HealthyPhase 1NCT06701305
A Study of Efinopegdutide in Healthy Obese Participants (MK-6024-015)
A Phase 1 study testing Efinopegdutide and Acetaminophen in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
The goal of this study is to learn about the safety of efinopegdutide (MK-6024) and how well overweight healthy people tolerate it. Researchers also want to know what happens to efinopegdutide in a person's body over time when taken as a single dose (Part 1) or as multiple doses (Part 2). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Efinopegdutide and Acetaminophen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2024to 18 Feb 2025
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The main inclusion criteria include but are not limited to the following:
- Is in good health
- Has body mass index (BMI) between 29 kg/m^2 and 38 kg/m^2
Who cannot join
- The main exclusion criteria include but are not limited to the following:
- History of clinically significant endocrine, gastrointestinal (GI), cardiovascular (CV), hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- History of cancer (malignancy)
- Positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or Human immunodeficiency virus (HIV)
Trial locations and contacts
1 site in 1 country.
United States1 site
QPS-MRA, LLC (Site 0001)
South Miami, Florida, 33143
About this study
Official title: A Single and Multiple-Ascending Dose Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Efinopegdutide (MK-6024) in Otherwise Healthy Obese Participants and the Effect of Multiple Doses of Efinopegdutide on the Pharmacokinetics of Acetaminophen
The goal of this study is to learn about the safety of efinopegdutide (MK-6024) and how well overweight healthy people tolerate it. Researchers also want to know what happens to efinopegdutide in a person's body over time when taken as a single dose (Part 1) or as multiple doses (Part 2). In addition, the study will assess the amount of acetaminophen in the blood after receiving different strength doses of efinopegdutide (Part 2 only).
- Conditions
- Healthy
- Being tested
- Efinopegdutide, Placebo, Acetaminophen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EfinopegdutideDrug
Also called MK-6024
Subcutaneous injectable solution
PlaceboDrug
Subcutaneous injectable solution
AcetaminophenDrug
Oral solution
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Efinopegdutide | Experimental | Part 1: Participants receive a single subcutaneous (SC) dose of efinopegdutide. Receives: Drug: Efinopegdutide |
| Part 1: Placebo | Placebo comparator | Part 1: Participants receive a single SC dose of placebo. Receives: Drug: Placebo |
| Part 2: Efinopegdutide | Experimental | Part 2: Participants receive multiple SC doses of efinopegdutide titrated from Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, or Dosage 6. Participants receive a SC dose of efinopegdutide, Dosage 1 on Days 1 and 8; Dosage 2 on Days 15 and 22; Dosage 3 on Days 29, 36, 43 and 50; Dosage 4 on Days 57, 64, 71 and 78; Dosage 5 on Days 85, 92, 99, 106; and Dosage 6 on Days 113, 120, 127, and 134. Participants also receive oral acetaminophen on Day -2, Day 6, 62, and 83. Receives: Drug: Efinopegdutide; Drug: Acetaminophen |
| Part 2: Placebo | Placebo comparator | Part 2: Participants receive multiple SC doses of Placebo titrated from Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, or Dosage 6.
Participants receive a SC dose of Placebo, Dosage 1 on Days 1 and 8; Dosage 2 on Days 15 and 22; Dosage 3 on Days 29, 36, 43 and 50; Dosage 4 on Days 57, 64, 71 and 78; Dosage 5 on Days 85, 92, 99, 106; and Dosage 6 on Days 113, 120, 127, and 134. Participants also receive oral acetaminophen on Day -2, Day 6, 62, and 83. Receives: Drug: Placebo; Drug: Acetaminophen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: 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 35 days
Part 1: 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 35 days
Part 1: Maximum Plasma Concentration (Cmax) of Efinopegdutide
Blood samples will be collected to determine the Cmax of Efinopegdutide.
Measured: Pre-dose and at designated time points up to 35 days post dose
Part 1: Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide
Blood samples will be collected to determine the Tmax of Efinopegdutide.
Measured: Pre-dose and at designated time points up to 35 days post dose
Part 1: Area Under the Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-last) of Efinopegdutide
Blood samples will be collected to determine the AUC0-last of Efinopegdutide.
Measured: Pre-dose and at designated time points up to 35 days post dose
Part 1: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Efinopegdutide
Blood samples will be collected to determine the AUC0-Inf of Efinopegdutide.
Measured: Pre-dose and at designated time points up to 35 days post dose
Part 1: Apparent Terminal Half-life (t1/2) of Efinopegdutide
Blood samples will be collected to determine the t1/2 of Efinopegdutide.
Measured: Pre-dose and at designated time points up to 35 days post dose
Part 1: Apparent Clearance (CL/F) of Efinopegdutide
Blood samples will be collected to determine the CL/F of Efinopegdutide.
Measured: Pre-dose and at designated time points up to 35 days post dose
Part 1: Apparent volume of distribution during terminal phase (Vz/F) of Efinopegdutide
Blood samples will be collected to determine the Vz/F of Efinopegdutide.
Measured: Pre-dose and at designated time points up to 35 days post dose
Part 2: 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 184 days
Part 2: 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 184 days
Part 2: Cmax of Efinopegdutide
Blood samples will be collected to determine the Cmax of Efinopegdutide.
Measured: At designated time points up to approximately 184 days
Part 2: Tmax of Efinopegdutide
Blood samples will be collected to determine the Tmax of Efinopegdutide.
Measured: At designated time points up to approximately 184 days
Part 2: Area Under the Concentration-Time Curve from Time 0 to the End of the Dosing Interval (AUC0-tau) of Efinopegdutide
Blood samples will be collected to determine the AUC0-tau of Efinopegdutide.
Measured: At designated time points up to approximately 184 days
Part 2: t1/2 of Efinopegdutide
Blood samples will be collected to determine the CL/F of Efinopegdutide.
Measured: At designated time points up to approximately 184 days
Part 2: Vz/F of Efinopegdutide
Blood samples will be collected to determine the Vz/F of Efinopegdutide.
Measured: At designated time points up to approximately 184 days
Part 2: Concentration Immediately Before the Next Dose is Administered (Ctrough) of Efinopegdutide
Blood samples will be collected to determine the Ctrough of Efinopegdutide.
Measured: At designated time points up to approximately 184 days
Secondary outcomes (4)
Part 2: AUC0-Inf of Acetaminophen
Blood samples will be collected to determine the AUC0-inf of Acetaminophen.
Measured: At designated time points up to approximately 184 days
Part 2: Cmax of Acetaminophen
Blood samples will be collected to determine the Cmax of Acetaminophen.
Measured: At designated time points up to approximately 184 days
Part 2: Tmax of Acetaminophen
Blood samples will be collected to determine the Tmax of Acetaminophen.
Measured: At designated time points up to approximately 184 days
Part 2: t1/2 of Acetaminophen
Blood samples will be collected to determine the t1/2 of Acetaminophen.
Measured: At designated time points up to approximately 184 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start13 Jun 2024
- Primary completion18 Feb 2025
- Study completion18 Feb 2025
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
- 48 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
- NCT06701305
- Sponsor's protocol ID
- 6024-015
- Other IDs
- MK-6024-015
- Status last verified
- Feb 2025
- First submitted
- 20 Nov 2024
- Last updated
- 26 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 26 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single and Multiple-Ascending Dose Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Efinopegdutide (MK-6024) in Otherwise Healthy Obese Participants and the Effect of Multiple Doses of Efinopegdutide on the Pharmacokinetics of Acetaminophen
- ClinicalTrials.gov ID
- NCT06701305
- Acronym / sponsor ID
- 6024-015
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 18 Feb 2025 (actual)
- Study completion
- 18 Feb 2025 (actual)
- First posted
- 22 Nov 2024 (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 of efinopegdutide (MK-6024) and how well overweight healthy people tolerate it. Researchers also want to know what happens to efinopegdutide in a person's body over time when taken as a single dose (Part 1) or as multiple doses (Part 2). In addition, the study will assess the amount of acetaminophen in the blood after receiving different strength doses of efinopegdutide (Part 2 only).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: Efinopegdutide | Experimental | Drug: EfinopegdutidePart 1: Participants receive a single subcutaneous (SC) dose of efinopegdutide. |
| Part 1: Placebo | Placebo comparator | Drug: PlaceboPart 1: Participants receive a single SC dose of placebo. |
| Part 2: Efinopegdutide | Experimental | Drug: Efinopegdutide, Drug: AcetaminophenPart 2: Participants receive multiple SC doses of efinopegdutide titrated from Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, or Dosage 6. Participants receive a SC dose of efinopegdutide, Dosage 1 on Days 1 and 8; Dosage 2 on Days 15 and 22; Dosage 3 on Days 29, 36, 43 and 50; Dosage 4 on Days 57, 64, 71 and 78; Dosage 5 on Days 85, 92, 99, 106; and Dosage 6 on Days 113, 120, 127, and 134. Participants also receive oral acetaminophen on Day -2, Day 6, 62, and 83. |
| Part 2: Placebo | Placebo comparator | Drug: Placebo, Drug: AcetaminophenPart 2: Participants receive multiple SC doses of Placebo titrated from Dosage 1, Dosage 2, Dosage 3, Dosage 4, Dosage 5, or Dosage 6. Participants receive a SC dose of Placebo, Dosage 1 on Days 1 and 8; Dosage 2 on Days 15 and 22; Dosage 3 on Days 29, 36, 43 and 50; Dosage 4 on Days 57, 64, 71 and 78; Dosage 5 on Days 85, 92, 99, 106; and Dosage 6 on Days 113, 120, 127, and 134. Participants also receive oral acetaminophen on Day -2, Day 6, 62, and 83. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Is in good health
- Has body mass index (BMI) between 29 kg/m^2 and 38 kg/m^2
Key exclusion criteria (4 listed)
- History of clinically significant endocrine, gastrointestinal (GI), cardiovascular (CV), hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- History of cancer (malignancy)
- Positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies, or Human immunodeficiency virus (HIV)
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-6024Subcutaneous injectable solution | Drug | Part 1: Efinopegdutide, Part 2: Efinopegdutide |
| PlaceboSubcutaneous injectable solution | Drug | Part 1: Placebo, Part 2: Placebo |
| AcetaminophenOral solution | Drug | Part 2: Efinopegdutide, Part 2: Placebo |
Primary outcome
Part 1: Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 35 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.
Part 1: Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 35 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.
Part 1: Maximum Plasma Concentration (Cmax) of Efinopegdutide
Time frame: Pre-dose and at designated time points up to 35 days post dose
Blood samples will be collected to determine the Cmax of Efinopegdutide.
Part 1: Time to Maximum Plasma Concentration (Tmax) of Efinopegdutide
Time frame: Pre-dose and at designated time points up to 35 days post dose
Blood samples will be collected to determine the Tmax of Efinopegdutide.
Part 1: Area Under the Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-last) of Efinopegdutide
Time frame: Pre-dose and at designated time points up to 35 days post dose
Blood samples will be collected to determine the AUC0-last of Efinopegdutide.
Part 1: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Efinopegdutide
Time frame: Pre-dose and at designated time points up to 35 days post dose
Blood samples will be collected to determine the AUC0-Inf of Efinopegdutide.
Part 1: Apparent Terminal Half-life (t1/2) of Efinopegdutide
Time frame: Pre-dose and at designated time points up to 35 days post dose
Blood samples will be collected to determine the t1/2 of Efinopegdutide.
Part 1: Apparent Clearance (CL/F) of Efinopegdutide
Time frame: Pre-dose and at designated time points up to 35 days post dose
Blood samples will be collected to determine the CL/F of Efinopegdutide.
Part 1: Apparent volume of distribution during terminal phase (Vz/F) of Efinopegdutide
Time frame: Pre-dose and at designated time points up to 35 days post dose
Blood samples will be collected to determine the Vz/F of Efinopegdutide.
Part 2: Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 184 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.
Part 2: Number of Participants Who Discontinue Study Treatment Due to an AE
Time frame: Up to approximately 184 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.
Part 2: Cmax of Efinopegdutide
Time frame: At designated time points up to approximately 184 days
Blood samples will be collected to determine the Cmax of Efinopegdutide.
Part 2: Tmax of Efinopegdutide
Time frame: At designated time points up to approximately 184 days
Blood samples will be collected to determine the Tmax of Efinopegdutide.
Part 2: Area Under the Concentration-Time Curve from Time 0 to the End of the Dosing Interval (AUC0-tau) of Efinopegdutide
Time frame: At designated time points up to approximately 184 days
Blood samples will be collected to determine the AUC0-tau of Efinopegdutide.
Part 2: t1/2 of Efinopegdutide
Time frame: At designated time points up to approximately 184 days
Blood samples will be collected to determine the CL/F of Efinopegdutide.
Part 2: Vz/F of Efinopegdutide
Time frame: At designated time points up to approximately 184 days
Blood samples will be collected to determine the Vz/F of Efinopegdutide.
Part 2: Concentration Immediately Before the Next Dose is Administered (Ctrough) of Efinopegdutide
Time frame: At designated time points up to approximately 184 days
Blood samples will be collected to determine the Ctrough of Efinopegdutide.
4 secondary outcomes
Part 2: AUC0-Inf of Acetaminophen
Time frame: At designated time points up to approximately 184 days
Part 2: Cmax of Acetaminophen
Time frame: At designated time points up to approximately 184 days
Part 2: Tmax of Acetaminophen
Time frame: At designated time points up to approximately 184 days
Part 2: t1/2 of Acetaminophen
Time frame: At designated time points up to approximately 184 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 26 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 and Acetaminophen in people with Healthy, run by Merck Sharp & Dohme LLC at 1 site in United States.
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 4 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 26 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 United States. 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?
Part 1: Number of Participants Who Experience an Adverse Event (AE) (time frame: Up to approximately 35 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 26 Feb 2025.