Clinical Trials List
2020-10-01 - 2023-11-21
Phase II
Not yet recruiting3
Recruiting1
Terminated3
ICD-10K74.4
Secondary biliary cirrhosis
ICD-10K75.81
Nonalcoholic steatohepatitis (NASH)
ICD-10K76.0
Fatty (change of) liver, not elsewhere classified
ICD-10K76.89
Other specified diseases of liver
ICD-10R16.2
Hepatomegaly with splenomegaly, not elsewhere classified
ICD-9571.8
Other chronic nonalcoholic liver disease
A Phase 2b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis.
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
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Sponsor
Merck Sharp & Dohme Corp.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 邱彥程 Division of General Internal Medicine
- 簡世杰 Division of General Internal Medicine
- Chiu Hung Chiu Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- I-Shyan Sheen Digestive System Department
- 戴達英 Digestive System Department
- 滕威 Digestive System Department
- Rong-Nan Chien Digestive System Department
- Wen-Juei Jeng Digestive System Department
- 曾振輝 Division of Radiology
- Yi-Cheng Chen Digestive System Department
- 鄭雅婷 Digestive System Department
- Chun-Yen Lin Digestive System Department
- Chien-Hao Huang Digestive System Department
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Jia-Horng Kao Division of General Internal Medicine
- Tiffany Ting-Fang Shih Division of Radiology
- 蘇東弘 Division of General Internal Medicine
- 楊宏志 Division of General Internal Medicine
- 曾岱宗 Division of General Internal Medicine
- PEI-JER CHEN Division of General Internal Medicine
- 吳志宏 Division of Radiology
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Ming-Lung Yu Digestive System Department
- 許博堯 Digestive System Department
- 徐成鼎 Digestive System Department
- Chia-Yen Dai Digestive System Department
- Chung-Feng Huang Digestive System Department
- 黃駿逸 Digestive System Department
- Wan-Long Chuang Digestive System Department
- 梁博程 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- TENG-YU LEE Digestive System Department
- 陳家昌 Digestive System Department
- 張碧倚 Division of Radiology
- 李少武 Digestive System Department
- 林宛姿 Digestive System Department
- 呂宜達 Digestive System Department
- 林穎正 Digestive System Department
- CHUNG-HSIN CHANG Digestive System Department
- 廖苡君 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- 許銘澤 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
MK-3655
Dosage Form
Dosage
100 mg/mL
Endpoints
Participants With Nonalcoholic Steatohepatitis (NASH) Resolution Without Worsening of Fibrosis After 52 Weeks [ Time Frame: Week 52 ]
The NASH CRN scoring system evaluated by Blinded Independent Central Review [BICR] is used to assess treatment response. The NASH CRN scoring scales are: lobular inflammation score (0-3); hepatocyte ballooning score (0-2); steatosis score (0-3); and fibrosis score (0-4). NASH resolution is defined as a score of 0-1 for inflammation, 0 for ballooning, and any grade of steatosis.
Participants Who Experienced an Adverse Event (AE) [ Time Frame: Up to 56 weeks ]
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Participants Discontinuing Study Medication Due to an AE [ Time Frame: Up to 52 weeks ]
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.
Inclution Criteria
Has histological confirmation of NASH
Is a male or a postmenopausal 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.
Female Participants should be postmenopausal
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
The Estimated Number of Participants
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Taiwan
20 participants
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Global
328 participants
