Open-label Extension Study of Enlicitide Decanoate (MK-0616/Enlicitide Oral PCSK9 Inhibitor) in Adults With Hypercholesterolemia (MK-0616-019) CORALreef Extension
Launched by MERCK SHARP & DOHME LLC · Jul 1, 2024
Trial Information
Current as of June 16, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called the CORALreef Extension, is studying a medication called enlicitide decanoate in adults who have high cholesterol, also known as hypercholesterolemia. It is an extension of previous studies, which means it is looking to see how safe and effective this treatment is over a longer period after participants have already taken part in earlier trials. The study is currently recruiting adults aged 65 to 74 who have successfully completed one of the earlier studies and followed the treatment plan well.
To be eligible, participants need to have finished the initial study without any major issues related to the treatment and should not be planning to start any other similar medications during this trial. Those who join can expect to continue receiving the study drug and will be monitored for their health and cholesterol levels over time. It's important to know that this trial is focused on understanding the long-term effects and benefits of enlicitide decanoate for managing cholesterol levels.
Gender
ALL
Eligibility criteria
- 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
About Merck Sharp & Dohme Llc
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that address unmet medical needs. With a strong focus on research and development, Merck Sharp & Dohme leverages advanced science and technology to enhance patient outcomes across various therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Committed to ethical practices and regulatory compliance, the company actively engages in clinical trials to advance medical knowledge and improve health care for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Troy, Michigan, United States
Manassas, Virginia, United States
Changhua County, Changhua, Taiwan
Taipei, , Taiwan
Rotorua, Bay Of Plenty, New Zealand
Camperdown, New South Wales, Australia
Christchurch, Canterbury, New Zealand
New Taipei City, New Taipei, Taiwan
Naka, Ibaraki, Japan
Ushiku, Ibaraki, Japan
Kanazawa, Ishikawa, Japan
Morioka, Iwate, Japan
Sendai, Miyagi, Japan
Izumisano, Osaka, Japan
Kashiwara, Osaka, Japan
Suita Shi, Osaka, Japan
Bunkyo Ku, Tokyo, Japan
Chuo Ku, Tokyo, Japan
Chuo Ku, Tokyo, Japan
Katsushika Ku, Tokyo, Japan
Mitaka, Tokyo, Japan
Nerima Ku, Tokyo, Japan
Ota Ku, Tokyo, Japan
Fukuoka, , Japan
Tokyo, , Japan
Cheongju Si, Chungbuk, Korea, Republic Of
Wonju, Kang Won Do, Korea, Republic Of
Gwangju Si, Kwangju Kwangyokshi, Korea, Republic Of
Seongnam, Kyonggi Do, Korea, Republic Of
Suwon, Kyonggi Do, Korea, Republic Of
Busan, Pusan Kwangyokshi, Korea, Republic Of
Haeundae Gu, Pusan Kwangyokshi, Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Ankara, , Turkey
Eskisehir, , Turkey
Iruma, Saitama, Japan
Seoul, , Korea, Republic Of
Helsinki, Uusimaa, Finland
Nijmegen, Gelderland, Netherlands
Amsterdam, Noord Holland, Netherlands
Rapid City, South Dakota, United States
Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan
Tainan, , Taiwan
Kocaeli, , Turkey
Clayton, Victoria, Australia
Flossmoor, Illinois, United States
Itabashi Ku, Tokyo, Japan
Budapest, , Hungary
Utrecht, , Netherlands
Brno, Brno Mesto, Czechia
Szeged, Csongrad, Hungary
Debrecen, , Hungary
Hiroshima, , Japan
Singapore, Central Singapore, Singapore
Guadalajara, Jalisco, Mexico
Taipei, , Taiwan
Bornova, Izmir, Turkey
Dresden, Sachsen, Germany
Rome, Lazio, Italy
Milan, Milano, Italy
A Coruña, La Coruna, Spain
Santiago De Compostela, La Coruna, Spain
Alcorcón, Madrid, Comunidad De, Spain
Valencia, Valenciana, Comunitat, Spain
Torino, Piemonte, Italy
Rome, Roma, Italy
Castilleja De La Cuesta, Sevilla, Spain
Shatin, , Hong Kong
Daegu, Taegu Kwangyokshi, Korea, Republic Of
Phoenix, Arizona, United States
Fort Myers, Florida, United States
Jacksonville, Florida, United States
Tampa, Florida, United States
Rockville, Maryland, United States
Lincoln, Nebraska, United States
Las Vegas, Nevada, United States
Albuquerque, New Mexico, United States
Fort Mill, South Carolina, United States
Kingsport, Tennessee, United States
Knoxville, Tennessee, United States
Salt Lake City, Utah, United States
Newport News, Virginia, United States
Sacramento, California, United States
San Bernardino, California, United States
Boca Raton, Florida, United States
Port Orange, Florida, United States
Macon, Georgia, United States
Indianapolis, Indiana, United States
Gulfport, Mississippi, United States
Hazelwood, Missouri, United States
Fargo, North Dakota, United States
Duncansville, Pennsylvania, United States
Greenville, South Carolina, United States
West Jordan, Utah, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Renton, Washington, United States
North York, Ontario, Canada
Daphne, Alabama, United States
Foley, Alabama, United States
Beverly Hills, California, United States
Washington, District Of Columbia, United States
Coral Gables, Florida, United States
Hallandale Beach, Florida, United States
Miramar, Florida, United States
Winter Park, Florida, United States
Evansville, Indiana, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Slidell, Louisiana, United States
Las Vegas, Nevada, United States
East Syracuse, New York, United States
Yardley, Pennsylvania, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
North Vancouver, British Columbia, Canada
Valdivia, Los Rios, Chile
Providencia, Region M. De Santiago, Chile
Santiago, Region M. De Santiago, Chile
Medellín, Antioquia, Colombia
Bogotá, Cundinamarca, Colombia
Zipaquira, Cundinamarca, Colombia
Cali, Valle Del Cauca, Colombia
Hksar, , Hong Kong
Busan, Pusan Kwangyokshi, Korea, Republic Of
Hoorn, Noord Holland, Netherlands
New York, New York, United States
North Charleston, South Carolina, United States
Caba, Buenos Aires, Argentina
Caba, Buenos Aires, Argentina
Mar Del Plata, Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Chicoutimi, Quebec, Canada
Trois Rivieres, Quebec, Canada
Barranquilla, Atlantico, Colombia
Barranquilla, Atlantico, Colombia
Lincoln, Nebraska, United States
Haifa, , Israel
Jerusalem, , Israel
Zerifin, , Israel
Caba, Buenos Aires, Argentina
Caba, , Argentina
Montpellier, Herault, France
Saint Herblain, Loire Atlantique, France
Hadera, , Israel
Jerusalem, , Israel
Ramat Gan, , Israel
Kitakyushu, Fukuoka, Japan
Shinjuku Ku, Tokyo, Japan
Tokyo, , Japan
Oslo, , Norway
Covington, Louisiana, United States
Zárate, Buenos Aires, Argentina
Caba, , Argentina
Beijing, Beijing, China
Chongqing, Chongqing, China
Guangzhou, Guangdong, China
Wuhan, Hubei, China
Changzhou, Jiangsu, China
Yangzhou, Jiangsu, China
Siping, Jilin, China
Chengdu, Sichuan, China
Lishui, Zhejiang, China
Bron, Rhone, France
Paris, , France
Zerifin, , Israel
Guadalajara, Jalisco, Mexico
Bodø, Nordland, Norway
Reus, Tarragona, Spain
Barcelona, , Spain
Tainan City, Tainan, Taiwan
Taipei City, Taipei, Taiwan
Taipei, , Taiwan
Taoyuan, , Taiwan
São Paulo, Sao Paulo, Brazil
Montreal, Quebec, Canada
Chongqing, Chongqing, China
Huizhou, Guangdong, China
Changsha, Hunan, China
Yangzhou, Jiangsu, China
Brno, Brno Mesto, Czechia
Prague, Praha 4, Czechia
Jerusalem, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Petah Tikva, , Israel
Catania, , Italy
Malaga, Andalucia, Spain
Barcelona, Cataluna, Spain
A Coruña, La Coruna, Spain
Ankara, , Turkey
London, England, United Kingdom
Caba, , Argentina
Fortaleza, Ceara, Brazil
Sao Paulo, , Brazil
Beijing, Beijing, China
Chongqing, Chongqing, China
Guangzhou, Guangdong, China
Shenzhen, Guangdong, China
Jingzhou, Hubei, China
Nanchang, Jiangxi, China
Haifa, , Israel
Sakhnin, , Israel
Ota Ku, Tokyo, Japan
Bloemfontein, Free State, South Africa
Cape Town, Western Cape, South Africa
Figueres, Gerona, Spain
Kayseri, , Turkey
Mar Del Plata., Buenos Aires, Argentina
Cambridge, Ontario, Canada
Xianyang City, Shaanxi, China
Essen, Nordrhein Westfalen, Germany
Hohenmoelsen, Sachsen Anhalt, Germany
Berlin, , Germany
Berlin, , Germany
Petah Tikva, , Israel
Hiroshima, , Japan
Johannesburg, Gauteng, South Africa
Cape Town, Western Cape, South Africa
Cape Town, Western Cape, South Africa
Centelles, Barcelona, Spain
London, England, United Kingdom
Soweto, Gauteng, South Africa
Madrid, , Spain
Sevilla, , Spain
New Taipei City, New Taipei, Taiwan
Pozuelo De Alarcon, Madrid, Spain
Bad Berka, Thuringen, Germany
Mexico City, Distrito Federal, Mexico
Anderson, South Carolina, United States
Changhua, , Taiwan
Rapid City, South Dakota, United States
Bron, Rhone, France
Dresden, Sachsen, Germany
Mexico City, Distrito Federal, Mexico
Patients applied
Trial Officials
Medical Director
Study Director
Merck Sharp & Dohme LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported