Trials / Completed
CompletedNCT04019561
A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH.
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 74 (actual)
- Sponsor
- MedImmune LLC · Industry
- Sex
- All
- Age
- 18 Years – 101 Years
- Healthy volunteers
- Not accepted
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
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | MEDI0382 high dose | MEDI0382 high dose administered subcutaneously |
| DRUG | Placebo for MEDI0382 high dose | Placebo for MEDI0382 high dose administered subcutaneously |
| DRUG | MEDI0382 low dose | MEDI0382 low dose administered subcutaneously |
| DRUG | Placebo for MEDI0382 low dose | Placebo for MEDI0382 low dose administered subcutaneously |
Timeline
- Start date
- 2019-09-23
- Primary completion
- 2021-05-06
- Completion
- 2021-05-06
- First posted
- 2019-07-15
- Last updated
- 2023-01-17
- Results posted
- 2022-05-31
Locations
27 sites across 2 countries: United States, Puerto Rico
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04019561. Inclusion in this directory is not an endorsement.