Trial · NCT02279524

A Clinical Trial to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With NASH

NCT02279524, Phase 2, Completed, Galmed Research and Development, Ltd.; results first posted 2021-07-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Clinical Trial to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With NASH. Trials, record NCT02279524. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02279524

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Trial

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

Title: A Clinical Trial to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With NASH
NCT number: NCT02279524
Status: Completed
Phases: Phase 2
Enrollment: 247 participants, actual
Lead sponsor: Galmed Research and Development, Ltd.
Conditions: Fatty Liver, Non-Alcoholic Steatohepatitis, Liver Diseases, Liver Fibroses
Interventions: Aramchol
First posted: 2014-10-31
Last updated: 2021-07-14
Results first posted: 2021-07-14

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Change From Baseline in Mean Liver Fat	At screening (baseline) and at week 52	absolute % change from baseline to end of study in liver triglycerides to water ratio (fat/water+fat) as measured by MRS
Secondary	NASH Resolution Without Worsening of Fibrosis	At screening and at week 52	The endpoint was defined as end of study biopsy, observed under microscope and showing: * Cell Ballooning (special form of liver cell injury associated with cell swelling and enlargement)= 0 * Inflammation (presence or absence of cells from the immune system) = 0 or 1 * No worsening of fibrosis (scar formation) = increase in fibrosis score by 1 or more point
Secondary	Fibrosis Improvement Without Worsening of NASH	At screening and at week 52	The endpoint was defined as end of study biopsy showing: * A decrease in fibrosis score ≥ 1 point * No worsening of NASH (defined by an increase of inflammation and/or ballooning)
Secondary	Change From Baseline to Week 52/Termination in ALT	At baseline until week 52	Change from baseline to Week 52 or Termination visit in ALT levels (U/L)
Other	Change From Baseline to Termination/Early Termination in HbA1C	At baseline until week 52	Change from baseline to Week 52 or Termination visit in Hemoglobin A1C (%)

Source ClinicalTrials.gov

Outcomes8

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Mean Liver Fat	At screening (baseline) and at week 52	Pre-defined FASmri analysis set	Abs. % Change from Baseline Liver Fat	MEAN
SECONDARY	NASH Resolution Without Worsening of Fibrosis	At screening and at week 52	FASBiopsy analysis set	% of subjects reaching the end-point	NUMBER
SECONDARY	Fibrosis Improvement Without Worsening of NASH	At screening and at week 52	Predefined FASBiopsy analysis set	% of subjects reaching the end-point	NUMBER
SECONDARY	Change From Baseline to Week 52/Termination in ALT	At baseline until week 52	Pre-defined FASALT analysis set	U/L	LEAST_SQUARES_MEAN
OTHER_PRE_SPECIFIED	Change From Baseline to Termination/Early Termination in HbA1C	At baseline until week 52	Analysis Set: FASHgA1C	% of HbA1C	LEAST_SQUARES_MEAN
POST_HOC	Change From Baseline to Week 52/Termination in AST	At baseline until week 52	FASAST Analysis Set	U/L	LEAST_SQUARES_MEAN
POST_HOC	Change From Baseline in Mean Liver Fat - Responder Analysis	Baseline to 52 weeks		percentage of participants	NUMBER
POST_HOC	Progression to Cirrhosis	Week 52	This analysis is limited by low number of events, and the duration of the study.	Participants	COUNT_OF_PARTICIPANTS

Source ClinicalTrials.gov

Results by group24

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

Outcome	Group	Value	Spread	Units
Change From Baseline in Mean Liver Fat	Aramchol 600mg	-3.18	Standard Deviation 1.01	Abs. % Change from Baseline Liver Fat
Change From Baseline in Mean Liver Fat	Aramchol 400mg	-3.41	Standard Deviation 0.96	Abs. % Change from Baseline Liver Fat
Change From Baseline in Mean Liver Fat	Placebo	-0.09	Standard Deviation 1.38	Abs. % Change from Baseline Liver Fat
NASH Resolution Without Worsening of Fibrosis	Aramchol 600mg	16.7		% of subjects reaching the end-point
NASH Resolution Without Worsening of Fibrosis	Aramchol 400mg	7.5		% of subjects reaching the end-point
NASH Resolution Without Worsening of Fibrosis	Placebo	5		% of subjects reaching the end-point
Fibrosis Improvement Without Worsening of NASH	Aramchol 600mg	29.5		% of subjects reaching the end-point
Fibrosis Improvement Without Worsening of NASH	Aramchol 400mg	21.3		% of subjects reaching the end-point
Fibrosis Improvement Without Worsening of NASH	Placebo	17.5		% of subjects reaching the end-point
Change From Baseline to Week 52/Termination in ALT	Aramchol 600mg	-17.3	Standard Error 3.7	U/L

1 to 10 of 24Source ClinicalTrials.gov

See all 24 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Aramchol 600mg	98
Overall Study	STARTED	Aramchol 400mg	101
Overall Study	STARTED	Placebo	48
Overall Study	COMPLETED	Aramchol 600mg	88
Overall Study	COMPLETED	Aramchol 400mg	90
Overall Study	COMPLETED	Placebo	41
Overall Study	NOT COMPLETED	Aramchol 600mg	10
Overall Study	NOT COMPLETED	Aramchol 400mg	11
Overall Study	NOT COMPLETED	Placebo	7

Source ClinicalTrials.gov

Adverse events147

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
other	Abdominal distension	Gastrointestinal disorders	Aramchol 600mg	6	98
other	Abdominal distension	Gastrointestinal disorders	Aramchol 400mg	0	101
other	Abdominal distension	Gastrointestinal disorders	Placebo	2	48
other	Abdominal pain	Gastrointestinal disorders	Aramchol 600mg	4	98
other	Abdominal pain	Gastrointestinal disorders	Aramchol 400mg	7	101
other	Abdominal pain	Gastrointestinal disorders	Placebo	2	48
other	Abdominal pain upper	Gastrointestinal disorders	Aramchol 600mg	6	98
other	Abdominal pain upper	Gastrointestinal disorders	Aramchol 400mg	4	101
other	Abdominal pain upper	Gastrointestinal disorders	Placebo	2	48
other	Arthralgia	Musculoskeletal and connective tissue disorders	Aramchol 600mg	4	98

1 to 10 of 147Source ClinicalTrials.gov

See all 147 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Aramchol 600mg	0	98
Total, all-cause mortality	Aramchol 400mg	0	101
Total, all-cause mortality	Placebo	0	48
Total, other adverse events	Aramchol 600mg	77	98
Total, other adverse events	Aramchol 400mg	75	101
Total, other adverse events	Placebo	33	48
Total, serious adverse events	Aramchol 600mg	9	98
Total, serious adverse events	Aramchol 400mg	9	101
Total, serious adverse events	Placebo	6	48

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34621052	DERIVED

Source PubMed

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 comparisons0

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

None in this release.

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.

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