Trial Outcomes & Findings for The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment Trial(FLINT) (NCT NCT01265498)
NCT ID: NCT01265498
Last Updated: 2018-04-06
Results Overview
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: 1. No worsening in fibrosis; and 2. A decrease in NAFLD Activity Score (NAS) of at least 2 points
COMPLETED
PHASE2
283 participants
baseline to 72 weeks
2018-04-06
Participant Flow
Participant milestones
| Measure |
Obeticholic Acid
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
141
|
142
|
|
Overall Study
Both Baseline and Week 72 Biopsy
|
102
|
98
|
|
Overall Study
COMPLETED
|
110
|
109
|
|
Overall Study
NOT COMPLETED
|
31
|
33
|
Reasons for withdrawal
| Measure |
Obeticholic Acid
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Overall Study
Protocol modified to eliminate wk72 bx
|
31
|
33
|
Baseline Characteristics
The Farnesoid X Receptor (FXR) Ligand Obeticholic Acid in NASH Treatment Trial(FLINT)
Baseline characteristics by cohort
| Measure |
Obeticholic Acid
n=141 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=142 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
Total
n=283 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 11 • n=5 Participants
|
51 years
STANDARD_DEVIATION 12 • n=7 Participants
|
51 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
187 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
22 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
119 Participants
n=5 Participants
|
121 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 participants
n=5 Participants
|
10 participants
n=7 Participants
|
16 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African-American
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
123 participants
n=5 Participants
|
111 participants
n=7 Participants
|
234 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
10 participants
n=5 Participants
|
17 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
SF-36 Quality of life: Physical component summary
|
45 units on a scale
STANDARD_DEVIATION 11 • n=5 Participants
|
44 units on a scale
STANDARD_DEVIATION 11 • n=7 Participants
|
44 units on a scale
STANDARD_DEVIATION 11 • n=5 Participants
|
|
SF-36 Quality of life: Mental component summary
|
48 units on a scale
STANDARD_DEVIATION 12 • n=5 Participants
|
48 units on a scale
STANDARD_DEVIATION 12 • n=7 Participants
|
48 units on a scale
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Liver enzymes: Alanine aminotransferase
|
83 U/L
STANDARD_DEVIATION 49 • n=5 Participants
|
82 U/L
STANDARD_DEVIATION 51 • n=7 Participants
|
83 U/L
STANDARD_DEVIATION 50 • n=5 Participants
|
|
Liver enzymes: Aspartate aminotransferase
|
64 U/L
STANDARD_DEVIATION 38 • n=5 Participants
|
58 U/L
STANDARD_DEVIATION 34 • n=7 Participants
|
61 U/L
STANDARD_DEVIATION 36 • n=5 Participants
|
|
Liver enzymes: Alkaline phosphatase
|
82 U/L
STANDARD_DEVIATION 29 • n=5 Participants
|
81 U/L
STANDARD_DEVIATION 25 • n=7 Participants
|
82 U/L
STANDARD_DEVIATION 27 • n=5 Participants
|
|
Liver enzymes: γ-glutamyl transpeptidase
|
78 U/L
STANDARD_DEVIATION 85 • n=5 Participants
|
76 U/L
STANDARD_DEVIATION 97 • n=7 Participants
|
77 U/L
STANDARD_DEVIATION 91 • n=5 Participants
|
|
Liver enzymes: Total bilirubin
|
11.5 μmol/L
STANDARD_DEVIATION 5.9 • n=5 Participants
|
11.3 μmol/L
STANDARD_DEVIATION 7.5 • n=7 Participants
|
11.4 μmol/L
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Lipids: Total cholesterol
|
4.9 mmol/L
STANDARD_DEVIATION 1.2 • n=5 Participants
|
4.8 mmol/L
STANDARD_DEVIATION 1.2 • n=7 Participants
|
4.9 mmol/L
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Lipids: HDL cholesterol
|
1.1 mmol/L
STANDARD_DEVIATION 0.3 • n=5 Participants
|
1.1 mmol/L
STANDARD_DEVIATION 0.4 • n=7 Participants
|
1.1 mmol/L
STANDARD_DEVIATION 0.3 • n=5 Participants
|
|
Lipids: LDL cholesterol
|
2.9 mmol/L
STANDARD_DEVIATION 1.0 • n=5 Participants
|
2.9 mmol/L
STANDARD_DEVIATION 1.1 • n=7 Participants
|
2.9 mmol/L
STANDARD_DEVIATION 1.0 • n=5 Participants
|
|
Lipids: Triglycerides
|
2.2 mmol/L
STANDARD_DEVIATION 1.5 • n=5 Participants
|
2.0 mmol/L
STANDARD_DEVIATION 1.7 • n=7 Participants
|
2.1 mmol/L
STANDARD_DEVIATION 1.6 • n=5 Participants
|
|
Haematology: Haemoglobin
|
140 g/L
STANDARD_DEVIATION 15 • n=5 Participants
|
140 g/L
STANDARD_DEVIATION 14 • n=7 Participants
|
140 g/L
STANDARD_DEVIATION 14 • n=5 Participants
|
|
Haematology: Haematocrit
|
0.41 proportion of 1·0
STANDARD_DEVIATION 0.04 • n=5 Participants
|
0.41 proportion of 1·0
STANDARD_DEVIATION 0.04 • n=7 Participants
|
0.41 proportion of 1·0
STANDARD_DEVIATION 0.04 • n=5 Participants
|
|
Haematology: Mean corpuscular volume
|
88.7 fL
STANDARD_DEVIATION 4.8 • n=5 Participants
|
89.0 fL
STANDARD_DEVIATION 5.3 • n=7 Participants
|
88.9 fL
STANDARD_DEVIATION 5.1 • n=5 Participants
|
|
Haematology: White blood cell count
|
7.3 white blood cells *10^9 per L
STANDARD_DEVIATION 1.9 • n=5 Participants
|
6.9 white blood cells *10^9 per L
STANDARD_DEVIATION 2.3 • n=7 Participants
|
7.1 white blood cells *10^9 per L
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Haematology: Platelet count
|
237 platelets *10^9 per L
STANDARD_DEVIATION 59 • n=5 Participants
|
237 platelets *10^9 per L
STANDARD_DEVIATION 65 • n=7 Participants
|
237 platelets *10^9 per L
STANDARD_DEVIATION 62 • n=5 Participants
|
|
Chemistries: Bicarbonate
|
25.9 mmol/L
STANDARD_DEVIATION 2.5 • n=5 Participants
|
26.2 mmol/L
STANDARD_DEVIATION 2.6 • n=7 Participants
|
26.0 mmol/L
STANDARD_DEVIATION 2.5 • n=5 Participants
|
|
Chemistries: Calcium
|
2.4 mmol/L
STANDARD_DEVIATION 0.1 • n=5 Participants
|
2.4 mmol/L
STANDARD_DEVIATION 0.1 • n=7 Participants
|
2.4 mmol/L
STANDARD_DEVIATION 0.1 • n=5 Participants
|
|
Chemistries: Phosphate
|
1.1 mmol/L
STANDARD_DEVIATION 0.2 • n=5 Participants
|
1.1 mmol/L
STANDARD_DEVIATION 0.2 • n=7 Participants
|
1.1 mmol/L
STANDARD_DEVIATION 0.2 • n=5 Participants
|
|
Chemistries: Creatinine
|
71 μmol/L
STANDARD_DEVIATION 18 • n=5 Participants
|
70 μmol/L
STANDARD_DEVIATION 16 • n=7 Participants
|
71 μmol/L
STANDARD_DEVIATION 17 • n=5 Participants
|
|
Chemistries: Uric acid
|
375 μmol/L
STANDARD_DEVIATION 89 • n=5 Participants
|
366 μmol/L
STANDARD_DEVIATION 86 • n=7 Participants
|
370 μmol/L
STANDARD_DEVIATION 87 • n=5 Participants
|
|
Chemistries: Albumin
|
43 g/L
STANDARD_DEVIATION 4 • n=5 Participants
|
43 g/L
STANDARD_DEVIATION 4 • n=7 Participants
|
43 g/L
STANDARD_DEVIATION 4 • n=5 Participants
|
|
Chemistries: Total protein
|
73 g/L
STANDARD_DEVIATION 5 • n=5 Participants
|
74 g/L
STANDARD_DEVIATION 5 • n=7 Participants
|
73 g/L
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Other laboratory results: Prothrombin time
|
11.7 s
STANDARD_DEVIATION 2.1 • n=5 Participants
|
11.7 s
STANDARD_DEVIATION 2.2 • n=7 Participants
|
11.7 s
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Other laboratory results: International normalised ratio
|
1.01 ratio
STANDARD_DEVIATION 0.08 • n=5 Participants
|
1.00 ratio
STANDARD_DEVIATION 0.07 • n=7 Participants
|
1.00 ratio
STANDARD_DEVIATION 0.07 • n=5 Participants
|
|
Metabolic factors: Fasting serum glucose
|
6.5 mmol/L
STANDARD_DEVIATION 1.8 • n=5 Participants
|
6.4 mmol/L
STANDARD_DEVIATION 2.2 • n=7 Participants
|
6.4 mmol/L
STANDARD_DEVIATION 2.0 • n=5 Participants
|
|
Metabolic factors: Insulin
|
201 pmol/L
STANDARD_DEVIATION 226 • n=5 Participants
|
138 pmol/L
STANDARD_DEVIATION 129 • n=7 Participants
|
169 pmol/L
STANDARD_DEVIATION 186 • n=5 Participants
|
|
Metabolic factors: HOMA-IR
|
61 glucose [mmol/L] × insulin [pmol/L]/22.5
STANDARD_DEVIATION 74 • n=5 Participants
|
40 glucose [mmol/L] × insulin [pmol/L]/22.5
STANDARD_DEVIATION 42 • n=7 Participants
|
50 glucose [mmol/L] × insulin [pmol/L]/22.5
STANDARD_DEVIATION 61 • n=5 Participants
|
|
Metabolic factors: Glycated haemoglobin A1c
|
48 mmol/mol
STANDARD_DEVIATION 12 • n=5 Participants
|
47 mmol/mol
STANDARD_DEVIATION 11 • n=7 Participants
|
47 mmol/mol
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Metabolic factors: Weight
|
100 kg
STANDARD_DEVIATION 23 • n=5 Participants
|
96 kg
STANDARD_DEVIATION 18 • n=7 Participants
|
98 kg
STANDARD_DEVIATION 21 • n=5 Participants
|
|
Metabolic factors: Body-mass index
|
35 kg/m²
STANDARD_DEVIATION 7 • n=5 Participants
|
34 kg/m²
STANDARD_DEVIATION 6 • n=7 Participants
|
35 kg/m²
STANDARD_DEVIATION 6 • n=5 Participants
|
|
Metabolic factors: Waist circumference
|
112 cm
STANDARD_DEVIATION 15 • n=5 Participants
|
109 cm
STANDARD_DEVIATION 14 • n=7 Participants
|
111 cm
STANDARD_DEVIATION 15 • n=5 Participants
|
|
Metabolic factors: Waist-to-hip ratio
|
0.96 ratio
STANDARD_DEVIATION 0.07 • n=5 Participants
|
0.95 ratio
STANDARD_DEVIATION 0.09 • n=7 Participants
|
0.95 ratio
STANDARD_DEVIATION 0.08 • n=5 Participants
|
|
Metabolic factors: Systolic blood pressure
|
132 mm Hg
STANDARD_DEVIATION 17 • n=5 Participants
|
132 mm Hg
STANDARD_DEVIATION 15 • n=7 Participants
|
132 mm Hg
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Metabolic factors: Diastolic blood pressure
|
77 mm Hg
STANDARD_DEVIATION 11 • n=5 Participants
|
78 mm Hg
STANDARD_DEVIATION 10 • n=7 Participants
|
77 mm Hg
STANDARD_DEVIATION 10 • n=5 Participants
|
|
Comorbidities: Hyperlipidaemia
|
87 participants
n=5 Participants
|
86 participants
n=7 Participants
|
173 participants
n=5 Participants
|
|
Comorbidities: Hypertension
|
87 participants
n=5 Participants
|
85 participants
n=7 Participants
|
172 participants
n=5 Participants
|
|
Comorbidities: Cardiovascular disease
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Comorbidities: Diabetes
|
75 participants
n=5 Participants
|
74 participants
n=7 Participants
|
149 participants
n=5 Participants
|
|
Concomitant medications in the past 6 months: Antilipidaemic
|
72 participants
n=5 Participants
|
64 participants
n=7 Participants
|
136 participants
n=5 Participants
|
|
Concomitant medications in the past 6 months: Cardiovascular
|
97 participants
n=5 Participants
|
92 participants
n=7 Participants
|
189 participants
n=5 Participants
|
|
Concomitant medications in the past 6 months: Antidiabetic
|
67 participants
n=5 Participants
|
73 participants
n=7 Participants
|
140 participants
n=5 Participants
|
|
Concomitant medications in the past 6 months: Metformin
|
55 participants
n=5 Participants
|
62 participants
n=7 Participants
|
117 participants
n=5 Participants
|
|
Concomitant medications in the past 6 months: Pioglitazone
|
1 participants
n=5 Participants
|
6 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Concomitant medications in the past 6 months: Vitamin E
|
29 participants
n=5 Participants
|
32 participants
n=7 Participants
|
61 participants
n=5 Participants
|
|
Concomitant medications in the past 6 months: Thiazolidinedione
|
3 participants
n=5 Participants
|
5 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Concomitant medications in the past 6 months: Aspirin (81 mg)
|
37 participants
n=5 Participants
|
33 participants
n=7 Participants
|
70 participants
n=5 Participants
|
|
Liver histology findings: Definite steatohepatitis
|
114 participants
n=5 Participants
|
111 participants
n=7 Participants
|
225 participants
n=5 Participants
|
|
Liver histology findings: Fibrosis stage
|
1.9 units on a scale
STANDARD_DEVIATION 1.1 • n=5 Participants
|
1.8 units on a scale
STANDARD_DEVIATION 1.0 • n=7 Participants
|
1.8 units on a scale
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Liver histology findings: Total NAFLD activity score
|
5.3 units on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
5.1 units on a scale
STANDARD_DEVIATION 1.3 • n=7 Participants
|
5.2 units on a scale
STANDARD_DEVIATION 1.3 • n=5 Participants
|
|
Liver histology findings: Hepatocellular ballooning score
|
1.4 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
1.3 units on a scale
STANDARD_DEVIATION 0.7 • n=7 Participants
|
1.4 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Liver histology findings: Steatosis score
|
2.1 units on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 0.8 • n=7 Participants
|
2.0 units on a scale
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Liver histology findings: Lobular inflammation score
|
1.8 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
1.8 units on a scale
STANDARD_DEVIATION 0.7 • n=7 Participants
|
1.8 units on a scale
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Liver histology findings: Portal inflammation score
|
1.2 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
1.1 units on a scale
STANDARD_DEVIATION 0.6 • n=7 Participants
|
1.1 units on a scale
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
Liver histology findings: Biopsy length
|
21 mm
STANDARD_DEVIATION 10 • n=5 Participants
|
21 mm
STANDARD_DEVIATION 10 • n=7 Participants
|
21 mm
STANDARD_DEVIATION 10 • n=5 Participants
|
PRIMARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
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: 1. No worsening in fibrosis; and 2. A decrease in NAFLD Activity Score (NAS) of at least 2 points
Outcome measures
| Measure |
Obeticholic Acid
n=110 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=109 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Hepatic Histological Improvement in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS)
|
50 participants
|
23 participants
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: Number of patients with biopsy specimens at baseline and 72 weeks
Resolution of definite nonalcoholic steatohepatitis. Resolution defined as either not NAFLD, or NAFLD but not non-alcoholic steatohepatitis on week 72 biopsy
Outcome measures
| Measure |
Obeticholic Acid
n=102 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=98 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Resolution of NASH Diagnosis
|
22 participants
|
13 participants
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: Number of patients with biopsy specimens at baseline and 72 weeks
Patients with improvement in fibrosis score. Fibrosis was assessed on a scale of 0-4, with higher scores showing more severe fibrosis.
Outcome measures
| Measure |
Obeticholic Acid
n=102 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=98 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Fibrosis: Patient With Improvement
|
36 participants
|
19 participants
|
SECONDARY outcome
Timeframe: baseline to 72 weeksChange in fibrosis score. Fibrosis was assessed on a scale of 0-4, with higher scores showing more severe fibrosis.
Outcome measures
| Measure |
Obeticholic Acid
n=102 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=98 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Fibrosis: Change in Score
|
-0.2 units on a scale
Standard Deviation 1.0
|
0.1 units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: Number of patients with biopsy specimens at baseline and 72 weeks
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 \[assessed on a scale of 0-2\]).
Outcome measures
| Measure |
Obeticholic Acid
n=102 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=98 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Total NAFLD Activity Score: Change in Score
|
-1.7 units on a scale
Standard Deviation 1.8
|
-0.7 units on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: Number of patients with biopsy specimens at baseline and 72 weeks
Patients with improvement in hepatocellular ballooning score. Hepatocellular ballooning was assessed on a scale of 0-2, with higher scores showing more severe ballooning.
Outcome measures
| Measure |
Obeticholic Acid
n=102 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=98 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Hepatocellular Ballooning: Patients With Improvement
|
47 participants
|
30 participants
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: Number of patients with biopsy specimens at baseline and 72 weeks
Change in hepatocellular ballooning score. Hepatocellular ballooning was assessed on a scale of 0-2, with higher scores showing more severe ballooning.
Outcome measures
| Measure |
Obeticholic Acid
n=102 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=98 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Hepatocellular Ballooning: Change in Score
|
-0.5 units on a scale
Standard Deviation 0.9
|
-0.2 units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: Number of patients with biopsy specimens at baseline and 72 weeks
Patients with improvement in steatosis score. Steatosis was assessed on a scale of 0-3, with higher scores showing more severe steatosis.
Outcome measures
| Measure |
Obeticholic Acid
n=102 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=98 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Steatosis: Patients With Improvement
|
62 participants
|
37 participants
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: Number of patients with biopsy specimens at baseline and 72 weeks
Change in steatosis score. Steatosis was assessed on a scale of 0-3, with higher scores showing more severe steatosis.
Outcome measures
| Measure |
Obeticholic Acid
n=102 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=98 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Steatosis: Change in Score
|
-0.8 units on a scale
Standard Deviation 1.0
|
-0.4 units on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: Number of patients with biopsy specimens at baseline and 72 weeks
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.
Outcome measures
| Measure |
Obeticholic Acid
n=102 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=98 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Lobular Inflammation: Patients With Improvement
|
54 participants
|
34 participants
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: Number of patients with biopsy specimens at baseline and 72 weeks
Change in lobular inflammation score. Lobular inflammation was assessed on a scale of 0-3, with higher scores showing more severe lobular inflammation.
Outcome measures
| Measure |
Obeticholic Acid
n=102 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=98 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Lobular Inflammation: Change in Score
|
-0.5 units on a scale
Standard Deviation 0.8
|
-0.2 units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: Number of patients with biopsy specimens at baseline and 72 weeks
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.
Outcome measures
| Measure |
Obeticholic Acid
n=102 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=98 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Portal Inflammation: Patients With Improvement
|
12 participants
|
13 participants
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: Number of patients with biopsy specimens at baseline and 72 weeks
Change in portal inflammation score. Portal inflammation was assessed on a scale of 0-3, with higher scores showing more severe portal inflammation.
Outcome measures
| Measure |
Obeticholic Acid
n=102 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=98 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Portal Inflammation: Change in Score
|
0.2 units on a scale
Standard Deviation 0.7
|
0.2 units on a scale
Standard Deviation 0.7
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Alanine Aminotransferase
|
-38 U/L
Standard Deviation 47
|
-18 U/L
Standard Deviation 44
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Asparate Aminotransferase
|
-27 U/L
Standard Deviation 37
|
-10 U/L
Standard Deviation 31
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Alkaline Phosphatase
|
12 U/L
Standard Deviation 26
|
-6 U/L
Standard Deviation 20
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in γ-glutamyl Transpeptidase
|
-37 U/L
Standard Deviation 70
|
-6 U/L
Standard Deviation 48
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Total Bilirubin
|
-1.0 μmol/L
Standard Deviation 4.1
|
0.6 μmol/L
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Total Cholesterol
|
0.16 mmol/L
Standard Deviation 1.07
|
-0.19 mmol/L
Standard Deviation 0.96
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in HDL Cholesterol
|
-0.02 mmol/L
Standard Deviation 0.20
|
0.03 mmol/L
Standard Deviation 0.19
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in LDL Cholesterol
|
0.22 mmol/L
Standard Deviation 0.90
|
-0.22 mmol/L
Standard Deviation 0.80
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Triglycerides
|
-0.22 mmol/L
Standard Deviation 1.27
|
-0.08 mmol/L
Standard Deviation 1.74
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Haemoglobin
|
0.6 g/L
Standard Deviation 9.6
|
0.3 g/L
Standard Deviation 9.5
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Haematocrit
|
0.00 proportion of 1.0
Standard Deviation 0.03
|
0.00 proportion of 1.0
Standard Deviation 0.03
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Mean Corpuscular Volume
|
-0.8 fL
Standard Deviation 2.6
|
0.3 fL
Standard Deviation 3.5
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in White Blood Cell Count
|
0.0 white blood cells *10^9 per L
Standard Deviation 1.5
|
0.0 white blood cells *10^9 per L
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Platelet Count
|
12 platelets *10^9 per L
Standard Deviation 33
|
-4 platelets *10^9 per L
Standard Deviation 46
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Bicarbonate
|
-0.7 mmol/L
Standard Deviation 3.2
|
-0.1 mmol/L
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Calcium
|
0.01 mmol/L
Standard Deviation 0.10
|
-0.01 mmol/L
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Phosphate
|
0.01 mmol/L
Standard Deviation 0.18
|
0.02 mmol/L
Standard Deviation 0.16
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Creatinine
|
1.5 μmol/L
Standard Deviation 11.3
|
-1.1 μmol/L
Standard Deviation 9.6
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Uric Acid
|
2 μmol/L
Standard Deviation 68
|
-11 μmol/L
Standard Deviation 56
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Albumin
|
-0.2 gl/L
Standard Deviation 3.1
|
0.3 gl/L
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Total Protein
|
0.2 gl/L
Standard Deviation 4.5
|
-0.5 gl/L
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Prothrombin Time
|
-0.1 s
Standard Deviation 2.4
|
0.0 s
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in International Normalised Ratio
|
-0.03 ratio
Standard Deviation 0.07
|
0.00 ratio
Standard Deviation 0.08
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Fasting Serum Glucose
|
0.4 mmol/L
Standard Deviation 2.1
|
0.2 mmol/L
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Insulin
|
29 pmol/L
Standard Deviation 159
|
10 pmol/L
Standard Deviation 111
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in HOMA-IR
|
15 glucose[mmol/L]× insulin[pmol/L] / 22.5
Standard Deviation 50
|
4 glucose[mmol/L]× insulin[pmol/L] / 22.5
Standard Deviation 29
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Glycated Haemoglobin A1c
|
0.5 mmol/mol
Standard Deviation 9.7
|
0.4 mmol/mol
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Weight
|
-2.3 kg
Standard Deviation 6.7
|
0.0 kg
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Body-mass Index
|
-0.7 kg/m²
Standard Deviation 2.4
|
0.1 kg/m²
Standard Deviation 2.2
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Waist Circumference
|
-1.5 cm
Standard Deviation 7.1
|
-0.6 cm
Standard Deviation 8.7
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Waist-to-hip Ratio
|
0.00 ratio
Standard Deviation 0.06
|
0.00 ratio
Standard Deviation 0.06
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Systolic Blood Pressure
|
-4 mm Hg
Standard Deviation 17
|
-1 mm Hg
Standard Deviation 16
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in Diastolic Blood Pressure
|
0 mm Hg
Standard Deviation 11
|
0 mm Hg
Standard Deviation 10
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in SF-36 Quality of Life Physical Component Summary
|
0 units on a scale
Standard Deviation 7
|
-1 units on a scale
Standard Deviation 7
|
SECONDARY outcome
Timeframe: baseline to 72 weeksPopulation: 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.
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.
Outcome measures
| Measure |
Obeticholic Acid
n=126 Participants
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=131 Participants
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Change in SF-36 Quality of Life Mental Component Summary
|
0 units on a scale
Standard Deviation 9
|
1 units on a scale
Standard Deviation 9
|
Adverse Events
Obeticholic Acid
Placebo
Serious adverse events
| Measure |
Obeticholic Acid
n=141 participants at risk
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=142 participants at risk
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Cardiac disorders
Cardiovascular death or non-fatal myocardial infarction or non-fatal stroke
|
2.1%
3/141 • Number of events 3
|
0.70%
1/142 • Number of events 2
|
|
Cardiac disorders
Other coronary artery disease or angina
|
1.4%
2/141 • Number of events 2
|
1.4%
2/142 • Number of events 2
|
|
Cardiac disorders
Other cardiovascular event
|
0.71%
1/141 • Number of events 1
|
0.70%
1/142 • Number of events 1
|
|
Nervous system disorders
Other neurological event
|
0.71%
1/141 • Number of events 1
|
1.4%
2/142 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritis
|
0.71%
1/141 • Number of events 1
|
0.00%
0/142
|
|
Hepatobiliary disorders
Hepatobiliary events
|
0.71%
1/141 • Number of events 1
|
0.70%
1/142 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/141
|
1.4%
2/142 • Number of events 2
|
|
Gastrointestinal disorders
Pancreatitis
|
0.71%
1/141 • Number of events 1
|
0.70%
1/142 • Number of events 1
|
|
Gastrointestinal disorders
Other gastrointestinal event
|
1.4%
2/141 • Number of events 2
|
0.00%
0/142
|
|
Renal and urinary disorders
Other renal event
|
0.71%
1/141 • Number of events 1
|
0.00%
0/142
|
Other adverse events
| Measure |
Obeticholic Acid
n=141 participants at risk
obeticholic acid
obeticholic acid: 25 mg daily for 72 weeks
|
Placebo
n=142 participants at risk
Placebo
placebo: placebo capsule, 25 mg daily for 72 weeks
|
|---|---|---|
|
Cardiac disorders
Other cardiovascular event
|
5.0%
7/141 • Number of events 7
|
3.5%
5/142 • Number of events 5
|
|
Nervous system disorders
Dizziness or syncope
|
2.1%
3/141 • Number of events 3
|
2.8%
4/142 • Number of events 4
|
|
Nervous system disorders
Headache
|
1.4%
2/141 • Number of events 2
|
3.5%
5/142 • Number of events 5
|
|
Nervous system disorders
Neuralgia
|
2.1%
3/141 • Number of events 3
|
1.4%
2/142 • Number of events 2
|
|
Nervous system disorders
Other neurological event
|
2.8%
4/141 • Number of events 4
|
5.6%
8/142 • Number of events 8
|
|
Renal and urinary disorders
Urinary tract infection or cystitis
|
1.4%
2/141 • Number of events 2
|
2.1%
3/142 • Number of events 3
|
|
Renal and urinary disorders
Kidney stones
|
4.3%
6/141 • Number of events 6
|
1.4%
2/142 • Number of events 2
|
|
Renal and urinary disorders
Other renal event
|
0.71%
1/141 • Number of events 1
|
1.4%
2/142 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
22.7%
32/141 • Number of events 32
|
6.3%
9/142 • Number of events 9
|
|
Gastrointestinal disorders
Abdominal pain
|
5.0%
7/141 • Number of events 7
|
4.9%
7/142 • Number of events 7
|
|
Gastrointestinal disorders
Dental or tooth pain
|
2.8%
4/141 • Number of events 4
|
0.70%
1/142 • Number of events 1
|
|
Gastrointestinal disorders
Liver pain post biopsy
|
0.71%
1/141 • Number of events 1
|
0.70%
1/142 • Number of events 1
|
|
Gastrointestinal disorders
Nausea, vomiting, or diarrhoea
|
8.5%
12/141 • Number of events 12
|
8.5%
12/142 • Number of events 12
|
|
Gastrointestinal disorders
Constipation
|
3.5%
5/141 • Number of events 5
|
0.70%
1/142 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
2.1%
3/141 • Number of events 3
|
0.70%
1/142 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/141
|
0.70%
1/142 • Number of events 1
|
|
Gastrointestinal disorders
Other gastrointestinal event
|
5.0%
7/141 • Number of events 7
|
2.8%
4/142 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place