Recruiting

Niacin

Sponsor:

Université de Sherbrooke

Code:

NCT06843148

Conditions

Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)

Liver Fibrosis/NASH

Non-Alcoholic Steato-Hepatitis (NASH)

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Interventions

Niacin (250mg)

Placebo Oral Tablet

Study Details

Brief summary:

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 20 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

Conditions

Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)

Liver Fibrosis/NASH

Non-Alcoholic Steato-Hepatitis (NASH)

Study ID

NCT06843148

Start date

Jun 22, 2026

Status verified date

Jun, 2026

Completion date

Jul, 2030

Anticipated

Primary completion date

Mar, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • aged 20 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;

Exclusion Criteria:

1\) Presence of advanced fibrosis using any of the following criteria 1.1 (i.e., ≥ F3 based on liver stiffness > 10kPa) using vibration-controlled transient elastography (FibroScan), 1.2 (Index for Liver Fibrosis > 2.67) using Fibrosis-4 (FIB-4) which is a calculated score based on age and a combination of lab tests (aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], and platelet count), 1.3 serum ALT > 3 times the normal upper limit, 1.4 or signs of portal hypertension. 2) Other hepatic disease. 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.

10\) Women who are pregnant or breastfeeding.

Study Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

placebo comparator: Placebo group

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

active comparator: Niacin group

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

Interventions

Niacin (250mg)

Niacin will be orally taken once daily with the largest meal. There will be a 3-week escalation period from 250 mg to 750 mg:

  • Week 1: 250mg
  • Week 2: 500mg
  • Week 3 to Week 12: 750mg (3 x 250mg caplets)

Placebo Oral Tablet

Placebo will be orally taken once daily with the largest meal. There will be a 3-week escalation period from 250 mg to 750 mg:

  • Week 1: 250mg
  • Week 2: 500mg
  • Week 3 to Week 12: 750mg (3 x 250mg caplets)

Primary outcome measure

  • Prolonged small-dose niacin treatment does not lead to desensitization of the niacin-induced reduction in hepatic total fatty acids flux. [ Time Frame: Week 12, Week 28 ]

Central Contacts and Locations

Central contacts

Locations

Centre de recherche du CHUS

Recruiting

Sherbrooke, Quebec, Canada, J1H 5N4

Contacts

More Information

Sponsor

Université de Sherbrooke

Last update posted

Jul 2, 2026

Last verified

Jun, 2026

Keywords

  • Fatty liver
  • Niacin
  • vitamin B3
  • nicotinic acid

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2026-07-02.