Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension
Phase 3 – large-scale trial before approval
Conditions:
Hypercholesterolemia
Sponsor: Merck Sharp & Dohme LLC
trial.available_in:
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Overview
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).
Who can participate
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
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
Locations
28
Argentina (1)
CEDIC ( Site 0603)
CABA , Buenos Aires
Australia (1)
Royal Prince Alfred Hospital-6West CV Ambulatory Care ( Site 2808)
Camperdown , New South Wales
Brazil (1)
Universidade Federal Do Ceara ( Site 0702)
Fortaleza , Ceará
Canada (1)
The Medical Arts Health Research Group ( Site 0506)
North Vancouver , British Columbia
Chile (1)
Clinical Research Chile SpA ( Site 0800)
Valdivia , Los Ríos Region
China (1)
Beijing Anzhen Hospital, Capital Medical University-Cardiovascular ( Site 6000)
Beijing , Beijing Municipality
Colombia (1)
Fundación Centro de Investigación Clínica CIC ( Site 0904)
Medellín , Antioquia
Czech Republic (1)
Fakultni Nemocnice u sv. Anny v Brne ( Site 3604)
Brno , Brno-mesto
Finland (1)
Meilahden tornisairaala - Meilahti Tower Hospital ( Site 1300)
Helsinki , Uusimaa
France (1)
Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 5002)
Montpellier , Herault
Germany (1)
Unterfrintroper Hausarztzentrum Klinische Forschung ( Site 1543)
Essen , North Rhine-Westphalia
Hong Kong (1)
Queen Mary Hospital-Medical ( Site 3300)
Hksar
Hungary (1)
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ-Belgyógyászati Klinika ( Site 1603)
Szeged , Csongrád megye
Israel (1)
Hillel Yaffe Medical Center ( Site 1731)
Hadera
Italy (1)
Fondazione Policlinico Tor Vergata ( Site 1809)
Rome , Lazio
Japan (1)
Hirohata Naika Clinic ( Site 3513)
Kitakyushu , Fukuoka
Mexico (1)
Instituto Jalisciense de Investigacion en Diabetes y Obesidad-Endocrinology ( Site 1057)
Guadalajara , Jalisco
Netherlands (1)
Radboudumc-internal medicine ( Site 1952)
Nijmegen , Gelderland
New Zealand (1)
Pacific Clinical Research Network - Rotorua ( Site 2902)
Rotorua , Bay of Plenty
Norway (1)
Nordlandssykehuset ( Site 2041)
Bodø , Nordland
Singapore (1)
Changi General Hospital ( Site 3211)
Singapore , Central Singapore
South Africa (1)
IATROS International ( Site 2204)
Bloemfontein , Free State
South Korea (1)
Wonju Severance Christian Hospital ( Site 3008)
Wŏnju , Kang-won-do
Spain (1)
Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 2358)
Málaga , Andalusia
Taiwan (1)
Mackay Memorial Hospital -Tamsui Branch ( Site 3109)
New Taipei City , New Taipei
Turkey (1)
Ege Universitesi Hastanesi-Cardilogy Department ( Site 2502)
Bornova , İzmir
United Kingdom (1)
Barts Health NHS Trust-William Harvey Clinical Research Centre ( Site 4001)
London , England
United States (1)
Alliance for Multispecialty Research, LLC ( Site 0027)
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