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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 belowSelect...
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:Select...
I have had a liver transplant.
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My liver is severely damaged and cannot function properly.
Select...
My hemoglobin level is below the normal range for my gender.
Select...
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 60: assessment of aes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 60: assessment of aes
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 • NCT0277400534%
Total
19%
Headache
17%
Nasopharyngitis
10%
Diarrhoea
8%
Nausea
8%
Alanine aminotransferase increased
7%
Oropharyngeal pain
7%
Aspartate aminotransferase increased
7%
Abdominal pain upper
7%
Blood creatine phosphokinase increased
6%
Cough
5%
Gamma-glutamyltransferase increased
5%
Back pain
4%
Influenza
4%
Fatigue
4%
Sinusitis
4%
Toothache
4%
Abdominal pain
4%
Depression
3%
Rash
3%
Eye pain
3%
Malaise
3%
Dyspepsia
3%
Upper respiratory tract infection
3%
Vomiting
3%
Blood triglycerides increased
3%
Visual impairment
3%
Pyrexia
2%
Insomnia
2%
Lower respiratory tract infection
2%
Urinary tract infection
2%
Anxiety
2%
Influenza like illness
2%
Nasal congestion
2%
Seasonal allergy
2%
Pain
2%
Urine abnormality
2%
Gastroenteritis viral
2%
Myalgia
2%
Suicide attempt
2%
Neutrophil count decreased
2%
Ear pain
2%
Bronchitis
2%
Gastroenteritis
2%
Chromaturia
2%
Neutrophil count increased
2%
Arthralgia
2%
Dizziness
2%
Somnolence
2%
Blood cholesterol increased
2%
Bacterial test positive
2%
Hypertension
2%
Blood alkaline phosphatase increased
2%
Blood bilirubin increased
2%
Lymphocyte count increased
2%
Dysmenorrhoea
2%
Abdominal discomfort
2%
Protein urine present
2%
White blood cell count decreased
2%
Hypertriglyceridaemia
2%
Neck pain
1%
Product administration error
1%
Polyp
1%
Anxiety disorder
1%
Hypersensitivity
1%
Candida infection
1%
Tendonitis
1%
Raynaud's phenomenon
1%
Pulmonary congestion
1%
Photopsia
1%
Presyncope
1%
Cervical dysplasia
1%
Foot fracture
1%
Musculoskeletal discomfort
1%
Syncope
1%
Radius fracture
1%
Musculoskeletal chest pain
1%
Polydipsia psychogenic
1%
Viral infection
1%
Urobilinogen urine increased
1%
Ketoacidosis
1%
Metabolic acidosis
1%
Splenomegaly
1%
Tachycardia
1%
Hypoacusis
1%
Gastritis
1%
Chest pain
1%
Chills
1%
Cyst
1%
Medical device pain
1%
Pulpitis dental
1%
Tooth infection
1%
Corneal abrasion
1%
Sunburn
1%
Gastric pH decreased
1%
Haematocrit decreased
1%
Intervertebral disc protrusion
1%
Periostitis
1%
Generalised tonic-clonic seizure
1%
Confusional state
1%
Depressive symptom
1%
Hallucination
1%
Irritability
1%
Mood altered
1%
Sleep disorder
1%
Asthma
1%
Dyspnoea
1%
Epistaxis
1%
Rash pruritic
1%
Skin lesion
1%
Gastrointestinal viral infection
1%
Blood bicarbonate decreased
1%
Glycosuria
1%
Skin fissures
1%
Hepatitis C
1%
Hyperthyroidism
1%
Tendon rupture
1%
Motion sickness
1%
Bacteriuria
1%
Ear infection
1%
Oral herpes
1%
Lymphocyte count decreased
1%
Synovial cyst
1%
Hyperaesthesia
1%
Haematuria
1%
Restlessness
1%
Infrequent bowel movements
1%
Tooth abscess
1%
Blood creatine phosphokinase
1%
Anogenital warts
1%
Burning sensation
1%
Migraine
1%
Skin irritation
1%
Monocyte count decreased
1%
Scab
1%
Suicidal ideation
1%
Hordeolum
1%
Major depression
1%
Head injury
1%
Foreign body in eye
1%
Suicidal behaviour
1%
Urinary sediment present
1%
Ophthalmic migraine
1%
Fungal skin infection
1%
Transaminases increased
1%
Panic attack
1%
Lacrimation increased
1%
Photophobia
1%
Osteoporosis
1%
Hot flush
1%
Multiple sclerosis
1%
Drug reaction with eosinophilia and systemic
1%
Blepharitis
1%
Frequent bowel movements
1%
Arthropod bite
1%
Epilepsy
1%
Alcohol abuse
1%
Psychotic behaviour
1%
Hereditary optic atrophy
1%
Ocular hyperaemia
1%
Constipation
1%
Eosinophilic oesophagitis
1%
Food poisoning
1%
Tooth disorder
1%
Thyroiditis
1%
Bronchitis viral
1%
Herpes zoster
1%
Monocyte count increased
1%
Pruritus
1%
Psoriasis
1%
Orthostatic hypotension
1%
Hepatosplenomegaly
1%
Multiple organ dysfunction syndrome
1%
Hypogammaglobulinaemia
1%
Appendicitis
1%
Diverticulitis intestinal perforated
1%
Pyelonephritis
1%
Trichomoniasis
1%
Rash maculo-papular
1%
Miscarriage of partner
1%
Hepatic failure
1%
Bacterial abdominal infection
1%
Cellulitis
1%
Skin laceration
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%
Mean cell volume increased
1%
Weight increased
1%
Decreased appetite
1%
Hypercholesterolaemia
1%
Arthritis
1%
Periarthritis
1%
Seizure
1%
Tremor
1%
Adjustment disorder with depressed mood
1%
Prostatitis
1%
Testicular pain
1%
Allergic bronchitis
1%
Gastrointestinal pain
1%
Skin infection
1%
Lower limb fracture
1%
Urine ketone body present
1%
Anger
1%
Hallucination, visual
1%
Eye infection
1%
Arthropod sting
1%
Liver function test increased
1%
Red blood cell count decreased
1%
Conjunctivitis
1%
Eye haemorrhage
1%
Overdose
1%
Ingrown hair
1%
Delirium
1%
Heat stroke
1%
Nephrolithiasis
1%
Eyelid pain
1%
Salivary hypersecretion
1%
Infection
1%
Rhinitis
1%
Contusion
1%
Haemoglobin decreased
1%
Dysphonia
1%
Enterobiasis
1%
Wound
1%
Gastrooesophageal reflux disease
1%
Thermal burn
1%
Tooth impacted
1%
Pancreatitis
1%
Ankle fracture
1%
Pharyngitis
1%
Pharyngitis streptococcal
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
2,491 Previous Clinical Trials
17,519,208 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
2,464 Previous Clinical Trials
4,337,408 Total Patients Enrolled
57 Trials studying Non-alcoholic Fatty Liver Disease
10,177 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