Non-alcoholic Steatohepatitis (NASH) Clinical Trial
Official title:
A Phase I/II, Randomised, Single-blind, Placebo-controlled, Multiple-ascending-dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD9550 in Overweight and Obese Participants With Type 2 Diabetes Mellitus
AZD9550 is in early development for the treatment of NASH, a type of liver disease that commonly affects overweight and obese patients who have T2DM. The purpose of this study is to investigate the safety, tolerability, and effects of increasing doses of AZD9550 in overweight and obese participants aged 18 through 65 years living with T2DM, and to investigate how AZD9550 is absorbed, distributed, and eliminated from the body.
This Phase I/II, randomised, single-blind, placebo-controlled, MAD study will assess the safety and tolerability of AZD9550 and characterise the PK and PD of AZD9550 following SC administration to overweight and obese participants living with T2DM, including men and women of non-childbearing potential. Inclusion of participants receiving placebo is appropriate for benchmarking the safety and tolerability of AZD9550. A randomised and single-blind study design has been chosen to minimise bias and includes placebo to facilitate identification of effects related to administration of study intervention rather than the study procedures or situation. ;
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