Niacin for Non-Alcoholic Fatty Liver Disease
(AGL13 Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAndré Carpentier, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Université de Sherbrooke

Trial Summary

What is the purpose of this trial?Metabolic dysfunction-associated steatotic liver disease (MASLD) (aka non-alcoholic fatty liver disease), commonly occurring in individuals with obesity and type 2 diabetes can lead to liver inflammation/ fibrosis. MASLD results from fat being disproportionately deposited in the liver. The goal of this mechanistic study is to investigate metabolic response in patients aged 50 to 80 years with non-alcoholic fatty liver disease, after niacin (vitamin B3) treatment. The main questions it aims to answer are: * Does Niacin lower the fat deposition in the liver? * Does Niacin raise White Adipose Tissue storage of dietary fatty acids? Researchers will compare Niacin to a placebo (a look-alike substance that contains no drug) to compare the metabolic response. Duration of study per participant: Up to 28 weeks

Eligibility Criteria

This trial is for individuals aged 50 to 80 with non-alcoholic fatty liver disease, often linked to obesity and type 2 diabetes. The study seeks participants who have not yet developed severe liver complications like cirrhosis.

Inclusion Criteria

I am between 50 and 80 years old.

I am post-menopausal.

I have been diagnosed with MASLD and have a fatty liver and abdominal obesity.

Exclusion Criteria

I have a liver condition.

Being allergic to eggs

Previous intolerance or allergy to nicotinic acid

+6 more

Participant Groups

The study tests if Niacin (vitamin B3) can reduce fat in the liver compared to a placebo. Participants will receive either Niacin or a look-alike pill without active ingredients, aiming to understand its effect on fat storage in both the liver and white adipose tissue.

2Treatment groups

Active Control

Placebo Group

Group I: Niacin groupActive Control1 Intervention

It will be a 12-week treatment phase. The treatment will be administered once daily, at the end of the largest meal.

Group II: Placebo groupPlacebo Group1 Intervention

It will be a 12-week treatment phase. The placebo treatment will be administered once daily, at the end of the largest meal.