Clinical Trials List
2019-12-01 - 2022-09-02
Phase II
Not yet recruiting1
Recruiting2
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 randomized, double-blind, parallel-group, multicenter study to assess efficacy, safety, and tolerability of oral tropifexor (LJN452) & licogliflozin (LIK066) combination therapy and each monotherapy compared with placebo, for treatment of adult participants with nonalcoholic steatohepatitis (NASH) and liver fibrosis (ELIVATE).
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Novartis Pharmaceuticals
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 劉妙真 無
- Yi-Chung Hsieh 無
- 曾振輝 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Chiu Hung Chiu 未分科
- 簡世杰 未分科
- 邱彥程 未分科
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chia-Yen Dai 無
- 梁博程 無
- Ming-Lung Yu 無
- 黃駿逸 無
- Chung-Feng Huang 無
- 許博堯 無
- Wan-Long Chuang 無
- Ming-Lun Yeh 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
tropifexor
Dosage Form
Film-coated tablets
Dosage
10
Endpoints
1. Whether the participant achieves at least one stage of improvement in fibrosis without worsening of NASH (YES/NO)
2. Whether the participant has resolution of NASH without worsening of fibrosis (YES/NO)
Secondary Outcome Measures:
1. Whether the participant achieves resolution of NASH and no worsening of fibrosis OR improvement in fibrosis by at least one stage without worsening of NASH (YES/NO).
2. Whether the participant has at least one stage improvement in fibrosis (YES/NO).
3. Whether the participant has at least two stage improvement in fibrosis without worsening of NASH (YES/NO).
4. Whether the participant has 5% or more reduction in body weight (YES/NO).
5. Change in liver fat content based on MRI - PDFF (in 40% of participants).
6. Change in ALT and AST over time.
7. Change in GGT over time.
8. Occurrence of adverse events, serious adverse events, adverse events resulting in discontinuation of study treatment, adverse events of special interest and changes in vital signs and laboratory parameters .
Inclution Criteria
2. Fibrosis stage 2 or 3 using NASH CRN fibrosis criteria.
Exclusion Criteria
2.Uncontrolled type 2 diabetes defined as glycated hemoglobin (HbA1c) ≥ 9.0% at screening.
3.HbA1c < 6.5% at screening in Type 2 diabetics currently treated with insulin or sulfonylureas.
4.Clinical evidence of liver impairment as defined by the presence of any of the following abnormalities:
--Platelet count < LLN (see Central laboratory manual).
--Serum albumin < LLN (see Central laboratory manual).
--International Normalized Ratio (INR) > ULN (see Central laboratory manual).
--ALT or AST > 5× ULN (confirmed by 2 values during screening).
--Total bilirubin > ULN (see Central laboratory manual) (confirmed by 2 values during screening), including Gilbert's syndrome.
--Alkaline phosphatase > 300 IU/L (confirmed by 2 values during screening).
--History of esophageal varices, ascites or hepatic encephalopathy.
--Splenomegaly.
--MELD score >12.
The Estimated Number of Participants
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Taiwan
6-14 participants
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Global
380 participants
