Trial · NCT01865812

Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis

NCT01865812, Phase 2, Completed, Intercept Pharmaceuticals; results first posted 2016-10-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis. Trials, record NCT01865812. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01865812

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Phase 2 Study on Effects of Obeticholic Acid (OCA) on Lipoprotein Metabolism in Participants With Primary Biliary Cirrhosis
NCT number: NCT01865812
Status: Completed
Phases: Phase 2
Enrollment: 27 participants, actual
Lead sponsor: Intercept Pharmaceuticals
Conditions: Primary Biliary Cirrhosis
Interventions: Obeticholic Acid
First posted: 2013-05-31
Last updated: 2022-08-24
Results first posted: 2016-10-19

Source ClinicalTrials.gov

Registered outcomes56

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Absolute Change From Baseline In High-density Lipoprotein (HDL) Cholesterol Concentration	Baseline, Week 8
Primary	Absolute Change From Baseline In HDL Particle Size	Baseline, Week 8
Primary	Absolute Change From Baseline In HDL Particle Number	Baseline, Week 8
Secondary	Median Change From Baseline In HDL Cholesterol Concentration At Weeks 4, 8, and 12	Baseline, Week 4, Week 8, Week 12
Secondary	Median Change From Baseline In HDL Particle Size At Weeks 4, 8, and 12	Baseline, Week 4, Week 8, Week 12
Secondary	Median Change From Baseline In HDL Particle Number At Weeks 4, 8, and 12	Baseline, Week 4, Week 8, Week 12
Secondary	Median Change From Week 8 In HDL Cholesterol Concentration At Week 12	Week 8, Week 12
Secondary	Median Change From Week 8 In HDL Particle Size At Week 12	Week 8, Week 12
Secondary	Median Change From Week 8 In HDL Particle Number At Week 12	Week 8, Week 12
Secondary	Maximum Plasma Concentration (Cmax) Of OCA And Conjugates	Week 8	Results are reported in nanograms per milliliter (ng/mL).

1 to 10 of 56Source ClinicalTrials.gov

See all 56 registered outcomes

Outcomes56

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Absolute Change From Baseline In High-density Lipoprotein (HDL) Cholesterol Concentration	Baseline, Week 8	Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.	mmol/L	LEAST_SQUARES_MEAN
PRIMARY	Absolute Change From Baseline In HDL Particle Size	Baseline, Week 8	Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.	nm	LEAST_SQUARES_MEAN
PRIMARY	Absolute Change From Baseline In HDL Particle Number	Baseline, Week 8	Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.	umol/L	LEAST_SQUARES_MEAN
SECONDARY	Median Change From Baseline In HDL Cholesterol Concentration At Weeks 4, 8, and 12	Baseline, Week 4, Week 8, Week 12	Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.	mmol/L	MEDIAN
SECONDARY	Median Change From Baseline In HDL Particle Size At Weeks 4, 8, and 12	Baseline, Week 4, Week 8, Week 12	Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.	nm	MEDIAN
SECONDARY	Median Change From Baseline In HDL Particle Number At Weeks 4, 8, and 12	Baseline, Week 4, Week 8, Week 12	Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.	umol/L	MEDIAN
SECONDARY	Median Change From Week 8 In HDL Cholesterol Concentration At Week 12	Week 8, Week 12	Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.	mmol/L	MEDIAN
SECONDARY	Median Change From Week 8 In HDL Particle Size At Week 12	Week 8, Week 12	Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.	nm	MEDIAN
SECONDARY	Median Change From Week 8 In HDL Particle Number At Week 12	Week 8, Week 12	Intent-to-treat: all enrolled participants who received at least 1 dose of OCA during the study. All efficacy and safety endpoints were analyzed using the intent-to-treat population.	umol/L	MEDIAN
SECONDARY	Maximum Plasma Concentration (Cmax) Of OCA And Conjugates	Week 8	The PK Population was comprised of all subjects who had at least 1 confirmed analyzable fasting sample at Week 8 and who did not have any major protocol deviations that potentially affected exposure levels. The PK Population was used for the OCA PK and bile acid analyses.	ng/mL	MEAN

1 to 10 of 56Source ClinicalTrials.gov

See all 56 outcomes

Results by group259

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Absolute Change From Baseline In High-density Lipoprotein (HDL) Cholesterol Concentration	Primary Treatment Phase		-0.38	95% Confidence Interval -0.51 to -0.24	mmol/L
Absolute Change From Baseline In HDL Particle Size	Primary Treatment Phase		-0.44	95% Confidence Interval -0.63 to -0.25	nm
Absolute Change From Baseline In HDL Particle Number	Primary Treatment Phase		-0.06	95% Confidence Interval -1.58 to 1.46	umol/L
Median Change From Baseline In HDL Cholesterol Concentration At Weeks 4, 8, and 12	Primary Treatment Phase	Week 4	-0.2072	Inter-Quartile Range -0.5957 to -0.0259	mmol/L
Median Change From Baseline In HDL Cholesterol Concentration At Weeks 4, 8, and 12	Primary Treatment Phase	Week 8	-0.3108	Inter-Quartile Range -0.4403 to -0.0777	mmol/L
Median Change From Baseline In HDL Cholesterol Concentration At Weeks 4, 8, and 12	Primary Treatment Phase	Week 12	0.0518	Inter-Quartile Range -0.2849 to 0.1554	mmol/L
Median Change From Baseline In HDL Particle Size At Weeks 4, 8, and 12	Primary Treatment Phase	Week 4	-0.30	Inter-Quartile Range -0.50 to -0.10	nm
Median Change From Baseline In HDL Particle Size At Weeks 4, 8, and 12	Primary Treatment Phase	Week 8	-0.30	Inter-Quartile Range -0.60 to -0.10	nm
Median Change From Baseline In HDL Particle Size At Weeks 4, 8, and 12	Primary Treatment Phase	Week 12	0.00	Inter-Quartile Range -0.20 to 0.10	nm
Median Change From Baseline In HDL Particle Number At Weeks 4, 8, and 12	Primary Treatment Phase	Week 4	0.55	Inter-Quartile Range -2.60 to 1.60	umol/L

1 to 10 of 259Source ClinicalTrials.gov

See all 259 results by group

Participant flow16

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Primary Treatment Phase	STARTED	Primary Treatment Phase	27
Primary Treatment Phase	STARTED	Long-term Safety Extension Phase	0
Primary Treatment Phase	Received at Least 1 Dose of Study Drug	Primary Treatment Phase	27
Primary Treatment Phase	Received at Least 1 Dose of Study Drug	Long-term Safety Extension Phase	0
Primary Treatment Phase	COMPLETED	Primary Treatment Phase	25
Primary Treatment Phase	COMPLETED	Long-term Safety Extension Phase	0
Primary Treatment Phase	NOT COMPLETED	Primary Treatment Phase	2
Primary Treatment Phase	NOT COMPLETED	Long-term Safety Extension Phase	0
Long-term Safety Extension Phase	STARTED	Primary Treatment Phase	0
Long-term Safety Extension Phase	STARTED	Long-term Safety Extension Phase	21

1 to 10 of 16Source ClinicalTrials.gov

See all 16 participant flow

Adverse events64

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Pruritus	Skin and subcutaneous tissue disorders	Primary Treatment Phase	13	26	17
other	Pruritus	Skin and subcutaneous tissue disorders	Long-term Safety Extension Phase	6	21	13
other	Fatigue	General disorders	Primary Treatment Phase	4	26	4
other	Fatigue	General disorders	Long-term Safety Extension Phase	0	21	0
other	Oedema peripheral	General disorders	Primary Treatment Phase	2	26	3
other	Oedema peripheral	General disorders	Long-term Safety Extension Phase	0	21	0
other	Pyrexia	General disorders	Primary Treatment Phase	2	26	2
other	Pyrexia	General disorders	Long-term Safety Extension Phase	0	21	0
other	Diarrhoea	Gastrointestinal disorders	Primary Treatment Phase	2	26	4
other	Diarrhoea	Gastrointestinal disorders	Long-term Safety Extension Phase	2	21	3

1 to 10 of 64Source ClinicalTrials.gov

See all 64 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Primary Treatment Phase	0	26
Total, all-cause mortality	Long-term Safety Extension Phase	0	21
Total, other adverse events	Primary Treatment Phase	18	26
Total, other adverse events	Long-term Safety Extension Phase	17	21
Total, serious adverse events	Primary Treatment Phase	1	26
Total, serious adverse events	Long-term Safety Extension Phase	5	21

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Primary Treatment Phase vs Long-term Safety Extension Phase: deaths from any cause	Trial comparisons
Primary Treatment Phase vs Long-term Safety Extension Phase: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01865812

GET https://conductscience.org/api/trials/v1/NCT01865812/registered?page=2

API reference For AI assistants