| Primary | Percentage of Responders With Disappearance of Steatohepatitis Without Worsening of Fibrosis (ie, Participants no Longer Meeting the Criteria for Steatohepatitis) | Percentage of responders from baseline to Week 52 defined by the disappearance of steatohepatitis (ie, participants no longer meeting the criteria for steatohepatitis) without worsening of fibrosis. Worsening of fibrosis was evaluated using Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) fibrosis staging system and defined as:
- Progression to stage 3 or 4 for participants at stage 0, 1 or 2 on diagnostic liver biopsy
- Progression to stage 4 for participants at stage 3 on diagnostic liver biopsy
| Analysis was done of the efficacy evaluable sample, (Efficacy Evaluable Set) formed by participants with liver biopsy available at end-of-treatment and considered as the Intent to Treat population in the protocol. Robustness analysis was also performed in the Full Analysis Set, formed by all randomized participants that received at least one dose of study drug. | Posted | | Count of Participants | | Participants | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
| | | Title | Denominators | Categories |
|---|
| Efficacy evaluable set | - ParticipantsOG00082
- ParticipantsOG00178
- ParticipantsOG00277
| | Title | Measurements |
|---|
| Responders | |
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| H_01: OR_80 less than or equal to 1 versus H_11 : OR_80 greater than 1 H_02: OR_120 less than or equal to 1 versus H_12 : OR_120 greater than 1 | Regression, Logistic | Baseline NAS, Log transformed baseline aspartate aminotransferase and baseline plasminogen activator inhibitor 1 values | 0.8539 | To deal with multiplicity of comparisons, a step-down approach was adopted to control the type I error to 0.05. The contrast GFT120 mg versus placebo was examined first. If not significant the GFT 80mg versus placebo contrast was not examined. | Odds Ratio (OR) | 1.092 | | | 2-Sided | 95 | 0.427 | 2.795 | | | Standard error of the estimate |
|
| Secondary | Change From Baseline to Week 52 in Non-alcoholic Fatty Liver Disease Activity Score | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg the change from baseline to Week 52, in Non-alcoholic Fatty Liver Disease Activity Score (NAS score). NAS score is a composite score equal to the sum of the steatosis grade (0 to 3), lobular inflammation grade (0 to 3) and hepatocellular ballooning grade (0 to 2). The overall scale of the NAS is 0 to 8, with higher scores indicating more severe disease. The outcome measure, change from baseline in NAFLD Activity Score (NAS), has a possible range from -8 to +8, with negative values indicating a better outcome (improvement) and positive values indicating a worse outcome. | | Posted | | Mean | Standard Deviation | NAS score | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | |
|
| Secondary | Number of Participants With Change From Baseline to Week 52 in Non-alcoholic Fatty Liver Disease Activity Score of at Least 2 Points | To evaluate the number of participants with at least a 2 point decrease from baseline in Non-alcoholic Fatty Liver Disease Activity Score (NAS) after 52 weeks of daily administration of GFT505 80mg or 120mg. The NAS refers to the severity of ongoing liver injury as assessed by a liver biopsy and is used to assess the activity of the disease. It is based on the NASH CRN methodology for scoring the severity of steatosis (score of 0 to 3), inflammation (score of 0 to 3), and hepatocellular ballooning (score of 0 to 2), with a maximum score of 8. A total NAS score of five or greater correlates with the diagnosis of steatohepatitis. In table below for raw "Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)" and the column "GFT505 80mg" the result should be read as : 2 participants (out of 10 participants analysed with a baseline NAS at 3) had at Least 2 points decrease on their NAS after 52 weeks of daily administration of GFT505 80mg. It corresponds to 20% (2 out of 10). | | Posted | | Count of Participants | | Participants | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | |
|
| Secondary | Number of Participants With Decrease in Steatosis Score of at Least 1 Point Between Baseline and Week 52 | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in steatosis score of at least 1 point between baseline and Week 52. Steatosis is assessed by a liver biopsy and evaluated on a scale of 0 to 3 with higher scores indicating more severe steatosis. A score of 0 indicating a lower severity with low parenchymal involvement (<5%), while a score of 3 is indicative of higher involvment/severity (> 66%). In below table and for helping how results are reported, as an example for raw "Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)" and the column "GFT505 80mg" the result should be read as : 1 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease Steatosis Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10). | | Posted | | Count of Participants | | Participants | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. |
|
| Secondary | Number of Participants With Decrease in Lobular Inflammation Score of at Least 1 Point Between Baseline and Week 52 | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in lobular inflammation score of at least 1 point between baseline and Week 52. Lobular inflammation is assessed by a liver biopsy and evaluated on a scale of 0 to 3. A score of 0 indicating the absence of inflammation loci, while a score of 3 is indicative of a higher degree of inflammation with more than 4 inflammation loci 200 x field. In below table and for helping how results are reported, as an example for raw "Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)" and the column "GFT505 80mg" the result should be read as : 1 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease of Lobular Inflammation Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10). | | Posted | | Count of Participants | | Participants | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. |
|
| Secondary | Title: Number of Participants With Decrease in Ballooning Score of at Least 1 Point Between Baseline and Week 52 | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, number of participants with a decrease in ballooning score of at least 1 point between baseline and Week 52. Ballooning is assessed by a liver biopsy and evaluated on a scale of 0 to 2 with higher scores indicating more severe ballooning (0: No ballooned cells, 1: Few [rare but definite] ballooned hepatocytes; 2: Many ballooned cells/prominent ballooning). In below table and for helping how results are reported, as an example for raw "Mild (Nonalcoholic Fatty Liver Disease Activity Score 3)" and the column "GFT505 80mg" the result should be read as : 4 participants (out of 10 participants analysed with a baseline NAS at 3) had at least 1 point decrease of Ballooning Score after 52 weeks of daily administration of GFT505 80mg. It corresponds to 10% (1 out of 10). | | Posted | | Count of Participants | | Participants | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. |
|
| Secondary | Changes From Baseline to Week 52 in the Stages of Fibrosis | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in stages of fibrosis (based on Non-Alcoholic Steatohepatitis Clinical Research Network [NASH CRN] scoring). Fibrosis is assessed on a scale of 0 to 4 with higher scores indicating more severe fibrosis. | | Posted | | Mean | Standard Deviation | Change in fibrosis score | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
| |
| Secondary | Changes From Baseline to Visit 8 (Week 52) in Liver Enzymes | To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in liver enzymes. | | Posted | | Mean | Standard Deviation | U/L | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
| |
| Secondary | Changes From Baseline to Visit 8 (Week 52) in Aspartate Transaminase/Alanine Aminotransferase Ratio | To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in aspartate transaminase/alanine aminotransferase ratio | | Posted | | Mean | Standard Deviation | ratio | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
| |
| Secondary | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: CK 18-M65 | To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in CK 18-M65 (non-invasive markers of fibrosis and steatosis). | | Posted | | Mean | Standard Deviation | U/L | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
| |
| Secondary | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: CK18 M30 | To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in CK18 M30 (non-invasive markers of fibrosis and steatosis). Participants with missing data for CK18 M30 at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow. | | Posted | | Mean | Standard Deviation | pmol/L | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
|
| Secondary | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Adiponectin | To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in adiponectin (non-invasive markers of fibrosis and steatosis). | | Posted | | Mean | Standard Deviation | μg/mL | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
| |
| Secondary | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Ferritin | To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in ferritin (non-invasive markers of fibrosis and steatosis). Participants with missing data for Ferritin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow. | | Posted | | Mean | Standard Deviation | μg/L | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
|
| Secondary | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: FG19 and FG21 | To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in FG19 and FG21 (non-invasive markers of fibrosis and steatosis). | | Posted | | Mean | Standard Deviation | pg/mL | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
| |
| Secondary | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Alpha2 Macroglobulin | To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in alpha2 macroglobulin (a non-invasive marker of fibrosis and steatosis). Participants with missing data for Alpha2 Macroglobulin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow. | | Posted | | Mean | Standard Deviation | g/L | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
|
| Secondary | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Hyaluronic Acid, N-terminal Pro-peptide of Collagen Type III (PIIINP), and Tissue Inhibitor of Matrix Metalloprotease-1 (TIMP-1) | To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in hyaluronic acid, N-terminal pro-peptide of collagen type III (PIIINP), and tissue inhibitor of matrix metalloprotease-1 (TIMP-1) (non-invasive markers of fibrosis and steatosis). | | Posted | | Mean | Standard Deviation | ng/mL | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
|
| Secondary | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Fibrotest | Fibrotest combines α2-macroglobulin (a2m), apolipoprotein A1 (aA1), total bilirubin (BIL), haptoglobin (h), GGT, and ALT with adjustment for age and gender. Fibrotest is calculated as: z = 4.467 x log(a2m) - 1.357 x log(h) + 1.017 x log(GGT) + 0.0281 x Age + 1.737 x log(BIL) - 1.184 x (aA1) + 0.301 x Gender - 5.54 where Gender = 1 for male and Gender = 0 for female. The score is then: 1/(1+e^-z). Calculated score range from 0 (no fibrosis) to 1 (severe fibrosis or cirrhosis) In below table for "Fibrotest" and for column "GFT505 80mg" the result should be read as: the mean of change from baseline to week 52 of Fibrotest calculated in 81 participants is -0.06 with a standard deviation of 0.08. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo |
|
| Secondary | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Steatotest | SteatoTest combines α2-macroglobulin, haptoglobin, apolipoprotein A1, total bilirubin, GGT, fasting glucose, triglycerides, cholesterol, and ALT, adjusted for patient's age, sex, weight, and height. Patented formula. Calculated score range from 0 (no steatosis) to 1 (severe steatosis) In below table for "Steatotest" and for column "GFT505 80mg" the result should be read as: the mean of change from baseline to week 52 of Steatotest calculated in 81 participants is -0.09 with a standard deviation of 0.11. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
|
| Secondary | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Angulo Index or Non-Alcoholic Fatty Liver Disease Fibrosis Score | Angulo Index or Non-Alcoholic Fatty Liver Disease Fibrosis Score is based on age, hyperglycemia, BMI, platelet count, albumin level, and AST/ALT ratio. Score is calculated using the following formula: -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 score of <-1.455 indicates no advanced fibrosis and a score of >0.676 indicates liver fibrosis. In below table for "Angulo index" and for column "GFT505 80mg" the result should be read as: the mean of change from baseline to week 52 of Angulo index calculated in 82 participants is 0.06 with a standard deviation of 0.53. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 |
|
| Secondary | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Enhanced Liver Fibrosis (ELF) | Enhanced Liver Fibrosis (ELF) combines measurements of tissue inhibitor of metalloprotein-ases-1 (TIMP-1), amino-terminal propeptide of type III procollagen (PIIINP), and hyaluronic acid (HA) . The ELF score is calculated as : 2.278 + 0.851 ln (HA) + 0.751 ln (PIIINP) + 0.394 ln (TIMP-1). ELF score range from 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. A decrease in ELF score represents a positive outcome In below table for "Enhanced Liver Fibrosis" and for column "GFT505 80mg" the result should be read as : the mean of change from baseline to week 52 of Enhanced Liver Fibrosis calculated in 81 analysed participants is -0.01 with a standard deviation of 0.54. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. |
|
| Secondary | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Fatty Liver Index (FLI) | The Fatty Liver Index (FLI) combines triglycerides, BMI, GGT and Waist circumference. FLI is calculated as : (e0.953×loge[triglycerides]+0.139× Body Mass Index[BMI]+0.718×loge Gamma- Glutamyl Transferase [GGT]+0.053×waistcircumference-15.745)/ (1 +e0.953×loge[triglycerides]+0.139×BMI+0.718×loge [GGT]+0.053×waistcircumference-15.745) × 100. Calculated index range from 0 to 100. FLI score below 30 indicate absence of Fatty Liver and FLI Score of 60 and above indicates presence of Fatty Liver. In below table for "Fatty Liver Index" and for column "GFT505 80mg" the result should be read as : the mean of change from baseline to week 52 of Fatty Liver Index calculated in 82 analysed participants is -7.94 with a standard deviation of 11.74. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | |
|
| Secondary | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Fibrometer | Fibrometer combines Platelets, AST, ALT, ferritin, glucose (fasting plasma), Weight and gender. Patented formula. Score ranges from 0 (no fibrosis) to 1 (severe fibrosis or cirrhosis) In below table for "Fibrometer" and for column "GFT505 80mg" the result should be read as : the mean of change from baseline to week 52 of Fibrometer calculated in 81 analysed participants is 0.04 with a standard deviation of 0.23. | | Posted | | Mean | Standard Deviation | score on a scale | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
|
| Secondary | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Total Bilirubin and Conjugated Bilirubin | To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in total bilirubin and conjugated bilirubin (non-invasive markers of fibrosis and steatosis). | | Posted | | Mean | Standard Deviation | umol/L | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
| |
| Secondary | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: Prothrombin Ratio | To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in prothrombin ratio (non-invasive marker of fibrosis and steatosis). The Prothrombin ratio is the ratio of a participants measured prothrombin time (in seconds) to the normal laboratory reference prothrombin time. Participants with missing data for Prothrombin ratio at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow. | | Posted | | Mean | Standard Deviation | ratio | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
|
| Secondary | Changes From Baseline to Week 52 in Non-invasive Markers of Fibrosis and Steatosis: International Normalized Ratio (INR) | To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg, the changes from baseline to week 52, in international normalized ratio (INR; non-invasive marker of fibrosis and steatosis). Participants with missing data for International Normalized Ratio (INR) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow. | | Posted | | Mean | Standard Deviation | ratio | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
|
| Secondary | Changes From Baseline to Week 52 in Lipid Parameters (Cardiovascular Risk Profile) | To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in lipid parameters (used to assess cardiovascular risk) | | Posted | | Mean | Standard Deviation | mmol/L | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
| |
| Secondary | Changes From Baseline to Week 52 in Outcomes Related to Biochemistry | To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to week 52, in secondary outcomes related to biochemistry | | Posted | | Mean | Standard Deviation | mg/dL | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
| |
| Secondary | Changes From Baseline to Week 52 in Insulin Resistance: Leptin | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in leptin (to assess insulin resistance). | | Posted | | Mean | Standard Deviation | ng/mL | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
| |
| Secondary | Changes From Baseline to Week 52 in Insulin Resistance: Insulin | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in insulin (to assess insulin resistance). Participants with missing data for Insulin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow. | | Posted | | Mean | Standard Deviation | pmol/L | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
|
| Secondary | Changes From Baseline to Week 52 in Insulin Resistance: C Peptide | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in C peptide (to assess insulin resistance). Participants with missing data for C Peptide at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow. | | Posted | | Mean | Standard Deviation | nmol/L | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
|
| Secondary | Changes From Baseline to Week 52 in Insulin Resistance: Homeostatic Model Assessment-insulin Resistance (HOMA-IR) | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in homeostatic model assessment-insulin resistance (HOMA-IR; to assess insulin resistance). The HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/ml) x fasting plasma glucose (mmol/l) / 22.5 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. Participants with missing data for HOMA-IR at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow. | | Posted | | Mean | Standard Deviation | HOMA-IR score | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | |
|
| Secondary | Changes From Baseline to Week 52 in Insulin Resistance: Free Fatty Acids (FFA) | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in free fatty acids (FFA; to assess insulin resistance). Participants with missing data for Free Fatty Acids (FFA) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow. | | Posted | | Mean | Standard Deviation | mmol/L | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
|
| Secondary | Changes From Baseline to Week 52 in Insulin Resistance: Plasma Glucose | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in plasma glucose (to assess insulin resistance). Participants with missing data for Plasma Glucose at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow. | | Posted | | Mean | Standard Deviation | mmol/L | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
|
| Secondary | Changes From Baseline to Week 52 in Insulin Resistance: Glycosylated Haemoglobin A1c (HbA1c) | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in glycosylated haemoglobin A1c (HbA1c; to assess insulin resistance). Participants with missing data for Haemoglobin A1c (HbA1c) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow. | | Posted | | Mean | Standard Deviation | percentage of HbA1c | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
|
| Secondary | Changes From Baseline to Week 52 in Insulin Resistance: Fructosamine | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in Fructosamine (to assess insulin resistance). | | Posted | | Mean | Standard Deviation | umol/L | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
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| Secondary | Changes From Baseline to Week 52 in Inflammatory Markers: Fibrinogen and Haptoglobin | To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in fibrinogen and haptoglobin (inflammatory markers). | | Posted | | Mean | Standard Deviation | g/L | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
| |
| Secondary | Changes From Baseline to Week 52 in Inflammatory Markers: Tumour Necrosis Factor Alpha and Interleukine 6 | To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in tumour necrosis factor alpha and interleukine 6 (inflammatory markers). | | Posted | | Mean | Standard Deviation | pg/mL | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
| |
| Secondary | Changes From Baseline to Week 52 in Inflammatory Markers: Plasminogen Activator Inhibitor 1 (PAI-1) | To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in plasminogen activator inhibitor 1 (PAI-1; inflammatory marker). Participants with missing data for Plasminogen Activator Inhibitor 1 (PAI-1) at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow | | Posted | | Mean | Standard Deviation | ng/mL | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
|
| Secondary | Changes From Baseline to Week 52 in Inflammatory Markers: C-Reactive Protein (CRP) | To evaluate after 52 weeks of daily administration of GFT505 80mg or GFT505 120mg the changes from baseline to Week 52, in C-Reactive Protein (CRP; inflammatory marker). | | Posted | | Mean | Standard Deviation | Log (mg/L) | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
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| Secondary | Changes From Baseline to Week 52 in Safety Markers: Creatinine (Renal Function Parameter) | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in creatinine (safety markers; renal function parameter). | | Posted | | Mean | Standard Deviation | μmol/L | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
| |
| Secondary | Changes From Baseline to Week 52 in Safety Markers: Creatinine Clearance (Renal Function Parameter) | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in creatinine clearance (safety marker; renal function parameter). | | Posted | | Mean | Standard Deviation | mL/min | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
| |
| Secondary | Changes From Baseline to Week 52 in Safety Markers: Uric Acid (Renal Function Parameter) | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in uric acid (safety marker; renal function parameter). | | Posted | | Mean | Standard Deviation | mmol/L | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
| |
| Secondary | Changes From Baseline to Week 52 in Safety Markers: Blood Urea Nitrogen (BUN; Renal Function Parameter) | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in blood urea nitrogen (BUN; safety marker; renal function parameter). | | Posted | | Mean | Standard Deviation | mmol urea/L | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
| |
| Secondary | Changes From Baseline to Week 52 in Safety Markers: Cystatin C (Renal Function Parameter) | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in cystatin C (safety marker; renal function parameter). Participants with missing data for Cystatin C at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow. | | Posted | | Mean | Standard Deviation | mg/L | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
|
| Secondary | Changes From Baseline to Week 52 in Safety Markers: Beta2-microglobulin (Renal Function Parameter) | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in beta2-microglobulin (safety marker; renal function parameter). Participants with missing data for Beta2-microglobulin at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow. | | Posted | | Mean | Standard Deviation | μg/L | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
|
| Secondary | Changes From Baseline to Week 52 in Safety Markers: N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP; Cardiac Function Parameter) | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in N-terminal prohormone of brain natriuretic peptide (NT-proBNP; safety marker; cardiac function parameter). Participants with missing data for NT-proBNP at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow. | | Posted | | Mean | Standard Deviation | pmol/L | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
|
| Secondary | Changes From Baseline to Week 52 in Safety Markers: Troponin T (Cardiac Function Parameter) | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to week 52, in troponin T (safety marker; cardiac function parameter). Participants with missing data for Troponin T at baseline (Visit 2) or Visit 8 were not imputed in the analysis explaining the difference with the number of participants reported in the "Efficacy Evaluable Set" of the Participant Flow. | | Posted | | Mean | Standard Deviation | μg/L | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
|
| Secondary | Changes From Baseline to Week 52 in Body Weight | To evaluate after 52 weeks of daily administration of GFT505 80mg, or GFT505 120mg, the changes from baseline to Week 52, in body weight. | Efficacy evaluable set (EES) | Posted | | Mean | Standard Deviation | kg | | Baseline (Visit 2; Week 0) to Visit 8 (Week 52) | | | | ID | Title | Description |
|---|
| OG000 | GFT505 80mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules per day (2 capsules of GFT505 40 mg and 1 capsule of placebo), before breakfast with a glass of water. | | OG001 | GFT505 120mg | Hard gelatin capsules dosed at 40mg, oral administration. 3 capsules of GFT505 40 mg per day, before breakfast with a glass of water. | | OG002 | Placebo | Hard gelatin capsules, oral administration. Capsules of placebo were identical to capsules of investigational product to ensure double-blind conditions. 3 placebo capsules per day, before breakfast with a glass of water. |
| |