| Primary | Hepatic Histological Improvement in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) | Centrally scored histological improvement in nonalcoholic fatty liver disease (NAFLD) from baseline to the end of 72 weeks of treatment, where improvement is defined as:
- No worsening in fibrosis; and
- A decrease in NAFLD Activity Score (NAS) of at least 2 points
| Number of randomly assigned patients with observed or expected week 72 visit before protocol modified on Jan 6, 2014, to eliminate week 72 biopsy. 11 patients in the placebo group and eight in the obeticholic acid group had missing histological data at week 72, and the results for these patients were imputed as a lack of improvement. | Posted | | Number | | participants | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| | | Title | Denominators | Categories |
|---|
| | |
| | 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 |
|---|
| | Cochran-Mantel-Haenszel | p values and relative benefit were calculated with the Cochran-Mantel-Haenszel chi-square test, stratified by clinic and diabetes status. | 0.0002 | | Risk Ratio (RR) | 1.9 | | | 2-Sided | 95 | 1.3 | 2.8 | | | obeticholic acid vs placebo | | Superiority or Other | | |
|
| Secondary | Resolution of NASH Diagnosis | Resolution of definite nonalcoholic steatohepatitis. Resolution defined as either not NAFLD, or NAFLD but not non-alcoholic steatohepatitis on week 72 biopsy | Number of patients with biopsy specimens at baseline and 72 weeks | Posted | | Number | | participants | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Fibrosis: Patient With Improvement | Patients with improvement in fibrosis score. Fibrosis was assessed on a scale of 0-4, with higher scores showing more severe fibrosis. | Number of patients with biopsy specimens at baseline and 72 weeks | Posted | | Number | | participants | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Fibrosis: Change in Score | Change in fibrosis score. Fibrosis was assessed on a scale of 0-4, with higher scores showing more severe fibrosis. | | Posted | | Mean | Standard Deviation | units on a scale | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Total NAFLD Activity Score: Change in Score | NAFLD activity score was assessed on a scale of 0-8, with higher scores showing more severe disease (the components of this measure are steatosis [assessed on a scale of 0-3], lobular inflammation [assessed on a scale of 0-3], and hepatocellular ballooning [assessed on a scale of 0-2]). | Number of patients with biopsy specimens at baseline and 72 weeks | Posted | | Mean | Standard Deviation | units on a scale | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Hepatocellular Ballooning: Patients With Improvement | Patients with improvement in hepatocellular ballooning score. Hepatocellular ballooning was assessed on a scale of 0-2, with higher scores showing more severe ballooning. | Number of patients with biopsy specimens at baseline and 72 weeks | Posted | | Number | | participants | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Hepatocellular Ballooning: Change in Score | Change in hepatocellular ballooning score. Hepatocellular ballooning was assessed on a scale of 0-2, with higher scores showing more severe ballooning. | Number of patients with biopsy specimens at baseline and 72 weeks | Posted | | Mean | Standard Deviation | units on a scale | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Steatosis: Patients With Improvement | Patients with improvement in steatosis score. Steatosis was assessed on a scale of 0-3, with higher scores showing more severe steatosis. | Number of patients with biopsy specimens at baseline and 72 weeks | Posted | | Number | | participants | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Steatosis: Change in Score | Change in steatosis score. Steatosis was assessed on a scale of 0-3, with higher scores showing more severe steatosis. | Number of patients with biopsy specimens at baseline and 72 weeks | Posted | | Mean | Standard Deviation | units on a scale | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Lobular Inflammation: Patients With Improvement | Patients with improvement in lobular inflammation score. Lobular inflammation was assessed on a scale of 0-3, with higher scores showing more severe lobular inflammation. | Number of patients with biopsy specimens at baseline and 72 weeks | Posted | | Number | | participants | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Lobular Inflammation: Change in Score | Change in lobular inflammation score. Lobular inflammation was assessed on a scale of 0-3, with higher scores showing more severe lobular inflammation. | Number of patients with biopsy specimens at baseline and 72 weeks | Posted | | Mean | Standard Deviation | units on a scale | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Portal Inflammation: Patients With Improvement | Patients with improvement in portal inflammation score. Portal inflammation was assessed on a scale of 0-2, with higher scores showing more severe portal inflammation. | Number of patients with biopsy specimens at baseline and 72 weeks | Posted | | Number | | participants | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Portal Inflammation: Change in Score | Change in portal inflammation score. Portal inflammation was assessed on a scale of 0-3, with higher scores showing more severe portal inflammation. | Number of patients with biopsy specimens at baseline and 72 weeks | Posted | | Mean | Standard Deviation | units on a scale | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Alanine Aminotransferase | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | U/L | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Asparate Aminotransferase | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | U/L | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Alkaline Phosphatase | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | U/L | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in γ-glutamyl Transpeptidase | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | U/L | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Total Bilirubin | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | μmol/L | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Total Cholesterol | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | mmol/L | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in HDL Cholesterol | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | mmol/L | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in LDL Cholesterol | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | mmol/L | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Triglycerides | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | mmol/L | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Haemoglobin | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | g/L | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Haematocrit | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | proportion of 1.0 | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Mean Corpuscular Volume | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | fL | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in White Blood Cell Count | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | white blood cells *10^9 per L | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Platelet Count | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | platelets *10^9 per L | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Bicarbonate | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | mmol/L | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Calcium | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | mmol/L | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Phosphate | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | mmol/L | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Creatinine | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | μmol/L | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Uric Acid | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | μmol/L | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Albumin | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | gl/L | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Total Protein | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | gl/L | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Prothrombin Time | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | s | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in International Normalised Ratio | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | ratio | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Fasting Serum Glucose | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | mmol/L | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Insulin | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | pmol/L | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in HOMA-IR | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | glucose[mmol/L]× insulin[pmol/L] / 22.5 | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Glycated Haemoglobin A1c | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | mmol/mol | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Weight | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | kg | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Body-mass Index | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | kg/m² | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Waist Circumference | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | cm | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Waist-to-hip Ratio | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | ratio | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Systolic Blood Pressure | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | mm Hg | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in Diastolic Blood Pressure | | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | mm Hg | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in SF-36 Quality of Life Physical Component Summary | Short Form (36) Health Survey The SF-36 evaluates health-related quality of life in 8 domains consisting of two components: physical and mental. The score for each domain ranges from 0 to 100. Norm based scoring (based on the general US population) is used with a mean of 50 and standard deviation of 10. Higher values represent a better outcome. | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | units on a scale | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |
| Secondary | Change in SF-36 Quality of Life Mental Component Summary | Short Form (36) Health Survey The SF-36 evaluates health-related quality of life in 8 domains consisting of two components: physical and mental. The score for each domain ranges from 0 to 100. Norm based scoring (based on the general US population) is used with a mean of 50 and standard deviation of 10. Higher values represent a better outcome. | All patients who completed their final on-treatment study visit and the visit 24 weeks after stopping treatment (including those without a final biopsy due to early treatment termination) were included in the group comparisons of non-histological secondary outcomes. | Posted | | Mean | Standard Deviation | units on a scale | | baseline to 72 weeks | | | | ID | Title | Description |
|---|
| OG000 | Obeticholic Acid | obeticholic acid obeticholic acid: 25 mg daily for 72 weeks | | OG001 | Placebo | Placebo placebo: placebo capsule, 25 mg daily for 72 weeks |
| |