A Study to Investigate the Effect of MEDI0382 on Hepatic Glycogen Metabolism in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.
Completed
MedImmune LLC
Phase 2
A phase 2 study in two parts (A & B) designed to evaluate the effect of MEDI0382 on Hepatic
Glycogen Metabolism in subjects with Type 2 Diabetes Mellitus (T2DM). Approximately 20
subjects will be enrolled in Part A and approximately 30 subjects in Part B.
A Study to Assess Safety, Tolerability, and Pharmacokinetics of MEDI0382 in Non-diabetic Obese Participants
Completed
MedImmune LLC
Phase 1
This is a Phase 1, randomized, blinded, placebo-controlled study in up to approximately 51
non-diabetic obese participants with a body mass index (BMI) ≥ 35 kg/m^2. The participants
will be observed among 3 separate cohorts and participate in the study for up to
approximately 27 weeks, including a screening period (including a run-in), treatment period,
and safety follow-up.
A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH.
Completed
MedImmune LLC
Phase 2
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
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