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Study to determine the effect of the investigational drug bezafibrate (BZF) alone and in combination with the investigational drug obeticholic acid (OCA) in participants with Primary Biliary Cholangitis (PBC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double Blind (DB) Phase Treatment A: BZF 100 milligrams (mg) Immediate Release (IR) tablet | Active Comparator | Each Participant will take one OCA placebo tablet, one BZF 100 mg IR tablet and one BZF placebo tablet daily. |
|
| Double Blind (DB) Phase Treatment B: BZF 400 mg IR tablet | Active Comparator | Each Participant will take one OCA placebo tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily. |
|
| Double Blind (DB) Phase Treatment C: OCA 5 mg + BZF 100 mg IR | Experimental | Each participant will take one OCA 5 mg tablet, one BZF 100 mg IR tablet and one BZF placebo tablet, daily. |
|
| Double Blind (DB) Phase Treatment D: OCA 5 mg + BZF 400 mg IR | Experimental | Each participant will take one OCA 5 mg tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily. |
|
| Long Term Safety Extension (LTSE) Phase Treatment D of the DB phase: OCA 5 mg + BZF 400 mg IR |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bezafibrate 100 mg | Drug | One tablet of bezafibrate 100 mg IR once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Alkaline Phosphatase (ALP) from Baseline to Week 12 | Baseline, and at Weeks 2, 4, 6, 8, 10 and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in response rates of ≥10 percent, ≥20 percent, ≥30 percent and ≥40 percent reduction and normalization rates of biochemical disease marker ALP | Baseline and at Weeks 2, 4, 6, 8, 10 and 12 | |
| Number of participants with normalization rates of alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), alanine aminotransferase (AST), total and conjugated bilirubin and lipid panel |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Lynda Szczech, M.D. | Intercept Pharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Southern California Gastrointestinal (GI) and Liver Centers (SCLC) - Coronado |
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| Experimental |
Each participant will take one OCA 5 mg tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily. |
|
| Bezafibrate 200 mg | Drug | Two tablets of bezafibrate 200 mg IR once daily for BZF 400 mg IR |
|
| Obeticholic Acid 5 mg | Drug | One tablet of obeticholic acid 5 mg tablet once daily. |
|
| Obeticholic Acid placebo | Drug | One tablet of obeticholic acid placebo tablet once daily |
|
| Bezafibrate Placebo | Drug | One tablet of bezafibrate placebo tablet once daily |
|
| Baseline and at Weeks 2, 4, 6, 8, 10 and 12 |
| Change from Baseline in biochemical disease marker GGT | Baseline and at Weeks 2, 4, 6, 8, 10 and 12 |
| Change from Baseline in biochemical disease marker ALT | Baseline and at Weeks 2, 4, 6, 8, 10 and 12 |
| Change from Baseline in biochemical disease marker AST | Baseline and at Weeks 2, 4, 6, 8, 10 and 12 |
| Change from Baseline in biochemical disease markers, total & conjugated bilirubin | Baseline and at Weeks 2, 4, 6, 8, 10 and 12 |
| Change from Baseline in lipid panel | Baseline and at Weeks 2, 4, 6, 8, 10 and 12 |
| Change from Baseline of the plasma value of 7 alpha (α) hydroxy 4 cholesten-3 one (C4) | Baseline and at Weeks 2, 4, 6, 8, 10, and 12 |
| Change from Baseline of the plasma value of bile acids, in unit of nanograms per milliliter (ng/ml) | Baseline and at Weeks 2, 4, 6, 8, 10, and 12 |
| Coronado |
| California |
| 92118 |
| United States |
| Facey Medical Group | Mission Hills | California | 91345 | United States |
| Schiff Center for Liver Diseases / University of Miami | Miami | Florida | 33136 | United States |
| Tampa General Medical Group | Tampa | Florida | 33606 | United States |
| Piedmont Atlanta Hospital | Atlanta | Georgia | 30309 | United States |
| Loyola University Medical Center | Maywood | Illinois | 60459 | United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States |
| Beth Israel Deaconess Medical Center Harvard Liver Research Center | Boston | Massachusetts | 02215 | United States |
| NYU Langone Medical Center | New York | New York | 10016-6402 | United States |
| Wake Endoscopy Center | Raleigh | North Carolina | 27607 | United States |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
| Gastro One | Cordova | Tennessee | 38018 | United States |
| Gastrointestinal Associates of Northeast Tennessee | Johnson City | Tennessee | 37604 | United States |
| Methodist Clinical Research Institute (CRI) | Dallas | Texas | 75203 | United States |
| Houston Methodist Cancer Center | Houston | Texas | 77030-2717 | United States |
| American Research Corporation at the Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| Hospital Italiano La Plata | La Plata | Buenos Aires | Argentina |
| DIM Clinical Privada | Ramos Mejía | Buenos Aires | Argentina |
| Hospital Italiano de Buenos Aires | Buenos Aires | Argentina |
| Hospital Universitario Austral | Pilar | Argentina |
| Hospital Provincial del Centenario | Rosario | Argentina |
| The Northern Alberta Clinical Trials and Research Centre | Edmonton | Alberta | T6G 287 | Canada |
| Pacific Gastroenterology Associates | Vancouver | British Columbia | V6Z 2K5 | Canada |
| University of Montreal | Montreal | Quebec | Canada |
| Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi | Bologna | Italy |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 17, 2026 |
| ID | Term |
|---|---|
| D008105 | Liver Cirrhosis, Biliary |
| D005355 | Fibrosis |
| ID | Term |
|---|---|
| D002780 | Cholestasis, Intrahepatic |
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001629 | Bezafibrate |
| C464660 | obeticholic acid |
| ID | Term |
|---|---|
| D001549 | Benzamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D058607 | Fibric Acids |
| D058610 | Isobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D001565 | Benzoates |
| D000146 | Acids, Carbocyclic |
| D002723 | Chlorobenzoates |
| D010647 | Phenyl Ethers |
| D004987 | Ethers |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D010636 | Phenols |
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