Risks

There are some small risks with this study, both related to the study medication (semaglutide) and the tests. There may also be unforeseen risks.

Semaglutide has been linked to the following side effects:

Very Common

    Nausea (feeling sick)

    Diarrhoea

    Low blood sugar levels (when used with insulin or other diabetic medications)

Common

    Vomiting

    Abdominal pain

    Bloating sensation, constipation

    Gastritis, gastro-oesophageal reflux disease

    Gallstones

    Fatigue

    Increased amylase and lipase (pancreatic damage)

    Eye complications related to diabetes

    Weight loss and loss of appetite

    Feeling dizzy

Uncommon

    Alterations in taste

    Heart palpitations

    Injection site reactions (rash, pain)

    Acute pancreatitis (inflammation of the pancreas)

    Delayed gastric emptying

Rare

    Allergic reactions, including anaphylaxis

Unknown Frequency

    bowel obstruction, swelling

    Risk of chest infections as a complication of getting a general anaesthetic (called aspiration pneumonia). Semaglutide slows down stomach emptying, which can increase the risk of aspiration (fluids leaking into lungs) and subsequent chest infections when undergoing anaesthesia. Therefore, if you have a surgery planned or are considering one, it is important to inform your doctor before participating in the trial or throughout the trial if already enrolled.

Risks to pregnant women: There may be risks to an unborn baby. You must agree to avoid pregnancy for the duration of the study and at least 2 months after finishing semaglutide.

Risks related to study procedures:

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Blood Tests

Blood tests can be uncomfortable but rarely cause any significant problems. Rarely, people feel light-headed, faint, a blood clot forms, get bruising and/or an infection at the site of the needle stick.

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DXA Scans

The DXA scans involve exposure to a very small amount of ionising radiation – about the same amount of radiation as a flight from Dublin to Spain. Ionising radiation can cause call damage that may become cancerous many decades after exposure. We are all at risk of developing cancer during our lifetime. The added risk of developing cancer from having the DXA scans in this study is negligible.

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Fibroscans

The only risk is a mild discomfort that you might feel from the pressure of the scan probe on your abdomen and between the ribs.

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ECG

There are no risks associated with this procedure and it is not painful or uncomfortable.

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