Clinical trials: NASH - Nonalcoholic Steatohepatitis
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASH) / Nonalcoholic Steatohepatitis (NASH) With Fibrosis
A Study Evaluating the Efficacy and Safety of Pegozafermin in Participants With MASH and Fibrosis (ENLIGHTEN-Fibrosis)
The study will assess the efficacy and safety of 2 dose regimens of pegozafermin compared to placebo for the treatment of liver fibrosis stage F2 or F3 in adult participants with MASH.
- Trial name
- NCT06318169
- Testing
- Pegozafermin
- Where
- 370 sites in United States, Argentina and 25 more
- Volunteers
- 1,350 people
- Sponsor
- Hoffmann-La Roche
Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
A Study to Evaluate the Efficacy and Safety of Pegozafermin in Participants With Compensated Cirrhosis Due to MASH
The study will assess the efficacy and safety of pegozafermin administered in participants with biopsy-confirmed and clinically confirmed compensated cirrhosis due to MASH .
- Trial name
- NCT06419374
- Testing
- Pegozafermin
- Where
- 330 sites in United States, Argentina and 23 more
- Volunteers
- 1,800 people
- Sponsor
- Hoffmann-La Roche
Obesity, Morbid, Metabolic Syndrome
Biometabolic Outcomes After Weight Loss Surgery: An Individualized Approach
Variable outcomes after weight loss surgery are likely attributable to complex, poorly understood mechanisms. Due to the significant impact that morbid obesity has on a patient's health, successful management of obesity and its…
- Conditions
- Obesity, Morbid, Metabolic Syndrome, NASH - Nonalcoholic Steatohepatitis
- Trial name
- NCT04841057
- Testing
- 50 cm BP limb length, 100 cm BP limb length, 150 cm BP limb length
- Where
- United States
- Volunteers
- 750 people, healthy volunteers welcome
- Sponsor
- University of Missouri-Columbia
Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis
Evaluating the Pharmacokinetics and Safety of Miricorilant
A Phase 1b, Open-Label Study Evaluating the Pharmacokinetics and Safety of Miricorilant in Adult Patients With Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- Conditions
- Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-Associated Steatohepatitis (MASH) / Nonalcoholic Steatohepatitis (NASH) With Compensated Cirrhosis, Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), Non-alcoholic Fatty Liver Disease (NAFLD)
- Trial name
- NCT07553663
- Testing
- Miricorilant
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Corcept Therapeutics
Liver Transplant; Complications, Diabetes Mellitus
Semaglutide vs Sitagliptin
The effect of once daily dosing of oral Semaglutide versus once daily dosing Sitagliptin on glycemic control, body weight, and safety and tolerability will be compared in Liver Transplant Recipients with poorly-controlled…
- Conditions
- Liver Transplant; Complications, Diabetes Mellitus, NASH - Nonalcoholic Steatohepatitis, NAFLD
- Trial name
- NCT05195944
- Testing
- Semaglutide Treatment, Sitagliptin 100mg
- Where
- Canada
- Volunteers
- 58 people
- Sponsor
- University Health Network, Toronto
NASH - Nonalcoholic Steatohepatitis, MASH - Metabolic Dysfunction-Associated Steatohepatitis
A Study Evaluating Efruxifermin in Subjects With Compensated Cirrhosis Due to NASH/MASH
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis due to NASH/MASH.
- Trial name
- NCT06528314
- Testing
- Efruxifermin
- Where
- 345 sites in United States, Argentina and 19 more
- Volunteers
- 2,150 people
- Sponsor
- Akero Therapeutics, Inc
NASH - Nonalcoholic Steatohepatitis
Efocipegtrutide (HM15211) in Adults With Biopsy-Confirmed Nonalcoholic Steatohepatitis (NASH)
This study is a phase 2 study to Evaluate Efficacy, Safety and Tolerability of HM15211 Treatment for 12 Months in Subjects with Biopsy Confirmed NASH
- Trial name
- HM-TRIA-201 (NCT04505436)
- Testing
- HM15211
- Where
- 60 sites in United States, South Korea
- Volunteers
- 215 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
NASH - Nonalcoholic Steatohepatitis
Vertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis
Participants meeting study entry criteria are randomized with equal probability to one of two study groups: (1) Lifestyle modification or (2) Vertical Sleeve Gastrectomy (VSG) with Iifestyle modification, followed for 12 months.
- Trial name
- NCT03587831
- Testing
- Vertical Sleeve Gastrectomy, Lifestyle Modification Counseling
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- University of Minnesota
Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Evaluation of Miricorilant on Liver Fat in Patients With MASLD
A Phase 1, Open-Label Study Evaluating the Effect of Miricorilant on Hepatic Lipids in Patients with Presumed Metabolic Dysfunction-Associated Steatohepatitis (MASH)
- Conditions
- Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-Associated Steatohepatitis (MASH), Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), Non-alcoholic Fatty Liver Disease (NAFLD)
- Trial name
- NCT06947304
- Testing
- Miricorilant
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Corcept Therapeutics
Nonalcoholic Steatohepatitis (NASH), Metabolic Dysfunction-associated Steatohepatitis (MASH)
A Phase 2b, Study Evaluating Miricorilant in Adult Patients With Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Miricorilant in Adult Patients with Nonalcoholic Steatohepatitis/Metabolic Dysfunction-Associated Steatohepatitis (MONARCH)
- Trial name
- NCT06108219
- Testing
- Miricorilant (Cohort A), Miricorilant (Cohort B)
- Where
- 77 sites in United States, India and 1 more
- Volunteers
- 175 people
- Sponsor
- Corcept Therapeutics
Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH)
Quantitative Ultrasound Techniques for Diagnosis of Nonalcoholic Steatohepatitis
Nonalcoholic fatty liver disease is the most common liver disease in Western countries, due in large part to its association with type 2 diabetes and obesity.
- Trial name
- QUS in NASH (NCT03572465)
- Testing
- Acoustic radiation force impulse (ARFI), magnetic resonance elastography (MRE)
- Where
- Canada
- Volunteers
- 102 people, healthy volunteers welcome
- Sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
NASH - Nonalcoholic Steatohepatitis, Diabetes Mellitus, Type 2
Placebo-controlled, Proof-of-concept Study to Evaluate the Safety and Efficacy of Lanifibranor Alone and in Combination With SGLT2 Inhibitor EmpaGliflozin in patiEnts With NASH and Type 2 Diabetes Mellitus
The study in the T2DM population is intended to confirm the lanifibranor effect versus placebo on glycemic control and assess a positive effect of the combination of lanifibranor with an SGLT2 inhibitor on glycemic control.
- Trial name
- LEGEND (NCT05232071)
- Testing
- Lanifibranor, Empagliflozin
- Where
- 42 sites in United States, Belgium and 3 more
- Volunteers
- 39 people
- Sponsor
- Inventiva Pharma
End Stage Liver Disease, NASH - Nonalcoholic Steatohepatitis
Tocotrienol Against the Progression of End Stage Liver Disease
The purpose of this Phase 2 trial is to validate the outcome observed in a previous trial that oral Tocotrienol (TCT) attenuates the rise in MELD score over time in patients with end stage liver disease / cirrhosis.
- Conditions
- End Stage Liver Disease, NASH - Nonalcoholic Steatohepatitis, NAFLD - Nonalcoholic Fatty Liver Disease
- Trial name
- NCT02581085
- Testing
- Tocotrienol (TCT)
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Chandan Sen
Nonalcoholic Steatohepatitis (NASH), Type 2 Diabetes
HTD1801 in Adults With Nonalcoholic Steatohepatitis and Liver Fibrosis Who Have Type 2 Diabetes or Pre-Diabetes
A phase 2b, multicenter, randomized, double-blind, placebo-controlled study of HTD1801 in adult subjects with non-alcoholic steatohepatitis and liver fibrosis who have type 2 diabetes mellitus or pre-diabetes.
- Trial name
- CENTRICITY (NCT05623189)
- Testing
- HTD1801
- Where
- 45 sites in United States, Hong Kong and 1 more
- Volunteers
- 218 people
- Sponsor
- HighTide Therapeutics (Hong Kong) Limited
NASH - Nonalcoholic Steatohepatitis
Estrogen Administration for the Treatment of NASH in Postmenopausal Women
Non-alcoholic fatty liver disease (NAFLD) is a growing epidemic in the United States. Despite this, the treatment options remain limited.
- Trial name
- NCT04833140
- Testing
- Estradiol patch
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Massachusetts General Hospital
NASH - Nonalcoholic Steatohepatitis
A Study of Efruxifermin in Subjects With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH) (Symmetry)
This is a multi-center evaluation of efruxifermin (EFX) in a randomized, double-blind, placebo-controlled study in cirrhotic subjects with biopsy-proven F4 compensated NASH.
- Trial name
- NCT05039450
- Testing
- EFX
- Where
- 49 sites in United States, Mexico and 1 more
- Volunteers
- 213 people
- Sponsor
- Akero Therapeutics, Inc
Nonalcoholic Steatohepatitis (NASH)
A Study of BOS-580 in Obese Subjects at Risk for, or With Biopsy-confirmed, Nonalcoholic Steatohepatitis (NASH) With an Extension
This is a randomized, blinded, placebo-controlled study of Efimosfermin in obese participants at risk for, or with biopsy-confirmed, nonalcoholic steatohepatitis (NASH), with a single arm open-label extension.
- Trial name
- NCT04880031
- Testing
- Efimosfermin
- Where
- 48 sites in United States
- Volunteers
- 231 people
- Sponsor
- GlaxoSmithKline
NASH - Nonalcoholic Steatohepatitis
A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
This Phase 3 study is conducted to evaluate lanifibranor in adults with NASH and liver fibrosis histological stage F2 or F3
- Trial name
- NATiV3 (NCT04849728)
- Testing
- IVA337
- Where
- 459 sites in United States, Argentina and 22 more
- Volunteers
- 1,000 people
- Sponsor
- Inventiva Pharma
Prevention of Esophageal Varices, NASH - Nonalcoholic Steatohepatitis
Study Evaluating the Efficacy and Safety of Belapectin for the Prevention of Esophageal Varices in NASH Cirrhosis
This seamless, adaptive, two-stage, Phase 2b/3, randomized, double-blind, multicenter, parallel-groups, placebo-controlled study will assess the efficacy, safety, and tolerability of belapectin compared with placebo in patients…
- Conditions
- Prevention of Esophageal Varices, NASH - Nonalcoholic Steatohepatitis, Cirrhosis
- Trial name
- NAVIGATE (NCT04365868)
- Testing
- belapectin
- Where
- 156 sites in United States, Argentina and 13 more
- Volunteers
- 357 people
- Sponsor
- Galectin Therapeutics Inc.
NASH - Nonalcoholic Steatohepatitis, NAS
Hepatic Energy Fluxes in NASH and NAS Patients
Diseases along the nonalcoholic fatty liver disease spectrum, which are tightly coupled to the obesity epidemic, are soon to become the commonest indication for liver transplantation in the United States.
- Conditions
- NASH - Nonalcoholic Steatohepatitis, NAS, Overweight or Obesity, Weight Loss
- Trial name
- NCT03997422
- Testing
- Vertical Sleeve Gastrectomy (VSG)
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- University of Minnesota