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Antioxidant

Oral Idebenone for Fatty Liver Disease

Phase 1 & 2
Waitlist Available
Led By Natalie Torok, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of NASH: NAFLD activity score (NAS) of 4 or greater with a score of 1 for each of the following (steatosis scored 0-3, lobular inflammation scored 0-3, ballooning scored 0-2)
Fibrosis (Ishak fibrosis score ≥1 on liver biopsy) within 6 months of enrollment with MELD<10, or based on MRE
Must not have
History of liver transplantation
Decompensated cirrhosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 60: assessment of aes
Awards & highlights
All Individual Drugs Already Approved

Summary

This trial is testing a new drug to treat non-alcoholic steatohepatitis, a fatty liver disease. They will test how well the drug works and if it is safe.

Who is the study for?
Adults over 18 with non-alcoholic steatohepatitis (NASH) and moderate liver fibrosis can join this study. They must have a specific level of fat, inflammation, and cell damage in the liver but not severe liver dysfunction or other serious health issues like heart disease or recent drug trial participation.
What is being tested?
The trial is testing Idebenone, an oral medication, against a placebo to see if it's safe and can improve liver health in NASH patients. Participants are randomly chosen to receive either the real drug or a fake pill without knowing which one they get.
What are the potential side effects?
While the side effects for Idebenone in treating NASH aren't fully known yet, potential risks may include digestive discomfort, fatigue, skin reactions or headaches as commonly seen with new treatments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with NASH with a specific severity score.
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My liver has some scarring but my overall liver function is still good.
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I am an adult over 18 and not pregnant or breastfeeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a liver transplant.
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My liver is severely damaged and cannot function properly.
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My hemoglobin level is below the normal range for my gender.
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I have a history of inflammatory bowel disease.
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I have a liver disease such as hepatitis or alcoholic liver disease.
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I have or had liver cancer.
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I have a history of heart disease or long QT syndrome.
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I have had weight loss surgery in the past.
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I do not consume more than 20g (women) or 30g (men) of alcohol daily.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 60: assessment of aes
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 60: assessment of aes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Secondary study objectives
Change in fibrosis stage

Side effects data

From 2021 Phase 4 trial • 199 Patients • NCT02774005
34%
Total
19%
Headache
17%
Nasopharyngitis
10%
Diarrhoea
8%
Nausea
8%
Alanine aminotransferase increased
7%
Oropharyngeal pain
7%
Abdominal pain upper
7%
Aspartate aminotransferase increased
7%
Blood creatine phosphokinase increased
6%
Cough
5%
Gamma-glutamyltransferase increased
5%
Back pain
4%
Influenza
4%
Toothache
4%
Fatigue
4%
Sinusitis
4%
Abdominal pain
4%
Depression
3%
Eye pain
3%
Dyspepsia
3%
Upper respiratory tract infection
3%
Visual impairment
3%
Rash
3%
Vomiting
3%
Malaise
3%
Blood triglycerides increased
3%
Pyrexia
2%
Urine abnormality
2%
Seasonal allergy
2%
Lower respiratory tract infection
2%
Urinary tract infection
2%
Anxiety
2%
Blood cholesterol increased
2%
Hypertension
2%
Bacterial test positive
2%
Gastroenteritis viral
2%
Myalgia
2%
Dizziness
2%
Suicide attempt
2%
Neutrophil count decreased
2%
Ear pain
2%
Bronchitis
2%
Gastroenteritis
2%
Blood alkaline phosphatase increased
2%
Blood bilirubin increased
2%
Lymphocyte count increased
2%
Neutrophil count increased
2%
Chromaturia
2%
Influenza like illness
2%
Pain
2%
Arthralgia
2%
Somnolence
2%
Insomnia
2%
Dysmenorrhoea
2%
Nasal congestion
2%
Abdominal discomfort
2%
Protein urine present
2%
White blood cell count decreased
2%
Hypertriglyceridaemia
2%
Neck pain
1%
Periostitis
1%
Polyp
1%
Candida infection
1%
Musculoskeletal chest pain
1%
Skin fissures
1%
Raynaud's phenomenon
1%
Tendon rupture
1%
Tendonitis
1%
Ingrown hair
1%
Photopsia
1%
Foot fracture
1%
Sunburn
1%
Presyncope
1%
Cervical dysplasia
1%
Scab
1%
Gastrointestinal pain
1%
Blood creatine phosphokinase
1%
Syncope
1%
Hepatitis C
1%
Radius fracture
1%
Overdose
1%
Polydipsia psychogenic
1%
Anogenital warts
1%
Rash pruritic
1%
Gastrointestinal viral infection
1%
Blood bicarbonate decreased
1%
Urine ketone body present
1%
Burning sensation
1%
Glycosuria
1%
Motion sickness
1%
Bacteriuria
1%
Ear infection
1%
Oral herpes
1%
Lymphocyte count decreased
1%
Synovial cyst
1%
Hyperaesthesia
1%
Haematuria
1%
Hyperthyroidism
1%
Restlessness
1%
Nephrolithiasis
1%
Multiple sclerosis
1%
Musculoskeletal discomfort
1%
Suicidal ideation
1%
Hordeolum
1%
Major depression
1%
Product administration error
1%
Blepharitis
1%
Contusion
1%
Foreign body in eye
1%
Suicidal behaviour
1%
Urinary sediment present
1%
Ophthalmic migraine
1%
Eye haemorrhage
1%
Fungal skin infection
1%
Transaminases increased
1%
Panic attack
1%
Lacrimation increased
1%
Photophobia
1%
Gastrooesophageal reflux disease
1%
Osteoporosis
1%
Hot flush
1%
Frequent bowel movements
1%
Drug reaction with eosinophilia and systemic
1%
Corneal abrasion
1%
Arthropod bite
1%
Lower limb fracture
1%
Pulmonary congestion
1%
Thermal burn
1%
Generalised tonic-clonic seizure
1%
Skin irritation
1%
Epilepsy
1%
Migraine
1%
Alcohol abuse
1%
Anxiety disorder
1%
Psychotic behaviour
1%
Hereditary optic atrophy
1%
Thyroiditis
1%
Ocular hyperaemia
1%
Constipation
1%
Eosinophilic oesophagitis
1%
Food poisoning
1%
Gastritis
1%
Salivary hypersecretion
1%
Tooth disorder
1%
Hepatosplenomegaly
1%
Hypersensitivity
1%
Bacterial abdominal infection
1%
Bronchitis viral
1%
Cellulitis
1%
Herpes zoster
1%
Infection
1%
Viral infection
1%
Head injury
1%
Skin laceration
1%
Monocyte count decreased
1%
Monocyte count increased
1%
Pruritus
1%
Psoriasis
1%
Orthostatic hypotension
1%
Rash maculo-papular
1%
Hypoacusis
1%
Eyelid pain
1%
Enterobiasis
1%
Eye infection
1%
Arthropod sting
1%
Wound
1%
Haemoglobin decreased
1%
Liver function test increased
1%
Red blood cell count decreased
1%
Periarthritis
1%
Infrequent bowel movements
1%
Tooth impacted
1%
Mean cell volume increased
1%
Skin lesion
1%
Delirium
1%
Conjunctivitis
1%
Heat stroke
1%
Sleep disorder
1%
Pancreatitis
1%
Multiple organ dysfunction syndrome
1%
Hypogammaglobulinaemia
1%
Appendicitis
1%
Diverticulitis intestinal perforated
1%
Pyelonephritis
1%
Trichomoniasis
1%
Ankle fracture
1%
Urobilinogen urine increased
1%
Ketoacidosis
1%
Metabolic acidosis
1%
Miscarriage of partner
1%
Hepatic failure
1%
Splenomegaly
1%
Tachycardia
1%
Chest pain
1%
Chills
1%
Cyst
1%
Medical device pain
1%
Pharyngitis
1%
Pharyngitis streptococcal
1%
Pulpitis dental
1%
Rhinitis
1%
Skin infection
1%
Tooth abscess
1%
Tooth infection
1%
Blood creatinine increased
1%
Blood glucose increased
1%
Blood phosphorus decreased
1%
Blood urea decreased
1%
Blood urea increased
1%
Blood uric acid increased
1%
Eosinophil count increased
1%
Gastric pH decreased
1%
Haematocrit decreased
1%
Weight increased
1%
Decreased appetite
1%
Hypercholesterolaemia
1%
Arthritis
1%
Intervertebral disc protrusion
1%
Seizure
1%
Tremor
1%
Adjustment disorder with depressed mood
1%
Anger
1%
Confusional state
1%
Depressive symptom
1%
Hallucination
1%
Hallucination, visual
1%
Irritability
1%
Mood altered
1%
Prostatitis
1%
Testicular pain
1%
Allergic bronchitis
1%
Asthma
1%
Dysphonia
1%
Dyspnoea
1%
Epistaxis
1%
Myocardial Infarction
1%
Disease Reoccurance
1%
Malpositioned teeth
1%
Cardiac Arrest
1%
Diverticulitis
1%
Anaemia
1%
Vulvovaginitis
1%
Acute kidney injury
1%
Coronary artery disease
1%
Excessive cerumen production
1%
Pupils unequal
1%
Vision blurred
1%
Visual acuity reduced
1%
Abdominal migraine
1%
Dental caries
1%
Dental necrosis
1%
White blood cells urine positive
1%
Dehydration
1%
Fluid retention
1%
Hyperlipidaemia
1%
Hyponatraemia
1%
Pain in extremity
1%
Pain in jaw
1%
Sinus headache
1%
Depressed mood
1%
Mood swings
1%
Respiratory acidosis
1%
Sinus congestion
1%
Tonsillar hypertrophy
1%
Upper respiratory tract congestion
1%
Upper-airway cough syndrome
1%
Orthosis user
1%
Pregnancy of partner
1%
Acne
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Raxone

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: IdebenoneExperimental Treatment1 Intervention
Participants will take Idebenone 200 mg for 48 weeks, with study visits in clinic for physical and laboratory assessments at weeks 0, 2, 4, 12, 24, 36, and 48 weeks during treatment period and at 4, and 12 weeks after the last dose.
Group II: PlaceboPlacebo Group1 Intervention
Participants will take Placebo for 48 weeks, with study visits in clinic for physical and laboratory assessments at weeks 0, 2, 4, 12, 24, 36, and 48 weeks during treatment period and at 4, and 12 weeks after the last dose.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Idebenone
FDA approved

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,472 Previous Clinical Trials
17,501,773 Total Patients Enrolled
1 Trials studying Non-alcoholic Fatty Liver Disease
110 Patients Enrolled for Non-alcoholic Fatty Liver Disease
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,446 Previous Clinical Trials
4,331,787 Total Patients Enrolled
56 Trials studying Non-alcoholic Fatty Liver Disease
10,127 Patients Enrolled for Non-alcoholic Fatty Liver Disease
Natalie Torok, MD1.02 ReviewsPrincipal Investigator - Stanford University
Stanford University
2 Previous Clinical Trials
139 Total Patients Enrolled
2 Trials studying Non-alcoholic Fatty Liver Disease
139 Patients Enrolled for Non-alcoholic Fatty Liver Disease
~11 spots leftby Nov 2025
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