Clinical trials: NASH
Nonalcoholic Steatohepatitis (NASH)
Study in Healthy Volunteers to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GS-9674 (Cilofexor), and the Effect of Food on GS-9674 Pharmacokinetics and Pharmacodynamics
This study will evaluate the safety and tolerability of escalating single- and multiple-oral doses of cilofexor, and characterize the single- and multiple-dose pharmacokinetics (PK) of cilofexor.
- Trial name
- NCT02654002
- Testing
- Cilofexor
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Non Alcoholic Steatohepatitis
Ezetimibe Versus Placebo in the Treatment of Non-alcoholic Steatohepatitis
The purpose of the study is to see if the drug ezetimibe is a potential treatment for Nonalcoholic Steatohepatitis(NASH).
- Trial name
- NCT01766713
- Testing
- Ezetimibe
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
Non-Alcoholic Fatty Liver Disease, Obesity
Effects of Dietary Fructose on Gut Microbiota and Fecal Metabolites in Obese Men and Postmenopausal Women: A Pilot Study
Non alcoholic fatty liver disease (NAFLD) is the most common cause of abnormal liver function tests in the U.S. (Browning, et al., 2004), ranging from steatosis to end-stage liver disease.
- Trial name
- NCT03339245
- Testing
- Fructose Solution (75 Grams), Glucose Solution (75 grams)
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Rockefeller University
Healthy
Study of Multiple Oral Doses of PF-06835919 in Healthy Adult Japanese Participants
This is a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of multiple oral doses of PF-06835919 in healthy adult Japanese participants.
- Trial name
- NCT04427917
- Testing
- PF-06835919
- Where
- Belgium
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Pfizer
Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis
Conditionally Increased Output (CIO) Enhanced Ultrasound System
This study aims to assess possible bioeffects that may be caused by the use of shear wave elastography (SWE) with conditionally increased acoustic output pressure (CIO).
- Conditions
- Nonalcoholic Fatty Liver, Nonalcoholic Steatohepatitis, Fatty Liver
- Trial name
- NCT05792423
- Testing
- GE ultrasound system with increased acoustic output settings
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Fatty Liver, Insulin Resistance
Insulin Resistance in Non-alcoholic Fatty Liver Disease
The purpose of this study is to determine whether nonalcoholic fatty liver disease (NAFLD) is associated with altered peripheral and hepatic insulin sensitivity and to investigate potential mechanisms underlying insulin…
- Trial name
- NCT00252499
- Testing
- rosiglitazone, fenofibrate
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- US Department of Veterans Affairs
Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver Disease
University of Texas H.S.C. San Antonio Pioglitazone in Non-Alcoholic Steatohepatitis Trial (UTHSCSA NASH Trial)
Obesity and Type 2 diabetes are creating a silent epidemic, Non-alcoholic fatty liver disease, which is a chronic liver disease associated with insulin resistance, impaired glucose intolerance, and hepatic fat accumulation.
- Conditions
- Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver Disease, Type 2 Diabetes Mellitus
- Trial name
- NCT00994682
- Testing
- Pioglitazone study drug, Pioglitazone Open Label
- Where
- United States
- Volunteers
- 176 people, healthy volunteers welcome
- Sponsor
- University of Florida
Non-alcoholic Steatohepatitis, Hepatic Impairment
A Study of Efinopegdutide in Participants With Hepatic Impairment (MK-6024-014)
The purpose of this study was to evaluate the pharmacokinetics of efinopegdutide in participants with hepatic impairment compared to healthy participants, and to examine the safety and tolerability of efinopegdutide.
- Trial name
- NCT06052566
- Testing
- Efinopegdutide
- Where
- 4 sites in United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
NASH - Nonalcoholic Steatohepatitis; NAFLD - Nonalcoholic Fatty Liver Disease
Biomarkers of Liver Pathology in Patients With Presumed Non-Alcoholic Steatohepatitis Following Bariatric Surgery
The purpose of this study is to evaluate imaging and other biomarkers of non-alcoholic fatty liver disease before and after bariatric surgery.
- Trial name
- BARI (NCT03294850)
- Testing
- Bariatric surgery, HepQuant SHUNT Dual Cholate Liver Diagnostic Kit
- Where
- United States
- Volunteers
- 14 people, healthy volunteers welcome
- Sponsor
- AdventHealth Translational Research Institute
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
Hepatic Impairment, Healthy Volunteers
Effect Of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of PF-06865571 In Subjects With Hepatic Impairment and in Healthy Subjects
The current study is proposed to evaluate whether there is any clinically meaningful effect of hepatic impairment on the plasma PK of PF-06865571.
- Trial name
- NCT04091061
- Testing
- PF-06865571 100 mg
- Where
- 2 sites in United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Pfizer
Nonalcoholic Steatohepatitis (NASH), Primary Sclerosing Cholangitis (PSC)
Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function
The primary objective of this study is to evaluate the single-dose pharmacokinetics of cilofexor in adults with impaired hepatic function relative to matched, healthy controls with normal hepatic function.
- Trial name
- NCT02808312
- Testing
- Cilofexor
- Where
- 5 sites in United States, New Zealand
- Volunteers
- 57 people, healthy volunteers welcome
- Sponsor
- Gilead Sciences
Non-Alcoholic Fatty Liver Disease, Obesity
Alternate Day Fasting, Exercise, and NAFLD
Approximately 65% of obese individuals have non-alcoholic fatty liver disease (NAFLD), and this condition is strongly related to the development of insulin resistance and diabetes.
- Trial name
- NCT04004403
- Testing
- Alternate day fasting, Exercise
- Where
- United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University of Illinois Chicago
Hepatic Impairment, Healthy Participants
A STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN PARTICIPANTS WITH AND WITHOUT HEPATIC IMPAIRMENT
The study is proposed to characterize the effect of varying degrees of hepatic impairment on the plasma PK of PF-06835919
- Trial name
- NCT04193436
- Testing
- PF-06835919 25 mg
- Where
- 3 sites in Belgium, Czechia and 1 more
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Pfizer
Obesity, Type2diabetes
The Effects of Glucagon on Hepatic Metabolism
Whether impaired postprandial glucagon suppression in prediabetes and T2DM is an attempt to overcome resistance to glucagon's actions on hepatic AA catabolism, a defect in α-cell function, or a combination of both are important…
- Conditions
- Obesity, Type2diabetes, NAFLD
- Trial name
- NCT05500586
- Testing
- Glucagon response study
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Adrian Vella
Non-alcoholic Fatty Liver Disease (NAFLD)
How Does Dietary Carbohydrate Influence the Formation of an Atherogenic Lipoprotein Phenotype (ALP)?
The hypothesis of this study is that a diet high in sugars will increase abnormalities in blood lipids which are associated with increased cardiovascular disease risk, relative to a diet which is low in sugar.
- Trial name
- CHOT (NCT01790984)
- Testing
- High sugar low starch diet, Low sugar high starch diet
- Where
- United Kingdom
- Volunteers
- 27 people, healthy volunteers welcome
- Sponsor
- Bruce A. Griffin
Hepatitis C, Chronic, Non-Alcoholic Fatty Liver Disease
Intra-Individual Reproducibility of the Non-Invasive Assessment of the Portal Circulation
HepQuant tests are new liver tests that are being developed to accurately measure liver function with sensitivity and specificity while being safe and non-invasive.
- Trial name
- Repro (NCT01579162)
- Testing
- Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123)
- Where
- United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- HepQuant, LLC
Nonalcoholic Fatty Liver Disease (NAFLD), Type 2 Diabetes (T2DM)
Lanifibranor in Patients With Type 2 Diabetes & Nonalcoholic Fatty Liver Disease
The primary aim is to establish the safety, efficacy and mechanism of action of lanifibranor in patients with type 2 diabetes (T2DM) and nonalcoholic fatty liver disease (NAFLD).
- Trial name
- NCT03459079
- Testing
- Lanifibranor
- Where
- United States
- Volunteers
- 128 people, healthy volunteers welcome
- Sponsor
- University of Florida
Non-alcoholic Fatty Liver, Metabolic Syndrome
Dairy Fat as a Mediator of Vitamin E Adequacy in Individuals With Metabolic Syndrome
This study is conducted to investigate if vitamin E status in healthy individuals and individuals with metabolic syndrome can be improved by dairy fat.
- Trial name
- NCT01787591
- Testing
- Fat-Free Milk, Low-Fat Milk, Full-Fat Milk
- Where
- United States
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Ohio State University
NASH With Fibrosis
Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male Subjects
This is a single-center, single-period, single-dose, open-label, non-randomized study to assess the mass balance recovery, metabolite profile and metabolite identification of 14C- labelled rencofilstat ([14C] CRV431).
- Trial name
- NCT05737433
- Testing
- [14C]-rencofilstat 225mg
- Where
- United Kingdom
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- Hepion Pharmaceuticals, Inc.