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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06492291
Registration number
NCT06492291
Ethics application status
Date submitted
1/07/2024
Date registered
9/07/2024
Date last updated
10/07/2025
Titles & IDs
Public title
Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension
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Scientific title
A Phase 3, Open-label Extension Study to Evaluate the Safety and Efficacy of MK-0616 in Adults With Hypercholesterolemia
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Secondary ID [1]
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0
2023-504922-20-00
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Secondary ID [2]
0
0
0616-019
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia
0
0
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Condition category
Condition code
Metabolic and Endocrine
0
0
0
0
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Other metabolic disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Enlicitide Decanoate
Experimental: Enlicitide Decanoate - Participants will receive 20 mg of enlicitide decanoate orally once daily (QD)
Treatment: Drugs: Enlicitide Decanoate
Oral tablet
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Intervention code [1]
0
0
Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of participants with one or more adverse events (AEs)
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Assessment method [1]
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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.
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Timepoint [1]
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Up to approximately 3 years
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Primary outcome [2]
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Number of participants who discontinue study drug due to an AE
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Assessment method [2]
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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.
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Timepoint [2]
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Up to approximately 3 years
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Secondary outcome [1]
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Mean percent change from baseline of the parent study in LDL-C at Week 8 of this extension study
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Assessment method [1]
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The percent change from baseline in LDL-C. Each participant's baseline data from their parent study will be used as baseline data for this analysis.
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Timepoint [1]
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Baseline of the parent study and Week 8 of this extension study
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Secondary outcome [2]
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Mean percent change from baseline of the parent study in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 8 of this Extension Study
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Assessment method [2]
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The percent change from baseline in Non-HDL-C. Each participant's baseline data from their parent study will be used as baseline data for this analysis.
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Timepoint [2]
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Baseline of the parent study and Week 8 of this extension study
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Secondary outcome [3]
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Mean percent change from baseline of the parent study in apolipoprotein B (ApoB) at Week 8 of this extension study
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Assessment method [3]
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The percent change from baseline in apolipoprotein B. Each participant's baseline data from their parent study will be used as baseline data for this analysis.
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Timepoint [3]
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Baseline of the parent study and Week 8 of this extension study
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Secondary outcome [4]
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Percent change from baseline of the parent study in lipoprotein(a) (Lp[a]) at Week 8 of this extension study
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Assessment method [4]
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The percent change from baseline in Lp(a). Each participant's baseline data from their parent study will be used as baseline data for this analysis.
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Timepoint [4]
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Baseline of the parent study and Week 8 of this extension study
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Secondary outcome [5]
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Percentage of participants with LDL-C <70 mg/dL and =50% reduction from baseline of the parent study
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Assessment method [5]
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The percentage of participants who have LDL-C \<70 mg/dL and =50% reduction from baseline at any point during the study. Each participant's baseline data from their parent study will be used as baseline data for this analysis.
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Timepoint [5]
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Baseline in the parent study and up to approximately 3 years in this extension study
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Secondary outcome [6]
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Percentage of participants with LDL-C <55 mg/dL and =50% reduction from baseline of the parent study
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Assessment method [6]
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The percentage of participants who have LDL-C \<55 mg/dL and =50% reduction from baseline at any point during the study. Each participant's baseline data from their parent study will be used as baseline data for this analysis.
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Timepoint [6]
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Baseline in the parent study and up to approximately 3 years in this extension study
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Eligibility
Key inclusion criteria
* Has completed an enlicitide decanoate (also known as enlictide and MK-0616) parent study [MK-0616-013 (NCT05952856), MK-0616-017 (NCT05952869), and MK-0616-018 (NCT06450366)] per protocol (including the final assessments/procedures of their parent study)
* Had an overall study intervention compliance =80% while participating in their parent study
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Has discontinued study intervention in their parent study
* Has an ongoing serious adverse event considered related to study intervention by the investigator in the parent study
* Is planning to begin treatment with a nonstudy protein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) while enrolled in the study
* Is currently participating in an interventional clinical study other than an enlicitide decanoate parent study
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
5/08/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
13/10/2028
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Actual
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Sample size
Target
3000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC
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Recruitment hospital [1]
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Royal Prince Alfred Hospital-6West CV Ambulatory Care ( Site 2808) - Camperdown
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Recruitment hospital [2]
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Victorian Heart Hospital-Monash Cardiovascular Research Centre (MCRC) ( Site 2803) - Clayton
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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3168 - Clayton
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Recruitment outside Australia
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Germany
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Germany
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Shatin
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Csongrad
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Hadera
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Israel
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Haifa
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Israel
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Israel
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Israel
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Petah Tikva
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Israel
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Ramat Gan
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Israel
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Sakhnin
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Israel
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Italy
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Lazio
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Italy
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Milano
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Italy
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Piemonte
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Italy
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Roma
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Italy
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Catania
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Fukuoka
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Miyagi
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Seoul
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Turkey
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State/province [129]
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Eskisehir
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Country [130]
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Turkey
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State/province [130]
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Kayseri
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Country [131]
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Turkey
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State/province [131]
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Kocaeli
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United Kingdom
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State/province [132]
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England
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Merck Sharp & Dohme LLC
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is an extension study to evaluate the longer-term safety and efficacy of enlicitide decanoate in adults with hypercholesterolemia who completed either study MK-0616-013 (NCT05952856), study MK-0616-017 (NCT05952869), or study MK-0616-018 (NCT06450366).
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Trial website
https://clinicaltrials.gov/study/NCT06492291
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Medical Director
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Merck Sharp & Dohme LLC
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Contact person for public queries
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Toll Free Number
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Phone
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1-888-577-8839
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06492291
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