LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorBoehringer Ingelheim
About this trial
This study is open to adults who are at least 18 years old and have:
* A confirmed liver disease called non-alcoholic steatohepatitis (NASH) or * A confirmed liver disease called metabolic-associated steatohepatitis (MASH) * BMI of 27 kg/m2 or more or * 25 kg/m2 or more if the participant is Asian.
People with a history of other chronic liver diseases or high alcohol intake cannot take part in this study. The purpose of this study is to find out whether a medicine called survodutide helps people with NASH or MASH improve their liver function.
Participants are put into 2 groups randomly, which means by chance. 1 group gets survodutide and 1 group gets placebo. Placebo looks like survodutide but does not contain any medicine. Each participant has twice the chance of getting survodutide. Participants and doctors do not know who is in which group. Participants inject survodutide or placebo under their skin once a week. All participants regularly receive counselling to make changes to their diet and to exercise regularly.
Participants are in the study for up to 4 and a half years. During this time, they visit the study site or have a remote visit by video call every 2, 4 or 6 weeks for about a 1 year and 5 months. After this time participants visit the trial site or have a remote visit every 3 months until the end of the study.
The doctors check participants' health and take note of any unwanted effects. The participants' body weight is regularly measured. At some visits the liver parameters are measured using different imaging methods. The participants also fill in questionnaires about their symptoms. The results are compared between the groups to see whether the treatment works.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Portal hypertension-related upper gastrointestinal (GI) bleeding
Ascites
Trial design
Design model
Parallel
Treatments tested in this trial
Survodutide
Combination productSubcutaneous injection, pre-filled syringe
Placebo matching survodutide
Combination productSubcutaneous injection, pre-filled syringe
Treatment groups
1,590 Participants
are divided into 2 treatment groupsGroup A: SurvodutideExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Time to first occurrence of any component of the composite clinical endpoint (at EoS) consisting of: all-cause mortality, liver transplant, hepatic decompensation events, worsening of MELD score to ≥15 and progression to CSPH
MELD = model of end-stage liver disease CSPH = Clinically significant portal hypertension
Time frame
up to 4.5 years.Secondary outcomes
1
Key secondary endpoint: Absolute change from baseline in enhanced liver fibrosis (ELF) score
Time frame
At baseline and at Week 76.2
Key secondary endpoint: Percentage change from baseline in body weight
Time frame
At baseline and at Week 76.3
Key secondary endpoint: Absolute change from baseline in glycosylated haemoglobin A1c (HbA1c) (%) in participants with type 2 diabetes mellitus (T2DM) at baseline
Time frame
At baseline and at Week 76.4
Key secondary endpoint: Absolute change from baseline in liver stiffness (kPa) in FibroScan® vibration-controlled transient elastography (VCTE)
Time frame
At baseline and at Week 76.Sponsors and contacts
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Source ClinicalTrials.gov