Trial Outcomes & Findings for Safety And Efficacy Study Of Orally Administered Epeleuton In Patients With NAFLD (NCT NCT02941549)

NCT ID: NCT02941549

Last Updated: 2022-10-12

Results Overview

Change in serum ALT from baseline to Week 16 using ANCOVA.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

96 participants

Primary outcome timeframe

16 Weeks

Results posted on

2022-10-12

Participant Flow

A total of 96 patients were randomised in a 1:1:1 ratio.

Participant milestones

Participant milestones
Measure	Placebo 2 x placebo 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks	1000 mg Epeleuton 1 x Epeleuton 500 mg capsule and 1 x placebo 500 mg capsule orally administered twice a day (4 capsules daily) for 16 weeks	2000mg Epeleuton 2 x Epeleuton 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks
Overall Study STARTED	31	32	33
Overall Study COMPLETED	28	31	31
Overall Study NOT COMPLETED	3	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo 2 x placebo 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks	1000 mg Epeleuton 1 x Epeleuton 500 mg capsule and 1 x placebo 500 mg capsule orally administered twice a day (4 capsules daily) for 16 weeks	2000mg Epeleuton 2 x Epeleuton 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks
Overall Study Adverse Event	1	0	0
Overall Study Withdrawal by Subject	2	1	2

Baseline Characteristics

Safety And Efficacy Study Of Orally Administered Epeleuton In Patients With NAFLD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=31 Participants 2 x placebo 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks	1000 mg Epeleuton n=32 Participants 1 x Epeleuton 500 mg capsule and 1 x placebo 500 mg capsule orally administered twice a day (4 capsules daily) for 16 weeks	2000 mg Epeleuton n=33 Participants 2 x Epeleuton 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks	Total n=96 Participants Total of all reporting groups
Age, Continuous	48.4 years STANDARD_DEVIATION 11.67 • n=5 Participants	50.8 years STANDARD_DEVIATION 13.72 • n=7 Participants	46.1 years STANDARD_DEVIATION 11.92 • n=5 Participants	48.4 years STANDARD_DEVIATION 12.44 • n=4 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	12 Participants n=7 Participants	12 Participants n=5 Participants	33 Participants n=4 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	20 Participants n=7 Participants	21 Participants n=5 Participants	63 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants	30 Participants n=7 Participants	33 Participants n=5 Participants	91 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants

PRIMARY outcome

Timeframe: 16 Weeks

Population: The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement.

Change in serum ALT from baseline to Week 16 using ANCOVA.

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants 2 x placebo 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.	1000 mg Epeleuton n=32 Participants 1 x Epeleuton 500 mg capsule and 1 x placebo 500 mg capsule orally administered twice a day (4 capsules daily) for 16 weeks.	2000 mg Epeleuton n=31 Participants 2 x Epeleuton 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.
Change in Serum ALT (Alanine Aminotransferase) From Baseline to Week 16	-16.3 U/L Interval -44.2 to 11.7	-6.9 U/L Interval -34.5 to 20.7	-10.1 U/L Interval -36.9 to 16.8

PRIMARY outcome

Timeframe: 16 Weeks

Population: The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement.

To evaluate change in liver stiffness measurements using Transient Elastography from baseline to Week 16 using FibroScan® 502 Touch model or equivalent.

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants 2 x placebo 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.	1000 mg Epeleuton n=32 Participants 1 x Epeleuton 500 mg capsule and 1 x placebo 500 mg capsule orally administered twice a day (4 capsules daily) for 16 weeks.	2000 mg Epeleuton n=31 Participants 2 x Epeleuton 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.
Change in Liver Stiffness Measurements by Transient Elastography From Baseline to Week 16	-2.226 kPa Interval -3.07 to -1.38	-1.308 kPa Interval -2.11 to -0.51	-0.727 kPa Interval -1.55 to 0.1

PRIMARY outcome

Timeframe: 20 Weeks

Population: The Safety Analysis Set consists of all patients who took at least one administration of study treatment. Patients were analysed according to the treatment actually taken.

Subjects with at least 1 TEAE leading to treatment discontinuation

Outcome measures

Outcome measures
Measure	Placebo n=31 Participants 2 x placebo 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.	1000 mg Epeleuton n=32 Participants 1 x Epeleuton 500 mg capsule and 1 x placebo 500 mg capsule orally administered twice a day (4 capsules daily) for 16 weeks.	2000 mg Epeleuton n=33 Participants 2 x Epeleuton 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.
Number of Treatment Emergent Adverse Events (TEAEs) in Each Treatment Group Leading to Treatment Discontinuation	1 TEAEs	0 TEAEs	0 TEAEs

SECONDARY outcome

Timeframe: 12 Weeks

Population: The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement.

Change in serum ALT from baseline to weeks 2, 4, 8 and 12.

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants 2 x placebo 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.	1000 mg Epeleuton n=32 Participants 1 x Epeleuton 500 mg capsule and 1 x placebo 500 mg capsule orally administered twice a day (4 capsules daily) for 16 weeks.	2000 mg Epeleuton n=31 Participants 2 x Epeleuton 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.
Change in Serum ALT (Alanine Aminotransferase) From Baseline to Weeks 2, 4, 8 and 12 Change from Baseline to Week 4	-3.4 U/L Interval -14.9 to 8.2	4.0 U/L Interval -7.6 to 15.7	-1.9 U/L Interval -13.0 to 9.3
Change in Serum ALT (Alanine Aminotransferase) From Baseline to Weeks 2, 4, 8 and 12 Change from Baseline to Week 2	-0.4 U/L Interval -13.3 to 12.4	-0.1 U/L Interval -13.0 to 12.8	-5.8 U/L Interval -18.2 to 6.6
Change in Serum ALT (Alanine Aminotransferase) From Baseline to Weeks 2, 4, 8 and 12 Change from Baseline to Week 8	-8.7 U/L Interval -23.1 to 5.7	-12.7 U/L Interval -27.1 to 1.6	-3.8 U/L Interval -17.4 to 9.9
Change in Serum ALT (Alanine Aminotransferase) From Baseline to Weeks 2, 4, 8 and 12 Change from Baseline to Week 12	-18.3 U/L Interval -45.3 to 8.8	-19.2 U/L Interval -45.3 to 6.9	-3.8 U/L Interval -28.7 to 21.0

SECONDARY outcome

Timeframe: 16 Weeks

Population: The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement.

Change in serum AST from baseline to weeks 2, 4, 8, 12 and 16.

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants 2 x placebo 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.	1000 mg Epeleuton n=32 Participants 1 x Epeleuton 500 mg capsule and 1 x placebo 500 mg capsule orally administered twice a day (4 capsules daily) for 16 weeks.	2000 mg Epeleuton n=31 Participants 2 x Epeleuton 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.
Change in AST (Aspartate Aminotransferase) From Baseline to Weeks 2, 4, 8, 12 and 16 Change from Baseline to Week 16	-8.9 U/L Interval -35.4 to 17.6	7.7 U/L Interval -18.3 to 33.7	-4.6 U/L Interval -32.5 to 23.4
Change in AST (Aspartate Aminotransferase) From Baseline to Weeks 2, 4, 8, 12 and 16 Change from Baseline to Week 2	-5.6 U/L Interval -22.1 to 10.8	-4.9 U/L Interval -21.3 to 11.5	4.9 U/L Interval -11.3 to 21.1
Change in AST (Aspartate Aminotransferase) From Baseline to Weeks 2, 4, 8, 12 and 16 Change from Baseline to Week 4	-4.0 U/L Interval -12.5 to 4.6	-1.1 U/L Interval -9.7 to 7.5	2.0 U/L Interval -6.4 to 10.5
Change in AST (Aspartate Aminotransferase) From Baseline to Weeks 2, 4, 8, 12 and 16 Change from Baseline to Week 8	-4.6 U/L Interval -13.1 to 3.8	-9.9 U/L Interval -18.2 to -1.6	-0.9 U/L Interval -9.0 to 7.2
Change in AST (Aspartate Aminotransferase) From Baseline to Weeks 2, 4, 8, 12 and 16 Change from Baseline to Week 12	-13.7 U/L Interval -28.3 to 0.9	-11.2 U/L Interval -25.3 to 2.8	-3.2 U/L Interval -17.0 to 10.5

SECONDARY outcome

Timeframe: 16 Weeks

Population: The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement.

Change in AST: ALT ratio from baseline to weeks 2, 4, 8, 12 and 16.

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants 2 x placebo 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.	1000 mg Epeleuton n=32 Participants 1 x Epeleuton 500 mg capsule and 1 x placebo 500 mg capsule orally administered twice a day (4 capsules daily) for 16 weeks.	2000 mg Epeleuton n=31 Participants 2 x Epeleuton 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.
Change in AST:ALT Ratio From Baseline to Weeks 2, 4, 8, 12 and 16 Change from Baseline to Week 12	0.02 Ratio Interval -0.07 to 0.11	0.03 Ratio Interval -0.05 to 0.11	0.01 Ratio Interval -0.07 to 0.09
Change in AST:ALT Ratio From Baseline to Weeks 2, 4, 8, 12 and 16 Change from Baseline to Week 16	0.03 Ratio Interval -0.07 to 0.14	0.10 Ratio Interval 0.01 to 0.19	0.02 Ratio Interval -0.08 to 0.13
Change in AST:ALT Ratio From Baseline to Weeks 2, 4, 8, 12 and 16 Change from Baseline to Week 2	0.00 Ratio Interval -0.12 to 0.12	-0.04 Ratio Interval -0.15 to 0.07	0.05 Ratio Interval -0.06 to 0.16
Change in AST:ALT Ratio From Baseline to Weeks 2, 4, 8, 12 and 16 Change from Baseline to Week 4	0.02 Ratio Interval -0.06 to 0.09	-0.03 Ratio Interval -0.1 to 0.05	0.06 Ratio Interval -0.02 to 0.13
Change in AST:ALT Ratio From Baseline to Weeks 2, 4, 8, 12 and 16 Change from Baseline to Week 8	0.01 Ratio Interval -0.06 to 0.08	0.00 Ratio Interval -0.06 to 0.06	0.03 Ratio Interval -0.04 to 0.09

SECONDARY outcome

Timeframe: 16 Weeks

Population: The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement for FIB-4 Index.

Change in FIB-4 Index from baseline to week 16. This index is based on age, platelet count, ALT level, and AST level and will be assessed at Baseline (Visit 2) and week 16 (Visit 10). FIB-4 was calculated using the following formula: FIB4 = (Age (years) x AST (U/L))/(Platelet count (10\^9/L) x √ALT (U/L)). A decrease in FIB-4 represents a positive outcome. A FIB-4 Index of \<1.45 indicates none to moderate fibrosis and an Index of \>3.25 indicates advanced fibrosis.

Outcome measures

Outcome measures
Measure	Placebo n=24 Participants 2 x placebo 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.	1000 mg Epeleuton n=27 Participants 1 x Epeleuton 500 mg capsule and 1 x placebo 500 mg capsule orally administered twice a day (4 capsules daily) for 16 weeks.	2000 mg Epeleuton n=25 Participants 2 x Epeleuton 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.
Change in FIB-4 Index From Baseline to Week 16	-0.109 Scores on a scale Interval -0.398 to 0.181	0.114 Scores on a scale Interval -0.196 to 0.424	-0.068 Scores on a scale Interval -0.384 to 0.248

SECONDARY outcome

Timeframe: 16 Weeks

Population: The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement for NFS.

Change in NAFLD fibrosis score (NFS) from baseline to week 16. The NFS is based on age, hyperglycemia, BMI, platelet count, albumin level, and AST/ALT ratio. NFS was calculated using the following formula: NAFLD fibrosis score = -1.675 + 0.037 × age (years) + 0.094 × BMI (kg/m\^2) + 1.13 × IFG/diabetes (yes = 1, no = 0) + 0.99 × AST/ALT ratio - 0.013 × platelet (×10\^9/l) - 0.66 × albumin (g/dl). A decrease in NFS score represents a positive outcome. An NFS score of \<-1.455 indicates no advanced fibrosis and a score of \>0.676 indicates liver fibrosis.

Outcome measures

Outcome measures
Measure	Placebo n=24 Participants 2 x placebo 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.	1000 mg Epeleuton n=27 Participants 1 x Epeleuton 500 mg capsule and 1 x placebo 500 mg capsule orally administered twice a day (4 capsules daily) for 16 weeks.	2000 mg Epeleuton n=25 Participants 2 x Epeleuton 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.
Change in Non-Alcoholic Fatty Liver Disease (NAFLD) Fibrosis Score (NFS) From Baseline to Week 16	-0.0073 Scores on a scale Interval -0.2653 to 0.2507	0.2250 Scores on a scale Interval -0.0529 to 0.5028	-0.0340 Scores on a scale Interval -0.3149 to 0.2469

SECONDARY outcome

Timeframe: 16 Weeks

Population: The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement for ELF.

Change in ELF from baseline to week 16. Enhanced Liver Fibrosis score is an extracellular matrix marker set consisting of tissue inhibitor of metalloproteinases 1 (TIMP-1), amino-terminal propeptide of type III procollagen (PIIINP) and hyaluronic acid (HA). A decrease in ELF score represents a positive outcome. The ELF score was calculated for the instrument based on the following equation: ELF score = 2.494 + 0.846 In (CHA) + 0.735 In (CPIIINP) + 0.391 In (CTIMP-1). An ELF score of less than 7.7 indicates no fibrosis. An ELF score greater than or equal to 9.8 indicates severe fibrosis. An ELF score of 11.3 or greater indicates cirrhosis.

Outcome measures

Outcome measures
Measure	Placebo n=25 Participants 2 x placebo 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.	1000 mg Epeleuton n=29 Participants 1 x Epeleuton 500 mg capsule and 1 x placebo 500 mg capsule orally administered twice a day (4 capsules daily) for 16 weeks.	2000 mg Epeleuton n=29 Participants 2 x Epeleuton 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.
Change in ELF (Enhanced Liver Fibrosis Score) From Baseline to Week 16	0.24 Scores on a scale Interval -0.09 to 0.56	0.10 Scores on a scale Interval -0.19 to 0.39	0.01 Scores on a scale Interval -0.29 to 0.31

SECONDARY outcome

Timeframe: 16 Weeks

Population: The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement.

Change in HOMA-IR from baseline to weeks 2,4,8,12,16. Homeostatic model assessment for insulin resistance (HOMA-IR) was assessed as a measure of insulin resistance. HOMA-IR is calculated by multiplying fasting plasma insulin by fasting plasma glucose, then dividing by the constant 405. A decrease in HOMA-IR indicates a positive outcome. HOMA-IR values of greater than 1.9 indicates early insulin resistance and levels above 2.9 indicate significant insulin resistance.

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants 2 x placebo 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.	1000 mg Epeleuton n=31 Participants 1 x Epeleuton 500 mg capsule and 1 x placebo 500 mg capsule orally administered twice a day (4 capsules daily) for 16 weeks.	2000 mg Epeleuton n=31 Participants 2 x Epeleuton 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.
Change in HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) From Baseline to Weeks 2, 4, 8, 12 and 16 Change from Baseline to Week 4	2.175 HOMA-IR Interval -1.393 to 5.743	-0.540 HOMA-IR Interval -4.154 to 3.075	2.347 HOMA-IR Interval -1.166 to 5.86
Change in HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) From Baseline to Weeks 2, 4, 8, 12 and 16 Change from Baseline to Week 2	1.208 HOMA-IR Interval -1.102 to 3.518	1.250 HOMA-IR Interval -1.024 to 3.525	-0.569 HOMA-IR Interval -2.762 to 1.623
Change in HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) From Baseline to Weeks 2, 4, 8, 12 and 16 Change from Baseline to Week 8	6.606 HOMA-IR Interval 0.563 to 12.649	1.817 HOMA-IR Interval -4.28 to 7.913	4.283 HOMA-IR Interval -1.707 to 10.273
Change in HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) From Baseline to Weeks 2, 4, 8, 12 and 16 Change from Baseline to Week 12	-0.045 HOMA-IR Interval -1.769 to 1.68	0.00 HOMA-IR Interval -1.677 to 1.678	-0.258 HOMA-IR Interval -1.858 to 1.343
Change in HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) From Baseline to Weeks 2, 4, 8, 12 and 16 Change from Baseline to Week 16	-0.393 HOMA-IR Interval -1.31 to 0.524	-0.326 HOMA-IR Interval -1.234 to 0.582	-2.037 HOMA-IR Interval -2.912 to -1.162

SECONDARY outcome

Timeframe: 16 Weeks

Population: The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement.

Change in Adipo-IR from baseline to weeks 2, 4, 8, 12 and 16. Adipose tissue insulin resistance (Adipo-IR) was assessed as a measure of insulin resistance. Adipo- IR is calculated by multiplying fasting non-esterified fatty acids by fasting insulin. A decrease in Adipo-IR indicates a positive outcome.

Outcome measures

Outcome measures
Measure	Placebo n=30 Participants 2 x placebo 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.	1000 mg Epeleuton n=31 Participants 1 x Epeleuton 500 mg capsule and 1 x placebo 500 mg capsule orally administered twice a day (4 capsules daily) for 16 weeks.	2000 mg Epeleuton n=31 Participants 2 x Epeleuton 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.
Change in Adipo-IR (Adipose Tissue Insulin Resistance) From Baseline to Weeks 2, 4, 8, 12 and 16. Change from Baseline to Week 2	9.69 Adipo-IR Interval -6.05 to 25.42	-5.55 Adipo-IR Interval -21.08 to 9.97	-10.80 Adipo-IR Interval -25.66 to 4.06
Change in Adipo-IR (Adipose Tissue Insulin Resistance) From Baseline to Weeks 2, 4, 8, 12 and 16. Change from Baseline to Week 4	24.88 Adipo-IR Interval 1.94 to 47.82	3.45 Adipo-IR Interval -19.86 to 26.75	4.19 Adipo-IR Interval -18.09 to 26.47
Change in Adipo-IR (Adipose Tissue Insulin Resistance) From Baseline to Weeks 2, 4, 8, 12 and 16. Change from Baseline to Week 8	25.52 Adipo-IR Interval 5.86 to 45.18	10.40 Adipo-IR Interval -9.28 to 30.07	6.63 Adipo-IR Interval -11.79 to 25.05
Change in Adipo-IR (Adipose Tissue Insulin Resistance) From Baseline to Weeks 2, 4, 8, 12 and 16. Change from Baseline to Week 12	4.20 Adipo-IR Interval -12.46 to 20.86	-6.28 Adipo-IR Interval -22.88 to 10.32	-20.66 Adipo-IR Interval -36.35 to -4.97
Change in Adipo-IR (Adipose Tissue Insulin Resistance) From Baseline to Weeks 2, 4, 8, 12 and 16. Change from Baseline to Week 16	3.66 Adipo-IR Interval -12.54 to 19.86	-10.68 Adipo-IR Interval -26.8 to 5.43	-21.07 Adipo-IR Interval -36.44 to -5.69

SECONDARY outcome

Timeframe: 16 Weeks

Population: The Full Analysis Set (FAS) includes all randomised patients who received at least one administration of study treatment and have at least one post-baseline measurement for hepatic fat measured by CAP.

Change in hepatic fat measured by CAP (controlled attenuation parameter) from baseline to week 16 using FibroScan® 502 Touch model or equivalent. CAP score is measured in decibels per meter (dB/m). A reduction in hepatic fat measured non-invasively by CAP indicates an improvement in hepatic steatosis. CAP scores range from 100 to 400dB/m. 0 to 237 dB/M indicates no hepatic steatosis, 238 to 260 dB/m indicates mild hepatic steatosis, 260 to 290 dB/m indicates moderate steatosis and a CAP score greater than 290 dB/m indicates severe steatosis.

Outcome measures

Outcome measures
Measure	Placebo n=27 Participants 2 x placebo 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.	1000 mg Epeleuton n=31 Participants 1 x Epeleuton 500 mg capsule and 1 x placebo 500 mg capsule orally administered twice a day (4 capsules daily) for 16 weeks.	2000 mg Epeleuton n=29 Participants 2 x Epeleuton 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks.
Change in Hepatic Fat Measured by CAP (Controlled Attenuation Parameter) From Baseline to Week 16.	-12.3 dB/m Interval -34.4 to 9.9	-16.3 dB/m Interval -36.8 to 4.1	-22.4 dB/m Interval -43.0 to -1.8

Adverse Events

Placebo

Serious events: 1 serious events

Other events: 16 other events

Deaths: 0 deaths

1000 mg Epeleuton

Serious events: 0 serious events

Other events: 20 other events

Deaths: 0 deaths

2000 mg Epeleuton

Serious events: 1 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=31 participants at risk 2 x placebo 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks	1000 mg Epeleuton n=32 participants at risk 1 x Epeleuton 500 mg capsule and 1 x placebo 500 mg capsule orally administered twice a day (4 capsules daily) for 16 weeks	2000 mg Epeleuton n=33 participants at risk 2 x Epeleuton 500 mg capsules orally administered twice a day (4 capsules daily) for 16 weeks
Infections and infestations Pilonidal Cyst	3.2% 1/31 • Up to 20 Weeks An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational IMP(s). All Adverse Events (AEs) must be recorded in the CRF, defining relationship to IMP and severity. AEs should also be recorded by the Investigator in the patient file/notes.	0.00% 0/32 • Up to 20 Weeks An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational IMP(s). All Adverse Events (AEs) must be recorded in the CRF, defining relationship to IMP and severity. AEs should also be recorded by the Investigator in the patient file/notes.	0.00% 0/33 • Up to 20 Weeks An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational IMP(s). All Adverse Events (AEs) must be recorded in the CRF, defining relationship to IMP and severity. AEs should also be recorded by the Investigator in the patient file/notes.
Psychiatric disorders Schizophrenia	0.00% 0/31 • Up to 20 Weeks An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational IMP(s). All Adverse Events (AEs) must be recorded in the CRF, defining relationship to IMP and severity. AEs should also be recorded by the Investigator in the patient file/notes.	0.00% 0/32 • Up to 20 Weeks An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational IMP(s). All Adverse Events (AEs) must be recorded in the CRF, defining relationship to IMP and severity. AEs should also be recorded by the Investigator in the patient file/notes.	3.0% 1/33 • Up to 20 Weeks An adverse event is any undesirable experience occurring to a patient that has signed the ICF and who has taken their first dose of the study drug, whether or not considered related to the investigational IMP(s). All Adverse Events (AEs) must be recorded in the CRF, defining relationship to IMP and severity. AEs should also be recorded by the Investigator in the patient file/notes.

Other adverse events

Additional Information

Study Director

Afimmune

Phone: +3532946380

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place