A Study of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-3655-001)
Launched by MERCK SHARP & DOHME LLC · Oct 9, 2020
Trial Information
Current as of May 03, 2025
Terminated
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Has histological confirmation of NASH
- • Is a male or female aged 18 years to 80 years (in Japan and Taiwan aged 20 to 80 years)
- • Has a body mass index (BMI) ≥25 kg/m\^2 and ≤50 kg/m\^2 and stable weight for the past 3 months
- • Has no history of Type 2 diabetes mellitus (T2DM) OR a history of T2DM controlled by diet or stable doses of antihyperglycemic agents (AHAs)
- • Contraceptive use by male participants should be consistent with local regulations.
- • A female participant is eligible to participate if she is not pregnant or breastfeeding, and she is not a woman of child-bearing potential (WOCBP) OR she is a WOCBP and uses a contraceptive method that is highly effective during the intervention period and for at least 16 weeks after the last dose of study intervention.
- • Exclusion Criteria
- • Has presence of cirrhosis on liver biopsy
- • Has Type 1 diabetes
- • Has a history of malignancy, unless cancer free ≥5 years, or is under evaluation for active or suspected malignancy except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
- • Has a history of bariatric surgery ≤5 years before study participation
- • Has undergone a major surgical procedure ≤3 months before study participation or has major surgery planned during the study
- • Has a history or evidence of chronic liver disease other than NASH. Individuals with a history of Hepatitis B or C may be eligible for participation.
- • Has significant systemic or major illnesses other than liver disease, including recent events (≤6 months before study entry) of congestive heart failure, unstable coronary artery disease, arterial revascularization, pulmonary disease, renal failure, stroke, transient ischemic attack, or organ transplantation
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
Taipei, , Taiwan
Tucson, Arizona, United States
Tucson, Arizona, United States
Canoga Park, California, United States
Huntington Park, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Montclair, California, United States
Panorama City, California, United States
San Francisco, California, United States
Santa Ana, California, United States
Colorado Springs, Colorado, United States
Cutler Bay, Florida, United States
Gainesville, Florida, United States
Hialeah, Florida, United States
Hialeah, Florida, United States
Miami Lakes, Florida, United States
Miami Springs, Florida, United States
Miami, Florida, United States
Ocoee, Florida, United States
Orlando, Florida, United States
Iowa City, Iowa, United States
Marrero, Louisiana, United States
Biloxi, Mississippi, United States
Kansas City, Missouri, United States
Las Vegas, Nevada, United States
East Syracuse, New York, United States
New York, New York, United States
Arlington, Texas, United States
Dallas, Texas, United States
Edinburg, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Richmond, Virginia, United States
Mar Del Plata, Buenos Aires, Argentina
Pilar, Buenos Aires, Argentina
Ramos Mejía, Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Santa Fe, , Argentina
Camperdown, New South Wales, Australia
Kogarah, New South Wales, Australia
Bedford Park, South Australia, Australia
Vancouver, British Columbia, Canada
Toronto, Ontario, Canada
Montréal, Quebec, Canada
Concepcion, Biobio, Chile
La Serena, Coquimbo, Chile
Valdivia, Los Rios, Chile
Santiago, Region M. De Santiago, Chile
Vina Del Mar, Valparaiso, Chile
Beijing, Beijing, China
Wanzhou District, Chongqing, China
Foshan, Guangdong, China
Yinchuan City, Ningxia, China
Shanghai, Shanghai, China
Hangzhou, Zhejiang, China
Bogotá, Distrito Capital De Bogota, Colombia
Nice, Alpes Maritimes, France
Pessac, Aquitaine, France
Lyon, Auvergne, France
Dijon, Bourgogne, France
Besançon, Franche Comte, France
Limoges, Haute Vienne, France
Clichy, Hauts De Seine, France
Vandoeuvre Les Nancy, Meurthe Et Moselle, France
Lille, Nord, France
Creteil, Val De Marne, France
Paris, , France
Paris, , France
Freiburg, Baden Wurttemberg, Germany
Frankfurt, Hessen, Germany
Mainz, Rheinland Pfalz, Germany
Leipzig, Sachsen, Germany
Berlin, , Germany
Thessaloniki, Kentriki Makedonia, Greece
Hong Kong, , Hong Kong
Shatin, , Hong Kong
Shatin, , Hong Kong
Haifa, , Israel
Haifa, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Ramat Hasharon, , Israel
Tel Aviv, , Israel
Rozzano, Lombardia, Italy
Modena, , Italy
Roma, , Italy
Verona, , Italy
Nagakute, Aichi, Japan
Toon, Ehime, Japan
Ogaki, Gifu, Japan
Sapporo, Hokkaido, Japan
Kita Gun, Kagawa, Japan
Takamatsu, Kagawa, Japan
Kawasaki, Kanagawa, Japan
Yokohama, Kanagawa, Japan
Kashihara, Nara, Japan
Suita, Osaka, Japan
Fukui, , Japan
Gifu, , Japan
Hiroshima, , Japan
Kagoshima, , Japan
Kyoto, , Japan
Okayama, , Japan
Osaka, , Japan
Tokyo, , Japan
Seongnam, Kyonggi Do, Korea, Republic Of
Busan, Pusan Kwangyokshi, Korea, Republic Of
Dongjak Gu, Seoul, Korea, Republic Of
Songpagu, Seoul, Korea, Republic Of
Incheon, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Seoul, , Korea, Republic Of
Kuala Lumpur, , Malaysia
Guadalajara, Jalisco, Mexico
Zapopan, Jalisco, Mexico
Merida, Yucatan, Mexico
Mexico City, , Mexico
Christchurch, Canterbury, New Zealand
Auckland, , New Zealand
Auckland, , New Zealand
Rio Piedras, , Puerto Rico
San Juan, , Puerto Rico
San Juan, , Puerto Rico
Moscow, Moskva, Russian Federation
Moscow, Moskva, Russian Federation
Moscow, Moskva, Russian Federation
Moscow, Moskva, Russian Federation
Moscow, Moskva, Russian Federation
Saint Petersburg, Sankt Peterburg, Russian Federation
Saint Petersburg, Sankt Peterburg, Russian Federation
Saint Petersburg, Sankt Peterburg, Russian Federation
St Petersburg, Sankt Peterburg, Russian Federation
Santander, Cantabria, Spain
Santiago De Compostela, La Coruna, Spain
Majadahonda, Madrid, Spain
Sevila, Sevilla, Spain
Barcelona, , Spain
Barcelona, , Spain
Uppsala, Uppsala Lan, Sweden
Taoyuan County, Taoyuan, Taiwan
Kaohsiung, , Taiwan
Taichung, , Taiwan
Tainan, , Taiwan
Ankara, , Turkey
Ankara, , Turkey
Ankara, , Turkey
Istanbul, , Turkey
Istanbul, , Turkey
Istanbul, , Turkey
Izmir, , Turkey
Tucson, Arizona, United States
Los Angeles, California, United States
Dalton, Georgia, United States
Flourtown, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Wyomissing, Pennsylvania, United States
Buenos Aires, Caba, Argentina
Buenos Aires, Caba, Argentina
Hong Kong, , Hong Kong
Fort Myers, Florida, United States
Clarksville, Tennessee, United States
Waco, Texas, United States
Toon, Ehime, Japan
Kanazawa, Ishikawa, Japan
Mexico City, Distrito Federal, Mexico
Huddinge, Stockholms Lan, Sweden
Taichung City, Taichung, Taiwan
Pasadena, California, United States
Edinburg, Texas, United States
North Little Rock, Arkansas, United States
Ciudad De Buenos Aires, Caba, Argentina
Mar Del Plata, Buenos Aires, Argentina
Los Angeles, California, United States
Toon, Ehime, Japan
Vancouver, British Columbia, Canada
Kagoshima, , Japan
Zapopan, Jalisco, Mexico
Panorama City, California, United States
Miami Lakes, Florida, United States
Santiago, Region M. De Santiago, Chile
Paris, , France
Yokohama, Kanagawa, Japan
Chiayi City, Chiayi, Taiwan
Patients applied
Trial Officials
Medical Director, MD
Study Director
Merck Sharp & Dohme LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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