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

Phase 1

Recruiting

• Conditions: on-alcoholic steatohepatitis (NASH); MedDRA version: 22.0Level: PTClassification code: 10053219Term: Non-alcoholic steatohepatitis Class: 100000004871; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: CTIS2023-504215-32-00
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-02
• Last Update Posted: 21 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Males or females of non-childbearing potential age 18 through 65 years at the time of screening., Participants with or without T2DM. If participants have a diagnosis of T2DM, the glucose control is 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)., 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 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 authorisation (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).

Exclusion Criteria

Participants with T2DM treated with insulin., Symptoms of insulinopenia or poor blood glucose control (eg, significant thirst, nocturia, polyuria, polydipsia, or weight loss)., Positive hepatitis B or hepatitis C virus serology at screening., Positive human immunodeficiency virus test at screening or participant taking antiretroviral medications as determined by medical history or participant’s verbal report., At screening blood tests, any of the following: ? AST = 1.5 × ULN ? ALT = 1.5 × ULN ? TBL = 1.5 × ULN (with the exception of Gilbert’s syndrome) ? Haemoglobin below the lower limit of the normal range or any other clinically significant haematological abnormality as judged by the investigator., Impaired renal function defined as estimated glomerular filtration rate (eGFR) = 60 mL/minute/1.73m2 as defined by Chronic Kidney Disease Epidemiology Collaboration (2021)., Any clinically important abnormalities in clinical chemistry, haematology, coagulation, or urinalysis results other than those specifically described as exclusion criteria herein, as judged by the investigator., Significant late diabetic complications (macroangiopathy with symptoms of congestive heart disease or peripheral arterial disease, microangiopathy with symptoms of neuropathy, gastroparesis, retinopathy requiring treatment, nephropathy) detected in laboratory results or in clinical history/documentation as judged by the investigator., Abnormal vital signs, after 10 minutes of supine rest, defined as any of the following: ? Systolic BP < 90 mmHg or = 150 mmHg ? Diastolic BP < 50 mmHg or = 90 mmHg ? HR < 50 or > 85 bpm at resting state ? Participants may be re-tested for the vital signs criteria only once if, in the investigator’s judgement, they are not representative of the participant., Any clinically important abnormalities in rhythm, conduction, or morphology of the resting ECG and any abnormalities in the 12-lead ECG that, as considered by the investigator, may interfere with the interpretation of QTc interval changes, including abnormal ST-T-wave morphology or left ventricular hypertrophy., Participants with implantable cardiac defibrillator or a permanent pacemaker, and participants with symptomatic tachy- or brady-arrhythmias., Participants with T2DM treated with more than 3 anti-diabetic therapies., Participants with unstable angina pectoris or stable angina pectoris classified higher than Canadian Cardiovascular Society class II or an acute coronary syndrome/acute myocardial infarction or coronary intervention with percutaneous coronary intervention or coronary artery bypass grafting or stroke within 6 months., History of hospitalisation caused by heart failure or a diagnosis of heart failure., Known or suspected history of drug abuse within the past 3 years as judged by the investigator and /or a positive screen for drugs of abuse at screening., History of severe allergy/hypersensitivity or ongoing clinically important allergy/hypersensitivity as judged by the investigator., Whole blood or red blood cell donation, or any blood loss > 500 mL (or > 400 mL in Part D) during the 3 months prior to screening., Psychiatric illness such that participants have been committed to an institution by way of official or judicial order., History of lactic acidosis or ketoacidosis., Use of any of the following medicinal products: - Use of systemic corticosteroids within 28 days prior to screening. - Use of compounds known to prolong the QTc interval. - Use of any herba

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified