HealthyPhase 1NCT06655311
A Study of Enlicitide Chloride (MK-0616) in Healthy Participants and Participants Taking Statins (MK-0616-012)
A Phase 1 study testing Enlicitide Chloride in people with Healthy and Hypercholesterolemia, run by Merck Sharp & Dohme LLC at 1 site in United States.
Trial summary
The goal of this study is to learn what happens to different doses of enlicitide chloride over time in the body of healthy participants and participants taking statins, a group of medicines used to reduce the levels of high cholesterol in the bloodstream. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Hypercholesterolemia
- What is being tested?
- Enlicitide Chloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2022to 2 Jan 2024
- 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 key inclusion criteria include but are not limited to the following:
- Is in good health based on medical history, physical examination, vital signs (VS) measurements, electrocardiograms (ECGs), and laboratory safety tests performed before randomization
- Has a body mass index (BMI)≥18 and ≤32 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 (including stroke and chronic seizures) abnormalities or diseases
- Has a history of cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Clinical Kansas, Inc. (Site 0002)
Overland Park, Kansas, 66212
About this study
Official title: Multiple-Rising Dose Clinical Study to Evaluate the Safety and Pharmacokinetics of MK-0616 in Healthy Participants and in Male and Female Participants Taking Statins
The goal of this study is to learn what happens to different doses of enlicitide chloride over time in the body of healthy participants and participants taking statins, a group of medicines used to reduce the levels of high cholesterol in the bloodstream. The researchers want to learn about the safety of enlicitide chloride when administered at high doses.
- Conditions
- Healthy, Hypercholesterolemia
- Being tested
- Enlicitide Chloride, Placebo
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enlicitide ChlorideBiological
Also called MK-0616
Oral administration
PlaceboOther
Oral administration
| Study group | Role | What they receive |
|---|---|---|
| Enlicitide Chloride | Experimental | Participants receive enlicitide chloride titrated orally from Dose 1, Dose 2, or Dose 3 once daily (QD) over the course of a 14-day treatment for each dose based on the safety and tolerability of the previous starting dose. The total treatment duration is up to approximately 6 weeks. Receives: Biological: Enlicitide Chloride |
| Placebo | Placebo comparator | Participants receive placebo orally for up to approximately 6 weeks. Receives: Other: 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 participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Measured: Up to approximately 56 days
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Measured: Up to approximately 42 days
Secondary outcomes (6)
Area Under the Curve from Time 0 to 24 Hours (AUC0-24) of Enlicitide Chloride
Blood samples will be collected to determine the AUC0-24 of enlicitide chloride.
Measured: At designated timepoints (up to approximately 24 hours)
Maximum Plasma Concentration (Cmax) of Enlicitide Chloride
Blood samples will be collected to determine the Cmax of enlicitide chloride.
Measured: At designated timepoints (up to approximately 1 week)
Plasma Concentration 24 Hours Postdose (C24) of Enlicitide Chloride
Blood samples will be collected to determine the C24 of enlicitide chloride.
Measured: At designated timepoints (up to approximately 1 week)
Time to Maximum Plasma Concentration (Tmax) of Enlicitide Chloride
Blood samples will be collected to determine the Tmax of enlicitide chloride.
Measured: At designated timepoints (up to approximately 1 week)
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Chloride
Blood samples will be collected to determine the AUC0-Last of enlicitide chloride.
Measured: At designated timepoints (up to approximately 1 week)
Percent Change from Baseline of Plasma Low Density Lipoprotein (LDL-C) Concentration After Administration of Enlicitide Chloride
Blood samples will be collected to determine the LDL-C of enlicitide chloride.
Measured: Baseline, Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start30 Sep 2022
- Primary completion2 Jan 2024
- Study completion2 Jan 2024
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
- Treatment
- 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
- NCT06655311
- Sponsor's protocol ID
- 0616-012
- Other IDs
- MK-0616-012
- Status last verified
- Oct 2024
- First submitted
- 21 Oct 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multiple-Rising Dose Clinical Study to Evaluate the Safety and Pharmacokinetics of MK-0616 in Healthy Participants and in Male and Female Participants Taking Statins
- ClinicalTrials.gov ID
- NCT06655311
- Acronym / sponsor ID
- 0616-012
- Conditions
- Healthy, Hypercholesterolemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 2 Jan 2024 (actual)
- Study completion
- 2 Jan 2024 (actual)
- First posted
- 23 Oct 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 what happens to different doses of enlicitide chloride over time in the body of healthy participants and participants taking statins, a group of medicines used to reduce the levels of high cholesterol in the bloodstream. The researchers want to learn about the safety of enlicitide chloride when administered at high doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enlicitide Chloride | Experimental | Biological: Enlicitide ChlorideParticipants receive enlicitide chloride titrated orally from Dose 1, Dose 2, or Dose 3 once daily (QD) over the course of a 14-day treatment for each dose based on the safety and tolerability of the previous starting dose. The total treatment duration is up to approximately 6 weeks. |
| Placebo | Placebo comparator | Other: PlaceboParticipants receive placebo orally for up to approximately 6 weeks. |
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 based on medical history, physical examination, vital signs (VS) measurements, electrocardiograms (ECGs), and laboratory safety tests performed before randomization
- Has a body mass index (BMI)≥18 and ≤32 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 (including stroke and chronic seizures) abnormalities or diseases
- Has a history of cancer
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 |
|---|---|---|
| Enlicitide ChlorideAlso: MK-0616Oral administration | Biological | Enlicitide Chloride |
| PlaceboOral administration | Other | Placebo |
Primary outcome
Number of Participants Who Experience an Adverse Event (AE)
Time frame: Up to approximately 56 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. 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 42 days
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
6 secondary outcomes
Area Under the Curve from Time 0 to 24 Hours (AUC0-24) of Enlicitide Chloride
Time frame: At designated timepoints (up to approximately 24 hours)
Maximum Plasma Concentration (Cmax) of Enlicitide Chloride
Time frame: At designated timepoints (up to approximately 1 week)
Plasma Concentration 24 Hours Postdose (C24) of Enlicitide Chloride
Time frame: At designated timepoints (up to approximately 1 week)
Time to Maximum Plasma Concentration (Tmax) of Enlicitide Chloride
Time frame: At designated timepoints (up to approximately 1 week)
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Chloride
Time frame: At designated timepoints (up to approximately 1 week)
Percent Change from Baseline of Plasma Low Density Lipoprotein (LDL-C) Concentration After Administration of Enlicitide Chloride
Time frame: Baseline, Week 1
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 23 Oct 2024.
- Merck Clinical Trials InformationLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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 Enlicitide Chloride in people with Healthy and Hypercholesterolemia, 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 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 23 Oct 2024. 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?
Number of Participants Who Experience an Adverse Event (AE) (time frame: Up to approximately 56 days). The study lists 2 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 23 Oct 2024.