to determine the number of participants with ADA to efinopegdutide
Measured: At designated timepoints up to 112 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start5 Sep 2022
- Primary completion2 Feb 2023
- Study completion2 Feb 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 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
- NCT06836037
- Sponsor's protocol ID
- 6024-011
- Other IDs
- MK-6024-011, 2020-005136-30
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 21 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 21 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 of MK-6024 in Healthy Chinese Participants
- ClinicalTrials.gov ID
- NCT06836037
- Acronym / sponsor ID
- 6024-011
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 5 Sep 2022 (actual)
- Primary completion
- 2 Feb 2023 (actual)
- Study completion
- 2 Feb 2023 (actual)
- First posted
- 20 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 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Efinopegdutide Low Dose | Experimental | Drug: EfinopegdutideParticipants receive low dose efinopegdutide at a single dose on day 1 |
| Efinopegdutide Medium dose | Experimental | Drug: EfinopegdutideParticipants receive medium dose efinopegdutide at a single dose on day 1 |
| Efinopegdutide High Dose | Experimental | Drug: EfinopegdutideParticipants receive high dose efinopegdutide at a single dose on day 1 |
| Efinopegdutide Multiple Dose | Experimental | Drug: EfinopegdutideParticipants receive multiple doses of efinopegdutide over 78 days |
| Placebo | Placebo comparator | Drug: PlaceboParticipants receive placebo to match efinopegdutide dose and regimen |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Is in good health before randomization
- Has a body mass index (BMI) ≥25 and ≤35 kg/m^2
Key exclusion criteria (3 listed)
- Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- Had major surgery, donated or lost approximately 400 mL blood within 4 weeks prior to entering the study
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 |
|---|---|---|
| EfinopegdutideAlso: MK-6024, HM12525A, JNJ-64565111,Subcutaneous injection | Drug | Efinopegdutide High Dose, Efinopegdutide Low Dose, Efinopegdutide Medium dose, Efinopegdutide Multiple Dose |
| Placeboplacebo matching efinopegdutide | Drug | Placebo |
Primary outcome
Number of Participants Who Experience an Adverse Event (AE)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At designated time points up to 112 days
Blood samples will be collected to determine the Cmax of efinopegdutide when multiple doses are administered
Minimum Plasma Concentration (Cmin) of Efinopegdutide- multiple dose
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At designated timepoints up to 112 days
Blood samples will be collected to determine the Vss of efinopegdutide when multiple doses are administered
Area Under the Concentration-Time Curve to the end of the dosing period (AUC 0-tau)of Efinopegdutide- multiple dose
Time frame: 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
6 secondary outcomes
Change from Baseline in Weight
Time frame: Baseline and day 112
Change from Baseline in HDL Cholesterol
Time frame: Baseline and day 112
Change from Baseline in LDL Cholesterol
Time frame: Baseline and day 112
Change from Baseline in Total Cholesterol
Time frame: Baseline and day 112
Change from Baseline in Triglycerides
Time frame: Baseline and day 112
Number of participants with anti drug antibodies (ADA) to efinopegdutide
Time frame: At designated timepoints up to 112 days
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 21 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 Efinopegdutide 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 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 21 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. Some participants in this study may receive a placebo. 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 112 days). The study lists 17 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 21 Feb 2025.