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

NCT06843148 | Recruiting DMC

• 1 other identifier: 2025-5648
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 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

Conditions

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

Keywords

Fatty liver; Niacin; vitamin B3; nicotinic acid

Outcome Measures

Primary Outcomes (1)

• Prolonged small-dose niacin treatment does not lead to desensitization of the niacin-induced reduction in hepatic total fatty acids flux.

  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.

  Week 12, Week 28

Secondary Outcomes (15)

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

  Week 12, Week 28

• Change in total hepatic fatty acid flux

  Week 12, Week 28

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

  Week 12, Week 28

• Change in Endogenous Glucose production and meal glucose systemic flux

  Week 12, Week 28

• Change in plasma NEFA flux

  Week 12, Week 28

Study Arms (2)

Placebo group

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Niacin group

ACTIVE COMPARATOR

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

Drug: Niacin (250mg)

Interventions

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)

Placebo group

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)

Also known as: Nicotinic Acid, Vitamin B3

Niacin group

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 \[106-109\].
• Other hepatic disease.
• Previous diagnosis of diabetes.
• Overt cardiovascular or renal disease, cancer (other than non-melanoma skin cancer), or other uncontrolled medical conditions.
• Any contraindication to MRI.
• Previous intolerance or allergy to nicotinic acid.
• 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
• Smoking (\>1 cigarette/day) and/or consumption of \>2 alcoholic beverages per day.

Sponsors & Collaborators

• Centre hospitalier universitaire de Québec- Université Laval: collaborator
• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: collaborator
• Université de Sherbrooke: lead

Study Sites (1)

Centre de recherche du CHUS

Sherbrooke, Quebec, J1H 5N4, Canada

RECRUITING

MeSH Terms

Conditions

Fatty Liver

Interventions

Niacin; Niacinamide

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• André Carpentier, MD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Frédérique Frisch

CONTACT

1-819-346-1110; frederique.frisch@usherbrooke.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Tenure professor

Study Record Dates

• First Submitted: February 12, 2025
• First Posted: February 24, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

CA (1)