What side effects are associated with this type of intervention?

Avenciguat (BI 685509), an sGC stimulator, is being studied for its effects on liver cirrhosis and portal hypertension. Common side effects of sGC stimulators can include headache, dizziness, and gastrointestinal issues such as nausea. Empagliflozin, an SGLT2 inhibitor, is used primarily for type 2 diabetes but is also being studied for liver conditions. Known side effects of SGLT2 inhibitors include urinary tract infections, genital mycotic infections, and potential dehydration due to increased urination. Both medications require close monitoring for any adverse effects during treatment.

What prior FDA approvals exist?

Currently, there are no FDA-approved soluble guanylate cyclase (sGC) stimulators specifically for the treatment of liver disease. However, sGC stimulators like riociguat have been approved for pulmonary hypertension, indicating potential for vascular-related conditions. For SGLT2 inhibitors, while empagliflozin is primarily approved for type 2 diabetes and reducing cardiovascular risk, there is growing interest in their potential benefits for liver conditions such as nonalcoholic steatohepatitis (NASH). Broader FDA-approved treatments for liver disease include antiviral therapies for hepatitis B and C, and medications like obeticholic acid for primary biliary cholangitis.

What other types of research exist?

Promising novel alternatives for liver disease patients in 2024 include Glucagon-like peptide-1 (GLP-1) receptor agonists such as Liraglutide and Semaglutide, which have shown benefits in liver conditions like non-alcoholic steatohepatitis (NASH). Another potential alternative is the use of Farnesoid X receptor (FXR) agonists like Obeticholic acid, which is being investigated for its efficacy in reducing liver fibrosis and portal hypertension. These alternatives offer different mechanisms of action and have shown promising results in recent studies.

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BI 685509 + Empagliflozin for Portal Hypertension

Phase 2

Recruiting

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

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

Must have

Male or female who is ≥ 18 (or who is of legal age in countries where that is greater than 18) and ≤ 75 years old at screening (Visit 1a)

Documented endoscopic-treated oesophageal varices as preventative treatment

Must not have

Previous clinically significant decompensation events (e.g. ascites [more than perihepatic ascites], Variceal Haemorrhage (VH) and / or overt / apparent Hepatic Encephalopathy (HE))

History of other forms of chronic liver disease (e.g. alcohol-related liver disease (ARLD), autoimmune liver disease, primary biliary sclerosis, primary sclerosing cholangitis, Wilson's disease, haemachromatosis, alpha-1 antitrypsin [A1At] deficiency)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests whether Avenciguat alone or with empagliflozin can help adults with liver cirrhosis and high blood pressure in the liver's main blood vessel. The medicines aim to lower this blood pressure and improve liver health. Empagliflozin is used to improve blood sugar levels in adults with type 2 diabetes and has shown benefits in reducing heart disease risk.

Who is the study for?

Adults aged 18-75 with liver cirrhosis due to hepatitis B, C or NASH who have high blood pressure in the portal vein can join. They must consent to the trial, have documented varices, stable medication doses if on statins or beta-blockers, and be able to undergo specific liver vein pressure tests.

What is being tested?

The study is testing BI 685509 alone or combined with Empagliflozin for treating high portal vein blood pressure in cirrhosis patients. Participants take BI 685509 tablets twice daily for eight weeks; some also take Empagliflozin once daily. The treatment's effect is monitored through regular health checks and measuring liver vein pressure.

What are the potential side effects?

Potential side effects are not detailed here but typically could include gastrointestinal issues, changes in blood sugar levels (for those taking Empagliflozin), potential kidney function impact, allergic reactions, and other drug-specific adverse events.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 75 years old.

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I have had a procedure to prevent bleeding from enlarged veins in my esophagus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had serious liver-related health events like fluid in the abdomen, bleeding varices, or confusion due to liver problems.

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I have a history of chronic liver disease.

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My liver function is impaired, with a score indicating moderate to severe issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 weeks 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 change in Hepatic Venous Pressure Gradient (HVPG) from baseline

Secondary study objectives

Occurrence of Common Terminology Criteria for Adverse Events (CTCAE) grade 3 (or higher) hypotension or syncope based on Investigator judgement

Occurrence of a response

Occurrence of discontinuation due to hypotension or syncope

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

4Treatment groups

Experimental Treatment

Group I: Avenciguat (BI 685509) NASH treatment groupExperimental Treatment1 Intervention

Non-Alcoholic Steatohepatitis (NASH)

Group II: Avenciguat (BI 685509) HCV treatment groupExperimental Treatment1 Intervention

Hepatitis C Virus (HCV)

Group III: Avenciguat (BI 685509) HBV treatment groupExperimental Treatment1 Intervention

Hepatitis B Virus (HBV)

Group IV: Avenciguat (BI 685509) + empagliflozin NASH treatment groupExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Empagliflozin

2017

Completed Phase 4

~181750

0 / 5Eligibility 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

Avenciguat (BI 685509) is a soluble guanylate cyclase (sGC) stimulator that enhances nitric oxide (NO) signaling, leading to vasodilation and reduced portal vein pressure, which is crucial for alleviating portal hypertension in liver cirrhosis patients. Empagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, lowers blood glucose by preventing its reabsorption in the kidneys and promoting excretion through urine, benefiting cardiovascular and renal health. These mechanisms are vital for liver disease patients as they help manage complications like portal hypertension and diabetes, improving overall prognosis and quality of life.