Non-alcoholic Steatohepatitis (NASH) Clinical Trial
Official title:
A Phase 1, Open-label, Single-dose, Adaptive Design Study to Evaluate the Effects of Hepatic Impairment on the Pharmacokinetics of Miricorilant
The primary objective of this study is to determine the effect of hepatic impairment on the pharmacokinetics (PK) of miricorilant following a single oral dose by comparing participants with normal hepatic function with participants with moderate hepatic impairment with or without nonalcoholic steatohepatitis (NASH).
A reduced, adaptive study design will be used to compare the PK of miricorilant between participants with normal hepatic function and participants with hepatic impairment according to the Child-Pugh (CP) classification. Initially, participants with moderate hepatic impairment will be enrolled. Since indications for the development of miricorilant include participants with NASH, 3 or 4 of these participants will have NASH. Healthy control participants will be selected matched to these participants with moderate hepatic impairment according to gender, age (± 10 years), and weight (± 20 %) using a mean matching procedure. Based on the observed effect of moderate hepatic impairment on the miricorilant PK profile following an interim PK analysis, an optional group of participants with mild hepatic impairment may be evaluated. This optional group, matched to the participants with moderate hepatic impairment using the same procedure, will be enrolled to evaluate the effect of mild hepatic impairment on miricorilant PK. ;
| 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 |
NCT04019561 -
A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH.
|
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 |
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 |