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BI456906 for Fatty Liver Disease

Phase 2
Waitlist Available
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48
Awards & highlights

Study Summary

This trial is for men and women with nonalcoholic steatohepatitis (NASH) and liver fibrosis. The purpose is to see if a medicine called BI 456906 helps patients. The study tests 3 different doses of BI 456906 to find the best dose. Participants are put into 4 groups randomly. They have 3 groups that each receive a different dose of BI 456906 and 1 group that receives placebo. BI 456906 and placebo are given as an injection under the skin once per week. The placebo injection looks like the BI 456906 injection but does not contain any medicine.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease (NAFLD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 48 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of patients with histological improvement of NASH (NAS reduction of 2 or more points) after 48 weeks of treatment
Secondary outcome measures
Absolute and relative change of liver fat content from baseline after 48 weeks of treatment assessed by MRI-PDFF
Absolute change from baseline in NAS after 48 weeks of treatment assessed by liver biopsy
Improvement of fibrosis (yes/no) defined as at least one stage decrease in fibrosis stage after 48 weeks of treatment assessed by liver biopsy
+1 more

Side effects data

From 2021 Phase 2 trial • 413 Patients • NCT04153929
12%
Nausea
10%
Diarrhoea
8%
Hypoglycaemia
6%
Constipation
6%
Decreased appetite
6%
Lipase increased
4%
Eructation
4%
Vomiting
4%
Gastrooesophageal reflux disease
2%
Abdominal pain upper
2%
Dyspepsia
2%
Urinary tract infection
2%
Abdominal distension
2%
Fatigue
2%
Weight decreased
2%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Semaglutide
BI 456906 1.8 mg
BI 456906 2.7 mg
BI 456906 1.8 Twice Weekly (3.6) mg
Placebo
BI 456906 0.3 mg
BI 456906 0.9 mg
BI 456906 1.2 Twice Weekly (2.4) mg

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: BI 456906 medium doseExperimental Treatment1 Intervention
medium dose
Group II: BI 456906 low doseExperimental Treatment1 Intervention
low dose
Group III: BI 456906 high doseExperimental Treatment1 Intervention
high dose
Group IV: PlaceboPlacebo Group1 Intervention
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 456906
2017
Completed Phase 2
~1290

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,505 Previous Clinical Trials
11,339,997 Total Patients Enrolled
7 Trials studying Non-alcoholic Fatty Liver Disease
1,092 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

BI 456906 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04771273 — Phase 2
Non-alcoholic Fatty Liver Disease Research Study Groups: Placebo, BI 456906 medium dose, BI 456906 high dose, BI 456906 low dose
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: BI 456906 Highlights & Side Effects. Trial Name: NCT04771273 — Phase 2
BI 456906 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04771273 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many centers are administrating this experiment?

"Currently, 46 medical centres are running this trial. Locations span from Coronado to Sarasota and numerous places in between. It is advised that participants select the closest site available in order to avoid unnecessary travel demands."

Answered by AI

Are participants currently signing up for this research?

"The information hosted on clinicaltrials.gov reveals that this particular medical trial has concluded its patient recruitment phase as of November 30th, 2022. Despite the closure of this study for enrolment, there exist 234 other trials seeking participants at present time."

Answered by AI

Is the enrollment for this trial open to individuals aged 18 and above?

"This research is inviting individuals aged 18 and above but not exceeding 80 years old to participate."

Answered by AI

Has BI 456906 been subjected to regulatory approval yet?

"Although there is evidence to suggest BI 456906's safety, it has yet to be proven effective; thus, the drug receives a rating of 2."

Answered by AI

What are the eligibility criteria for individuals to enter this medical trial?

"This specific clinical trial is targeting 1153 individuals aged between 18 and 80, who have been diagnosed with steatohepatitis. Additionally, these patients must satisfy certain criteria including a Non-Alcoholic Fatty Liver Disease (NAFLD) Activity Score of at least four points across inflammation and ballooning categories as well as having a liver fat fraction exceeding 8% on Magnetic Resonance Imaging (MRI)-Proton Density Fat Fraction scans, among other requirements. Both male and female participants need to be legally competent in their respective country and sign an informed consent document before being enrolled into the study; women of childbearing potential additionally"

Answered by AI

Who else is applying?

What state do they live in?
California
Florida
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1
3+
What site did they apply to?
Northwell Health

How responsive is this trial?

Typically responds via
Phone Call
Recent research and studies
clinicaltrials.govStudy
A Study to Test Safety and Efficacy of BI456906 in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)
2021. "A Study to Test Safety and Efficacy of BI456906 in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04771273.
~75 spots leftby Apr 2025
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