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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05952869




Registration number
NCT05952869
Ethics application status
Date submitted
10/07/2023
Date registered
19/07/2023

Titles & IDs
Public title
A Study of Enlicitide Decanoate (MK-0616 Oral PCSK9 Inhibitor) in Adults With Heterozygous Familial Hypercholesterolemia (MK-0616-017) CORALreef HeFH
Scientific title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-0616 in Adults With Heterozygous Familial Hypercholesterolemia
Secondary ID [1] 0 0
MK-0616-017
Secondary ID [2] 0 0
0616-017
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypercholesterolemia 0 0
Familial Hypercholesterolemia 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Enlicitide Decanoate
Treatment: Drugs - Placebo

Experimental: Enlicitide Decanoate - Participants will receive 20 mg of enlicitide decanoate orally once daily (QD) for up to 52 weeks.

Placebo comparator: Placebo - Participants will receive enlicitide decanoate-matching placebo orally QD for up to 52 weeks.


Treatment: Drugs: Enlicitide Decanoate
Oral tablet

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mean percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 24
Timepoint [1] 0 0
Baseline and Week 24
Primary outcome [2] 0 0
Number of participants with one or more adverse events (AEs)
Timepoint [2] 0 0
Up to ~60 weeks
Primary outcome [3] 0 0
Number of participants who discontinue study drug due to an AE
Timepoint [3] 0 0
Up to ~52 weeks
Secondary outcome [1] 0 0
Mean percent change from baseline in LDL-C at Week 52
Timepoint [1] 0 0
Baseline and Week 52
Secondary outcome [2] 0 0
Mean percent change from baseline in non-high-density lipoprotein cholesterol (HDL-C) at Week 24
Timepoint [2] 0 0
Baseline and Week 24
Secondary outcome [3] 0 0
Mean percent change from baseline in apolipoprotein B (ApoB) at Week 24
Timepoint [3] 0 0
Baseline and Week 24
Secondary outcome [4] 0 0
Percent change from baseline in lipoprotein(a) (Lp[a]) at Week 24
Timepoint [4] 0 0
Baseline and Week 24
Secondary outcome [5] 0 0
Percentage of participants with LDL-C <70 mg/dL and =50% reduction from baseline at Week 24
Timepoint [5] 0 0
Baseline and Week 24
Secondary outcome [6] 0 0
Percentage of participants with LDL-C <55 mg/dL and =50% reduction from baseline at Week 24
Timepoint [6] 0 0
Baseline and Week 24

Eligibility
Key inclusion criteria
* Has possible or definite diagnosis of heterozygous familial hypercholesterolemia (HeFH) based on a locally accepted diagnostic algorithm
* Has an LDL-C =55 mg/dL or =70 mg/dL depending on medical history
* Is treated with a moderate- or high-intensity statin medication
* Is on a stable dose of all background lipid-lowering therapies (LLTs) with no planned medication change
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH
* Has a history of heart failure or heart failure hospitalization within 3 months before first study visit
* Is undergoing or previously underwent an LDL-C apheresis program within 3 months before first study visit or plans to initiate an LDL-C apheresis program
* Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/08/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/04/2025
Actual
Sample size
Target
270
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital-6West CV Ambulatory Care ( Site 2808) - Camperdown
Recruitment hospital [2] 0 0
Victorian Heart Hospital-Monash Cardiovascular Research Centre (MCRC) ( Site 2803) - Clayton
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3168 - Clayton
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
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Nebraska
Country [6] 0 0
United States of America
State/province [6] 0 0
Nevada
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Utah
Country [9] 0 0
United States of America
State/province [9] 0 0
Virginia
Country [10] 0 0
Brazil
State/province [10] 0 0
Ceara
Country [11] 0 0
Brazil
State/province [11] 0 0
Sao Paulo
Country [12] 0 0
Canada
State/province [12] 0 0
Quebec
Country [13] 0 0
Chile
State/province [13] 0 0
Los Rios
Country [14] 0 0
Chile
State/province [14] 0 0
Region M. De Santiago
Country [15] 0 0
Colombia
State/province [15] 0 0
Antioquia
Country [16] 0 0
Colombia
State/province [16] 0 0
Atlantico
Country [17] 0 0
Colombia
State/province [17] 0 0
Cundinamarca
Country [18] 0 0
Czechia
State/province [18] 0 0
Brno-mesto
Country [19] 0 0
Czechia
State/province [19] 0 0
Jihomoravsky Kraj
Country [20] 0 0
Czechia
State/province [20] 0 0
Praha 4
Country [21] 0 0
Finland
State/province [21] 0 0
Uusimaa
Country [22] 0 0
Hong Kong
State/province [22] 0 0
Pok Fu Lam
Country [23] 0 0
Hong Kong
State/province [23] 0 0
Shatin
Country [24] 0 0
Hungary
State/province [24] 0 0
Csongrad
Country [25] 0 0
Hungary
State/province [25] 0 0
Budapest
Country [26] 0 0
Hungary
State/province [26] 0 0
Debrecen
Country [27] 0 0
Israel
State/province [27] 0 0
Jerusalem
Country [28] 0 0
Israel
State/province [28] 0 0
Petah Tikva
Country [29] 0 0
Israel
State/province [29] 0 0
Sakhnin
Country [30] 0 0
Netherlands
State/province [30] 0 0
Gelderland
Country [31] 0 0
Netherlands
State/province [31] 0 0
Noord-Holland
Country [32] 0 0
Netherlands
State/province [32] 0 0
Utrecht
Country [33] 0 0
New Zealand
State/province [33] 0 0
Bay Of Plenty
Country [34] 0 0
New Zealand
State/province [34] 0 0
Canterbury
Country [35] 0 0
Norway
State/province [35] 0 0
Nordland
Country [36] 0 0
Norway
State/province [36] 0 0
Oslo
Country [37] 0 0
Singapore
State/province [37] 0 0
Central Singapore
Country [38] 0 0
Spain
State/province [38] 0 0
Cataluna
Country [39] 0 0
Spain
State/province [39] 0 0
Tarragona
Country [40] 0 0
Spain
State/province [40] 0 0
Valenciana, Comunitat
Country [41] 0 0
Taiwan
State/province [41] 0 0
New Taipei
Country [42] 0 0
Taiwan
State/province [42] 0 0
Taipei
Country [43] 0 0
Taiwan
State/province [43] 0 0
Tainan

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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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/NCT05952869