What side effects are associated with this type of intervention?

Common treatments for liver disease, particularly those involving pharmacological interventions similar to BI 456906, often include medications like ursodeoxycholic acid (UDCA), statins, and direct-acting antivirals (DAAs). Known side effects of UDCA can include gastrointestinal issues such as diarrhea and constipation. Statins, used for managing hyperlipidemia in liver disease, may cause muscle pain, liver enzyme abnormalities, and, rarely, rhabdomyolysis. DAAs, used for hepatitis C, are generally well-tolerated but can cause fatigue, headache, and nausea. It is important for patients to discuss potential side effects with their healthcare provider to manage and mitigate any adverse effects effectively.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of liver diseases, particularly those that also address obesity and related metabolic conditions. Notably, GLP-1 receptor agonists like liraglutide and semaglutide have been approved for obesity and have shown beneficial effects on liver health, particularly in reducing liver fat and improving liver enzymes. Ursodeoxycholic acid (UDCA) is another FDA-approved drug for primary biliary cholangitis, a type of liver disease, which helps improve liver function and delay disease progression. These treatments are relevant as they share a focus on improving liver health and metabolic conditions, similar to the investigational drug BI 456906 being studied for its pharmacokinetics and tolerability in liver conditions and obesity.

What other types of research exist?

Promising novel alternatives to BI 456906 for liver disease patients include Tenofovir Alafenamide (TAF) and Entecavir. Both have shown efficacy in treating chronic hepatitis B with favorable safety profiles. Additionally, emerging hepatotoxicity biomarkers and new antiviral therapies such as Futibatinib for cholangiocarcinoma are also noteworthy. These alternatives have demonstrated significant clinical benefits and are likely to be relevant treatment options in 2024.

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BI 456906 for Liver Disease

Q: What is the mechanism of action of this treatment?

Common treatments for liver disease, such as ursodeoxycholic acid (UDCA) and obeticholic acid, work by improving bile flow and reducing liver inflammation. UDCA decreases cholesterol absorption and increases its catabolism into bile acids, which helps in conditions like primary biliary cholangitis. Obeticholic acid activates the farnesoid X receptor, reducing bile acid production and liver inflammation. These mechanisms are crucial for liver disease patients as they help manage symptoms, slow disease progression, and improve liver function. Understanding these mechanisms is important for developing new treatments like BI 456906, which aims to address similar issues in liver conditions and obesity.

Phase 1

Recruiting

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Women of childbearing potential must be willing and able to use two forms of effective contraception where at least one form is highly effective method of birth control per ICH M3 (R2) that results in a low failure rate (i.e. <1% per year when used consistently and correctly). A list of contraception methods meeting these criteria is provided in the subject information. Please note that oral contraceptives are not allowed during the treatment period.

Further inclusion criteria apply.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 360 hours

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a drug called BI 456906, given as an injection, in adults with and without liver problems. It aims to see how liver issues affect the drug's absorption and tolerance. Participants include both healthy individuals and those who are overweight or obese.

Who is the study for?

Adults aged 18-75, with or without liver problems and varying body weights (BMI of 18.5-40 kg/m2), can join this study. It's for those who are healthy as well as people with overweight (BMI ≥27 kg/m2) or obesity. Women must use two effective contraception methods during the trial, and men need to meet a minimum weight requirement.

What is being tested?

The study tests BI 456906 in two parts: Part 1 checks how it's absorbed by healthy individuals versus those with liver issues after one injection; Part 2 examines tolerance to increasing doses over time in people with overweight/obesity, both with and without liver problems.

What are the potential side effects?

While not specified here, participants will be monitored for any health issues that arise during treatment which could include typical drug side effects such as nausea, headaches, allergic reactions or more specific effects related to BI 456906.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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Women who can become pregnant must use two effective methods of birth control during the study, including at least one method with a low failure rate. The study provides a list of birth control methods that meet these criteria. Oral contraceptives cannot be used during the treatment period.

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There are additional requirements you must meet to be included in this study.

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You must weigh at least 70 kg (154 lbs) if you are a female, and at least 80 kg (176 lbs) if you are a male.

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You are between 18 and 75 years old at the time of screening, or the legal age of consent if it's higher than 18.

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Your body mass index (BMI) is between 18.5 and 40.0.

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You have signed a document that explains the details of the study and agree to participate according to ethical and legal standards.

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If you are a woman who could become pregnant, you will not be eligible for the study unless you have had a hysterectomy, bilateral salpingectomy, or bilateral oophorectomy (which permanently prevent pregnancy) or have gone without a period for 12 months without other medical reasons.

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You are between the ages of 18 and 75 years old.

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You are considered overweight or obese, which means your body mass index (BMI) is 27 or higher.

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You have provided a written consent form that states you understand and agree to participate in the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 360 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 360 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 360 hours 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 A: Area under the concentration-time curve of BI 456906 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

Part A: Maximum measured concentration of BI 456906 in plasma (Cmax)

Part B: Percentage of patients treated who experience treatment-emergent adverse event

Secondary study objectives

Part A: Percentage of patients treated who experience treatment-emergent adverse event

Side effects data

From 2021 Phase 2 trial • 413 Patients • NCT04153929

24%

Diarrhoea

20%

Nausea

14%

Vomiting

12%

Decreased appetite

Dyspepsia

Headache

Abdominal distension

Abdominal pain upper

Constipation

Fatigue

Eructation

Flatulence

Lipase increased

Back pain

Abdominal pain

Gastrooesophageal reflux disease

Asthenia

Hypoglycaemia

Dizziness

100%

80%

60%

40%

20%

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups

Experimental Treatment

Group I: Part B: BI456906: Cohort 3Experimental Treatment1 Intervention

Patients with overweight/obesity with cirrhosis + CTP Class B

Group II: Part B: BI456906: Cohort 2Experimental Treatment1 Intervention

Patients with overweight/obesity with cirrhosis + CTP Class A

Group III: Part B: BI456906: Cohort 1Experimental Treatment1 Intervention

Patients with overweight/obesity without cirrhosis/hepatic impairment

Group IV: Part A: BI 456906: Cohort 4Experimental Treatment1 Intervention

Patients with cirrhosis + CTP Class C

Group V: Part A: BI 456906: Cohort 3Experimental Treatment1 Intervention

Patients with cirrhosis + CTP Class B

Group VI: Part A: BI 456906: Cohort 2Experimental Treatment1 Intervention

Patients with cirrhosis + Child-Turcotte-Pugh (CTP) Class A

Group VII: Part A: BI 456906: Cohort 1Experimental Treatment1 Intervention

Healthy subjects

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BI 456906

2017

Completed Phase 2

~1380

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for liver disease, such as ursodeoxycholic acid (UDCA) and obeticholic acid, work by improving bile flow and reducing liver inflammation. UDCA decreases cholesterol absorption and increases its catabolism into bile acids, which helps in conditions like primary biliary cholangitis. Obeticholic acid activates the farnesoid X receptor, reducing bile acid production and liver inflammation. These mechanisms are crucial for liver disease patients as they help manage symptoms, slow disease progression, and improve liver function. Understanding these mechanisms is important for developing new treatments like BI 456906, which aims to address similar issues in liver conditions and obesity.

Pharmacotherapies that specifically target ammonia for the prevention and treatment of hepatic encephalopathy in adults with cirrhosis.