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 or Without 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 participants living with or without 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 or without T2DM, and to investigate how AZD9550 is absorbed, distributed, and eliminated from the body.
• Males or post-menopausal females aged 18 through 65 years at the time of screening.
• Parts A, B, C only: Participants with or without T2DM. If participants have a diagnosis of T2DM, the glucose control managed with diabetes diet and in addition to metformin treatment no more than two treatment options (with a stable dose 3 months prior to screening).
• Part D only: Participants who are diagnosed with T2DM, have inadequate glycaemic control with diet and exercise. Participants who are prescribed an oral anti-diabetic agent such as metformin, a DPP IV inhibitor, sulphonylurea, glinides, alphaglucosidase inhibitors, and an SGLT2 inhibitor may be eligible to enter the study following a washout of 4-weeks or 5-half lives (whichever is longer) washout period.
• Participants with a screening HbA1c value within the target range of
‣ ≥ 42 to ≤ 75 mmol/mol (6% to 9%) for T2DM patients
⁃ \< 48 mmol/mol (\< 6.5%) for participants without T2DM
• Body mass index from ≥27 (≥25 in Part D) to ≤39.9 kg/m2 (inclusive).
• Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• Written informed consent and any locally required authorization (eg, European Union Data Privacy Directive) obtained from the participant prior to performing any protocol-related procedures, including screening evaluations
• Ability to complete and meet all eligibility requirements for randomisation within 60 days after signing the ICF.
• Venous access suitable for multiple cannulations.
• Willing and able to self-administer weekly SC injections (Parts C and D only).