Study of OCA in Combination With BZF Evaluating Efficacy, Safety and Tolerability in Participants With PBC

Browse trials for

• Liver Cirrhosis, Biliary 208
• Fibrosis 3,255

Keywords

• Primary Biliary Cholangitis
• Primary Biliary Cirrhosis
• Hepatic Impairment
• Cirrhosis
• Liver

Liver Cirrhosis, Biliary

208 studies on the registry are indexed under Liver Cirrhosis, Biliary; 44 are open to participants now.

This study's enrollment of 72 is above the median of 60 across 150 interventional studies indexed under Liver Cirrhosis, Biliary.

Lead sponsor

Intercept Pharmaceuticals is the lead sponsor of 21 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Study arms

• Active comparator
  Double Blind (DB) Phase Treatment A: BZF 100 milligrams (mg) Immediate Release (IR) tablet

  Each Participant will take one OCA placebo tablet, one BZF 100 mg IR tablet and one BZF placebo tablet daily.

  Drug: Bezafibrate 100 mg · Drug: Obeticholic Acid placebo · Drug: Bezafibrate Placebo

• Active comparator
  Double Blind (DB) Phase Treatment B: BZF 400 mg IR tablet

  Each Participant will take one OCA placebo tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily.

  Drug: Bezafibrate 200 mg · Drug: Obeticholic Acid placebo

• Experimental
  Double Blind (DB) Phase Treatment C: OCA 5 mg + BZF 100 mg IR

  Each participant will take one OCA 5 mg tablet, one BZF 100 mg IR tablet and one BZF placebo tablet, daily.

  Drug: Bezafibrate 100 mg · Drug: Obeticholic Acid 5 mg · Drug: Bezafibrate Placebo

• Experimental
  Double Blind (DB) Phase Treatment D: OCA 5 mg + BZF 400 mg IR

  Each participant will take one OCA 5 mg tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily.

  Drug: Bezafibrate 200 mg · Drug: Obeticholic Acid 5 mg

• Experimental
  Long Term Safety Extension (LTSE) Phase Treatment D of the DB phase: OCA 5 mg + BZF 400 mg IR

  Each participant will take one OCA 5 mg tablet and two BZF 200 mg IR tablets (to achieve 400 mg dose) daily.

  Drug: Bezafibrate 200 mg · Drug: Obeticholic Acid 5 mg

Interventions

• DrugBezafibrate 100 mg

  One tablet of bezafibrate 100 mg IR once daily

• DrugBezafibrate 200 mg

  Two tablets of bezafibrate 200 mg IR once daily for BZF 400 mg IR

• DrugObeticholic Acid 5 mg

  One tablet of obeticholic acid 5 mg tablet once daily.

• DrugObeticholic Acid placebo

  One tablet of obeticholic acid placebo tablet once daily

• DrugBezafibrate Placebo

  One tablet of bezafibrate placebo tablet once daily

Primary outcomes

1. Change From Baseline in Alkaline Phosphatase (ALP)

   Serum samples were collected at scheduled visits during the double-blind treatment period. Changes in ALP were evaluated using a mixed-effects repeated-measures model (MMRM) to assess the effects of treatment groups over time. Baseline was defined as the mean of all available evaluations prior to the first administration of investigational product. Change from Baseline was calculated as post Baseline value minus Baseline value.

   Time frame: Baseline to Week 12

Secondary outcomes

1. Percentage of Participants With Response Rates of ≥10%, ≥20%, ≥30% and ≥40% Reduction From Baseline in ALP

   Responders were defined as participants achieving a ≥10%, ≥20%, ≥30%, or ≥40% reduction from baseline in serum ALP at week 12 during the DB treatment period with non-responder imputation applied. Baseline ALP was defined as the last evaluations prior to the first administration of investigational product. The percentage of responders were summarized by treatment group for each response threshold and compared using a Cochran Mantel Haenszel test stratified by the randomization stratification factor.

   Time frame: At Week 12

2. Normalization Rates of ALP at Week 12

   Percentage of participants achieving a response in serum ALP at week 12 during the DB treatment period was assessed using non-responder imputation. Analyses of ALP normalization rates were performed using a Cochran-Mantel-Haenszel test stratified by the randomization stratification factor.

   Time frame: At Week 12

3. Normalization Rates of Biochemical Disease Markers

   Percentage of participants achieving a response in biochemical disease markers including ALP, alanine amino transferase (ALT), aspartate amino transferase (AST), gamma-glutamyl transferase (GGT), total and conjugated bilirubin and lipid panel (cholesterol, high density lipoprotein \[HDL\] and low density lipoprotein \[LDL\]) at Week 12 during the DB treatment period has been presented. Analyses of response rates and normalization rates were performed using a Cochran-Mantel-Haenszel test stratified by the randomization stratification factor.

   Time frame: At Week 12

4. Change From Baseline in in GGT, ALT and AST Levels

   Blood samples were collected at indicated timepoint and Change from Baseline in GGT, ALT and AST were analyzed using the MMRM model and results were summarized in standard International System of Units (SI) by treatment group using descriptive statistics at baseline and at each on-study evaluation. Baseline was defined as the mean of all available evaluations prior to the first administration of investigational product. Change from baseline was calculated as post Baseline value minus Baseline value.

   Time frame: Baseline and At Week 12

5. Change From Baseline in Total and Conjugated Bilirubin

   Blood samples were collected at indicated timepoints and the changes in total and conjugated bilirubin were evaluated using MMRM to assess the effects of treatment groups over time. Baseline was defined as the mean of all available evaluations prior to the first administration of investigational product. Change from baseline was calculated as post Baseline value minus Baseline value.

   Time frame: Baseline and At Week 12

6. Change From Baseline in Lipid Panel

   Blood samples were collected at indicated timepoints and the changes in lipid panel including cholesterol, HDL and LDL were evaluated using MMRM to assess the effects of treatment groups over time. Baseline was defined as the mean of all available evaluations prior to the first administration of investigational product. Change from baseline was calculated as post Baseline value minus Baseline value.

   Time frame: Baseline and At Week 12

7. Change From Baseline of the Plasma Value of 7 Alpha (α) Hydroxy 4 Cholesten-3 One (C4)

   Blood samples were collected at indicated timepoints for the assessment of C4. Baseline was defined as the mean of all available evaluations prior to the first administration of investigational product. Change from baseline was calculated as post Baseline value minus Baseline value.

   Time frame: Baseline and At Week 12

8. Number of Participants With Clinically Significant Changes From Baseline in Bile Acids

   Blood samples were collected for the assessment of bile acids. Baseline was defined as the mean of all available evaluations prior to the first administration of investigational product.

   Time frame: At Week 12

Baseline characteristics

Study documents

• Study protocol · Dec 20, 2023
• Statistical analysis plan · Oct 15, 2025

Documents are hosted by the registry — open the source record to download them.