Clinical trials: NAFLD
Overweight, Obese
The Effect of Protein-enriched Diet on Body Composition and Appetite
Obesity is a major problem worldwide and current dietary interventions are not proving to be enough to cease the increase in levels of obesity and its detrimental side effects, such as nonalcoholic fatty liver disease (NAFLD).
- Conditions
- Overweight, Obese, Metabolic Syndrome, Non Alcoholic Fatty Liver Disease
- Trial name
- ProteinRich (NCT01634048)
- Testing
- High Protein, low calorie meal replacement
- Where
- United Kingdom
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Diabetes Mellitus, Type II, Fatty Liver
Study of INT-747 in Patients With Diabetes and Presumed NAFLD
The primary objectives of this study are to assess, in patients with Type 2 diabetes mellitus (DM) and presumed nonalcoholic fatty liver disease (NAFLD), the following: The safety and tolerability of multiple doses of INT 747…
- Trial name
- NCT00501592
- Testing
- INT-747
- Where
- 4 sites in United States
- Volunteers
- 64 people
- Sponsor
- Intercept Pharmaceuticals
Nonalcoholic Fatty Liver Disease (NAFLD)
Growth Hormone and Intrahepatic Lipid Content in Patients With Nonalcoholic Fatty Liver Disease
Nonalcoholic fatty liver disease (NAFLD), fatty infiltration of the liver in the absence of alcohol use, is an increasingly recognized complication of obesity, with prevalence estimates of about 30% of individuals in the United…
- Trial name
- NAFLD (NCT02217345)
- Testing
- Growth hormone
- Where
- United States
- Volunteers
- 131 people
- Sponsor
- Massachusetts General Hospital
T2 Diabetes and Fatty Liver Disease (Non-alcoholic Origin)
A Study to Investigate Effects of Omega-3 Carboxylic Acids and Dapagliflozin on Liver Fat Content in Diabetic Patients
This study is a double-blind randomized, placebo-controlled, parallel-group, 12 week study performed in up to 5 centres in Sweden to assess the effect of Omega-3 carboxylic acids and dapagliflozin on liver fat in patients with…
- Trial name
- EFFECTII (NCT02279407)
- Testing
- Omega-3 carboxylic acids, Dapagliflozin
- Where
- 5 sites in Sweden
- Volunteers
- 223 people
- Sponsor
- AstraZeneca
Non-alcoholic Steatohepatitis
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis
This study will evaluate the efficacy, safety, and pharmacokinetics of BFKB8488A compared to placebo in participants with non-alcoholic steatohepatitis (NASH).
- Trial name
- BANFF (NCT04171765)
- Testing
- BFKB8488A
- Where
- 53 sites in United States, Belgium and 3 more
- Volunteers
- 46 people
- Sponsor
- Genentech, Inc.
Liver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD)
A Study of Experimental Medication BMS-986036 in Adults With Nonalcoholic Steatohepatitis (NASH) and Stage 3 Liver Fibrosis
This is a study of experimental medication BMS-986036 given to adults with Nonalcoholic Steatohepatitis (NASH; the buildup of fat and inflammation in the liver that is not caused by alcohol) and stage 3 liver fibrosis (severe…
- Conditions
- Liver Fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis
- Trial name
- FALCON 1 (NCT03486899)
- Testing
- BMS-986036
- Where
- 89 sites in United States, Japan
- Volunteers
- 197 people
- Sponsor
- Bristol-Myers Squibb
Non-alcoholic Fatty Liver Disease (NAFLD), Non-alcoholic Steatohepatitis (NASH)
A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH.
A Phase 2 study with 4 treatment groups of two differing doses and matched placebos designed to evaluate the safety (including hepatic safety), tolerability and pharmacodynamic effects of two dose levels of MEDI0382 in obese…
- Trial name
- NCT04019561
- Testing
- MEDI0382 high dose, MEDI0382 low dose
- Where
- 27 sites in United States, Puerto Rico
- Volunteers
- 74 people
- Sponsor
- MedImmune LLC
Compensated Cirrhosis, Nonalcoholic Steatohepatitis
Study Evaluating the Efficacy and Safety of Obeticholic Acid in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis
The primary objective of this study is to evaluate whether obeticholic acid (OCA; INT-747) can lead to histological improvement in fibrosis with no worsening of NASH in adults with compensated cirrhosis due to NASH.
- Trial name
- REVERSE (NCT03439254)
- Testing
- Obeticholic acid (10 mg), Obeticholic acid (10 mg to 25 mg)
- Where
- 192 sites in United States, Australia and 10 more
- Volunteers
- 919 people
- Sponsor
- Intercept Pharmaceuticals
Non-Alcoholic Steatohepatitis
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis
A randomized, double-blind study to assess the safety, tolerability, PK and efficacy of EDP-305 in subjects with Non-Alcoholic Steatohepatitis
- Trial name
- NCT03421431
- Testing
- EDP-305 Dose 1, EDP-305 Dose 2
- Where
- 82 sites in United States, Canada and 4 more
- Volunteers
- 134 people
- Sponsor
- Enanta Pharmaceuticals, Inc
NASH - Nonalcoholic Steatohepatitis
Companion Protocol for ¹³C-Methacetin Breath Tests in BMS: NCT03486899, NCT03486912 Referenced Trials
This is a companion study assessing the ¹³C-Methacetin Breath Test (MBT) in subjects participating in the Bristol Myers-Squibb (BMS) NCT03486899 and NCT03486912 referenced studies using study drug BMS-986036.
- Trial name
- NCT03611101
- Testing
- ¹³C-Methacetin Breath Test, BMS-986036, BreathID MCS device
- Where
- United States
- Volunteers
- 124 people
- Sponsor
- Meridian Bioscience, Inc.
Non-alcoholic Steatohepatitis
Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH)
The primary objective of this study is to determine the effect of once-daily oral MGL-3196 on the percent change in hepatic fat fraction from baseline in participants with biopsy-proven Non-alcoholic Steatohepatitis (NASH).
- Trial name
- NCT02912260
- Testing
- MGL-3196
- Where
- 26 sites in United States
- Volunteers
- 125 people
- Sponsor
- Madrigal Pharmaceuticals, Inc.
Non-Alcoholic Fatty Liver Disease, Non-Alcoholic Steatohepatitis
Pediatric Liver Fat Quantification (LFQ) Phase 2 Pilot Study
This clinical study will involve performing a series of medical imaging procedures of the abdomen using both ultrasound and MRI modalities in subjects at risk for or already diagnosed with Nonalcoholic Fatty Liver Disease…
- Trial name
- NCT04800094
- Testing
- Investigational Liver Fat Quantification Software
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Non-alcoholic Fatty Liver Disease
Study of Changes in Hepatic Fat Following Administration of MK-4074 and Pioglitazone Hydrochloride (MK-4074-008)
This study will evaluate changes in liver fat content following multiple oral doses of MK-4074 and Pioglitazone Hydrochloride in adult males and females with fatty liver disease.
- Trial name
- NCT01431521
- Testing
- MK-4074 200 mg, Pioglitazone hydrochloride 30 mg
- Volunteers
- 31 people
- Sponsor
- Merck Sharp & Dohme LLC
Nonalcoholic Steatohepatitis (NASH), Nonalcoholic Fatty Liver Disease (NAFLD)
Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH)
The primary objective of this study is to evaluate the safety and tolerability of selonsertib, firsocostat, cilofexor, fenofibrate and/or Vascepa® in adults with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic…
- Trial name
- NCT02781584
- Testing
- SEL, FIR, CILO
- Where
- 13 sites in United States, New Zealand
- Volunteers
- 220 people
- Sponsor
- Gilead Sciences
Iron, Diabetes
Iron Reduction for the Treatment of Diabetes and Nonalcoholic Fatty Liver Disease
This is a treatment study to determine if reducing the body's iron stores by blood donation will improve diabetes control and other problems associated with diabetes such as fatty liver disease.
- Conditions
- Iron, Diabetes, Nonalcoholic Fatty Liver
- Trial name
- NCT03696797
- Testing
- Blood Donation
- Where
- 2 sites in United States
- Volunteers
- 132 people
- Sponsor
- Wake Forest University Health Sciences
NASH - Nonalcoholic Steatohepatitis
Phase 2a Study of HU6 in Subjects With Elevated Liver Fat and High BMI Volunteers
This is a Phase 2a, randomized, parallel-group, placebo-controlled, double-blind, repeated-dose study to evaluate the safety and efficacy of three oral dose levels of HU6 compared to placebo over the course of 61 days in subjects…
- Trial name
- NCT04874233
- Testing
- HU6
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Rivus Pharmaceuticals, Inc.
NAFLD, NASH - Nonalcoholic Steatohepatitis
Vitamin E for NASH Treatment in HIV Infected Individuals
The purpose of this study is to see how taking Vitamin E daily affects fatty liver in persons living with HIV. Subjects will have both HIV and a fatty liver and the purpose of the study is to learn if underlying liver condition…
- Conditions
- NAFLD, NASH - Nonalcoholic Steatohepatitis, HIV Infections
- Trial name
- NCT03669133
- Testing
- Vitamin E
- Where
- 2 sites in United States
- Volunteers
- 3 people
- Sponsor
- Indiana University
Nonalcoholic Steatohepatitis (NASH)
Leronlimab (PRO 140) in Patients With Nonalcoholic Steatohepatitis
This is a phase II study of of Leronlimab (PRO 140)-Humanized monoclonal antibody to CCR5 in patients with Nonalcoholic Steatohepatitis (NASH).
- Trial name
- NASH (NCT04521114)
- Testing
- leronlimab 700 mg, leronlimab 350 mg
- Where
- 7 sites in United States
- Volunteers
- 87 people
- Sponsor
- CytoDyn, Inc.
NASH - Nonalcoholic Steatohepatitis
Study of PXL065 in Patients With Nonalcoholic Steatohepatitis (NASH)
This study will assess the effect of 3 doses of PXL065 versus placebo on liver fat content in NASH patients after 36 weeks of treatment
- Trial name
- NCT04321343
- Testing
- PXL065
- Where
- 29 sites in United States
- Volunteers
- 117 people
- Sponsor
- Poxel SA
NAFLD
Study of the Safety and Tolerability of AXA1957 in Adolescent Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)
This is a randomized, single blind study to determine whether AXA1957, a novel composition of amino acids, is safe and well tolerated.
- Trial name
- NCT04073407
- Testing
- AXA1957
- Where
- 4 sites in United Kingdom
- Volunteers
- 9 people
- Sponsor
- Axcella Health, Inc