A Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018) CORALreef AddOn

PHASE3CompletedINTERVENTIONAL
Enrollment

301

Participants

Timeline

Start Date

July 8, 2024

Primary Completion Date

February 14, 2025

Study Completion Date

March 28, 2025

Conditions
Hypercholesterolemia
Interventions
DRUG

Enlicitide Decanoate

Administered orally.

DRUG

Ezetimibe

Administered orally.

DRUG

Bempedoic Acid

Administered orally.

OTHER

Placebo for Enlicitide Decanoate

Administered orally.

OTHER

Placebo for Ezetimibe

Administered orally.

OTHER

Placebo for Bempedoic Acid

Administered orally.

Trial Locations (35)

704

National Cheng Kung University Hospital-Internal Medicine ( Site 0403), Tainan City

10002

National Taiwan University Hospital ( Site 0400), Taipei

11217

Taipei Veterans General Hospital-Department of Medicine ( Site 0402), Taipei

15006

Hospital San Rafael de Coruna ( Site 0805), A Coruña

17600

Hospital de Figueres ( Site 0804), Figueres

20854

Velocity Clinical Research Rockville ( Site 1503), Rockville

29010

Hospital Universitario Virgen de la Victoria-UGC Endocrinologia y nutricion ( Site 0801), Málaga

29707

Piedmont Research Partners ( Site 1506), Fort Mill

33305

Chang Gung Medical Foundation-Linkou Branch ( Site 0404), Taoyuan District

34090

Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 0505), Montpellier

39503

Velocity Clinical Research, Gulfport ( Site 1505), Gulfport

40213

L-MARC Research Center ( Site 1501), Louisville

44093

Hôpital Nord Guillaume-et-René-Laennec / CHU de Nantes-CIC Endocrinology-Diabetology-Nutrition ( Sit, Nantes

60422

Healthcare Research Network - Chicago ( Site 1507), Flossmoor

69677

Hospices Civils de Lyon - Hopital Louis Pradel ( Site 0501), Bron

70300

Yitzhak Shamir Medical Center. ( Site 0702), Beer Yaakov

75018

Hôpital Bichat - Claude-Bernard ( Site 0504), Paris

95648

Clinical Trials Research ( Site 1509), Lincoln

98057

Rainier Clinical Research Center ( Site 1502), Renton

3109601

Rambam Health Care Campus ( Site 0700), Haifa

4428164

Meir Medical Center. ( Site 0703), Kfar Saba

8489507

Assuta Beersheba MC ( Site 0704), Beersheba

B7600FZO

Instituto de Investigaciones Clínicas Mar del Plata ( Site 1002), Mar del Plata

C1061AAS

CIPREC-CIPREC Sede Arenales ( Site 1000), Buenos Aires

S2000DEJ

Fundacion Estudios Clinicos ( Site 1001), Rosario

V7M 2H4

The Medical Arts Health Research Group ( Site 1606), Vancouver

N1R 6V6

Cambridge Cardiac Care Centre ( Site 1603), Cambridge

M6B 3H7

North York Diagnostic and Cardiac Centre ( Site 1605), North York

H1T 1C8

Institut de Cardiologie de Montreal ( Site 1604), Montreal

G9A 4P3

Diex Recherche Trois-Rivieres ( Site 1602), Trois-Rivières

08025

EAP Sardenya ( Site 0800), Barcelona

08035

Hospital Universitari Vall d'Hebron ( Site 0803), Barcelona

EC1M 6BQ

Barts Health NHS Trust-William Harvey Clinical Research Centre ( Site 0901), London

NW3 2QG

Royal Free Hospital ( Site 0900), London

NW1 2PG

National Institute for Health Research UCLH Clinical Research Facility ( Site 0908), London

All Listed Sponsors
lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT06450366 - A Study to Evaluate the Efficacy and Safety of Enlicitide Decanoate (MK-0616, Oral PCSK9 Inhibitor) Compared With Ezetimibe or Bempedoic Acid or Ezetimibe and Bempedoic Acid in Adults With Hypercholesterolemia (MK-0616-018) CORALreef AddOn | Biotech Hunter | Biotech Hunter