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Clinical Trials List

Protocol Number1404-0064

Active

2025-01-01 - 2030-01-31

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 Phase III double-blind, randomised, placebo-controlled trial to evaluate liver-related clinical outcomes and safety of once weekly injected survodutide in participants with compensated non- alcoholic steatohepatitis/metabolic dysfunction associated steatohepatitis (NASH/MASH) cirrhosis

Trial Applicant

PAREXEL INTERNATIONAL CO., LTD.
Sponsor

Boehringer Ingelheim
Trial scale

Multi-Regional Multi-Center
Update

2026/02/01

Investigators and Locations

Principal Investigator Pin-Nan Cheng 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator TENG-YU LEE 無

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳啟益無

Chia-Yi Christian Hosptal

Co-Principal Investigator

許銘澤無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 郭行道無

Chi Mei Medical Center

Co-Principal Investigator

王品貽無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林俊哲無

Chung Shan Medical University Hospital

Co-Principal Investigator

汪奇志無
翁立翰無

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Cheng Chen 無

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chun-Jen Liu Division of General Internal Medicine

National Taiwan University Hospital

Co-Principal Investigator

Shih-Jer Hsu Division of General Internal Medicine
楊宏志 Division of General Internal Medicine
Jia-Horng Kao 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
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

Principal Investigator Yi-Hsiang Huang Digestive System Department

Taipei Veterans General Hospital

Co-Principal Investigator

吳啟榮 Digestive System Department
齊振達 Digestive System Department
黃惠君 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 顏旭亨無

CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jee-Fu Huang 無

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wei-Yu Kao

Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

cirrhosis

Objectives

The primary objective of this trial is to demonstrate superiority of survodutide compared with placebo by means of the hazard ratio (survodutide vs. placebo) of time to composite endpoint that includes liver-related clinical outcome events, and all-cause mortality in participants with compensated MASH cirrhosis.

Test Drug

N/A

Active Ingredient

Survodutide (BI 456906)

Dosage Form

N/A

Dosage

N/A

Endpoints

 Time to first occurrence of any component of the composite
clinical endpoint (at EoS) consisting of:
o All-cause mortality
o Liver transplant
o Hepatic decompensation events including:
- Ascites requiring treatment
- HE requiring treatment
- Portal hypertension-related upper GI bleeding,
including events of bleeding from oesophageal
varices, gastric varices, and portal hypertensive
gastropathy (PHG)
o Worsening of MELD score to ≥15
o Progression to CSPH, defined as ‘high-risk’ GOVs
confirmed in UGE (the ‘high-risk’ GOVs are defined
as large varices)

Inclution Criteria

 Male or female adults ≥18 years of age at the time of
screening, and at least the legal age of consent in countries
where it is >18 years
 BMI ≥27 kg/m2 (≥25 kg/m2 for Asian trial participants)
 Compensated MASH cirrhosis diagnosed by 1 of the
following:
a) The most recent liver biopsy (≤5 years prior to
randomisation) showing cirrhosis with
steatohepatitis. There is no evidence for a competing
aetiology.
b) Historical biopsy (≤5 years prior to randomisation)
showed steatohepatitis with F1– F3 fibrosis, but now
with cirrhosis either by clinical history or current
features, imaging, non-invasive tests (NITs), or
biopsy. There is no evidence of competing aetiology.
If there is a current biopsy (≤6 months prior to
randomisation), and it does not show evidence of
steatosis or steatohepatitis, there is at least 1
coexisting or history of metabolic comorbidity.
c) The most recent liver biopsy (≤5 years prior to
randomisation) showing cirrhosis with steatosis.
There are at least 2 coexisting metabolic
comorbidities or history of metabolic comorbidities,
including obesity and/or T2DM. There is no evidence
for a competing aetiology.
d) Historical biopsy (≤5 years prior to randomisation)
showed steatosis, but now with cirrhosis, either by
clinical history or current features, imaging, NITs, or
biopsy. If there is a current biopsy (≤6 months prior
to randomisation), and it does not show evidence of
steatosis or steatohepatitis, there are at least 2
coexisting or history of metabolic comorbidities
including obesity and/or T2DM. There is no evidence
of competing aetiology.
e) Trial participant with cirrhosis with current or
previous imaging showing evidence of steatosis (by
liver ultrasound or computed tomography [CT] scan
or FibroScan® with Controlled Attenuation Parameter
[CAP] ≥288 dB/m or magnetic resonance imaging
proton density fat fraction [MRI-PDFF] ≥5%). There
is no liver histology available. There are at least 2
coexisting or history of metabolic comorbidities,
including obesity and/or T2DM. There is no evidence
of competing aetiology.
f) ‘Cryptogenic cirrhosis’ (either by clinical history or
current features, imaging, NITs, or biopsy) without
current or previous evidence of steatosis by imaging
or steatosis/steatohepatitis by histology (not to
exceed 5% of trial participants). There are at least 2
coexisting or history of metabolic comorbidities,
including obesity and/or T2DM. There is no evidence
of competing aetiology.

Exclusion Criteria

Liver related
 Current or history (<5 years) of significant alcohol
consumption, defined as an average of >140 g/week in
female patients and >210 g/week in male patients, for a
period of >3 consecutive months, or an inability to reliably
quantify alcohol consumption based upon judgment of the
investigator.
 MELD score >12 due to liver disease
 History or current (i.e. at screening) hepatic decompensation
event of any of the following but not limited to:
o History of portal hypertension-related upper GI
bleeding
o Ascites
o HE ≥Grade 1 according to the West Haven criteria
 Any of the following lab test result at screening
o Albumin below <3.5 g/dL (<35.0 g/L)
o INR >1.3 unless due to therapeutic anticoagulants
NOTE: INR may be repeated once to reassess
eligibility.
o Total bilirubin (TBL) >1.2x ULN
NOTE: Trial participants with Gilbert Syndrome are
eligible with a TBL >1.2x upper limit of normal
(ULN) if reticulocyte count is within normal limits,
haemoglobin is within normal limits unless due to
chronic anaemia and unrelated to haemolysis, and
direct bilirubin is <20% of TBL.
o Alkaline phosphatase >1.5x ULN
o Platelet count <100,000/µL (<100 GI/L)

The Estimated Number of Participants

Taiwan

80 participants
Global

1590 participants