Stimulating Fat Tissue Storage With Niacin to Reduce Fat Accumulation in the Liver. (AGL13)

Université de Sherbrooke

Status: Begins enrollment this month

Conditions: Liver Fibrosis/NASH; Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD); Non-Alcoholic Steato-Hepatitis (NASH)

Treatments: Drug: Niacin (250mg); Drug: Placebo Oral Tablet

Study type: Interventional

Funder types: Other

Identifiers

NCT06843148

2025-5648

Details and patient eligibility

About

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

Full description

It will be a randomized crossover study with two 12-week treatment phases (niacin vs. placebo) with a 4-week washout period between the two treatment phases.

The two 12-week treatment phases will be performed in random order. The treatment will be administered once daily, at the end of the largest meal. There will be a 3-week dose escalation: from 250mg (the first week) to 750mg from week 3 onward.

The outcomes will be assessed at the end of each of these two treatment phases in all participants with metabolic visit A and B (i.e., a total of 4 metabolic visits).

Each metabolic visit will last 9 hours: it will be a test meal with perfusion of stable tracers, blood sampling, PET acquisitions using radiopharmaceuticals (18FTHA and 11C-palmitate) and MRI acquisitions.

The two visits A and B will be performed without and with acute administration of niacin with the test meal, respectively, to determine acute niacin-induced reduction in hepatic fatty acid flux.

The two visits will be performed at four to seven-day interval, in random order during the last week of each of the treatment phase.

Enrollment: 36 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• aged 50 to 80 years;
• diagnosed with MASLD, defined as the presence of liver steatosis + abdominal obesity (as defined by the International Diabetes Federation country/ethnic group-specific criteria;
• all women will be post-menopausal.

Exclusion criteria

1. Presence of advanced fibrosis (i.e., ≥ F3 based on liver stiffness > 10kPa) using vibration-controlled transient elastography (FibroScan), serum ALT > 3 times the normal upper limit, or signs of portal hypertension [106-109].
2. Other hepatic disease.
3. Previous diagnosis of diabetes.
4. Overt cardiovascular or renal disease, cancer (other than non-melanoma skin cancer), or other uncontrolled medical conditions.
5. Any contraindication to MRI.
6. Previous intolerance or allergy to nicotinic acid.
7. Having participated to a research study with exposure to radiation in the last two years before the start of the study.
8. Being allergic to eggs
9. Smoking (>1 cigarette/day) and/or consumption of >2 alcoholic beverages per day.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

Placebo group

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo Oral Tablet

Niacin group

Active Comparator group

Description:

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

Treatment:

Drug: Niacin (250mg)