What side effects are associated with this type of intervention?

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) include weight reduction strategies and medications like orlistat. Weight reduction through lifestyle changes can sometimes lead to adverse events, although these are poorly reported. Orlistat, a weight-loss medication, can cause gastrointestinal side effects such as diarrhea, flatulence, and abdominal pain. For investigational treatments like BI 3006337, side effects are monitored closely, and participants are checked for any health problems that could be caused by the medication. Overall, the side effects of NAFLD treatments can vary but often include gastrointestinal issues and other mild to moderate adverse events.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of Non-alcoholic Fatty Liver Disease (NAFLD). Current management primarily focuses on lifestyle modifications such as diet, exercise, and weight loss. Some investigational drugs, like BI 3006337, are being studied for their potential benefits in treating NAFLD, but they are not yet approved. Other drugs under investigation include those targeting metabolic pathways, inflammation, and fibrosis, but none have received FDA approval to date.

What other types of research exist?

Promising novel alternatives to BI 3006337 for NAFLD patients include liraglutide, which has shown safety and efficacy in patients with non-alcoholic steatohepatitis (NASH), and pioglitazone, which has been effective in treating NASH in patients with type 2 diabetes or prediabetes. Additionally, statins have been observed to lower the risk of hepatocellular carcinoma in patients with chronic liver disease, which may be beneficial for NAFLD patients.

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BI 3006337 for Fatty Liver Disease

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

Male or female trial participants ≥18 years and ≤75 years of age at time of consent

Be older than 18 years old

Must not have

Intake of medications historically associated with liver injury, hepatic steatosis, or steatohepatitis (e.g. oral or intravenous corticosteroids, methotrexate, valproic acid, tamoxifen, tetracycline, amiodarone) for more than 14 consecutive days within 12 weeks prior to the screening visit

Presence of any form of acute or chronic liver disease other than simple steatosis (e.g. viral hepatitis, autoimmune liver disease, primary biliary sclerosis, primary sclerosing cholangitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency). Chronic viral hepatitis parameters that would be considered exclusionary for the participation to this trial are (hepatitis B and C testing will be done at the screening visit):

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 99 days

Awards & highlights

Summary

This trial is testing a new medicine called BI 3006337 in adults who are overweight or obese and have fatty liver disease. The goal is to find out how much of the medicine they can safely take. Participants receive regular injections and are closely monitored for any health issues.

Who is the study for?

Adults aged 18-75 with overweight or obesity (BMI of 25-40) and fatty liver disease can join this study. They must not drink alcohol excessively, use certain medications that affect the liver, or have other types of liver diseases. Women who can bear children and men with partners who can must agree to effective birth control.

What is being tested?

The trial is testing different doses of a new medicine called BI 3006337 versus a placebo in people with fatty liver disease and obesity. Participants are randomly assigned to one of four groups for about four months, receiving weekly injections while their health is monitored.

What are the potential side effects?

Potential side effects aren't specified here but will be closely monitored during the visits, especially any health problems possibly caused by BI 3006337.

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.

Exclusion Criteria

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

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I haven't taken medications known to harm the liver for more than 2 weeks in the last 3 months.

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I do not have liver disease except for simple fat buildup.

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I have or might have liver cancer.

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I have been diagnosed with type 1 diabetes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 99 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 99 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 99 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Occurrence of drug-related adverse events (AEs)

Secondary study objectives

Area under the concentration-time curve of the analyte in serum over the dosing interval tau at steady state (AUCτ,ss) after the last dose in Week 12

Maximum measured concentration of the analyte in serum at steady state (Cmax,ss) after the last dose in Week 12

Relative percentage change in liver steatosis from baseline after 12 weeks of treatment

+1 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: BI 3006337 dose group 4Experimental Treatment1 Intervention

Group II: BI 3006337 dose group 3 or placeboExperimental Treatment2 Interventions

Group III: BI 3006337 dose group 2 or placeboExperimental Treatment2 Interventions

Group IV: BI 3006337 dose group 1 or placeboExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BI 3006337

2021

Completed Phase 1

~80

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

Common treatments for Non-alcoholic Fatty Liver Disease (NAFLD) often target metabolic pathways to reduce liver fat and improve liver function. For instance, GLP-1 receptor agonists, which are similar to BI 3006337, enhance insulin secretion, improve glucose and lipid metabolism, and reduce hepatic fat content. These treatments are crucial for NAFLD patients as they address the underlying metabolic dysfunctions, potentially reversing liver damage and preventing progression to more severe liver diseases such as cirrhosis or hepatocellular carcinoma.