NCT06843148Recruiting
Stimulating Fat Tissue Storage With Niacin to Reduce Fat Accumulation in the Liver.
Stimulating Adipose Tissue Fatty Acid Disposal With Low-dose, Postprandial, Intermittent Niacin for the Treatment of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD).
Source: ClinicalTrials.gov · Last updated 2 Jul 2026
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 36 (estimated)
- First submitted
- 12 Feb 2025
- Start date
- 22 Jun 2026
- Primary completion date
- Mar 2030
- Lead sponsor
- Université de Sherbrooke
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT06843148
What you commit to
- Study type: Interventional
- Planned participants: 36
- From 22 Jun 2026 to the primary completion date, Mar 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 8\) Being allergic to eggs 9) Smoking (\>1 cigarette/day) and/or consumption of \>2 alcoholic beverages per day.
Lab values
- 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.
Other
- 10\) Women who are pregnant or breastfeeding.
Who the study is looking for
- 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;
Age in the registry: 20 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre de recherche du CHUS Coordinator of this site? Confirm its status | Sherbrooke | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.