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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

Summary

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.

Eligible Conditions
  • Fatty Liver Disease

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of patients with histological improvement of NASH (NAS reduction of 2 or more points) after 48 weeks of treatment
Secondary study objectives
Improvement of liver fat content (yes/no) defined as at least 30 percent (%) relative reduction in liver fat content after 48 weeks of treatment compared to baseline

Side effects data

From 2021 Phase 2 trial • 413 Patients • NCT04153929
24%
Diarrhoea
20%
Nausea
14%
Vomiting
12%
Decreased appetite
8%
Dyspepsia
8%
Headache
6%
Abdominal distension
6%
Abdominal pain upper
6%
Constipation
6%
Fatigue
4%
Eructation
4%
Flatulence
4%
Lipase increased
4%
Back pain
2%
Abdominal pain
2%
Gastrooesophageal reflux disease
2%
Asthenia
2%
Hypoglycaemia
2%
Dizziness
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
BI 456906 0.3 mg
BI 456906 0.9 mg
BI 456906 1.8 mg
BI 456906 2.7 mg
BI 456906 1.2 Twice Weekly (2.4) mg
BI 456906 1.8 Twice Weekly (3.6) mg
Semaglutide

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
~1460

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,551 Previous Clinical Trials
15,857,730 Total Patients Enrolled

Media Library

BI 456906 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04771273 — Phase 2
Fatty Liver Disease Research Study Groups: Placebo, BI 456906 medium dose, BI 456906 high dose, BI 456906 low dose
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
~64 spots leftby Dec 2025
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