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NCT Number: NCT06843148

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

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

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Key information

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) Digestive System Diseases Fatty Liver Liver Diseases Liver Fibrosis/NASH Non-Alcoholic Steato-Hepatitis (NASH)

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de recherche du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

Location status: Recruiting

Location contact

Frédérique Frisch

CONTACT

[email protected]

1-819-346-1110 ext. 12394

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.
  • 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.
  • Being allergic to eggs 9) Smoking (>1 cigarette/day) and/or consumption of >2 alcoholic beverages per day.
  • Women who are pregnant or breastfeeding.

Treatment and study plan

Niacin (250mg)

Drug

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)

Other names: Nicotinic Acid, Vitamin B3

Placebo oral tablet

Drug

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 outcomes

  1. 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

    Total 6 h integrated uptake of circulating NEFAs, DFAs, and all FAs in liver: represents the sum of the rate of NEFA uptake integrated over 360 min for the entire organ and the rate of DFA uptake integrated over 360 min for the entire organ.

Secondary outcomes

  1. Change in White Adipose Tissue (WAT) and lean tissue Dietary Fatty Acid (DFA) uptake

    Time frame: Week 12, Week 28

    Determined from the same static (whole-body) acquisition image using oral administration of [18F]-Fluoro-6-Thia-Heptadecanoic Acid (FTHA)

  2. Change in total hepatic fatty acid flux

    Time frame: Week 12, Week 28

    represents the sum of the rate of NEFA uptake and DFA uptake (PET scan using [18F]-FTHA and [11C]-palmitate

  3. Change in hepatic Non-Esterified-Fatty-Acid (NEFA) uptake oxidation, esterification and secretion into very low-density lipoprotein (VLDL)

    Time frame: Week 12, Week 28

    [11C]-Palmitate PET. Calculated from the same multicompartmental equation using liver [11C]-palmitate kinetics

  4. Change in Endogenous Glucose production and meal glucose systemic flux

    Time frame: Week 12, Week 28

    i.v. and oral stable isotope tracer

  5. Change in plasma NEFA flux

    Time frame: Week 12, Week 28

    calculated from i.v. stable isotope tracer (mass spectrometry).

  6. Change in hepatic Triglyceride (TG) content

    Time frame: Week 12, Week 28

    magnetic resonance imaging (MRI)

  7. Change in insulin secretion

    Time frame: Week 12, Week 28

    Determined by measuring C-peptide kinetics following the liquid meal

  8. Change in hormonal response

    Time frame: Week 12, Week 28

    Multiplex assay

  9. Change in metabolite response

    Time frame: Week 12, Week 28

    Colorimetric assay

  10. Change in plasma distribution of DFA metabolites

    Time frame: Week 12, Week 28

    calculated from i.v. and oral stable isotope tracers (mass spectrometry) incorporated into triglyceride-rich lipoproteins and NEFA.

  11. Change in glycerol turnover

    Time frame: Week 12, Week 28

    calculated from [1,1,2,3,3-2H]-glycerol i.v.

  12. Change in total substrate utilisation

    Time frame: Week 12, Week 28

    measured by using indirect calorimetry

  13. Change in insulin resistance /sensitivity

    Time frame: Week 12, Week 28

    Determined by measuring circulating glucose, NEFA and insulin following the liquid meal.

  14. Circulating markers of hepatic inflammation

    Time frame: Week1, Week 12, Week 16, Week 28

    Measurement of Alanine aminotransferase (ALT), Aspartate transaminase (AST) and platelet count for calculation of fibrosis-4 which is an index for liver fibrosis.

  15. Adverse events

    Time frame: up to 28 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Frédérique Frisch

CONTACT

[email protected]

1-819-346-1110 ext. 12394

Sponsors and collaborators

Lead sponsor

Université de Sherbrooke

Other

Collaborators

  • CHU de Quebec-Universite Laval
  • Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Registry information

Official study title

Stimulating Adipose Tissue Fatty Acid Disposal With Low-dose, Postprandial, Intermittent Niacin for the Treatment of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD).

Acronym: AGL13

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 24, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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