Clinical trial • Phase III • Cardiology

ENLICITIDE CHLORIDE for Hypercholesterolemia

Phase III trial of ENLICITIDE CHLORIDE for Hypercholesterolemia. open-label, none/not specified-controlled. 2870 participants.

Overview

Trial Therapeutic Area
Cardiology
Trial Disease
Hypercholesterolemia
Trial Stage
Phase III
Drug Modality
Small molecule

Key dates

Initial CTIS Submission Date
29-04-2024
First CTIS Authorization Date
21-08-2024

Trial design

open-label, none/not specified-controlled Phase III trial across 41 sites in Finland, Netherlands, Hungary and others.

Open Label
Yes
Comparator
None/Not specified
Target Sample Size
2870
Trial Duration For Participant
1095

Eligibility

Recruits 2870 No vulnerable populations selected; participants are adults and provide informed consent; assent not applicable..

Vulnerable Population
No vulnerable populations selected; participants are adults and provide informed consent; assent not applicable.

Inclusion criteria

  • {"criterion_text":"- Has completed an enlicitide (also known as enlicitide decanoate and MK-0616) parent study (MK-0616-013, MK-0616-017, MK-0616-018) per protocol including the final assessments/procedure of their parent study"}
  • {"criterion_text":"- Had overall study compliance ≥80% while participating in their parent study"}

Exclusion criteria

  • {"criterion_text":"- Had discontinued study intervention in their parent study"}
  • {"criterion_text":"- Has an ongoing serious adverse event (SAE) considered related to study intervention by the investigator in the parent study"}
  • {"criterion_text":"- Is planning to begin treatment with a nonstudy protein convertase subtilisin/kexin type 9 inhibitor (PCSK9i) while enrolled in the study"}
  • {"criterion_text":"- Is currently participating in an interventional clinical study other than an enlicitide parent study (i.e., MK-0616-013, MK-0616-017, MK-0616-018)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Number of participants with one or more adverse events (AEs)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Number of participants who discontinue study drug due to an AE","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- Percent change from baseline of the parent study in low-density lipoprotein cholesterol (LDL-C) at Week 8 of this extension study","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Percent change from baseline of the parent study in non-high-density lipoprotein cholesterol (non-HDL-C) at Week 8 of this extension study","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Percent change from baseline of the parent study in apolipoprotein B (ApoB) at Week 8 of this extension study","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Percent change from baseline of the parent study in lipoprotein(a) (Lp[a]) at Week 8 of this extension study","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Percentage of participants with LDL-C <70 mg/dL and ≥50% reduction from baseline of the parent study","definition_or_measurement_approach":""}
  • {"endpoint_text":"- Percentage of participants with LDL-C <55 mg/dL and ≥50% reduction from baseline of the parent study","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
2870
Recruitment Window Months
47
Consent Approach
Informed consent obtained from adult participants. Subject information and informed consent forms are provided in country-specific language versions (examples in the application: FIN_EN, NLD_NL, HUN_HU, ITA_IT, NOR_NN, DEU_DE, CZE_CS, FRA_FR, ESP_ES). Assent not applicable.

Geography

Total Number Of Sites
41
Total Number Of Participants
583

Finland

Earliest CTIS Part Ii Submission Date
25-07-2024
Latest Decision Or Authorization Date
29-07-2025
Processing Time Days
369
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
HUS-Yhtymae
Department Name
Meilahti Tower Hospital
Contact Person Name
Markku Pentikäinen
Contact Person Email
markku.pentikainen@hus.fi

Netherlands

Earliest CTIS Part Ii Submission Date
26-07-2024
Latest Decision Or Authorization Date
29-07-2025
Processing Time Days
368
Number Of Sites
4
Number Of Participants
25

Sites

Site Name
Stichting Radboud universitair medisch centrum
Department Name
Internal Medicine, Division of Vascular Medicine
Contact Person Name
Niels Riksen
Contact Person Email
researchunit.aig@radboudumc.nl
Site Name
Dijklander Ziekenhuis
Department Name
Vasculair Onderzoek Centrum Hoorn
Contact Person Name
Paul Van Bergen
Contact Person Email
DOC@dijklander.nl
Site Name
Amsterdam UMC Stichting
Department Name
Vasular medicine clinical trial unit
Contact Person Name
Erik Stroes
Contact Person Email
n.sons@amsterdamumc.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Vascular Medicine Research
Contact Person Name
Frank Visseren
Contact Person Email
f.l.j.visseren@umcutrecht.nl

Hungary

Earliest CTIS Part Ii Submission Date
31-07-2024
Latest Decision Or Authorization Date
30-07-2025
Processing Time Days
364
Number Of Sites
3
Number Of Participants
20

Sites

Site Name
Semmelweis University
Department Name
Városmajori Szív- és Érgyógyászati Klinika
Contact Person Name
Béla Merkely
Contact Person Email
merkely.bela@kardio.sote.hu
Site Name
University Of Szeged
Department Name
Belgyógyászati Klinika
Contact Person Name
Attila Farkas
Contact Person Email
farkasamed@gmail.com
Site Name
University Of Debrecen
Department Name
Belgyógyászati Klinika
Contact Person Name
Dénes Páll
Contact Person Email
pall.denes@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
02-08-2024
Latest Decision Or Authorization Date
04-08-2025
Processing Time Days
367
Number Of Sites
5
Number Of Participants
100

Sites

Site Name
Azienda Ospedaliero-Universitaria Sant Andre
Department Name
Internal medicine
Contact Person Name
Giorgio Sesti
Contact Person Email
giorgio.sesti@uniroma1.it
Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
Cardiology
Contact Person Name
Gaetano Maria De Ferrari
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
Cardiology
Contact Person Name
Saverio Muscoli
Contact Person Email
saverio.muscoli@ptvonline.it
Site Name
Presidio Ospedaliero Garibaldi-Nesima
Department Name
Internal medicine
Contact Person Name
Salvatore Piro
Contact Person Email
salvatore.piro@unict.it
Site Name
Centro Cardiologico Monzino S.p.A.
Department Name
Endocrinology
Contact Person Name
Josè Pablo Werba

Norway

Earliest CTIS Part Ii Submission Date
31-07-2024
Latest Decision Or Authorization Date
29-07-2025
Processing Time Days
363
Number Of Sites
2
Number Of Participants
18

Sites

Site Name
Oslo University Hospital HF
Department Name
Lipidklinikken, avd for endokrinologi, sykelig overvekt og forebyggende medisin
Contact Person Name
Emil Asprusten
Contact Person Email
b22400@ous-hf.no
Site Name
Nordlandssykehuset HF
Department Name
Medisinsk avdeling
Contact Person Name
Knut Lappegard
Contact Person Email
knut.tore.lappegard@gmail.com

Germany

Earliest CTIS Part Ii Submission Date
08-08-2024
Latest Decision Or Authorization Date
04-08-2025
Processing Time Days
361
Number Of Sites
6
Number Of Participants
150

Sites

Site Name
Hausarzt- und Diabetologischen Schwerpunktpraxis Hohenmölsen
Contact Person Name
Karsten Milek
Contact Person Email
office@doc-milek.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Kardiologie, Angiologie und Intensivmedizin
Contact Person Name
Ursula Rauch-Kröhnert
Contact Person Email
thomas.haese@dhzc-charite.de
Site Name
Technische Universitaet Dresden
Department Name
Universitätsstudienzentrum für Stoffwechselerkrankungen
Contact Person Name
Nikolaos Perakakis
Site Name
Zentralklinik Bad Berka GmbH
Department Name
Cardiology
Contact Person Name
Matthias Schreiber
Contact Person Email
studien@zentralklinik.de
Site Name
Velocity Clinical Research GmBH
Contact Person Name
Isabelle Schenkenberger
Site Name
Uhz Klinische Forschung
Contact Person Name
Georg Plaßmann
Contact Person Email
georg-plassmann@uhz-klifo.de

Czechia

Earliest CTIS Part Ii Submission Date
15-08-2024
Latest Decision Or Authorization Date
26-01-2026
Processing Time Days
529
Number Of Sites
3
Number Of Participants
25

Sites

Site Name
Institute For Clinical And Experimental Medicine
Department Name
Pracoviště preventivní kardiologie
Contact Person Name
Věra Adámková
Contact Person Email
vera.adamkova@ikem.cz
Site Name
Fakultni Nemocnice Brno
Department Name
Interní kardiologická klinika
Contact Person Name
Petr Kala
Contact Person Email
kala.petr@fnbrno.cz
Site Name
Fakultni Nemocnice U Sv Anny V Brne
Department Name
Oddělení klinické biochemie
Contact Person Name
Ondřej Kyselák
Contact Person Email
ondrej.kyselak@fnusa.cz

France

Earliest CTIS Part Ii Submission Date
19-06-2024
Latest Decision Or Authorization Date
18-02-2026
Processing Time Days
609
Number Of Sites
4
Number Of Participants
30

Sites

Site Name
Centre Hospitalier Universitaire De Montpellier
Department Name
Cardiologie
Contact Person Name
François Roubille
Contact Person Email
f-roubille@chu-montpellier.fr
Site Name
Hospices Civils De Lyon
Department Name
Diabetologie
Contact Person Name
Sybil Charrière
Contact Person Email
sybil.charriere@chu-lyon.fr
Site Name
Institut de Cancerologie de l Ouest
Department Name
Endocrinologie
Contact Person Name
Betrand Cariou
Contact Person Email
bertrand.cariou@univ-nantes.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Cardiologie
Contact Person Name
Gabriél Steg
Contact Person Email
gabriel.steg@aphp.fr

Spain

Earliest CTIS Part Ii Submission Date
02-08-2024
Latest Decision Or Authorization Date
13-04-2026
Processing Time Days
619
Number Of Sites
13
Number Of Participants
205

Sites

Site Name
Hospital Clinico Universitario De Valencia
Department Name
Cardiología
Contact Person Name
Julio Nuñez
Contact Person Email
juenuvi@uv.es
Site Name
Hospital Universitario Fundacion Alcorcon
Department Name
Medicina interna
Contact Person Name
Carlos Guijarro
Site Name
Fundacio Salut Emporda
Department Name
Medicina interna
Contact Person Name
Alex Vila
Contact Person Email
avila@salutemporda.cat
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Endocrinología
Contact Person Name
Esteban Jodar
Contact Person Email
esteban.jodar@gmail.com
Site Name
Hospital Universitario Virgen De La Macarena
Department Name
Cardiología
Contact Person Name
Rafael Jesus Hidalgo
Contact Person Email
rjhidalur@yahoo.es
Site Name
Hospital Universitario Virgen De La Victoria
Department Name
Endocrinología y nutrición
Contact Person Name
Francisco José Tinahones
Contact Person Email
fjtinahones@uma.es
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medicina Interna
Contact Person Name
Maria Urquizu
Contact Person Email
maria.urquizu@vallhebron.cat
Site Name
Hospital Universitario 12 De Octubre
Department Name
Medicina interna
Contact Person Name
Agustín Blanco
Contact Person Email
ablanco2000es@yahoo.es
Site Name
Salut Sant Joan De Reus
Department Name
Medicina vascular y metabolismo
Contact Person Name
Daiana Ibarretxe
Contact Person Email
daianaig@hotmail.com
Site Name
Hospital Nisa Sevilla Aljarafe
Department Name
Endocrinología
Contact Person Name
Cristóbal Morales
Contact Person Email
datos@vithas.es
Site Name
Area Sanitaria Da Coruna E Cee
Department Name
Medicina interna
Contact Person Name
Jose Luis Díaz Díaz
Contact Person Email
jose.luis.diaz.diaz@sergas.es
Site Name
Instituto Medico Quirurgico San Rafael S.A.
Department Name
Endocrinología
Contact Person Name
Alfonso Soto
Contact Person Email
asotog30@yahoo.com
Site Name
Equip D'atencio Primaria Barcelona Sardenya S.L.P.
Department Name
Atención Primaria
Contact Person Name
Carlen Reyes
Contact Person Email
creyes@eapsardenya.cat

Sponsor

Primary sponsor

Full Name
Merck Sharp & Dohme LLC
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Parexel International Corp.
Responsibilities
EUB services (call center and medical services)
Name
Signant Health Global LLC
Name
Labcorp Central Laboratory Services SARL

Third parties

  • {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"EUB services (call center and medical services)","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services SARL","duties_or_roles":"","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
MK-0616
Active Substance
ENLICITIDE CHLORIDE
Modality
Small molecule
Routes Of Administration
ORAL USE
Route
ORAL USE
Authorisation Status
prodAuthStatus=1
Maximum Dose
20 mg

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