Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)AGL13NCT06843148
Stimulating Fat Tissue Storage With Niacin to Reduce Fat Accumulation in the Liver.
A study testing Niacin (250mg) in people with Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) and Liver Fibrosis/NASH, run by Université de Sherbrooke at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), Liver Fibrosis/NASH, Non-Alcoholic Steato-Hepatitis (NASH)
- What is being tested?
- Niacin (250mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 22 Jun 2026to Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Centre de recherche du CHUS
Sherbrooke, Quebec, J1H 5N4
Frédérique Frisch, 1-819-346-1110 ext. 12394, frederique.frisch@usherbrooke.ca
About this study
Official title: Stimulating Adipose Tissue Fatty Acid Disposal With Low-dose, Postprandial, Intermittent Niacin for the Treatment of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD).
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.
Read more
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
Read the detailed 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.
- Conditions
- Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), Liver Fibrosis/NASH, Non-Alcoholic Steato-Hepatitis (NASH)
- Being tested
- Niacin (250mg), Placebo Oral Tablet
- Keywords
- Fatty liver, Niacin, vitamin B3, nicotinic acid
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Niacin (250mg)Drug
Also called Nicotinic Acid, Vitamin B3
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 TabletDrug
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Niacin (250mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12, Week 28
Secondary outcomes (15)
Change in White Adipose Tissue (WAT) and lean tissue Dietary Fatty Acid (DFA) uptake
Determined from the same static (whole-body) acquisition image using oral administration of [18F]-Fluoro-6-Thia-Heptadecanoic Acid (FTHA)
Measured: Week 12, Week 28
Change in total hepatic fatty acid flux
represents the sum of the rate of NEFA uptake and DFA uptake (PET scan using [18F]-FTHA and [11C]-palmitate
Measured: Week 12, Week 28
Change in hepatic Non-Esterified-Fatty-Acid (NEFA) uptake oxidation, esterification and secretion into very low-density lipoprotein (VLDL)
[11C]-Palmitate PET. Calculated from the same multicompartmental equation using liver [11C]-palmitate kinetics
Measured: Week 12, Week 28
Change in Endogenous Glucose production and meal glucose systemic flux
i.v. and oral stable isotope tracer
Measured: Week 12, Week 28
Change in plasma NEFA flux
calculated from i.v. stable isotope tracer (mass spectrometry).
Measured: Week 12, Week 28
Change in hepatic Triglyceride (TG) content
magnetic resonance imaging (MRI)
Measured: Week 12, Week 28
Change in insulin secretion
Determined by measuring C-peptide kinetics following the liquid meal
Measured: Week 12, Week 28
Change in hormonal response
Multiplex assay
Measured: Week 12, Week 28
Change in metabolite response
Colorimetric assay
Measured: Week 12, Week 28
Change in plasma distribution of DFA metabolites
calculated from i.v. and oral stable isotope tracers (mass spectrometry) incorporated into triglyceride-rich lipoproteins and NEFA.
Measured: Week 12, Week 28
Change in glycerol turnover
calculated from [1,1,2,3,3-2H]-glycerol i.v.
Measured: Week 12, Week 28
Change in total substrate utilisation
measured by using indirect calorimetry
Measured: Week 12, Week 28
Change in insulin resistance /sensitivity
Determined by measuring circulating glucose, NEFA and insulin following the liquid meal.
Measured: Week 12, Week 28
Circulating markers of hepatic inflammation
Measurement of Alanine aminotransferase (ALT), Aspartate transaminase (AST) and platelet count for calculation of fibrosis-4 which is an index for liver fibrosis.
Measured: Week1, Week 12, Week 16, Week 28
Adverse events
Measured: up to 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start22 Jun 2026
- Primary completionMar 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD)Studies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- CHU de Quebec-Universite Laval, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Responsible party
- Principal investigator, André Carpentier, Université de Sherbrooke
- Investigators
- André Carpentier, MD, Principal investigator, Université de Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06843148
- Sponsor's protocol ID
- 2025-5648
- Acronym
- AGL13
- Status last verified
- Jun 2026
- First submitted
- 12 Feb 2025
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulating Adipose Tissue Fatty Acid Disposal With Low-dose, Postprandial, Intermittent Niacin for the Treatment of Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD).
- ClinicalTrials.gov ID
- NCT06843148
- Acronym / sponsor ID
- AGL13 / 2025-5648
- Conditions
- Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), Liver Fibrosis/NASH, Non-Alcoholic Steato-Hepatitis (NASH)
- Keywords
- Fatty liver, Niacin, vitamin B3, nicotinic acid
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- CHU de Quebec-Universite Laval, Centre de recherche du Centre hospitalier universitaire de Sherbrooke
- Study start
- 22 Jun 2026 (actual)
- Primary completion
- Mar 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 24 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group | Placebo comparator | Drug: Placebo Oral TabletIt will be a 12-week treatment phase. The placebo treatment will be administered once daily, at the end of the largest meal. |
| Niacin group | Active comparator | Drug: Niacin (250mg)It will be a 12-week treatment phase. The treatment will be administered once daily, at the end of the largest meal. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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;
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Niacin (250mg)Also: Nicotinic Acid, Vitamin B3Niacin 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) | Drug | Niacin group |
| Placebo Oral TabletPlacebo 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) | Drug | Placebo group |
Primary outcome
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.
15 secondary outcomes
Change in White Adipose Tissue (WAT) and lean tissue Dietary Fatty Acid (DFA) uptake
Time frame: Week 12, Week 28
Change in total hepatic fatty acid flux
Time frame: Week 12, Week 28
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
Change in Endogenous Glucose production and meal glucose systemic flux
Time frame: Week 12, Week 28
Change in plasma NEFA flux
Time frame: Week 12, Week 28
Change in hepatic Triglyceride (TG) content
Time frame: Week 12, Week 28
Change in insulin secretion
Time frame: Week 12, Week 28
Change in hormonal response
Time frame: Week 12, Week 28
Change in metabolite response
Time frame: Week 12, Week 28
Change in plasma distribution of DFA metabolites
Time frame: Week 12, Week 28
Change in glycerol turnover
Time frame: Week 12, Week 28
Change in total substrate utilisation
Time frame: Week 12, Week 28
Change in insulin resistance /sensitivity
Time frame: Week 12, Week 28
Circulating markers of hepatic inflammation
Time frame: Week1, Week 12, Week 16, Week 28
Adverse events
Time frame: up to 28 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
André Carpentier, MD principal investigator
Université de Sherbrooke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Niacin (250mg) in people with Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) and Liver Fibrosis/NASH, run by Université de Sherbrooke at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Frédérique Frisch (1-819-346-1110 ext. 12394, frederique.frisch@usherbrooke.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026.