Trial · NCT02430077

Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients

NCT02430077, Phase 2, Completed, Abhimanyu Garg; results first posted 2023-12-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients. Trials, record NCT02430077. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02430077

On this page

Trial

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

Title: Phase 2 Study of Obeticholic Acid for Lipodystrophy Patients
NCT number: NCT02430077
Status: Completed
Phases: Phase 2
Enrollment: 10 participants, actual
Lead sponsor: Abhimanyu Garg
Conditions: Familial Partial Lipodystrophy
Interventions: Obeticholic Acid, Placebo
First posted: 2015-04-29
Last updated: 2024-08-27
Results first posted: 2023-12-13

Source ClinicalTrials.gov

Registered outcomes7

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

List	Outcome	Time frame	Description
Primary	Change in the Liver Triglycerides (TG).	Baseline, 4 months	The primary end-point variable was the change in the liver TG content assessed using proton-density fat fraction mapping by Magnetic Resonance Imaging (MRI).
Secondary	Change in Serum Triglyceride Levels	Baseline, Month 4	Change in the serum levels of Triglycerides from baseline to month 4 is being assessed.
Secondary	Change in Serum Levels of Alanine Aminotransferase	Baseline, Month 4	Change in serum levels of Alanine Aminotransferase from baseline to month 4 is assessed
Secondary	Change in Serum Levels of Aspartate Aminotransferases	Baseline, Month4	Change in serum levels of Aspartate Aminotransferases from baseline to month 4 is assessed
Secondary	Change in Serum Levels of Gamma-Glutamyl Transpeptidase	Baseline, Month 4	Change in serum levels of Gamma-Glutamyl Transpeptidase from baseline to month 4 is assessed
Secondary	Changes in Serum Insulin Levels	Baseline, Month 4	Changes in serum Insulin levels is assessed
Secondary	Change in Hepatic Insulin Sensitivity	Baseline, Month 4	Change in hepatic insulin sensitivity is assessed by suppression of hepatic glucose output during the low-dose and high-dose insulin infusions during the euglycemic clamp study.

Source ClinicalTrials.gov

Outcomes7

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in the Liver Triglycerides (TG).	Baseline, 4 months		percentage of liver triglycerides	MEDIAN
SECONDARY	Change in Serum Triglyceride Levels	Baseline, Month 4		mg/dL	MEDIAN
SECONDARY	Change in Serum Levels of Alanine Aminotransferase	Baseline, Month 4		U/L	MEDIAN
SECONDARY	Change in Serum Levels of Aspartate Aminotransferases	Baseline, Month4		U/L	MEDIAN
SECONDARY	Change in Serum Levels of Gamma-Glutamyl Transpeptidase	Baseline, Month 4		U/L	MEDIAN
SECONDARY	Changes in Serum Insulin Levels	Baseline, Month 4	Data was not collected
SECONDARY	Change in Hepatic Insulin Sensitivity	Baseline, Month 4	Data not collected.

Source ClinicalTrials.gov

Results by group20

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

Outcome	Group	Value	Spread	Units
Change in the Liver Triglycerides (TG).	Baseline (Month 0)	13.2	Full Range 2.8 to 28.5	percentage of liver triglycerides
Change in the Liver Triglycerides (TG).	Obeticholic Acid (Month 4)	6.4	Full Range 2.4 to 18.0	percentage of liver triglycerides
Change in the Liver Triglycerides (TG).	Placebo (Month 0)	12.3	Full Range 3.6 to 33.3	percentage of liver triglycerides
Change in the Liver Triglycerides (TG).	Placebo (Month 4)	10.6	Full Range 3.4 to 29.3	percentage of liver triglycerides
Change in Serum Triglyceride Levels	Baseline (Month 0)	199.2	Full Range 78 to 392	mg/dL
Change in Serum Triglyceride Levels	Obeticholic Acid (Month 4)	182.3	Full Range 102 to 309.3	mg/dL
Change in Serum Triglyceride Levels	Placebo (Month 0)	169.3	Full Range 103.5 to 562.0	mg/dL
Change in Serum Triglyceride Levels	Placebo (Month 4)	161.3	Full Range 93 to 655	mg/dL
Change in Serum Levels of Alanine Aminotransferase	Baseline (Month 0)	16.3	Full Range 13.5 to 31	U/L
Change in Serum Levels of Alanine Aminotransferase	Obeticholic Acid (Month 4)	15.8	Full Range 13 to 42.5	U/L

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow18

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

Period	Milestone	Group	Participants
First Intervention 4 Months	STARTED	Active Capsule of Obeticholic Acid, Then Placebo	5
First Intervention 4 Months	STARTED	Placebo for Obeticholic Acid, Then Active Drug	5
First Intervention 4 Months	COMPLETED	Active Capsule of Obeticholic Acid, Then Placebo	5
First Intervention 4 Months	COMPLETED	Placebo for Obeticholic Acid, Then Active Drug	5
First Intervention 4 Months	NOT COMPLETED	Active Capsule of Obeticholic Acid, Then Placebo	0
First Intervention 4 Months	NOT COMPLETED	Placebo for Obeticholic Acid, Then Active Drug	0
Washout 4 Months	STARTED	Active Capsule of Obeticholic Acid, Then Placebo	5
Washout 4 Months	STARTED	Placebo for Obeticholic Acid, Then Active Drug	5
Washout 4 Months	COMPLETED	Active Capsule of Obeticholic Acid, Then Placebo	5
Washout 4 Months	COMPLETED	Placebo for Obeticholic Acid, Then Active Drug	5

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events2

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	Itching	Skin and subcutaneous tissue disorders	Active Capsule of Obeticholic Acid	4	10
other	Itching	Skin and subcutaneous tissue disorders	Placebo for Obeticholic Acid	2	10

Source ClinicalTrials.gov

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Active Capsule of Obeticholic Acid	0	10
Total, all-cause mortality	Placebo for Obeticholic Acid	0	10
Total, other adverse events	Active Capsule of Obeticholic Acid	4	10
Total, other adverse events	Placebo for Obeticholic Acid	2	10
Total, serious adverse events	Active Capsule of Obeticholic Acid	0	10
Total, serious adverse events	Placebo for Obeticholic Acid	0	10

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
Active Capsule of Obeticholic Acid vs Placebo for Obeticholic Acid: deaths from any cause	Trial comparisons
Active Capsule of Obeticholic Acid vs Placebo for Obeticholic Acid: 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/NCT02430077

GET https://conductscience.org/api/trials/v1/NCT02430077/registered

API reference For AI assistants