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Combination Obeticholic Acid (OCA) and Statins for Monitoring of Lipids (CONTROL) (CONTROL)

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ClinicalTrials.gov Identifier: NCT02633956
Recruitment Status : Completed
First Posted : December 17, 2015
Results First Posted : June 4, 2018
Last Update Posted : June 4, 2018
Sponsor:
Information provided by (Responsible Party):
Intercept Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Nonalcoholic Steatohepatitis
Interventions Drug: Obeticholic Acid
Drug: Atorvastatin
Drug: Placebo
Enrollment 84
Recruitment Details  
Pre-assignment Details Subjects using statins within 30 days of the initial Screening visit (Screening Visit 1) are required to stop statin therapy immediately following this initial visit and must undergo a 4-week statin washout period prior to Screening Visit 2.
Arm/Group Title 5 mg Obeticholic Acid 10 mg Obeticholic Acid 25 mg Obeticholic Acid Placebo
Hide Arm/Group Description

5 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.

Obeticholic Acid: Once a day (QD) by mouth (PO)

Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).

Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.

Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.

10 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.

Obeticholic Acid: Once a day (QD) by mouth (PO)

Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).

Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.

Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.

25 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.

Obeticholic Acid: Once a day (QD) by mouth (PO)

Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).

Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.

Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.

One tablet daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.

Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).

Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.

Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.

Placebo: Once a day (QD) by mouth (PO)

Period Title: Overall Study
Started 20 21 22 21
Completed 19 19 20 21
Not Completed 1 2 2 0
Arm/Group Title 5 mg Obeticholic Acid 10 mg Obeticholic Acid 25 mg Obeticholic Acid Placebo Total
Hide Arm/Group Description

5 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.

Obeticholic Acid: Once a day (QD) by mouth (PO)

Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).

Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.

Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.

10 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.

Obeticholic Acid: Once a day (QD) by mouth (PO)

Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).

Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.

Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.

25 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.

Obeticholic Acid: Once a day (QD) by mouth (PO)

Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).

Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.

Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.

One tablet daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.

Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).

Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.

Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.

Placebo: Once a day (QD) by mouth (PO)

Total of all reporting groups
Overall Number of Baseline Participants 20 21 22 21 84
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants 21 participants 22 participants 21 participants 84 participants
52.9  (10.13) 57.1  (11.62) 62.2  (11.06) 59.8  (9.88) 58.1  (11.07)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 22 participants 21 participants 84 participants
Female
16
  80.0%
12
  57.1%
10
  45.5%
13
  61.9%
51
  60.7%
Male
4
  20.0%
9
  42.9%
12
  54.5%
8
  38.1%
33
  39.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 22 participants 21 participants 84 participants
Hispanic or Latino
7
  35.0%
4
  19.0%
5
  22.7%
4
  19.0%
20
  23.8%
Not Hispanic or Latino
13
  65.0%
17
  81.0%
17
  77.3%
17
  81.0%
64
  76.2%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 22 participants 21 participants 84 participants
American Indian or Alaska Native
0
   0.0%
1
   4.8%
0
   0.0%
0
   0.0%
1
   1.2%
Asian
1
   5.0%
0
   0.0%
2
   9.1%
3
  14.3%
6
   7.1%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
1
   4.5%
1
   4.8%
2
   2.4%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.8%
1
   1.2%
White
19
  95.0%
20
  95.2%
19
  86.4%
16
  76.2%
74
  88.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Fibrosis stage (NASH Clinical Research Network (CRN) categories)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 22 participants 21 participants 84 participants
Stage 1 and 2
10
  50.0%
10
  47.6%
11
  50.0%
10
  47.6%
41
  48.8%
Stage 3 and 4
10
  50.0%
11
  52.4%
11
  50.0%
11
  52.4%
43
  51.2%
[1]
Measure Description:

The NASH CRN Fibrosis Staging is based on the degree of liver fibrosis from Stage 0: no fibrosis to Stage 4: cirrhosis. The related histological classification of each stage is as follows: Fibrosis Stage: Stage 0: none; Stage 1a: zone 3 perisinusoidal, delicate; 1b: zone 3 perisinusoidal, dense; 1c: portal only; Stage 2: 1a or 1b + periportal fibrosis; Stage 3: bridging fibrosis; and Stage 4: cirrhosis.

The higher the fibrosis stage the worse the prognosis.

Screening LDL   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 21 participants 22 participants 21 participants 84 participants
Less than or equal 125 mg/dL
11
  55.0%
11
  52.4%
13
  59.1%
11
  52.4%
46
  54.8%
Greater than 125 mg/dL
9
  45.0%
10
  47.6%
9
  40.9%
10
  47.6%
38
  45.2%
[1]
Measure Description: Fasting LDL concentration
1.Primary Outcome
Title The Effect of Obeticholic Acid on Low-density Lipoprotein (LDL) Concentration (Least Squares Mean Change From Baseline at Week 16)
Hide Description The effect of Obeticholic Acid on LDL metabolism in subjects with biopsy confirmed nonalcoholic steatohepatitis (NASH) and the ability of atorvastatin to modulate this effect as measured by change (least squares mean) from baseline at week 16 in LDL concentration
Time Frame Baseline and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population
Arm/Group Title 5 mg Obeticholic Acid 10 mg Obeticholic Acid 25 mg Obeticholic Acid Placebo
Hide Arm/Group Description:

5 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.

Obeticholic Acid: Once a day (QD) by mouth (PO)

Atorvastatin: Initiate treatment with Atorvastatin at Week 4 Visit with a dose of 10 mg once daily (QD) by mouth (PO).

Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.

Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.

10 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.

Obeticholic Acid: Once a day (QD) by mouth (PO)

Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).

Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.

Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.

25 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.

Obeticholic Acid: Once a day (QD) by mouth (PO)

Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).

Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.

Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.

One tablet daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.

Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).

Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.

Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.

Placebo: Once a day (QD) by mouth (PO)

Overall Number of Participants Analyzed 13 17 18 19
Least Squares Mean (Standard Error)
Unit of Measure: mg/dL
-33.2  (4.93) -44.27  (4.10) -39.54  (4.24) -53.33  (3.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 25 mg Obeticholic Acid, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimation
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 13.79
Confidence Interval (2-Sided) 95%
2.28 to 25.30
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.75
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 10 mg Obeticholic Acid, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimation
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 9.06
Confidence Interval (2-Sided) 95%
-2.18 to 20.30
Parameter Dispersion
Type: Standard Error of the Mean
Value: 5.61
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 5 mg Obeticholic Acid, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimation
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 20.13
Confidence Interval (2-Sided) 95%
7.33 to 32.92
Parameter Dispersion
Type: Standard Error of the Mean
Value: 6.39
Estimation Comments [Not Specified]
2.Primary Outcome
Title The Effect of Obeticholic Acid on LDL Particle Size (Least Squares Mean Change From Baseline at Week 16)
Hide Description The effect of Obeticholic Acid on LDL metabolism in subjects with biopsy confirmed NASH and the ability of atorvastatin to modulate this effect as measured by change from baseline (least squares mean) at week 16 in LDL particle size. It is LDL particle diameter size (nm) that is reported.
Time Frame Baseline and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population
Arm/Group Title 5 mg Obeticholic Acid 10 mg Obeticholic Acid 25 mg Obeticholic Acid Placebo
Hide Arm/Group Description:

5 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.

Obeticholic Acid: Once a day (QD) by mouth (PO)

Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).

Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.

Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.

10 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.

Obeticholic Acid: Once a day (QD) by mouth (PO)

Atorvastatin: Initiate treatment with Atorvastatin at Week 4 Visit with a dose of 10 mg once daily (QD) by mouth (PO).

Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.

Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.

25 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.

Obeticholic Acid: Once a day (QD) by mouth (PO)

Atorvastatin: Initiate treatment with Atorvastatin at Week 4 Visit with a dose of 10 mg once daily (QD) by mouth (PO).

Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.

Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.

One tablet daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.

Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).

Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.

Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.

Placebo: Once a day (QD) by mouth (PO)

Overall Number of Participants Analyzed 12 17 17 17
Least Squares Mean (Standard Error)
Unit of Measure: nm
0.02  (0.15) -0.41  (0.12) -0.09  (0.12) -0.49  (0.12)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 25 mg Obeticholic Acid, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimation
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 0.41
Confidence Interval (2-Sided) 95%
0.07 to 0.75
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.17
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 10 mg Obeticholic Acid, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimation
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 0.09
Confidence Interval (2-Sided) 95%
-0.25 to 0.42
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.17
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 5 mg Obeticholic Acid, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimation
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 0.51
Confidence Interval (2-Sided) 95%
0.14 to 0.89
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.19
Estimation Comments [Not Specified]
3.Primary Outcome
Title The Effect of Obeticholic Acid on LDL Particle Concentration (Total) (Least Squares Mean Change From Baseline at Week 16)
Hide Description The effect of Obeticholic Acid on LDL metabolism in subjects with biopsy confirmed nonalcoholic NASH and the ability of atorvastatin to modulate this effect as measured by change (least squares mean) from baseline at week 16 in LDL particle concentration (total)
Time Frame Baseline and Week 16
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy evaluable population
Arm/Group Title 5 mg Obeticholic Acid 10 mg Obeticholic Acid 25 mg Obeticholic Acid Placebo
Hide Arm/Group Description:

5 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.

Obeticholic Acid: Once a day (QD) by mouth (PO)

Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).

Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.

Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.

10 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.

Obeticholic Acid: Once a day (QD) by mouth (PO)

Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).

Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.

Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.

25 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.

Obeticholic Acid: Once a day (QD) by mouth (PO)

Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).

Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.

Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.

One tablet daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.

Atorvastatin: Initiate treatment with Atorvastatin at Week 4 Visit with a dose of 10 mg once daily (QD) by mouth (PO).

Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.

Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.

Placebo: Once a day (QD) by mouth (PO)

Overall Number of Participants Analyzed 12 17 17 19
Least Squares Mean (Standard Error)
Unit of Measure: nmol/L
-224.79  (62.58) -325.04  (49.81) -336.22  (51.40) -439.84  (47.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 25 mg Obeticholic Acid, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimation
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 103.61
Confidence Interval (2-Sided) 95%
-35.58 to 242.81
Parameter Dispersion
Type: Standard Error of the Mean
Value: 69.51
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection 10 mg Obeticholic Acid, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimation
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 114.80
Confidence Interval (2-Sided) 95%
-21.53 to 251.13
Parameter Dispersion
Type: Standard Error of the Mean
Value: 68.08
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection 5 mg Obeticholic Acid, Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments Estimation
Method of Estimation Estimation Parameter Least Square Mean Difference
Estimated Value 215.05
Confidence Interval (2-Sided) 95%
55.84 to 374.26
Parameter Dispersion
Type: Standard Error of the Mean
Value: 79.51
Estimation Comments [Not Specified]
Time Frame From time of first dose to end of double-blind phase participation, up to 16 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 5 mg Obeticholic Acid 10 mg Obeticholic Acid 25 mg Obeticholic Acid Placebo
Hide Arm/Group Description

5 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.

Obeticholic Acid: Once a day (QD) by mouth (PO)

Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).

Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.

Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.

10 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.

Obeticholic Acid: Once a day (QD) by mouth (PO)

Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).

Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.

Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.

25 mg Obeticholic Acid daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.

Obeticholic Acid: Once a day (QD) by mouth (PO)

Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).

Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.

Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.

One tablet daily for the double-blind treatment period. 10 mg Atorvastatin titrating to 20mg.

Atorvastatin: Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).

Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.

Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated.

Placebo: Once a day (QD) by mouth (PO)

All-Cause Mortality
5 mg Obeticholic Acid 10 mg Obeticholic Acid 25 mg Obeticholic Acid Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)      0/21 (0.00%)      0/22 (0.00%)      0/21 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
5 mg Obeticholic Acid 10 mg Obeticholic Acid 25 mg Obeticholic Acid Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/20 (10.00%)      1/21 (4.76%)      1/22 (4.55%)      0/21 (0.00%)    
Hepatobiliary disorders         
Cholecystitis  1  0/20 (0.00%)  0 1/21 (4.76%)  1 0/22 (0.00%)  0 0/21 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast cancer stage IV  1  1/20 (5.00%)  1 0/21 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0
Skin and subcutaneous tissue disorders         
Angioedema  1  0/20 (0.00%)  0 0/21 (0.00%)  0 1/22 (4.55%)  1 0/21 (0.00%)  0
Vascular disorders         
Hypertensive crisis  1  1/20 (5.00%)  1 0/21 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
5 mg Obeticholic Acid 10 mg Obeticholic Acid 25 mg Obeticholic Acid Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/20 (65.00%)      9/21 (42.86%)      19/22 (86.36%)      9/21 (42.86%)    
Gastrointestinal disorders         
Constipation  1  0/20 (0.00%)  0 2/21 (9.52%)  2 3/22 (13.64%)  3 0/21 (0.00%)  0
Diarrhoea  1  2/20 (10.00%)  3 0/21 (0.00%)  0 2/22 (9.09%)  2 3/21 (14.29%)  3
Abdominal distension  1  2/20 (10.00%)  2 0/21 (0.00%)  0 1/22 (4.55%)  1 1/21 (4.76%)  2
Flatulence  1  0/20 (0.00%)  0 2/21 (9.52%)  2 1/22 (4.55%)  1 1/21 (4.76%)  1
Dyspepsia  1  0/20 (0.00%)  0 2/21 (9.52%)  2 0/22 (0.00%)  0 1/21 (4.76%)  1
Nausea  1  0/20 (0.00%)  0 0/21 (0.00%)  0 2/22 (9.09%)  3 0/21 (0.00%)  0
General disorders         
Fatigue  1  1/20 (5.00%)  1 3/21 (14.29%)  3 3/22 (13.64%)  3 1/21 (4.76%)  1
Infections and infestations         
Urinary tract infection  1  3/20 (15.00%)  3 0/21 (0.00%)  0 1/22 (4.55%)  1 2/21 (9.52%)  3
Upper respiratory tract infection  1  2/20 (10.00%)  2 0/21 (0.00%)  0 1/22 (4.55%)  1 1/21 (4.76%)  1
Bronchitis  1  0/20 (0.00%)  0 0/21 (0.00%)  0 2/22 (9.09%)  2 1/21 (4.76%)  1
Sinusitis  1  1/20 (5.00%)  1 0/21 (0.00%)  0 1/22 (4.55%)  1 2/21 (9.52%)  2
Injury, poisoning and procedural complications         
Ligament sprain  1  1/20 (5.00%)  1 0/21 (0.00%)  0 2/22 (9.09%)  2 0/21 (0.00%)  0
Investigations         
Weight increased  1  2/20 (10.00%)  2 0/21 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Muscle spasms  1  2/20 (10.00%)  2 3/21 (14.29%)  3 1/22 (4.55%)  1 0/21 (0.00%)  0
Myalgia  1  1/20 (5.00%)  1 0/21 (0.00%)  0 2/22 (9.09%)  2 0/21 (0.00%)  0
Rheumatoid arthritis  1  2/20 (10.00%)  2 0/21 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0
Nervous system disorders         
Headache  1  3/20 (15.00%)  3 0/21 (0.00%)  0 1/22 (4.55%)  1 1/21 (4.76%)  1
Hypoaesthesia  1  2/20 (10.00%)  3 0/21 (0.00%)  0 0/22 (0.00%)  0 0/21 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Cough  1  2/20 (10.00%)  2 1/21 (4.76%)  1 0/22 (0.00%)  0 1/21 (4.76%)  1
Skin and subcutaneous tissue disorders         
Pruritus  1  1/20 (5.00%)  1 2/21 (9.52%)  2 12/22 (54.55%)  19 1/21 (4.76%)  1
Pruritus generalised  1  0/20 (0.00%)  0 1/21 (4.76%)  1 4/22 (18.18%)  4 1/21 (4.76%)  1
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Principal Investigators must wait 18 months after the study end to publish their results and a multi-center publication must come first. The sponsor has a 45 day review period with the option to extend to an additional 90 days.
Results Point of Contact
Name/Title: Medical Information
Organization: Intercept Pharmaceuticals, Inc
Phone: 844-782-4278
Responsible Party: Intercept Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02633956     History of Changes
Other Study ID Numbers: 747-209
First Submitted: November 18, 2015
First Posted: December 17, 2015
Results First Submitted: March 21, 2018
Results First Posted: June 4, 2018
Last Update Posted: June 4, 2018