Clinical Trials Logo
  1. Home
  2. Other
  3. NCT04019561

A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH.

Non-alcoholic Steatohepatitis (NASH) Clinical Trial

Official title:
A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Pharmacodynamic Effects of MEDI0382 in Obese Subjects With Non-Alcoholic Fatty Liver Disease (NAFLD)/ Non-Alcoholic Steatohepatitis (NASH)

Clinical Trial Summary

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 subjects with non-alcoholic fatty liver disease (NAFLD)/non-alcoholic steatohepatitis (NASH). The subjects will have biopsy-confirmed NAFLD/NASH with liver fibrosis stage F1, F2 or F3. Approximately 72 subjects will be randomized

Clinical Trial Description

This is a randomized, double-blind, placebo-controlled, study to evaluate the safety (including hepatic safety), tolerability and pharmacodynamic effects of two dose levels of MEDI0382 in obese subjects with non-alcoholic fatty liver disease (NAFLD)/non-alcoholic steatohepatitis (NASH). The subjects will have biopsy-confirmed NAFLD/NASH with liver fibrosis stage F1, F2 or F3. Approximately 72 subjects will be randomized across multiple study sites. ;

Study Design

Related Conditions & MeSH terms

  • Fatty Liver
  • Liver Diseases
  • Non-alcoholic Fatty Liver Disease
  • Non-alcoholic Fatty Liver Disease (NAFLD)
  • Non-alcoholic Steatohepatitis (NASH)
Clinical Trial Details
NCT number NCT04019561
Study type Interventional
Source MedImmune LLC
Contact
Status Completed
Phase Phase 2
Start date September 23, 2019
Completion date May 6, 2021
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04481594 - A Study to Evaluate the Safety and Tolerability of Single and Multiple Ascending Doses of HPN-01 in Healthy Subjects Phase 1
Recruiting NCT06151964 - A Trial to Learn How Safe AZD9550 is in People With Type 2 Diabetes Who Are Overweight or Obese Phase 1/Phase 2
Completed NCT01694849 - Phase IIb Study to Evaluate the Efficacy and Safety of GFT505 Versus Placebo in Patients With Non-Alcoholic Steatohepatitis (NASH) Phase 2
Completed NCT02653300 - A Pilot Study to Assess the Safety of Oral Insulin in Patients With Nonalcolholic Steatohepatitis (NASH) Phase 2
Completed NCT03517540 - Study of Safety, Tolerability, and Efficacy of a Combination Treatment of LJN452 and CVC in Adult Patients With NASH and Liver Fibrosis Phase 2
Withdrawn NCT05050721 - Natural History of Non Alcoholic Fatty Liver Disease and Predictors of Advanced Fibrosis
Active, not recruiting NCT04682600 - The Sonic Incytes Liver Incytes System, Evaluation of Liver Fibrosis and Steatosis Versus MRE and MRI PDFF N/A
Enrolling by invitation NCT01950884 - Lifestyle Versus Ezetimibe Plus Lifestyle in Patients With Non-alcoholic Steatohepatitis Phase 4
Completed NCT04483947 - A Study to Assess Safety, Tolerability, PK and PD of AZD2693 in Non-alcoholic Steatohepatitis Patients Phase 1
Completed NCT02927314 - A Study of the Efficacy and Safety of CF102 in the Treatment of Non-Alcoholic Fatty Liver Disease Phase 2
Active, not recruiting NCT02612662 - A Study to Assess the Safety and Tolerability of Single Doses of AZD4076 in Healthy Male Subjects Phase 1
Recruiting NCT06168383 - To Evaluate the Efficacy and Safety of HSK31679 in Chinese Patients With Non-Alcoholic Steatohepatitis (NASH) . Phase 2
Terminated NCT02605616 - Use of a Novel Drug in People With Non-alcoholic Steatohepatitis (NASH) or Non-alcoholic Fatty Liver Disease (NAFLD) Phase 2
Completed NCT02158351 - Gut Microbiota and Modulation of Liver Damage in NAFLD
Recruiting NCT03151473 - Longitudinal Observational Study Of Chinese With NAFLD/NASH
Recruiting NCT04820036 - A Physiologic Analysis of Endoscopic Sleeve Gastroplasty (ESG) N/A
Recruiting NCT05553470 - Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Miricorilant Phase 1
Recruiting NCT04639414 - Combined Active Treatment in Type 2 Diabetes With NASH Phase 4
Withdrawn NCT04607655 - A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Administered GB1211 in Participants With Suspected or Confirmed Non-alcoholic Steatohepatitis (NASH) and Liver Fibrosis Phase 1/Phase 2
Recruiting NCT02654665 - Comparing Effects of Liraglutide and Bariatric Surgery on Weight Loss, Liver Function, Body Composition, Insulin Resistance, Endothelial Function and Biomarkers of Non-alcoholic Steatohepatitis (NASH) in Obese Asian Adults Phase 3