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Peptide

Survodutide for Fatty Liver Disease

Phase 3
Recruiting
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of MASH (non-alcoholic fatty liver disease (NAFLD) activity score [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
Be older than 18 years old
Must not have
History of or planned liver transplant
History of portal hypertension or presence of decompensated liver disease (including hepatic encephalopathy, variceal bleeding, ascites, and spontaneous bacterial peritonitis)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 7 years.
Awards & highlights
Pivotal Trial

Summary

"This trial is for adults with a liver disease called non-alcoholic steatohepatitis (NASH) or metabolic-associated steatohepatitis (MASH) and moderate or advanced liver fib

Who is the study for?
Adults over 18 with MASH (a type of non-alcoholic fatty liver disease) and moderate to advanced fibrosis confirmed by a biopsy can join. They must not have other chronic liver diseases or a history of heavy alcohol use, maintain stable body weight, and keep consistent diet and exercise during the trial.
What is being tested?
The LIVERAGE™ study is testing if Survodutide improves liver function in MASH patients with fibrosis. Participants are randomly assigned to receive either Survodutide or placebo via weekly injections, with double the chance of receiving Survodutide. The study spans up to 7 years with regular health checks.
What are the potential side effects?
While specific side effects aren't listed here, participants' health is closely monitored for any unwanted effects. This includes tracking changes in body weight and gastrointestinal symptoms as well as using imaging methods and occasional liver biopsies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with MASH, with a NAS score of 4 or more, and moderate liver fibrosis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had or am planning to have a liver transplant.
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I have a history of serious liver problems.
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I cannot or do not want to have a liver biopsy.
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I have liver disease, but it's not MASH.
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My liver has been diagnosed with severe scarring.
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My liver disease severity score is 12 or higher.
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I have or had liver cancer.
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I have had pancreatitis or my enzyme levels are high.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 7 years.
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 7 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Part 2: Time to first occurrence of any of components of the composite endpoint consisting of progression to cirrhosis, all-cause mortality, liver transplant, hepatic decompensation event(s), worsening of MELD score to ≥15, progression to CSPH
Secondary study objectives
Key secondary endpoint part 1: Absolute change from baseline in glycosylated haemoglobin (HbA1c)
Key secondary endpoint part 2: Absolute change from baseline in HbA1c
Part 1: Absolute change from baseline in LFC in MRI-PDFF
+3 more

Side effects data

From 2023 Phase 2 trial • 295 Patients • NCT04771273
67%
Nausea
54%
Diarrhoea
48%
Vomiting
22%
COVID-19
17%
Headache
17%
Constipation
17%
Nasopharyngitis
14%
Abdominal distension
14%
Fatigue
13%
Eructation
13%
Decreased appetite
10%
Gastrooesophageal reflux disease
9%
Dyspepsia
9%
Flatulence
7%
Abdominal pain
7%
Dizziness
6%
Arthralgia
6%
Lipase increased
6%
Upper respiratory tract infection
4%
Injection site reaction
4%
Hypoglycaemia
4%
Rash
4%
Pain in extremity
4%
Back pain
4%
Myalgia
4%
Pyrexia
3%
Early satiety
3%
Procedural pain
3%
Insomnia
3%
Anaemia
3%
Influenza
3%
Abdominal pain upper
1%
Spinal compression fracture
1%
Acute myocardial infarction
1%
Squamous cell carcinoma
1%
Post procedural haemorrhage
1%
Urinary tract infection
1%
Hyperglycaemia
1%
Alopecia
1%
Nephrolithiasis
1%
Blindness transient
1%
Asthenia
1%
Sudden hearing loss
1%
Injection site bruising
1%
Malaise
1%
Cholecystitis
1%
Cough
100%
80%
60%
40%
20%
0%
Study treatment Arm
Survodutide 4.8 mg - Actual Maintenance Treatment
Placebo - Actual Maintenance Treatment
Survodutide 2.4 mg - Actual Maintenance Treatment
Survodutide 6.0 mg - Actual Maintenance Treatment

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SurvodutideExperimental Treatment1 Intervention
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Survodutide
2021
Completed Phase 2
~300

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,554 Previous Clinical Trials
15,895,495 Total Patients Enrolled
~1200 spots leftby Dec 2031
Unbiased ResultsWe believe in providing patients with all the options.
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