Tirzepatide for Alcoholic Liver Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether the weight management drug Tirzepatide can help individuals with alcohol use disorder (AUD) and metabolic alcohol-associated liver disease (MetALD) reduce alcohol intake and improve liver health. Participants will receive weekly injections of either Tirzepatide or a placebo for 12 weeks, while researchers monitor effects on alcohol consumption and liver condition. Suitable candidates for the trial include those with AUD and MetALD, characterized by frequent heavy drinking and alcohol-related liver issues. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in treatment.
Do I have to stop taking my current medications for the trial?
The trial requires you to stop taking certain medications, especially those that interfere with tirzepatide or have glucose-lowering properties, like insulin or metformin, within the last 30 days. If you're on any of these, you might need to stop them before joining the trial.
Is there any evidence suggesting that Tirzepatide is likely to be safe for humans?
Research has shown that tirzepatide is generally safe for individuals with liver issues related to metabolism. Some studies suggest it might even help reduce liver damage from alcohol. However, rare cases of liver problems have been linked to tirzepatide, often involving other factors. Overall, tirzepatide is an approved drug for weight management and has been tested in humans for other conditions, indicating reasonable safety. Monitoring for any unusual symptoms during the trial is important.12345
Why do researchers think this study treatment might be promising for alcoholic liver disease?
Unlike the standard treatments for alcoholic liver disease, which mostly focus on lifestyle changes and managing symptoms, Tirzepatide offers a novel approach. This drug is unique because it targets both GLP-1 and GIP receptors, which are involved in regulating glucose and energy metabolism. Researchers are excited about Tirzepatide because it has the potential to improve liver health by reducing inflammation and fat accumulation, leading to better outcomes for patients. Additionally, it is administered as a once-weekly injection, which could be more convenient for patients compared to daily medications.
What evidence suggests that Tirzepatide might be an effective treatment for alcoholic liver disease?
Studies have shown that Tirzepatide, a medication already used for weight management, might help with liver problems related to alcohol use. Research indicates that drugs like Tirzepatide can improve liver health in heavy drinkers by reducing fat buildup in the liver. Additionally, Tirzepatide has shown promise in improving liver function and reducing liver fat in conditions similar to alcohol-related liver disease. This trial will compare Tirzepatide to a placebo to evaluate its effectiveness for alcohol-related liver issues by addressing the liver's energy processing problems. Initial findings are promising, but more research is needed to confirm its effectiveness for this specific condition.23678
Who Is on the Research Team?
Falk W Lohoff, M.D.
Principal Investigator
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Are You a Good Fit for This Trial?
This trial is for adults over 21 with alcohol use disorder (AUD) and metabolic alcohol-associated liver disease (MetALD). Participants must be able to undergo various tests, including blood work, heart function tests, and Fibroscan. They should also be willing to discuss their drinking habits and mental health.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Baseline assessments including physical exam, blood and urine tests, heart function test, Fibroscan, and questionnaires
Treatment
Participants receive weekly subcutaneous injections of Tirzepatide or placebo for 12 weeks, with repeated physical exams and tests
Follow-up
Participants are monitored for safety and effectiveness after treatment, with repeated tests and recommendations for reducing alcohol intake
What Are the Treatments Tested in This Trial?
Interventions
- Tirzepatide
Find a Clinic Near You
Who Is Running the Clinical Trial?
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Lead Sponsor