CompletedNCT02279524Aramchol_005Updated Jul 14, 2021Results posted

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

A Phase 2 interventional study of Aramchol in Fatty Liver, Non-Alcoholic Steatohepatitis and Liver Diseases, sponsored by Galmed Research and Development, Ltd.. Completed at 78 sites in 11 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-07-14.

Sponsored by Galmed Research and Development, Ltd. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 247
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study summary

This is a multicenter, Phase IIb, randomized, double blind, placebo-controlled study designed to evaluate the efficacy and safety of two Aramchol doses in subjects that are 18 to 75 years of age, with Non-Alcoholic Steatohepatitis (NASH) confirmed by liver biopsy performed in a period of 6 months before entering the study, with overweight or obesity and who are pre diabetic or type II diabetic.

Eligible subjects will be enrolled into three treatments arms: Aramchol 400 and 600 mg tablets and placebo tablets in ratio 2:2:1.

The subjects will be evaluated at study sites for 11 scheduled visits during one year (52 weeks). After completion of the study treatment period, the subjects will be followed for an additional period of 13 weeks without study medication (until visit 11 (week 65)).

Read the detailed description

Eligible subjects will be enrolled into three treatments arms: Aramchol 400 and 600 mg tablets and placebo tablets in ratio 2:2:1.

The subjects will be evaluated at study sites for 11 scheduled visits: at screening (visit 1(weeks -4 - 0)), baseline (visit 2 (day 0)), visit 3 (week 2), visit 4 week 4), visit 5 (week 8), visit 6 (week 12), visit 7 (week 24), visit 8 (week 32), visit 9 (week 40) and visit 10 (week 52 - (End of Treatment/early termination visit)). After completion of the study treatment period, the subjects will be followed for an additional period of 13 weeks without study medication (until visit 11 (week 65)).

During the screening period, the severity of the disease will be evaluated with blood tests, liver biopsy and NMRS.

During the study the following assessments will be performed:

Vital signs will be measured at each study visit.
A physical examination will be performed at the screening visit, 24 weeks, End of Treatment/early termination and week 65 visit.

The following blood tests will be performed: complete blood count (CBC), serum chemistry (including electrolytes, liver enzymes, direct and total bilirubin, glucose, lipid profile which include triglyceride, cholesterol, HDL, LDL and VLDL, CPK, creatinine, urea, albumin, alkaline phosphatase), ESR and urinalysis during the screening visit, baseline, week 2, 4, 8, 24, 40, 52 and 65 (end of follow up) visits. Serology (HBV, HCV and HIV) will be performed during the screening visit. Coagulation (fibrinogen, PT/INR, aPTT) will be measured during screening and at baseline, week 24, End of Treatment/early termination and week 65 visits. Insulin (HOMA) will be measured during the screening, at week 24 and End of Treatment/early termination visits. HbA1C will be measured during the screening, at week 8, 24, 40 and End of Treatment/early termination visits. C reactive protein, Leptin and Adiponectin will be measured during baseline visit and at end of treatment period. The blood samples taken at these visits, will be tested for possible biomarkers. TSH, T3 and T4 will be measured during the screening visit. beta-hCG in women of childbearing potential will be performed during the screening visit. A serum sample will be collected and kept frozen until study end in case special investigation needs to be performed. This sample will be collected during the screening and visit 10/Early Termination.

Body weight and waist circumference will be measured in screening, baseline, week 24, end of treatment and week 65 visits. Height will be measured during the screening visit.
ECG will be performed during the screening visit, visit 7 (week 24) and end of treatment visits.
All subjects will undergo two NMRS scans, at screening and end of treatment visits.
FibroMax test will be performed only if the investigator thinks it is necessary
Liver biopsy will be conducted during the screening and end of treatment visit. The biopsy in the screening visit will be performed only if it was not done within the 6 months prior to this visit.
Metabolomics blood test will be performed at the screening, visit 7 and the End-of-Treatment/Early Termination visits. From some consenting patients (about 15) a sample from the liver biopsy will be taken for analysis.
Endothelial Function will be conducted in selected sites. The test will be conducted during the baseline visit before the study treatment will be given and End of Treatment/early termination visit.
Blood sample for Aramchol trough level will be collected (pre-dose) from patients in Israel at baseline (visit 2) week 4 (visit 4), week 12 (visit 6), week 24 (visit 7), week 40 (visit 9), end of treatment (visit 10) and follow up (visit 11). At selected sites in Mexico, USA and Hong Kong one blood sample will be collected (pre-dose) on visit 4 (up to 10 subjects per country) to test for trough Aramchol blood level differences between populations (e.g., African American, Asian, Hispanic).
Blood sample for gene analysis will be taken from all consenting patients during the baseline visit, will be kept frozen and analyzed only at the study end.
Life style questionnaire will be completed at all visits.
Adverse events will be monitored throughout the study.
Concomitant Medications will be monitored throughout the study.
Telephone contacts will be performed on week 16, 20, 28, 36, 44 and 48. An interim safety analysis will be conducted as soon as 120 subjects will completed the follow up period of 24 weeks under study treatment. An independent DSMB will analyze the safety data and recommend a continued course of action. All patients will continue to be treated under the study protocol until conclusion of the analysis will be known.

Safety assessment will include frequency and severity of treatment-emergent AEs, clinically significant laboratory abnormalities, ECG changes and physical examination findings.

Conditions studied

Fatty Liver
Non-Alcoholic Steatohepatitis
Liver Diseases
Liver Fibroses

Browse trials for

Keywords

NASH
fibroses
obesity
diabetes

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 247 is above the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

Galmed Research and Development, Ltd. is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Male or female age 18 to 75 years.
BMI between 25kg/m2 to 40kg/m2 or waist circumference between 88 cm to 200 cm for women, and between 102 cm to 200 cm for men. If there is deviation above the upper limit, please consult the MRI center, to ensure that the machine is suitable for the patient.
Known type II Diabetes Mellitus or pre-Diabetes according to American Diabetes Association. One of the following 3 criteria is needed for pre-Diabetes: Fasting Plasma Glucose > 100mg/dl (5.5 mmol/l) or 2hPG following 75g OGTT > 140 (7.8 mmol/l) mg/dl or HbA1c > 5.7%. HbA1c can be repeated at Investigator's discretion.
Histologically proven Steatohepatitis on a diagnostic liver biopsy performed either during screening or within 6 months before screening visit, confirmed by central laboratory reading of the slides.(Steatosis ≥1 + inflammation ≥1 + ballooning ≥1).Total activity NAS score of 4 or more.
Liver fat concentration in the liver of 5.5% or more as measured by NMRS.
Biopsies with an activity NAS score of 4 or more.
Normal synthetic liver function (serum albumin >3.2g/dl, INR 0.8-1.2, conjugated bilirubin \< 35 µmol/L).
Understanding the nature of the study and signature of the written informed consent.
Negative pregnancy test at study entry for females of child bearing potential.
Females of child bearing potential practicing reliable contraception throughout the study period (including oral contraceptives) as well as negative pregnancy test at study entry.
Hypertensive patients must be well controlled by stable dose of anti-hypertensive medication for at least 2 months prior to screening.
Patients previously treated with vitamin E (>400IU/day), Polyunsaturated fatty acid (>2g/day) or Ursodeoxycholic acid or fish oil can be included if stopped or at least maintained on stable dose at least 3 months prior to diagnostic liver biopsy (and are not started during the trial). These treatments-dosages are allowed if they were stable for at least 12 months prior to biopsy and can remain stable throughout the study. (Dosages less than the amounts stated above are allowed without washout- or stable-period restrictions).
For patients with type II Diabetes, glycaemia must be controlled (Glycosylated Hemoglobin A1c ≤9%) while any HbA1c change should not exceed 1.5% during 6 months prior to enrolment). Treatments with anti-diabetic medications (except for those mentioned in Exclusion 16) are permitted if glycaemia is self-monitored by the patient. HbA1c can be repeated at Investigator's discretion.

Exclusion criteria

Exclusion Criteria:

Patients with other active (acute or chronic) liver disease other than NASH (e.g. viral hepatitis, unless eradicated at least 3 years prior to screening; genetic hemochromatosis; Wilson disease; alpha 1antitripsin deficiency; alcohol liver disease; drug-induced liver disease) at the time of randomization.
Patients with clinically or histologically documented liver cirrhosis
Known alcohol and/or any other drug abuse or dependence in the last five years.
Known history or presence of clinically significant cardiovascular, gastrointestinal, metabolic other than Diabetes Mellitus, neurologic, pulmonary, endocrine, psychiatric, neoplastic disorder or nephrotic syndrome, that in the opinion of the Investigator warrant exclusion from the study.
Patients with familial (i.e., genetic) hypertriglyceridemia and familial (i.e., genetic) hypercholesterolemia.
History or presence of any disease or condition known to interfere with the absorption distribution, metabolism or excretion of drugs including bile salt metabolites (e.g. inflammatory bowel disease (IBD)), previous intestinal (ileal or colonic) operation, chronic pancreatitis, celiac disease or previous vagotomy. Ongoing Chronic constipation
Patients with heart or brain pacemaker (i.e., implantable neurological devices).
Surgery during the last three month before screening which involved stent implantation of metal devices (e.g. knee, hip etc.)
Weight loss of more than 5% within 6 months prior to randomization.
History of bariatric surgery within 5 years of liver biopsy.
Uncontrolled arterial hypertension.
Women who are pregnant and breast feeding.
Diabetes Mellitus other than type II (type I, endocrinopathy, genetic syndromes etc.).
Patients with HIV infection.
Daily alcohol intake >20 g/day for women and >30 g/day for men (on average per day) as per medical history.
Treatment with other anti-diabetic medications:
GLP-1 receptor agonists and Thiazolidinediones (TZDs), unless started at least 12 months prior to biopsy and on stable dose for 6 months. In case of GLP-1 receptor agonists stopped, it should be at least 6 months before biopsy as per medical history.
SGLT-2 Inhibitors, Metformin, fibrates, statins, insulin, DPP-4 inhibitors and sulfonylurea unless prescribed dose has been stable for the last 6 months prior to the biopsy.
Treatment with Valproic acid, Tamoxifen, Methotrexate, Amiodarone or chronic treatment with anti-cholinergic agents, corticosteroids, high dose estrogen and tetracycline within 12 months prior to the screening visit.
Chronic treatment with antibiotics (e.g. Rifaximin).
Homeopathic and/or alternative treatments. Any treatment should be stopped during the screening period at least 48 hours before randomization.
Uncontrolled hypothyroidism defined as Thyroid Stimulating hormone >2X the upper limit of normal (ULN). Thyroid dysfunction controlled for at least 6 months prior to screening is permitted.
Patients with renal dysfunction eGFR\< 40.
Unexplained serum creatine phosphokinase (CPK) >3X the upper limit of normal (UNL). Patients with a reason for CPK elevation may have the measurement repeated prior to randomization; a CPK retest > 3X ULN leads to exclusion.
Patients with condition(s) that makes them unsuitable to perform the NMRS (as determined by the PI or the MRI facility).
Hypersensitivity to Aramchol or to any of the excipients in the tablets
Hypersensitivity to cholic acid or bile acid sequestrants

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 247 participants (actual)

Study arms

Experimental
Aramchol 600mg
One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg.
Drug: Aramchol
Experimental
Aramchol 400mg
One tablet of Aramchol 400 mg and one tablet of matching placebo for Aramchol.
Drug: Aramchol
Placebo comparator
Placebo
Two tablet of Aramchol matching placebo.
Drug: Aramchol

Interventions

DrugAramchol
Subjects will be administered Aramchol as follows: * One tablet of Aramchol 400 mg and one tablet of matching placebo for Aramchol. * One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg. * Two tablet of Aramchol matching placebo. The tablets should be taken orally in the morning within 30 min after breakfast with a glass of water (250 ml). Subjects are allowed to omit study drugs up to 3 consecutive days during the study.
Also known as: Placebo

What researchers measure

Primary outcomes

Change From Baseline in Mean Liver Fat
absolute % change from baseline to end of study in liver triglycerides to water ratio (fat/water+fat) as measured by MRS
Time frame: At screening (baseline) and at week 52

Secondary outcomes

NASH Resolution Without Worsening of Fibrosis
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
Time frame: At screening and at week 52
Fibrosis Improvement Without Worsening of NASH
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)
Time frame: At screening and at week 52
Change From Baseline to Week 52/Termination in ALT
Change from baseline to Week 52 or Termination visit in ALT levels (U/L)
Time frame: At baseline until week 52

Other outcomes

Change From Baseline to Termination/Early Termination in HbA1C
Change from baseline to Week 52 or Termination visit in Hemoglobin A1C (%)
Time frame: At baseline until week 52

Results

Posted Jul 14, 2021

Participant flow

Participant flow — Overall Study
Milestone	Aramchol 600mg	Aramchol 400mg	Placebo
Started	98	101	48
Completed	88	90	41
Not completed	10	11	7
Withdrew: Withdrawal by subject	3	6	3
Withdrew: Adverse event	4	3	2
Withdrew: Lost to follow-up	1	1	0
Withdrew: Disallowed medication	1	1	2
Withdrew: Bariatric surgery	1	0	0

Outcome measures

PrimaryChange From Baseline in Mean Liver Fat

absolute % change from baseline to end of study in liver triglycerides to water ratio (fat/water+fat) as measured by MRS

Time frame:: At screening (baseline) and at week 52
Reported as:: Mean · Abs. % Change from Baseline Liver Fat

Change From Baseline in Mean Liver Fat
Abs. % Change from Baseline Liver Fat	Aramchol 600mg	Aramchol 400mg	Placebo
Change From Baseline in Mean Liver Fat	-3.18 ± 1.01	-3.41 ± 0.96	-0.09 ± 1.38

Statistical analysis

Aramchol 600mg vs Placebo · Mixed Models Analysis · p = 0.0655 · Difference in least square means: -3.09
Aramchol 400mg vs Placebo · Mixed Models Analysis · p = 0.0450 · Difference in least square means: -3.32

SecondaryNASH Resolution Without Worsening of Fibrosis

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

Time frame:: At screening and at week 52
Reported as:: Number · % of subjects reaching the end-point

NASH Resolution Without Worsening of Fibrosis
% of subjects reaching the end-point	Aramchol 600mg	Aramchol 400mg	Placebo
NASH Resolution Without Worsening of Fibrosis	16.7	7.5	5

Statistical analysis

Aramchol 600mg vs Placebo · Regression, Logistic · p = 0.0514 · Odds ratio (or): 4.74 · 95% CI 0.99 to 22.66The method used was a Baseline Adjusted Logistic Regression
Aramchol 400mg vs Placebo · Regression, Logistic · p = 0.4955 · Odds ratio (or): 1.79 · 95% CI 0.33 to 9.61

SecondaryFibrosis Improvement Without Worsening of NASH

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)

Time frame:: At screening and at week 52
Reported as:: Number · % of subjects reaching the end-point

Fibrosis Improvement Without Worsening of NASH
% of subjects reaching the end-point	Aramchol 600mg	Aramchol 400mg	Placebo
Fibrosis Improvement Without Worsening of NASH	29.5	21.3	17.5

Statistical analysis

Aramchol 600mg vs Placebo · Regression, Logistic · p = 0.2110 · Odds ratio (or): 1.88 · 95% CI 0.70 to 5.04
Aramchol 400mg vs Placebo · Regression, Logistic · p = 0.8425 · Odds ratio (or): 1.11 · 95% CI 0.40 to 3.05

SecondaryChange From Baseline to Week 52/Termination in ALT

Change from baseline to Week 52 or Termination visit in ALT levels (U/L)

Time frame:: At baseline until week 52
Reported as:: Least squares mean · U/L

Change From Baseline to Week 52/Termination in ALT
U/L	Aramchol 600mg	Aramchol 400mg	Placebo
Change From Baseline to Week 52/Termination in ALT	-17.3 ± 3.7	-12.0 ± 3.6	11.8 ± 5.2

Statistical analysis

Aramchol 600mg vs Placebo · Mixed Models Analysis · p = < 0.0001 · Difference in least square means: -29.1
Aramchol 400mg vs Placebo · Mixed Models Analysis · p = 0.0002 · Difference in least square means: -23.8

Other pre-specifiedChange From Baseline to Termination/Early Termination in HbA1C

Change from baseline to Week 52 or Termination visit in Hemoglobin A1C (%)

Time frame:: At baseline until week 52
Reported as:: Least squares mean · % of HbA1C

Change From Baseline to Termination/Early Termination in HbA1C
% of HbA1C	Aramchol 600mg	Aramchol 400mg	Placebo
Change From Baseline to Termination/Early Termination in HbA1C	-0.1268 ± 0.0769	-0.0417 ± 0.0754	0.3202 ± 0.1089

Statistical analysis

Aramchol 600mg vs Placebo · Mixed Models Analysis · p = 0.0008 · Difference in least square means: -0.4470 · 95% CI -0.7063 to -0.1877
Aramchol 400mg vs Placebo · Mixed Models Analysis · p = 0.0061 · Difference in least square means: -0.3620 · 95% CI -0.6196 to -0.1043

Post-hocChange From Baseline to Week 52/Termination in AST

Change from baseline to Week 52 or termination visit in AST levels (U/L)

Time frame:: At baseline until week 52
Reported as:: Least squares mean · U/L

Change From Baseline to Week 52/Termination in AST
U/L	Aramchol 600mg	Aramchol 400mg	Placebo
Change From Baseline to Week 52/Termination in AST	-10.83 ± 2.49	-7.21 ± 2.42	6.68 ± 3.50

Statistical analysis

Aramchol 600mg vs Placebo · Mixed Models Analysis · p = <0.0001 · Difference in least square means: -17.5
Aramchol 400mg vs Placebo · Mixed Models Analysis · p = 0.0011 · Difference in least square means: -13.9

Post-hocChange From Baseline in Mean Liver Fat - Responder Analysis

A responder is defined according to \>5% absolute improvement from baseline. A cutoff of 5% absolute reduction in liver F/(F+W) ratio was used as a surrogate for potentially clinically meaningful MRI reduction.

Time frame:: Baseline to 52 weeks
Reported as:: Number · percentage of participants

Change From Baseline in Mean Liver Fat - Responder Analysis
percentage of participants	Aramchol 600mg	Aramchol 400mg	Placebo
Change From Baseline in Mean Liver Fat - Responder Analysis	47.0	36.7	24.4

Statistical analysis

Aramchol 600mg vs Placebo · Mixed Models Analysis · p = 0.0279 · Odds ratio (or): 2.77 · 95% CI 1.11 to 6.88
Aramchol 400mg vs Placebo · Regression, Logistic · p = 0.0878 · Odds ratio (or): 2.20 · 95% CI 0.89 to 5.46

Post-hocProgression to Cirrhosis

Fibrosis stage 4 in liver biopsy

Time frame:: Week 52
Reported as:: Count of participants · Participants

Progression to Cirrhosis
Participants	Aramchol 600mg	Aramchol 400mg	Placebo
Progression to Cirrhosis	1	6	3

Statistical analysis

Aramchol 600mg vs Placebo · Regression, Logistic · p = 0.1008 · Odds ratio (or): 0.14 · 95% CI 0.01 to 1.46This analysis is limited by low number of events, and the duration of the study.
Aramchol 400mg vs Placebo · Regression, Logistic · p = 0.5693 · Odds ratio (or): 0.63 · 95% CI 0.13 to 3.05This analysis is limited by low number of events, and the duration of the study.

Adverse events

Collected over 52 weeks + 13 weeks follow-up. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Aramchol 600mg	0/98 (0%)	9/98 (9.2%)	77/98 (78.6%)
Aramchol 400mg	0/101 (0%)	9/101 (8.9%)	75/101 (74.3%)
Placebo	0/48 (0%)	6/48 (12.5%)	33/48 (68.8%)

Most frequent serious events

Showing 10 of 29

Most frequent serious events
Event	Aramchol 600mg	Aramchol 400mg	Placebo
Bile duct stoneHepatobiliary disorders	0/98	0/101	1/48
Retinal detachmentEye disorders	0/98	0/101	1/48
CholecystitisHepatobiliary disorders	0/98	0/101	1/48
Abscess limbInfections and infestations	0/98	0/101	1/48
Mammogram abnormaInvestigations	0/98	0/101	1/48
Colon cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/98	0/101	1/48
Gallbladder cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/98	0/101	1/48
Hepatocellular carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/98	0/101	1/48
MyelofibrosisNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/98	0/101	1/48
Abdominal wall haematomaGastrointestinal disorders	1/98	0/101	0/48

Most frequent other events

Showing 10 of 20

Most frequent other events
Event	Aramchol 600mg	Aramchol 400mg	Placebo
HeadacheNervous system disorders	15/98	14/101	6/48
Urinary tract infectionRenal and urinary disorders	13/98	15/101	3/48
ConstipationGastrointestinal disorders	8/98	5/101	6/48
NauseaGastrointestinal disorders	9/98	10/101	6/48
PruritusSkin and subcutaneous tissue disorders	10/98	7/101	2/48
CoughRespiratory, thoracic and mediastinal disorders	5/98	4/101	4/48
FatigueGeneral disorders	3/98	8/101	4/48
InfluenzaRespiratory, thoracic and mediastinal disorders	5/98	8/101	2/48
Abdominal painGastrointestinal disorders	4/98	7/101	2/48
ArthralgiaMusculoskeletal and connective tissue disorders	4/98	7/101	1/48

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Aramchol 600mg	Aramchol 400mg	Placebo	Total
Mean	54.9 ± 9.8	53.9 ± 10.9	54.4 ± 10.3	54.4 ± 10.3

Sex: Female, Male
Sex: Female, Male(Participants)	Aramchol 600mg	Aramchol 400mg	Placebo	Total
Female	70	65	25	160
Male	28	36	23	87

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Aramchol 600mg	Aramchol 400mg	Placebo	Total
Asian	5	4	1	10
Black or African American	1	0	1	2
Hispanic	12	17	11	40
Latin	16	14	3	33
Latin American	1	1	1	3
Latin Race	0	1	1	2
Mixed (Martinican)	0	1	0	1
White	63	63	30	156

BMI (kg/m^2) at Screening
BMI (kg/m^2) at Screening(kg/m^2)	Aramchol 600mg	Aramchol 400mg	Placebo	Total
Mean	33 ± 4.2	32.4 ± 4.5	32.6 ± 4.9	32.7 ± 4.4

Study locations

78 sites

Profil Institue for Clinical Research Inc.
Chula Vista, California 91911, United States
Cedars-Sinai Medical Center
Los Angeles, California 90048, United States
California Liver Research Institute
Pasadena, California 91105, United States
Inland Empoire Liver Foundation
Rialto, California 92377, United States
University of California Department of Medicine Division of Gastroenterology
San Diego, California 92103, United States
Orange County Research Center
Tustin, California 92780, United States
Indiana University
Indianapolis, Indiana 46202, United States
Mount Sinai
New York, New York 10029, United States
Columbia University Medical Center
New York, New York 10032, United States
Duke University Medical Center
Durham, North Carolina 27710, United States
Wake Research
Raleigh, North Carolina 27612, United States
Texas Digestive Disease Consultants
Dallas, Texas 75246, United States
Brooke Army Medical Center
Fort Sam Houston, Texas 78234, United States
Gastroenterology Consultants of San Antonio
Live Oak, Texas 78233, United States
Texas Liver Institute San Antonio
San Antonio, Texas 78215, United States
Clinical Trials of Texas
San Antonio, Texas 78229, United States
University of Virginia Medical Center
Charlottesville, Virginia 22908, United States
Biomedica Research Group
Santiago, Chile
Centro de Investigacion Clinica CEIC
Santiago, Chile
Hospital Clinico Universidad de Chile
Santiago, Chile
Pontificia Universidad Catolica de Chile
Santiago, Chile
Centro de Investigaciones Clinicas Vina del Mar
Vina del Mar, Chile
Centre Hospitalier Universitaire (CHU) d'Angers
Angers, France
Centre Hospitalier Universitaire Dijon Bourgogne
Dijon, France
San Joseph Service Hepato Gastro Entrologie
Marseille, France
Hospital Saint Eloi
Montpellier, France
CHU Centre Hospiatalier Universitaire de Rennes
Paris, France
Hospital Pitie-Salpetriere
Paris, France
Hospital Saint-Antoine AP-HP
Paris, France
Hopital Paul Brousse
Villejuif, France
Unimed Adjara
Batumi, Georgia
Clinic Cortex
Tbilisi, Georgia
David Tatishvili Medical Center
Tbilisi, Georgia
LTD Diacor
Tbilisi, Georgia
Research Institute of Clinical Medicine
Tbilisi, Georgia
Medizinische Hochschule
Hannover, Germany
EUGASTRO GmbH
Leipzig, Germany
Universitat Leipzig Medizinische Fakultat
Leipzig, Germany
Humanity & Health Medical Centre
Central, Hong Kong
Carmel Medical Center
Haifa, Israel
Rambam Medical Center
Haifa, Israel
Hadassah Ein Karem Medical Cente
Jerusalem, Israel
Naharia Medical Center
Nahariya, Israel
The Holy family Medical Center
Nazareth, Israel
Sheba Medical Center
Ramat Gan, Israel
Tel-Aviv Saurasky Medical Center
Tel-Aviv, Israel
Asaf Harofeh Medical Center
Zrifin, Israel
Spedali Civili di Brescia
Brescia, Italy
A.O. San Paolo
Milano, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
A.O. U. "Federico II" di Napoli
Napoli, Italy
Azienda Ospedaliera di Rilievo Nazionale "A.Cardarelli"
Napoli, Italy
Azienda Ospidaliera Universitaria Seconda Universita di Napoli
Napoli, Italy
A.O.U. Maggiore della Carità
Novara, Italy
"Ospedale Cristo Re" dell'Istituto Figlie di N.S. al Monte Calvario
Roma, Italy
Fondazione Policlinico di Tor Vergata
Roma, Italy
Ospedale San Camillo
Roma, Italy
Policlinico A. Gemelli
Roma, Italy
Policlinico Umberto I Di Roma
Roma, Italy
Policlinico Univestitario Campus Biomedico
Roma, Italy
Hospital of Lithuanian University of Health Sciences Kaunas Clinics
Kaunas, Lithuania
Klaipeda University Hospital
Klaipeda, Lithuania
Vilinius University Hospital Santariskiu Klinikos
Vilnius, Lithuania
Unidad de Hígado Hospital Universitario Dr. José Eleuterio González
Monterrey, Nuevo León, Mexico
JM Research
Cuernavaca, Mexico
Consultorio Médico
Metepec, Mexico
Torre de Consultorios Clinica Londres
Mexico City, 06700, Mexico
Consultorio Medico
Mexico City, Mexico
Instituto de Ciencias Medicas y de la Nutricion Salvador Zubiran
Mexico City, Mexico
Torre de Consultorios Clinica Londres
Mexico Distrito Federal, Mexico
Accelerium Clinical Research
Monterrey, Mexico
Consultorio Medico del Dr. Mauricio Castillo Barradas
México Distrito Federal, Mexico
"Angeles Valle oriente" Hospital
San Pedro Garza Garcia, Mexico
Clinical Institute Colentina
Bucharest, Romania
The National Institute for Infectious Diseases "Prof. Dr. Matei Bals", Clinical Department for Adults II
Bucharest, Romania
Cluj County Emergency Hospital
Cluj Napoca, 400013, Romania
TVM Medical
Cluj Napoca, 400013, Romania
County Hospital Mures-Gastroenterology Department
Targu Mures, Romania

References and documents

Publications

Ratziu V, de Guevara L, Safadi R, Poordad F, Fuster F, Flores-Figueroa J, Arrese M, Fracanzani AL, Ben Bashat D, Lackner K, Gorfine T, Kadosh S, Oren R, Halperin M, Hayardeny L, Loomba R, Friedman S; ARREST investigator study group; Sanyal AJ. Aramchol in patients with nonalcoholic steatohepatitis: a randomized, double-blind, placebo-controlled phase 2b trial. Nat Med. 2021 Oct;27(10):1825-1835. doi: 10.1038/s41591-021-01495-3. Epub 2021 Oct 7. PubMed 34621052 ↗

Study documents

Protocol and statistical analysis plan · May 3, 2017

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02279524
Lead sponsor: Galmed Research and Development, Ltd.
Collaborators: Sharp, Diamond Pharma Services Regulatory Affairs Consultancy, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico, ClinIntel, Itamar-Medical, Israel, One Way Liver OWL, Medical University of Graz, Tel-Aviv Sourasky Medical Center, DSG EDC, TransPerfect, Clinical Reference Laboratory
Responsible party: Sponsor
First posted: Oct 31, 2014
Start date: Apr 29, 2015
Primary completion: May 22, 2018
Completion: May 22, 2018
Results posted: Jul 14, 2021
Last update: Jul 14, 2021

Study contacts

Vlad Ratziu, MD, PhD

principal investigator · Professor of Hepatology, Université Pierre et Marie Curie & Hospital Pitie Salpetriere Medical University, Paris.

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

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