Trial Outcomes & Findings for Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease (NCT NCT04031729)

NCT ID: NCT04031729

Last Updated: 2024-05-24

Results Overview

Absolute percentage change in intrahepatic lipid content, quantified by 1H-MRS

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 80 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2024-05-24

Participant Flow

Participant milestones

Measure	Aspirin Low-dose (81mg) aspirin tablets Aspirin 81 mg: Aspirin 81mg tablets will be given once daily, for the duration of the clinical trial.	Placebo Placebo tablets Placebo oral tablet: Identical, blinded placebo tablets will be given once daily, for the duration of the clinical trial.
Overall Study STARTED	40	40
Overall Study COMPLETED	37	34
Overall Study NOT COMPLETED	3	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease

Baseline characteristics by cohort

Measure	Aspirin n=40 Participants Low-dose (81mg) aspirin tablets Aspirin 81 mg: Aspirin 81mg tablets will be given once daily, for the duration of the clinical trial.	Placebo n=40 Participants Placebo tablets Placebo oral tablet: Identical, blinded placebo tablets will be given once daily, for the duration of the clinical trial.	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants	36 Participants n=7 Participants	73 Participants n=5 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Age, Continuous	46.6 years n=5 Participants	49.3 years n=7 Participants	47.9 years n=5 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	23 Participants n=7 Participants	44 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	17 Participants n=7 Participants	36 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American, non-Hispanic	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race/Ethnicity, Customized White, non-Hispanic	30 Participants n=5 Participants	33 Participants n=7 Participants	63 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants	40 participants n=7 Participants	80 participants n=5 Participants
Baseline hepatic lipid content (%) by 1H_MRS	39.1 percentage of hepatic lipid content STANDARD_DEVIATION 26.1 • n=5 Participants	31.4 percentage of hepatic lipid content STANDARD_DEVIATION 24.8 • n=7 Participants	35.0 percentage of hepatic lipid content STANDARD_DEVIATION 20.4 • n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Absolute percentage change in intrahepatic lipid content, quantified by 1H-MRS

Outcome measures

Measure	Aspirin n=40 Participants Low-dose (81mg) aspirin tablets Aspirin 81 mg: Aspirin 81mg tablets will be given once daily, for the duration of the clinical trial.	Placebo n=40 Participants Placebo tablets Placebo oral tablet: Identical, blinded placebo tablets will be given once daily, for the duration of the clinical trial.
Absolute Change in Intrahepatic Lipid Content, by 1H-MRS	-6.6 Mean absolute percentage change Interval -11.9 to -1.3	3.6 Mean absolute percentage change Interval -1.7 to 8.9

SECONDARY outcome

Timeframe: 6 months

Relative percentage point change in intrahepatic lipid content

Outcome measures

Measure	Aspirin n=40 Participants Low-dose (81mg) aspirin tablets Aspirin 81 mg: Aspirin 81mg tablets will be given once daily, for the duration of the clinical trial.	Placebo n=40 Participants Placebo tablets Placebo oral tablet: Identical, blinded placebo tablets will be given once daily, for the duration of the clinical trial.
Relative Change in Intrahepatic Lipid Content	-8.8 Mean percentage point change Interval -28.3 to 10.8	30.0 Mean percentage point change Interval 10.4 to 49.6

Adverse Events

Aspirin

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Aspirin n=40 participants at risk Low-dose (81mg) aspirin tablets Aspirin 81 mg: Aspirin 81mg tablets will be given once daily, for the duration of the clinical trial.	Placebo n=40 participants at risk Placebo tablets Placebo oral tablet: Identical, blinded placebo tablets will be given once daily, for the duration of the clinical trial.
Respiratory, thoracic and mediastinal disorders COVID-19 infection	2.5% 1/40 • Number of events 1 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.	0.00% 0/40 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.
Musculoskeletal and connective tissue disorders Gout	0.00% 0/40 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.	2.5% 1/40 • Number of events 1 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.

Other adverse events

Measure	Aspirin n=40 participants at risk Low-dose (81mg) aspirin tablets Aspirin 81 mg: Aspirin 81mg tablets will be given once daily, for the duration of the clinical trial.	Placebo n=40 participants at risk Placebo tablets Placebo oral tablet: Identical, blinded placebo tablets will be given once daily, for the duration of the clinical trial.
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	7.5% 3/40 • Number of events 3 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.	10.0% 4/40 • Number of events 4 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.
Musculoskeletal and connective tissue disorders Arthralgias	5.0% 2/40 • Number of events 2 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.	5.0% 2/40 • Number of events 2 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.
Musculoskeletal and connective tissue disorders Myalgias	2.5% 1/40 • Number of events 1 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.	7.5% 3/40 • Number of events 3 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.
Infections and infestations Other infection	2.5% 1/40 • Number of events 1 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.	2.5% 1/40 • Number of events 1 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.
Infections and infestations Fever	2.5% 1/40 • Number of events 1 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.	0.00% 0/40 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.
Gastrointestinal disorders Nausea	2.5% 1/40 • Number of events 1 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.	0.00% 0/40 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.
Cardiac disorders Tachycardia	2.5% 1/40 • Number of events 1 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.	0.00% 0/40 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.
Nervous system disorders Paresthesia	2.5% 1/40 • Number of events 1 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.	0.00% 0/40 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.
Renal and urinary disorders Kidney stone	2.5% 1/40 • Number of events 1 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.	0.00% 0/40 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.
Gastrointestinal disorders Abdominal pain	0.00% 0/40 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.	2.5% 1/40 • Number of events 1 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.
Psychiatric disorders Depression	0.00% 0/40 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.	2.5% 1/40 • Number of events 1 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.
Cardiac disorders Atherosclerosis	0.00% 0/40 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.	2.5% 1/40 • Number of events 1 • Adverse event data were collected for each trial participant from the date of screening to the final 6-month study visit date.

Additional Information

Dr. Tracey Simon

Massachusetts General Hospital

Phone: 617-724-2401

Email: tgsimon@partners.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place