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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

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
Scientific title
A Phase 3, Open-label Extension Study to Evaluate the Safety and Efficacy of MK-0616 in Adults With Hypercholesterolemia
Secondary ID [1] 0 0
2023-504922-20
Secondary ID [2] 0 0
0616-019
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with one or more adverse events (AEs)
Timepoint [1] 0 0
Up to approximately 3 years
Primary outcome [2] 0 0
Number of participants who discontinue study drug due to an AE
Timepoint [2] 0 0
Up to approximately 3 years
Secondary outcome [1] 0 0
Mean percent change from baseline of the parent study in LDL-C at Week 8 of this extension study
Timepoint [1] 0 0
Baseline of the parent study and Week 8 of this extension study
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
Baseline of the parent study and Week 8 of this extension study
Secondary outcome [3] 0 0
Mean percent change from baseline of the parent study in apolipoprotein B (ApoB) at Week 8 of this extension study
Timepoint [3] 0 0
Baseline of the parent study and Week 8 of this extension study
Secondary outcome [4] 0 0
Percent change from baseline of the parent study in lipoprotein(a) (Lp[a]) at Week 8 of this extension study
Timepoint [4] 0 0
Baseline of the parent study and Week 8 of this extension study
Secondary outcome [5] 0 0
Percentage of participants with LDL-C <70 mg/dL and =50% reduction from baseline of the parent study
Timepoint [5] 0 0
Baseline in the parent study and up to approximately 3 years in this extension study
Secondary outcome [6] 0 0
Percentage of participants with LDL-C <55 mg/dL and =50% reduction from baseline of the parent study
Timepoint [6] 0 0
Baseline in the parent study and up to approximately 3 years in this extension study

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/10/2028
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Kentucky
Country [10] 0 0
United States of America
State/province [10] 0 0
Louisiana
Country [11] 0 0
United States of America
State/province [11] 0 0
Maryland
Country [12] 0 0
United States of America
State/province [12] 0 0
Michigan
Country [13] 0 0
United States of America
State/province [13] 0 0
Mississippi
Country [14] 0 0
United States of America
State/province [14] 0 0
Missouri
Country [15] 0 0
United States of America
State/province [15] 0 0
Nebraska
Country [16] 0 0
United States of America
State/province [16] 0 0
Nevada
Country [17] 0 0
United States of America
State/province [17] 0 0
New Mexico
Country [18] 0 0
United States of America
State/province [18] 0 0
New York
Country [19] 0 0
United States of America
State/province [19] 0 0
North Dakota
Country [20] 0 0
United States of America
State/province [20] 0 0
Pennsylvania
Country [21] 0 0
United States of America
State/province [21] 0 0
South Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
South Dakota
Country [23] 0 0
United States of America
State/province [23] 0 0
Tennessee
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Utah
Country [26] 0 0
United States of America
State/province [26] 0 0
Virginia
Country [27] 0 0
United States of America
State/province [27] 0 0
Washington
Country [28] 0 0
Argentina
State/province [28] 0 0
Buenos Aires
Country [29] 0 0
Argentina
State/province [29] 0 0
Santa Fe
Country [30] 0 0
Canada
State/province [30] 0 0
British Columbia
Country [31] 0 0
Canada
State/province [31] 0 0
Ontario
Country [32] 0 0
Canada
State/province [32] 0 0
Quebec
Country [33] 0 0
Chile
State/province [33] 0 0
Los Rios
Country [34] 0 0
Chile
State/province [34] 0 0
Region M. De Santiago
Country [35] 0 0
Colombia
State/province [35] 0 0
Antioquia
Country [36] 0 0
Colombia
State/province [36] 0 0
Atlantico
Country [37] 0 0
Colombia
State/province [37] 0 0
Cundinamarca
Country [38] 0 0
Colombia
State/province [38] 0 0
Valle Del Cauca
Country [39] 0 0
Hong Kong
State/province [39] 0 0
Hksar
Country [40] 0 0
Hong Kong
State/province [40] 0 0
Shatin
Country [41] 0 0
Italy
State/province [41] 0 0
Roma
Country [42] 0 0
Japan
State/province [42] 0 0
Osaka
Country [43] 0 0
Japan
State/province [43] 0 0
Tokyo
Country [44] 0 0
Korea, Republic of
State/province [44] 0 0
Chungbuk
Country [45] 0 0
Korea, Republic of
State/province [45] 0 0
Kang-won-do
Country [46] 0 0
Korea, Republic of
State/province [46] 0 0
Kyonggi-do
Country [47] 0 0
Korea, Republic of
State/province [47] 0 0
Pusan-Kwangyokshi
Country [48] 0 0
Korea, Republic of
State/province [48] 0 0
Taegu-Kwangyokshi
Country [49] 0 0
Korea, Republic of
State/province [49] 0 0
Seoul
Country [50] 0 0
Netherlands
State/province [50] 0 0
Gelderland
Country [51] 0 0
Netherlands
State/province [51] 0 0
Noord-Holland
Country [52] 0 0
New Zealand
State/province [52] 0 0
Bay Of Plenty
Country [53] 0 0
New Zealand
State/province [53] 0 0
Canterbury

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
Trialsites@msd.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


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