Clinical Trials List
2023-02-01 - 2026-12-31
Phase II
Recruiting5
ICD-10K70.0
Alcoholic fatty liver
ICD-9571.0
Alcoholic fatty liver
A Randomised, Double-blind, Placebo-controlled, Multi-centre Phase 2b Study to Evaluate the Efficacy, Safety and Tolerability of AZD2693 in Participants With Non-cirrhotic Non-alcoholic Steatohepatitis (NASH) With Fibrosis Who Are Carriers of the PNPLA3 rs738409 148M Risk Allele
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Trial Applicant
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Sponsor
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 陳怡文 Division of Endocrinology
- Wen-Juei Jeng Digestive System Department
- Rong-Nan Chien Digestive System Department
- Chun-Yen Lin Digestive System Department
- 滕威 Digestive System Department
- 戴達英 Digestive System Department
- 林伯庭 Digestive System Department
- 劉彥君 Digestive System Department
- 賴盈傑 Division of Radiology
- 李晏榮 Division of Endocrinology
- 陳博煥 Digestive System Department
- 鄭雅婷 Digestive System Department
- Chung-Wei Su Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wan-Long Chuang Digestive System Department
- Ming-Lun Yeh Digestive System Department
- 梁博程 Digestive System Department
- 黃駿逸 Digestive System Department
- Chung-Feng Huang Digestive System Department
- Jee-Fu Huang Digestive System Department
- Chia-Yen Dai Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- I-Cheng Lee Digestive System Department
- 李癸汌 Digestive System Department
- Pei-Chang Lee Digestive System Department
- 王苑貞 Digestive System Department
- 黃惠君 Digestive System Department
- Chin-Sung Kuo 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
25 mg/mL or 80 mg/mL
Endpoints
Inclution Criteria
Participants are eligible to be included in the study only if all the following criteria apply:
Age
Participant must be 18 to 75 years of age (inclusive) at the time of signing the informed consent.
Type of Participant and Disease Characteristics
Participants who are carriers for the PNPLA3 rs738409 148M risk allele.
Participants with histological evidence of NASH based on central pathologist evaluation of a liver biopsy obtained up to 6 months before randomisation, or during screening, fulfilling both criteria:
Definitive NASH with NAS ≥ 4 with ≥ 1 in each component (ie, steatosis, lobular inflammation, and ballooning).
Presence of fibrosis stage F2 or F3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation.
Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions
Liver disease of other aetiologies (eg, alcoholic steatohepatitis; drug-induced, viral or autoimmune hepatitis; primary biliary cirrhosis; primary sclerosing cholangitis; hemochromatosis; alpha-1 antitrypsin deficiency; Wilson's disease)
History of cirrhosis and/or hepatic decompensation, including ascites, hepatic encephalopathy, or variceal bleeding.
Historical persistent or pre-existing renal disease marked by eGFR < 40 mL/min/1.73 m2 (as defined by Kidney Disease Improving Global Outcomes guidelines).
Confirmed platelet count outside the normal range at the screening visit.
Any of the following confirmed at the screening visit:
ALT > 5.0 × ULN
TBL > 1.5 mg/dL (TBL > 1.5 mg/dL is allowed if conjugated bilirubin is < 1.5 × ULN)
INR > 1.3
ALP > 1.5 × ULN (unless the ALP elevation is not from hepatic origin as determined by a bone-specific ALP)
The Estimated Number of Participants
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Taiwan
40 participants
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Global
318 participants
