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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)
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
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United States of America
State/province [2] 0 0
Arizona
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United States of America
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California
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United States of America
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District of Columbia
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United States of America
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Florida
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United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
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United States of America
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Indiana
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United States of America
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Kentucky
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United States of America
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Louisiana
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Maryland
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Michigan
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Mississippi
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Missouri
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Nebraska
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Nevada
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New Mexico
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New York
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North Dakota
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Pennsylvania
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South Carolina
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South Dakota
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Tennessee
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Texas
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Utah
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Virginia
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Washington
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Argentina
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Buenos Aires
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Argentina
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Santa Fe
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Argentina
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Caba
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Brazil
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Sao Paulo
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Los Rios
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Chile
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Region M. De Santiago
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China
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Beijing
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China
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Chongqing
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China
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Guangdong
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China
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Hubei
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China
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Hunan
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China
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Jiangsu
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China
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Jilin
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China
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Sichuan
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China
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Zhejiang
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Colombia
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Antioquia
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Colombia
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Atlantico
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Colombia
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Cundinamarca
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Colombia
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Valle Del Cauca
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Czechia
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Brno-mesto
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Czechia
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Praha 4
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Finland
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Uusimaa
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Herault
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Rhone
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Paris
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Hksar
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Shatin
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Hungary
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Budapest
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Debrecen
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Hadera
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Haifa
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Jerusalem
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Israel
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Kfar Saba
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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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Zerifin
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Italy
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Lazio
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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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Japan
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Fukuoka
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Japan
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Ibaraki
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Japan
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Ishikawa
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Iwate
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Miyagi
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Japan
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Osaka
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Saitama
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Japan
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Tokyo
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Japan
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Hiroshima
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Korea, Republic of
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Chungbuk
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Korea, Republic of
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Kang-won-do
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Korea, Republic of
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Kwangju-Kwangyokshi
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Korea, Republic of
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Kyonggi-do
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Korea, Republic of
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Pusan-Kwangyokshi
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Korea, Republic of
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Taegu-Kwangyokshi
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Korea, Republic of
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Seoul
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Mexico
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Jalisco
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Netherlands
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Gelderland
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Netherlands
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Noord-Holland
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Netherlands
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Utrecht
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New Zealand
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Bay Of Plenty
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New Zealand
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Canterbury
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Norway
State/province [95] 0 0
Nordland
Country [96] 0 0
Norway
State/province [96] 0 0
Oslo
Country [97] 0 0
Singapore
State/province [97] 0 0
Central Singapore
Country [98] 0 0
Spain
State/province [98] 0 0
Andalucia
Country [99] 0 0
Spain
State/province [99] 0 0
Cataluna
Country [100] 0 0
Spain
State/province [100] 0 0
La Coruna
Country [101] 0 0
Spain
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Tarragona
Country [102] 0 0
Spain
State/province [102] 0 0
Barcelona
Country [103] 0 0
Taiwan
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Changhua
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Taiwan
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Kaohsiung
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Taiwan
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New Taipei
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Taiwan
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Tainan
Country [107] 0 0
Taiwan
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Taipei
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Taiwan
State/province [108] 0 0
Taoyuan
Country [109] 0 0
Turkey
State/province [109] 0 0
Ankara
Country [110] 0 0
Turkey
State/province [110] 0 0
Eskisehir
Country [111] 0 0
Turkey
State/province [111] 0 0
Kocaeli
Country [112] 0 0
United Kingdom
State/province [112] 0 0
England

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