NCT04091373

Who might be able to join this trial:

• You are a healthy adult between 18 and 60 years old (inclusive) at the time of screening.
• You are willing and able to give your consent to take part, either in writing or electronically, before any study procedures begin.
• Your Body Mass Index (BMI) — a measure of weight relative to height — is between 19 and 30 at screening.
• A doctor has judged you to be in good general health based on your medical history, a physical exam, heart tracing (ECG), vital signs, and blood and urine tests.
• If you are a woman who could become pregnant, you must have a negative pregnancy test within 72 hours before receiving the study treatment, and you must not be breastfeeding.
• If you are a woman who could become pregnant and are sexually active with a male partner, you must use at least one highly effective form of contraception from screening until 4 weeks after your last dose of the study treatment.

Who may not be able to join:

• You have any existing medical condition that the investigator believes could interfere with the study, put you at risk, or affect the results.
• You have inflammatory bowel disease, slow stomach emptying (gastroparesis), other serious conditions affecting the upper digestive tract, or have had surgery on that area.
• Your kidneys are not filtering blood well enough, based on a specific blood test result (confirm with trial site).
• Your blood pressure or heart rate falls outside certain normal ranges after resting for 10 minutes (confirm with trial site for exact ranges).
• You currently have active hepatitis B or hepatitis C, shown by positive blood tests.
• You have tested positive for HIV.
• You have a history of acute or chronic inflammation of the pancreas (pancreatitis).
• You have a history of a specific type of thyroid cancer (medullary thyroid carcinoma) or a related hormonal condition (multiple endocrine neoplasia type 2), or a certain hormone level in your blood is too high at screening (confirm with trial site).
• You show signs of serious liver problems and/or certain liver-related blood test results are significantly above normal levels (confirm with trial site for exact values).
• You have symptoms of seriously uncontrolled blood sugar, a history of type 1 diabetes, or a history of a dangerous diabetes-related complication called diabetic ketoacidosis.
• You have been diagnosed with cancer in the past 5 years, with some exceptions for certain minor skin cancers or early-stage cervical conditions.
• You have a known or suspected allergy to the study drug (cotadutide) or any of its ingredients.
• You have taken any prescription or non-prescription medication (with some exceptions) in the 72 hours before the first study day.
• You have had problems with alcohol or drug misuse in the past 12 months.
• You are currently a smoker of cigarettes or any other tobacco products.
• You regularly consume very large amounts of caffeine or similar substances found in coffee, tea, energy drinks, cola, or chocolate, as judged by the investigator.
• You have donated blood in the past 3 months.
• You have taken part in another clinical study involving other medications or blood sampling in the past 30 days.
• The investigator believes you may have difficulty following the study rules or cooperating with the study team.
• You are dependent on substances that could affect your safety or ability to follow the study procedures, or you test positive for drugs of abuse or alcohol at screening or before your first dose.
• You have a psychiatric illness that has resulted in you being committed to an institution by a legal or official order.
• You or a close family member work for AstraZeneca, MedImmune, the research organisation running the trial, or the study centre.

Important: Always verify eligibility with the trial site directly before applying.