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A Clinical Trial to Evaluate the Efficacy and Safety of Two Aramchol Doses Versus Placebo in Patients With NASH
Phase 2 trial testing Aramchol in Fatty Liver in 247 participants. Completed in 22 May 2018.
| Lead sponsor | Galmed Research and Development, Ltd. |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 247 |
| Start date | 29 April 2015 |
| Primary completion | 22 May 2018 |
| Estimated completion | 22 May 2018 |
| Sites | 78 locations across Georgia, France, Hong Kong, Italy, Chile, Germany, Israel, Mexico |
Galmed Research and Development, Ltd. — full company profile →
Adults 18 to 75, any sex, with Fatty Liver or Non-Alcoholic Steatohepatitis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
absolute % change from baseline to end of study in liver triglycerides to water ratio (fat/water+fat) as measured by MRS
| Group | Value | 95% CI |
|---|---|---|
| Aramchol 600mg | -3.18 | ± 1.01 |
| Aramchol 400mg | -3.41 | ± 0.96 |
| Placebo | -0.09 | ± 1.38 |
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
| Group | Value | 95% CI |
|---|---|---|
| Aramchol 600mg | 16.7 | |
| Aramchol 400mg | 7.5 | |
| Placebo | 5 |
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)
| Group | Value | 95% CI |
|---|---|---|
| Aramchol 600mg | 29.5 | |
| Aramchol 400mg | 21.3 | |
| Placebo | 17.5 |
Change from baseline to Week 52 or Termination visit in ALT levels (U/L)
| Group | Value | 95% CI |
|---|---|---|
| Aramchol 600mg | -17.3 | ± 3.7 |
| Aramchol 400mg | -12.0 | ± 3.6 |
| Placebo | 11.8 | ± 5.2 |
Change from baseline to Week 52 or Termination visit in Hemoglobin A1C (%)
| Group | Value | 95% CI |
|---|---|---|
| Aramchol 600mg | -0.1268 | ± 0.0769 |
| Aramchol 400mg | -0.0417 | ± 0.0754 |
| Placebo | 0.3202 | ± 0.1089 |
Change from baseline to Week 52 or termination visit in AST levels (U/L)
| Group | Value | 95% CI |
|---|---|---|
| Aramchol 600mg | -10.83 | ± 2.49 |
| Aramchol 400mg | -7.21 | ± 2.42 |
| Placebo | 6.68 | ± 3.50 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Aramchol 600mg | 47.0 | |
| Aramchol 400mg | 36.7 | |
| Placebo | 24.4 |
Fibrosis stage 4 in liver biopsy
| Group | Value | 95% CI |
|---|---|---|
| Aramchol 600mg | 1 | |
| Aramchol 400mg | 6 | |
| Placebo | 3 |
Time frame: 52 weeks + 13 weeks follow-up. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Aramchol 600mg | Aramchol 400mg | Placebo |
|---|---|---|---|---|
| Bile duct stone | Hepatobiliary disorders | — | — | — |
| Pulmonary emboli | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Anaemia | Blood and lymphatic system disorders | — | — | — |
| Retinal detachment | Eye disorders | — | — | — |
| Abdominal wall haematoma | Gastrointestinal disorders | — | — | — |
| Food poisoning | Gastrointestinal disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Chest pain | General disorders | — | — | — |
| Cholecystitis | Hepatobiliary disorders | — | — | — |
| Anaphylactic reaction | Immune system disorders | — | — | — |
| Abscess limb | Infections and infestations | — | — | — |
| Cellulitis | Infections and infestations | — | — | — |
| Femur fracture | Injury, poisoning and procedural complications | — | — | — |
| Humerus fracture | Injury, poisoning and procedural complications | — | — | — |
| Mammogram abnorma | Investigations | — | — | — |
| Diabetic metabolic decompensation | Metabolism and nutrition disorders | — | — | — |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | — | — | — |
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Gallbladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Hepatocellular carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Myelofibrosis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | — | — | — |
| Lumbar radiculopathy . | Nervous system disorders | — | — | — |
| Radicular syndrome | Nervous system disorders | — | — | — |
| Confusional state | Psychiatric disorders | — | — | — |
| Reaction | System | Aramchol 600mg | Aramchol 400mg | Placebo |
|---|---|---|---|---|
| Headache | Nervous system disorders | — | — | — |
| Urinary tract infection | Renal and urinary disorders | — | — | — |
| Nausea | Gastrointestinal disorders | — | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — | — |
| Constipation | Gastrointestinal disorders | — | — | — |
| Fatigue | General disorders | — | — | — |
| Influenza | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — | — |
| Abdominal distension | Gastrointestinal disorders | — | — | — |
| Abdominal pain upper | Gastrointestinal disorders | — | — | — |
| Back Pain | Musculoskeletal and connective tissue disorders | — | — | — |
| Bronchitis | Infections and infestations | — | — | — |
| Diarrhea | Gastrointestinal disorders | — | — | — |
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Asthenia | General disorders | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — | — |
| Upper Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
Most-reported serious reactions: Bile duct stone, Pulmonary emboli, Anaemia, Retinal detachment, Abdominal wall haematoma, Food poisoning, Vomiting, Chest pain.
Data from ClinicalTrials.gov NCT02279524 adverse events section.
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)).
8 peer-reviewed publications reference this trial (live from Europe PMC):
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