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Clinical Trials List

Protocol Number1404-0064

NCT Number(ClinicalTrials.gov Identfier)NCT06632457

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

百瑞精鼎國際股份有限公司
Trial scale

Multi-Regional Multi-Center
Update

2026/04/10

Investigators and Locations

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

Taipei Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator

Chung Shan Medical University Hospital

Co-Principal Investigator

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

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator

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 Pin-Nan Cheng

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Metabolic Dysfunction Associated Steatohepatitis

Objectives

The primary objective of this trial was to demonstrate the superiority of survodutide over placebo in participants with compensated MASH cirrhosis by assessing the hazard ratio of elapsed time up to the composite endpoint (including liver-related clinical outcomes and all-cause mortality) compared to placebo. Secondary objectives were to demonstrate the superiority of survodutide over placebo from baseline to week 76/end of trial (EoS) in the following areas: • Mean difference in absolute change of enhanced liver fibrosis (ELF) score (at week 76) • Mean difference in percentage change of body weight (at week 76) • Mean difference in absolute change of glycated hemoglobin (HbA1c) in participants with type 2 diabetes mellitus (T2DM) at baseline (at week 76) • Mean difference in absolute change of liver stiffness as assessed by FibroScan® transient vibration elastography (VCTE) (at week 76) • Mean difference in percentage change of liver stiffness as assessed by FibroScan® VCTE (at week 76) • Hazard ratio of time elapsed until the first exacerbation to clinically significant portal hypertension (CSPH), defined as the time elapsed before upper gastrointestinal endoscopy (UGE). • Confirmation of new "high-risk" gastroesophageal varices (GOV) (EoS) • Hazard ratio of time elapsed until the first occurrence of any hepatic decompensation event (ascites, hepatic encephalopathy [HE], or portal hypertension-related upper gastrointestinal [GI] bleeding) or a MELD (Mechanism for End-Stage Liver Disease) score worsening to ≥ 15 (EoS) • Incidence of all-cause hospitalizations (first and relapse) (EoS) • Hazard ratio of time elapsed until the first occurrence of any determined component of the composite index, including cardiovascular (CV) death, nonfatal stroke, nonfatal myocardial infarction (MI), ischemic coronary revascularization, or heart failure (HF) events (including hospitalization for HF [HHF], emergency room return, emergency care return, or emergency outpatient HF return) (5P-MACE) (EoS)

Test Drug

Prefilled Injectable

Active Ingredient

Survodutide (BI 456906)

Dosage Form

230

Dosage

NA

Endpoints

Key endpoints:

 Time to first occurrence of any component of the composite clinical endpoint (EoS), including:

o All-cause death
o Liver transplantation
o Liver decompensation events, including:

- Ascites requiring treatment

- Hepatic effusion requiring treatment

- Portal hypertension-related upper gastrointestinal bleeding, including bleeding events caused by esophageal varices, gastric varices, and portal hypertensive gastropathy (PHG)

o Deterioration of MELD score to ≥ 15

o Deterioration to CSPH, defined as a "high-risk" GOV confirmed in UGE ("high-risk" GOV is defined as large varices)

Inclution Criteria

Inclusion 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
Body mass index (BMI) ≥27 kg/m2(≥25 kg/m2 for Asian trial participants)
Compensated metabolic dysfunction-associated steatohepatitis (MASH) cirrhosis.
Magnetic resonance imaging proton density fat fraction (MRI-PDFF) fat fraction ≥5% or FibroScan® with controlled attenuation parameter (CAP) ≥288 dB/m, obtained during the screening period or a historic MRI-PDFF ≤12 weeks prior to randomisation (except for patients with 'cryptogenic cirrhosis' where MRI-PDFF <5% or FibroScan® with CAP <288 dB/m is allowed). This inclusion criterion does not apply for participants with a recent (≤12 months prior to randomisation) liver biopsy showing steatosis/steatohepatitis.
Further inclusion criteria apply.

Exclusion Criteria

Exclusion criteria:

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.
Model of end-stage liver Disease (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:

Portal hypertension-related upper gastrointestinal (GI) bleeding
Ascites
Hepatic encephalopathy (HE) ≥Grade 1 according to the West Haven criteria
Any of the following lab test result at screening

Albumin below <3.5 g/dL (<35.0 g/L)
International normalised ratio (INR) >1.3 unless due to therapeutic anticoagulants
Total bilirubin (TBL) >1.2x upper limit of normal (ULN) NOTE: Trial participants with Gilbert Syndrome are eligible with a TBL >1.2x 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.
Alkaline phosphatase >1.5x ULN
PLT <100,000/µL (<100 GI/L)
History or evidence of other chronic liver diseases, such as primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis or overlap syndrome, Wilson's disease, alpha-1-antitrypsin deficiency, or genetic haemochromatosis
Hepatitis B positive (defined as positive hepatitis B surface antigen (HBsAg)) or history of chronic HBV infection
Hepatitis C positive (defined as positive hepatitis C virus (HCV) antibody and a positive HCV ribonucleic acid (RNA))
Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >5x ULN
Evidence of alcoholic liver disease, or drug-induced liver disease, as defined on the basis of typical exposure and history
History of liver transplantation or listed for liver transplantation
History of transjugular intrahepatic portosystemic shunt (TIPS) or other radiological/surgical procedure for portal hypertension treatment
Further exclusion criteria apply

The Estimated Number of Participants

Taiwan

80 participants
Global

1590 participants