Clinical trials: Nonalcoholic Steatohepatitis
Nonalcoholic Steatohepatitis (NASH), Overweight or Obesity
A Study of FT 4101 in Overweight/Obese Participants With Non-alcoholic Steatohepatitis
This Phase 1/2 study will evaluate safety, efficacy, PK, and PD of FT-4101 as a single agent in overweight/obese subjects with NASH. The study may be conducted in up to 2 dosing cohorts.
- Trial name
- NCT04004325
- Testing
- FT-4101, Deuterated Water
- Where
- 2 sites in United States
- Volunteers
- 14 people
- Sponsor
- Forma Therapeutics, Inc.
Nonalcoholic Steatohepatitis (NASH)
Study of ADI-PEG 20 Versus Placebo in Subjects With NASH
Evaluate efficacy and safety of ADI-PEG 20 in patients with NASH
- Trial name
- NCT05842512
- Testing
- ADI-PEG20
- Where
- 10 sites in Taiwan
- Volunteers
- 60 people
- Sponsor
- Polaris Group
NAFLD, NASH - Nonalcoholic Steatohepatitis
The Franciscus Obesity NASH Study
The purpose of this study is to evaluate Non-Alcoholic Fatty Liver Disease (NAFLD) and Non-Alcoholic Steatohepatitis (NASH) changes in terms of steatosis and elasticity in patients with morbid obesity 1, 3 and 5 years after…
- Conditions
- NAFLD, NASH - Nonalcoholic Steatohepatitis, Obesity, Morbid
- Trial name
- FONS (NCT05499949)
- Testing
- NASH screening, Cardiac dysfunction screening, Liver biopsy
- Where
- Netherlands
- Volunteers
- 300 people
- Sponsor
- Franciscus Gasthuis
NAFLD (Non-alcoholic Fatty Liver Disease), NASH (Nonalcoholic Steatohepatitis)
a Safety, Tolerability, and Pharmacokinetic Trial of Multiple Subcutaneous Injections of B1344 Injection in Patients With Nonalcoholic Fatty Liver Disease（NAFLD）
This is a randomized, double-blind, multicenter, placebo-controlled, multiple-dose escalating clinical trial designed to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity profile of B1344 in patients with…
- Trial name
- NCT07128797
- Testing
- B1344
- Where
- 5 sites in China
- Volunteers
- 32 people
- Sponsor
- Tasly Biopharmaceuticals Co., Ltd.
Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH)
A Trial to Learn if Receiving ALN-PNP siRNA is Safe and Well Tolerated, and How it Works in Adult Participants With Nonalcoholic Fatty Liver Disease (NAFLD) and a Genetic Risk Factor
This study is researching an experimental drug called ALN-PNP. This study is focused on participants who are known to have nonalcoholic fatty liver disease (NAFLD), and a specific variant of the patatin-like phospholipase domain…
- Conditions
- Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH), Genetic Risk Factor
- Trial name
- NCT06024408
- Testing
- ALN-PNP
- Where
- 5 sites in South Korea
- Volunteers
- 9 people
- Sponsor
- Regeneron Pharmaceuticals
Obesity, Weight Loss
Bariatric Embolization of Arteries for the Treatment of Nonalcoholic Steatohepatitis
Obesity is an epidemic in the US. With progression of obesity, Nonalcoholic steatohepatitis (NASH) has been a growing public health issue.
- Conditions
- Obesity, Weight Loss, Body Weight, Nonalcoholic Steatohepatitis
- Trial name
- NCT02933554
- Testing
- Embospheres Microspheres
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Keith Pereira, MD:
NASH, NASH - Nonalcoholic Steatohepatitis
Digital Therapeutic Lifestyle Intervention Program for Patients With MASLD
The ENLIGHTEN study that will evaluate the efficacy of a novel DTx lifestyle intervention in participants with non-cirrhotic MASH.
- Conditions
- NASH, NASH - Nonalcoholic Steatohepatitis, Liver Diseases
- Trial name
- ENLIGHTEN (NCT06352177)
- Testing
- Noom Weight Application
- Sponsor
- Milton S. Hershey Medical Center
Nonalcoholic Steatohepatitis (NASH)
Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)
The purpose of this study is to determine the safety, tolerability, and efficacy of NGM282 in patients with nonalcoholic steatohepatitis.
- Trial name
- NCT02443116
- Testing
- NGM282
- Where
- 22 sites in United States, Australia and 1 more
- Volunteers
- 254 people
- Sponsor
- NGM Biopharmaceuticals, Inc
Non-alcoholic Fatty Liver Disease, Fatty Liver, Nonalcoholic
Knockdown of HSD17B13 mRNA, Pharmacokinetics, Safety, and Tolerability, of AZD7503 in Non-Alcoholic Fatty Liver Disease
This is a two-part study. In Part A, eligible participants will undergo a baseline diagnostic liver biopsy to determine non-alcoholic fatty liver disease (NAFLD) Activity Score (NAS) and fibrosis stage, but will not receive study…
- Conditions
- Non-alcoholic Fatty Liver Disease, Fatty Liver, Nonalcoholic, NAFLD, Nonalcoholic Fatty Liver Disease
- Trial name
- NCT05560607
- Testing
- AZD7503 Intervention
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- AstraZeneca
Nonalcoholic Steatohepatitis
A Study of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis (NASH) (MK-3655-001)
This study will evaluate the effect of each dose of MK-3655 versus placebo on the percentage of individuals with NASH resolution without worsening of fibrosis after 52 weeks.
- Trial name
- NCT04583423
- Testing
- MK-3655
- Where
- 180 sites in United States, Argentina and 22 more
- Volunteers
- 183 people
- Sponsor
- Merck Sharp & Dohme LLC
NASH - Nonalcoholic Steatohepatitis
Evaluation of Efficacy, Safety and Tolerability of Aldafermin in a Phase 2b, Randomized, Double-blind, Placebo-controlled, Multi-center Study In Subjects With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis (ALPINE 2/3)
This is a multi-center evaluation of NGM282 in a randomized, double-blind, placebo-controlled study administered for 24 weeks in participants with histologically confirmed NASH and F2/F3 Fibrosis.
- Trial name
- NCT03912532
- Testing
- NGM282
- Where
- 37 sites in United States, Puerto Rico
- Volunteers
- 171 people
- Sponsor
- NGM Biopharmaceuticals, Inc
Nonalcoholic Steatohepatitis, Nonalcoholic Fatty Liver
Safety Study of OA-235i in Subjects With Nonalcoholic Steatohepatitis
This study is a Phase 1, first-in-human single-dose escalation and multiple dose study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of OA-235i in subjects with nonalcoholic steatohepatitis.
- Trial name
- NCT05680233
- Testing
- OA-235i (4 mg), OA-235i (8 mg), OA-235i (16 mg)
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Oasis Pharmaceuticals, LLC
Obesity, Nonalcoholic Steatohepatitis
ALT-801 (Pemvidutide) in Healthy Overweight and Obese Volunteers to Study Safety and Tolerability
This study was a FIH, Phase 1, randomized, double-blind, placebo-controlled, 2-part single-ascending dose (SAD) and multiple-ascending dose (MAD) study of ALT-801 (pemvidutide) in healthy overweight and obese subjects.
- Trial name
- NCT04561245
- Testing
- ALT-801
- Where
- Australia
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Altimmune, Inc.
NASH - Nonalcoholic Steatohepatitis
Pemvidutide (ALT-801) DDI Study in Healthy Volunteers
This is a Phase 1, open-label, drug-drug interaction (DDI) study of pemvidutide (ALT-801) under steady state conditions on concomitantly administered medications in healthy subjects.
- Trial name
- NCT04972396
- Testing
- Pemvidutide, Metformin, Atorvastatin
- Where
- 2 sites in Australia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Altimmune, Inc.
NASH - Nonalcoholic Steatohepatitis
A Study of Efruxifermin in Non-Cirrhotic Subjects With Histologically Confirmed Nonalcoholic Steatohepatitis (NASH)
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in non-cirrhotic subjects with biopsy-proven F2 - F3 NASH.
- Trial name
- Harmony (NCT04767529)
- Testing
- Efruxifermin
- Where
- 55 sites in United States, Puerto Rico
- Volunteers
- 128 people
- Sponsor
- Akero Therapeutics, Inc
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
Cirrhosis, End Stage Liver Disease
Mild Hypothermia and Acute Kidney Injury in Liver Transplantation
Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies).
- Conditions
- Cirrhosis, End Stage Liver Disease, Acute Kidney Injury, Liver Transplant; Complications
- Trial name
- MHALT (NCT03534141)
- Testing
- Esophageal cooling/warming device, Mild hypothermia, Normothermia
- Where
- 3 sites in United States
- Volunteers
- 175 people
- Sponsor
- University of California, San Francisco
Steatohepatitis, Nonalcoholic
The COherence of Scatter Identification and Exclusion Algorithm Study
Non-alcoholic fatty liver disease (NAFLD) is currently the most common liver condition worldwide; approximately 55% of the world population will have NAFLD by 2040.
- Trial name
- COSIE (NCT06975579)
- Testing
- Ultrasound image processing
- Where
- United Kingdom
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Institute of Cancer Research, United Kingdom
MASH, NASH
A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3 Fibrosis
A randomized, double-blind, placebo-controlled Phase 3 study to determine if denifanstat 50 mg or 25 mg is effective, as compared to placebo, in resolving MASH without the worsening of fibrosis and/or in fibrosis regression…
- Conditions
- MASH, NASH, Metabolic Dysfunction-associated Steatohepatitis, Noncirrhotic Metabolic Dysfunction-associated Steatohepatitis
- Trial name
- FASCINATE-3 (NCT06594523)
- Testing
- Denifanstat
- Sponsor
- Sagimet Biosciences Inc.
MASLD, MASH
A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASLD and MASH
A phase 3, randomized, double-blind, placebo-controlled study evaluating the safety and tolerability of denifanstat 50 mg compared to placebo in patients with metabolic dysfunction-associated steatotic liver disease…
- Conditions
- MASLD, MASH, NASH, Metabolic Dysfunction-Associated Steatotic Liver Disease
- Trial name
- FASCINIT (NCT06692283)
- Testing
- denifanstat
- Sponsor
- Sagimet Biosciences Inc.