Clinical Trials List
2025-01-01 - 2032-12-31
Phase III
Recruiting11
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 randomised, double-blind, placebo-controlled, multicentre, Phase III trial evaluating long-term efficacy and safety of survodutide weekly injections in adult participants with non- cirrhotic non-alcoholic steatohepatitis/metabolic dysfunction- associated steatohepatitis (NASH/MASH) and (F2) - (F3) stage of liver fibrosis
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Trial Applicant
PAREXEL INTERNATIONAL CO., LTD.
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Sponsor
Boehringer Ingelheim
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Trial scale
Multi-Regional Multi-Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 邱彥程 無
- 簡世杰 無
- Chiu Hung Chiu 無
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chih-Yiu Tsai 無
- Jia-Hong Lin 無
- 劉妙真 無
- 陳聰興 無
- 鄭雅婷 無
- 曾振輝 無
- Yi-Chung Hsieh 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Shih-Jer Hsu Division of General Internal Medicine
- 楊宏志 Division of General Internal Medicine
- 洪俊銘 Division of General Internal Medicine
- 曾岱宗 Division of General Internal Medicine
- 蘇東弘 無
- Jia-Horng Kao Division of General Internal Medicine
- PEI-JER CHEN Division of General Internal Medicine
- Chen-Hua Liu Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wan-Long Chuang 無
- Chia-Yen Dai 無
- 梁博程 無
- Ming-Lun Yeh 無
- 魏鈺儒 無
- Ming-Lung Yu 無
- Chung-Feng Huang 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
Endpoints
Resolution of MASH without worsening of liver fibrosis
on MASH Clinical Research Network (CRN) fibrosis
score
At least a 1-point improvement in fibrosis stage with no
worsening of MASH
Inclution Criteria
liver fibrosis
Main inclusion criteria
Male or female participants ≥18 years (or who are of legal
age in countries where that is greater than 18 years) of age
at time of consent living with obesity with
≥1 cardiometabolic risk factor(s) OR T2DM (for
cardiometabolic risk factors refer to slightly modified
Delphi consensus criteria in Section 3.3)
Diagnosis of MASH (NAS ≥4, with at least 1 point in
inflammation and ballooning each) and fibrosis stage
F2-F3 proven by a biopsy conducted during the screening
period or by a historical biopsy conducted within the last
6 months prior to randomisation.
Stable body weight defined as less than 5% self-reported
change in body weight 3 months prior to the screening or
during the period between the historical biopsy and
randomisation, if a historical biopsy is used.
The participants will be randomised based on the
sequential fulfilment of the following screening
parameters:
(1) AST >20 U/L
(2) Liver stiffness measured by FibroScan® VCTE
≥8.5k Pa OR FAST >0.36 at screening)
(3) Liver fat fraction ≥8% measured by MRI-PDFF
prior to scheduling the screening biopsy.
Exclusion Criteria
screening:
o Serum AST and/or ALT elevation >5x ULN
o Platelet count <140 000/mm3 (<140 GI/L)
o Alkaline phosphatase >2x ULN
o Abnormal synthetic liver function as defined by
screening central laboratory evaluation:
- Albumin below <3.5 g/dL (35.0 g/L)
- OR International normalised ratio (INR) of
prothrombin time >1.3 (unless participant is on
anticoagulants)
- OR total serum bilirubin concentration
≥1.5x ULN (participants with a documented
history of Gilbert’s syndrome can be enrolled if
the direct bilirubin is within normal reference
range)
Any history or evidence of acute or chronic liver disease
other than MASH.
Histologically documented liver cirrhosis (fibrosis stage
F4), either at screening or in a historical biopsy
History of or current diagnosis of hepatocellular carcinoma
History of or planned liver transplant
Inability or unwillingness to undergo a liver biopsy at
screening (if a suitable historical biopsy is unavailable for
central review), or during trial conduct.
History of portal hypertension or presence of
decompensated liver disease (including hepatic
encephalopathy, variceal bleeding, ascites, and
spontaneous bacterial peritonitis)
MELD score >12 due to liver disease
Note: MELD of >12 must be the result of liver disease to be
exclusionary, NOT isolated laboratory abnormalities such as elevated
creatinine due to chronic kidney disease, INR abnormality secondary
to anticoagulants or laboratory error, and bilirubin elevation due to
Gilbert’s Syndrome
Treatment with any medication for the indication obesity
within 3 months before screening biopsy or historical
biopsy time point.
HbA1c >10% (>86 mmol/mol) as measured by the central
laboratory at screening.
Impaired renal function, defined as eGFR
<30 mL/min/1.73 m2 (CKD-EPIcr) at screening (Visit 1) or
trial participant requiring dialysis
History of either chronic or acute pancreatitis or elevation
of serum lipase or amylase >2x ULN as measured by the
central laboratory at screening
Uncontrolled hypertension (mean SBP ≥160 mmHg and/or
mean DBP ≥100 mmHg) at screening (at least triplicate
measurements)
Major surgery (in the opinion of the investigator)
performed within 3 months prior to screening or planned
during the trial
The Estimated Number of Participants
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Taiwan
140 participants
-
Global
1800 participants
