Once daily oral intake of elafibranor 120 mg during 3 months

Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis.

Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis.

Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis.

Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis.

Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis.

Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis.

Blood samples were taken after minimum 10 hours of fasting. Baseline was defined as the last measurement before first intake of study treatment on Day 1.

HOMA IR measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR = fasting plasma insulin (micro international units per milliliter [mcIU/mL]) * fasting plasma glucose (mmol/L) / 22.5. A higher value indicates a greater insulin resistance. Blood samples were taken after minimum 10 hours of fasting. Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Blood samples were taken after minimum 10 hours of fasting. Baseline was defined as the last measurement before first intake of study treatment on Day 1. Here, "mIU/L" was abbreviated as "milli-international unit per liter".

Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Baseline was defined as the last measurement before first intake of study treatment on Day 1.

The BMI for a given age (in years) and gender (male) was converted to an exact z-score. Given a participant's age, sex, BMI, and an appropriate reference standard, a BMI Z-score was determined. BMI Z-score >=85th percentile was considered as overweight. Z-score was a statistical measure to describe whether a mean was above or below the standard. A Z-score of 0 was equal to the mean and is considered normal. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. Negative values are indicative of decrease in BMI (weight loss) and positive values are indicative of increase in BMI. Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Waist circumference (in centimeters [cm]) was measured at the midpoint between the lower margin of the least palpable rib and the top of the iliac crest. Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Blood samples to assess fibrinogen levels were taken after minimum 10 hours of fasting. Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Blood samples to assess Haptoglobin level were taken after minimum 10 hours of fasting. Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Blood samples to assess Interleukin-6 level were taken after minimum 10 hours of fasting. Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Blood samples to assess Necrosis Factor Alpha level were taken after minimum 10 hours of fasting. Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Blood samples to assess plasminogen activator inhibitor-1 level were taken after minimum 10 hours of fasting. Baseline was defined as the last measurement before first intake of study treatment on Day 1. Here, "IU/mL" was abbreviated as International units per milliliter.

The child, adolescent and parent/legal guardian PedsQL™ (Version 4.0) generic core scales was used to measure health-related quality of life (HRQOL). The response information was completed by the participant and by a parent/legal guardian individually. It consisted of 23 item questionnaire encompassing 4 core scale domains: Physical Functioning (8 items); Emotional Functioning (5 items); Social Functioning (5 items); and School Functioning (5 items). Items were scored on a 5 point Likert-type response scale: 0=never a problem to 1=almost never a problem; 2=sometimes a problem; 3=often a problem; and 4=almost always a problem). Once scored, items were reverse scored and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0), where higher scores indicated better HRQOL. Total Scale Score was the sum of all the items over the number of items answered on all the Scales. Baseline was defined as the last measurement before first intake of study treatment on Day 1.

An adverse event (AE) was any untoward medical in a participant or clinical investigation patient administered a pharmaceutical (investigational) product and which does not necessarily have to have a causal relationship with this treatment. A Serious adverse event (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization/prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was another medically important condition. TEAEs were defined as AEs that started prior to first study drug dose and that worsened after, and the AEs that started on or after first study drug dose. TEAEs: Serious and non-serious AEs.

ECG measurements were taken with the participants in resting position for at least 10 minutes. The investigator determined whether abnormal assessment results were clinically significant or not. The number of participants with abnormal clinically significant ECG findings were reported. Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Fasting blood samples (collected after 10 hours fasting) were used to assess the following clinical chemistry parameters: creatinine, glomerular filtration rate, creatinine clearance, total proteins, albumin, electrolytes (sodium, potassium, chloride, calcium), uric acid, urea nitrogen, urea, creatine phosphokinase (CPK), AST, ALT, GGT, ALP, total and conjugated bilirubin, high sensitivity C-reactive protein, fasting plasma glucose, fasting insulin, HOMA-IR, fructosamine, C-peptide, free fatty acids, glycated hemoglobin A1c, cystatin C. Abnormal clinical chemistry values were classified based on reference range: lower limit of normality (LLN); normal (>= LLN and <= upper limit of normality [ULN]); > ULN and <3 ULN; >=3 ULN and <5 ULN and >=5 ULN. Only the parameters for which at least one value of abnormality were reported and presented in this outcome measure.

Fasting blood samples (collected after 10 hours fasting) were used to assess the following hematology and coagulation parameters: hemoglobin, hematocrit, red blood cells (RBC), white blood cells (WBC), neutrophils, eosinophils, basophils, lymphocytes, monocytes, platelets, prothrombin time (PT) and international normalized ratio (INR). Hematology and coagulation values were classified based on the reference range: LLN; normal (>= LLN and <= ULN); > ULN and <3 ULN; >=3 ULN and <5 ULN and >=5 ULN.

Blood samples were collected to assess the following urinalysis parameters: alpha-1 macroglobulin, N-acetyl glucosamide, neutrophil gelatinase-associated lipocalin, albumin, and creatinine. Abnormal urinalysis values were classified based on the reference range: LLN; normal (>= LLN and <= ULN); > ULN and <3 ULN; >=3 ULN and <5 ULN and >=5 ULN.

Vital signs were taken before any invasive procedures. Following vital signs were assessed: systolic blood pressure, diastolic blood pressure, heart rate. Abnormal vita signs was defined as any abnormal findings in the vital sign parameters and were categorized as 'abnormal, not clinically significant (NCS)' and 'abnormal, clinically significant (CS)'.

Physical examination findings were collected according to pre-defined body systems: general appearance; skin; eyes; ears; nose; throat; neck and thyroid; lungs; heart; upper/lower extremities; lymph nodes; abdomen; musculoskeletal system; basic neurological assessment. Additional systems were evaluated as needed. Clinical significance was defined as any variation in assessment results that had medical relevance resulting in an alteration in medical care. Participants with at least one clinically significant abnormality in physical examination were reported and presented in this outcome measure. Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Total of all reporting groups

Tmax was defined as time to reach maximum observed plasma concentration.

Analysis was performed on PK population.

AUC0-24 defined as the area under the plasma concentration versus time curve of the study drug from time 0 to 24 hours.

Analysis was performed on PK population.

Plasma t1/2 was defined as the time taken by drug to reduce to half of its initial plasma concentration.

Analysis was performed on PK population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific categories.

Ctrough was defined as the plasma concentration of study drug observed just before treatment administration during repeated dosing.

Analysis was performed on PK population.

Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis. Normal range at screening: AST: 0 - 39 international units per liter (IU/L), ALT: 5 - 30 IU/L, GGT: 2 - 24 IU/L, and ALP: 74 - 390 IU/L.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific categories.

Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.

Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific categories.

Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.

Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific categories.

Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific categories.

Baseline was defined as the last measurement before first intake of study treatment on Day 1. Missing data were not imputed for the analysis.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.

Blood samples were taken after minimum 10 hours of fasting. Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.

HOMA IR measures insulin resistance based on fasting glucose and insulin measurements: HOMA IR = fasting plasma insulin (micro international units per milliliter [mcIU/mL]) * fasting plasma glucose (mmol/L) / 22.5. A higher value indicates a greater insulin resistance. Blood samples were taken after minimum 10 hours of fasting. Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.

Blood samples were taken after minimum 10 hours of fasting. Baseline was defined as the last measurement before first intake of study treatment on Day 1. Here, "mIU/L" was abbreviated as "milli-international unit per liter".

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.

Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.

Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.

Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.

Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific time points.

Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.

Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.

Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.

Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.

Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.

The BMI for a given age (in years) and gender (male) was converted to an exact z-score. Given a participant's age, sex, BMI, and an appropriate reference standard, a BMI Z-score was determined. BMI Z-score >=85th percentile was considered as overweight. Z-score was a statistical measure to describe whether a mean was above or below the standard. A Z-score of 0 was equal to the mean and is considered normal. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean. Negative values are indicative of decrease in BMI (weight loss) and positive values are indicative of increase in BMI. Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.

Waist circumference (in centimeters [cm]) was measured at the midpoint between the lower margin of the least palpable rib and the top of the iliac crest. Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.

Blood samples to assess fibrinogen levels were taken after minimum 10 hours of fasting. Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.

Blood samples to assess Haptoglobin level were taken after minimum 10 hours of fasting. Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.

Blood samples to assess Interleukin-6 level were taken after minimum 10 hours of fasting. Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.

Blood samples to assess Necrosis Factor Alpha level were taken after minimum 10 hours of fasting. Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.

Blood samples to assess plasminogen activator inhibitor-1 level were taken after minimum 10 hours of fasting. Baseline was defined as the last measurement before first intake of study treatment on Day 1. Here, "IU/mL" was abbreviated as International units per milliliter.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific timepoints.

The child, adolescent and parent/legal guardian PedsQL™ (Version 4.0) generic core scales was used to measure health-related quality of life (HRQOL). The response information was completed by the participant and by a parent/legal guardian individually. It consisted of 23 item questionnaire encompassing 4 core scale domains: Physical Functioning (8 items); Emotional Functioning (5 items); Social Functioning (5 items); and School Functioning (5 items). Items were scored on a 5 point Likert-type response scale: 0=never a problem to 1=almost never a problem; 2=sometimes a problem; 3=often a problem; and 4=almost always a problem). Once scored, items were reverse scored and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0), where higher scores indicated better HRQOL. Total Scale Score was the sum of all the items over the number of items answered on all the Scales. Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Analysis was performed on ITT population. Here, 'number analyzed' signifies participants who were evaluable for this outcome measure at the specific categories.

An adverse event (AE) was any untoward medical in a participant or clinical investigation patient administered a pharmaceutical (investigational) product and which does not necessarily have to have a causal relationship with this treatment. A Serious adverse event (SAE) was any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization/prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was another medically important condition. TEAEs were defined as AEs that started prior to first study drug dose and that worsened after, and the AEs that started on or after first study drug dose. TEAEs: Serious and non-serious AEs.

Analysis was performed safety population that included participants who had received at least one dose of study drug and had at least one post-baseline safety assessment.

ECG measurements were taken with the participants in resting position for at least 10 minutes. The investigator determined whether abnormal assessment results were clinically significant or not. The number of participants with abnormal clinically significant ECG findings were reported. Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Analysis was performed safety population.

Fasting blood samples (collected after 10 hours fasting) were used to assess the following clinical chemistry parameters: creatinine, glomerular filtration rate, creatinine clearance, total proteins, albumin, electrolytes (sodium, potassium, chloride, calcium), uric acid, urea nitrogen, urea, creatine phosphokinase (CPK), AST, ALT, GGT, ALP, total and conjugated bilirubin, high sensitivity C-reactive protein, fasting plasma glucose, fasting insulin, HOMA-IR, fructosamine, C-peptide, free fatty acids, glycated hemoglobin A1c, cystatin C. Abnormal clinical chemistry values were classified based on reference range: lower limit of normality (LLN); normal (>= LLN and <= upper limit of normality [ULN]); > ULN and <3 ULN; >=3 ULN and <5 ULN and >=5 ULN. Only the parameters for which at least one value of abnormality were reported and presented in this outcome measure.

Analysis was performed on safety population.

Fasting blood samples (collected after 10 hours fasting) were used to assess the following hematology and coagulation parameters: hemoglobin, hematocrit, red blood cells (RBC), white blood cells (WBC), neutrophils, eosinophils, basophils, lymphocytes, monocytes, platelets, prothrombin time (PT) and international normalized ratio (INR). Hematology and coagulation values were classified based on the reference range: LLN; normal (>= LLN and <= ULN); > ULN and <3 ULN; >=3 ULN and <5 ULN and >=5 ULN.

Analysis was performed on safety population.

Blood samples were collected to assess the following urinalysis parameters: alpha-1 macroglobulin, N-acetyl glucosamide, neutrophil gelatinase-associated lipocalin, albumin, and creatinine. Abnormal urinalysis values were classified based on the reference range: LLN; normal (>= LLN and <= ULN); > ULN and <3 ULN; >=3 ULN and <5 ULN and >=5 ULN.

Analysis was performed on safety population.

Vital signs were taken before any invasive procedures. Following vital signs were assessed: systolic blood pressure, diastolic blood pressure, heart rate. Abnormal vita signs was defined as any abnormal findings in the vital sign parameters and were categorized as 'abnormal, not clinically significant (NCS)' and 'abnormal, clinically significant (CS)'.

Analysis was performed on safety population.

Physical examination findings were collected according to pre-defined body systems: general appearance; skin; eyes; ears; nose; throat; neck and thyroid; lungs; heart; upper/lower extremities; lymph nodes; abdomen; musculoskeletal system; basic neurological assessment. Additional systems were evaluated as needed. Clinical significance was defined as any variation in assessment results that had medical relevance resulting in an alteration in medical care. Participants with at least one clinically significant abnormality in physical examination were reported and presented in this outcome measure. Baseline was defined as the last measurement before first intake of study treatment on Day 1.

Analysis was performed on safety population. Here, 'Overall number of participants analyzed' signifies participants who were evaluable for this outcome measure.

Participants received Elafibranor 120 mg tablets orally once daily for 12 weeks.