BI456906 for Fatty Liver Disease
Recruiting at 201 trial locations
BI
Overseen ByBoehringer Ingelheim
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Boehringer Ingelheim
Prior Safety DataThis treatment has passed at least one previous human trial
Trial Summary
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications, but it excludes those who have taken medications associated with liver injury or steatohepatitis within 12 weeks before the trial. It's best to discuss your current medications with the trial doctors to see if they might interfere with the study.
How is the drug BI 456906 different from other treatments for fatty liver disease?
BI 456906, also known as Survodutide, is unique because it is a glucagon-like peptide-1 receptor (GLP-1R) agonist, which is a class of drugs showing promise in treating non-alcoholic fatty liver disease (NAFLD) by improving liver health without worsening fibrosis. Unlike other treatments, there are no licensed drugs specifically for NAFLD, making BI 456906 a novel option in clinical trials.12345
What is the purpose of this trial?
This trial tests whether BI 456906, an injection, helps men and women with NASH and liver fibrosis. The study measures liver health improvements using biopsies, ultrasounds, and MRIs.
Eligibility Criteria
Inclusion Criteria
Diagnosis of non-alcoholic steatohepatitis (NASH) (Non-alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) ≥ 4, with at least 1 point in inflammation and ballooning each) and fibrosis stage F1-F3 proven by a biopsy conducted during the screening period or by a historical biopsy conducted within the last 6 months prior to randomization and stable body weight defined as less than 5% self-reported change in body weight between the historical biopsy and randomization, if a historical biopsy is used.
Liver fat fraction ≥ 8% measured by Magnetic Resonance Imaging (MRI)-Proton Density Fat Fraction (PDFF) and liver stiffness > 6.0 kPa measured by FibroScan® at Visit 1 (if biopsy is scheduled during the screening period MRI-PDFF and FibroScan® assessments have to be performed prior to the biopsy). However, the diagnosis of NASH and fibrosis at liver biopsy (including historical biopsy) is the primary assessment to establish patient eligibility.
Patients willing and able to undergo liver biopsies per protocol as judged by the Investigator.
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Exclusion Criteria
Current or history of significant alcohol consumption (defined as intake of > 210 g/ week in males and > 140 g/ week in females on average over a consecutive period of more than 3 months) or inability to reliably quantify alcohol consumption based on Investigator judgement within the last 5 years.
Intake of medications historically associated with liver injury, hepatic steatosis or steatohepatitis within 12 weeks prior to Visit 1. Intake of restricted medications or any medications considered likely to interfere with the safe conduct of the trial.
History of other forms of chronic liver disease (e.g., viral hepatitis, autoimmune liver disease, primary biliary sclerosis, primary sclerosing cholangitis, Wilson's disease, hemochromatosis, Alpha-1 Antitrypsin (A1At) deficiency, history of liver transplantation). Hepatitis B and C testing will be done at Visit 1. Patients with positive Hepatitis B surface antigen (HBsAg) should be excluded. Patients treated for hepatitis C must have a negative RNA test at screening and also be Hepatitis C Virus (HCV) RNA negative for at least 3 years prior to screening in order to be eligible for the trial.
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Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive weekly subcutaneous injections of BI 456906 or placebo for 48 weeks
48 weeks
Several in-person visits and some video calls
Follow-up
Participants are monitored for safety and effectiveness after treatment
8 weeks
Treatment Details
Interventions
- BI 456906
- Placebo
Participant Groups
4Treatment groups
Experimental Treatment
Placebo Group
Group I: Survodutide 6.0 mg - planned maintenance treatmentExperimental Treatment1 Intervention
Group II: Survodutide 4.8 mg - planned maintenance treatmentExperimental Treatment1 Intervention
Group III: Survodutide 2.4 mg - planned maintenance treatmentExperimental Treatment1 Intervention
Group IV: Placebo - planned maintenance treatmentPlacebo Group1 Intervention
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Who Is Running the Clinical Trial?
Boehringer Ingelheim
Lead Sponsor
Trials
2,566
Recruited
16,150,000+
Findings from Research
A systematic review of 25 trials involving 2597 adults found that PPAR agonists and GLP-1R agonists significantly improved liver histology in patients with non-alcoholic fatty liver disease (NAFLD), indicating their potential as effective treatments.
SGLT2 inhibitors were shown to reduce liver fat content, further supporting their role in managing NAFLD, especially in individuals with type 2 diabetes.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Efficacy of peroxisome proliferator-activated receptor agonists, glucagon-like peptide-1 receptor agonists, or sodium-glucose cotransporter-2 inhibitors for treatment of non-alcoholic fatty liver disease: a systematic review.Mantovani, A., Byrne, CD., Targher, G.[2022]
Statins, particularly atorvastatin, have shown promising results in improving liver health and reducing cardiovascular disease (CVD) risk in patients with non-alcoholic fatty liver disease (NAFLD) and nonalcoholic steatohepatitis (NASH), based on analyses of over 11,000 participants from randomized controlled trials.
Statin treatment not only improves liver enzyme levels and liver imaging results but also significantly reduces CVD morbidity and mortality, with statin-treated NAFLD/NASH patients experiencing a 50% reduction in CVD events compared to those with normal liver function.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Statins: An Under-Appreciated Asset for the Prevention and the Treatment of NAFLD or NASH and the Related Cardiovascular Risk.Athyros, VG., Boutari, C., Stavropoulos, K., et al.[2022]
In a systematic review of 10 studies involving patients with non-alcoholic fatty liver disease (NAFLD) or non-alcoholic steatohepatitis (NASH), treatment with 4 mg saroglitazar significantly reduced liver enzymes, including alanine transaminase (ALT) and aspartate transaminase (AST), indicating improved liver function.
Saroglitazar also led to significant improvements in liver stiffness and metabolic parameters such as glycated hemoglobin, total cholesterol, and triglycerides, suggesting it is an effective and safe treatment option for managing NAFLD and NASH.
NCBI (Pubmed)
pubmed.ncbi.nlm.nih.gov
Effects of saroglitazar in the treatment of non-alcoholic fatty liver disease or non-alcoholic steatohepatitis: A systematic review and meta-analysis.Bandyopadhyay, S., Samajdar, SS., Das, S.[2023]
References
Efficacy of peroxisome proliferator-activated receptor agonists, glucagon-like peptide-1 receptor agonists, or sodium-glucose cotransporter-2 inhibitors for treatment of non-alcoholic fatty liver disease: a systematic review. [2022]
Statins: An Under-Appreciated Asset for the Prevention and the Treatment of NAFLD or NASH and the Related Cardiovascular Risk. [2022]
Effects of saroglitazar in the treatment of non-alcoholic fatty liver disease or non-alcoholic steatohepatitis: A systematic review and meta-analysis. [2023]
Effects of Robuvit® on the progression of non-alcoholic fatty liver disease. [2022]
Insulin sensitizer MSDC-0602K in non-alcoholic steatohepatitis: A randomized, double-blind, placebo-controlled phase IIb study. [2022]
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