Study identifier:D5671C00002
ClinicalTrials.gov identifier:NCT04019561
EudraCT identifier:N/A
CTIS identifier:N/A
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)
Non-alcoholic Fatty Liver Disease (NAFLD)
Phase 2
No
MEDI0382 high dose, Placebo for MEDI0382 high dose, MEDI0382 low dose, Placebo for MEDI0382 low dose
All
74
Interventional
18 Years - 101 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Nov 2022 by MedImmune, LLC
MedImmune, LLC
-
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
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.
Location
Location
Durham, NC, United States, 27705
Location
San Antonio, TX, United States, 78215
Location
Los Angeles, CA, United States, 90057
Location
Miami, FL, United States, 33125
Location
Houston, TX, United States, 77002
Location
Montclair, CA, United States, 91763
Location
San Juan, PR, United States, 00927
Location
Richmond, VA, United States, 23219
Arms | Assigned Interventions |
---|---|
Experimental: MEDI0382 high dose MEDI0382 high dose administered subcutaneously | Drug: MEDI0382 high dose MEDI0382 high dose administered subcutaneously Other Name: Cotadutide high dose |
Placebo Comparator: Placebo for MEDI0382 high dose Placebo for MEDI0382 high dose administered subcutaneously | Drug: Placebo for MEDI0382 high dose Placebo for MEDI0382 high dose administered subcutaneously Other Name: Placebo high dose |
Experimental: MEDI0382 low dose MEDI0382 low dose administered subcutaneoously | Drug: MEDI0382 low dose MEDI0382 low dose administered subcutaneously Other Name: Cotadutide low dose |
Placebo Comparator: Placebo for MEDI0382 low dose Placebo for MEDI0382 low dose administered subcutaneously | Drug: Placebo for MEDI0382 low dose Placebo for MEDI0382 low dose administered subcutaneously Other Name: Placebo low dose |
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