Semaglutide effect on Furosemide & Rosuvastatin PK in healthy subjects

  • Research type

    Research Study

  • Full title

    A trial investigating the effect of oral semaglutide on the pharmacokinetics of furosemide and rosuvastatin in healthy subjects

  • IRAS ID

    206377

  • Contact name

    Muna Albayaty

  • Contact email

    Muna.Albayaty@parexel.com

  • Sponsor organisation

    Novo Nordisk A/S

  • Eudract number

    2015-003908-23

  • Duration of Study in the UK

    0 years, 6 months, 3 days

  • Research summary

    Oral semaglutide is an investigational drug that is being developed by Novo Nordisk for the treatment of type 2 diabetes mellitus (T2DM), a chronic disease where insulin-producing cells in the body are not able to produce enough insulin, or when the insulin produced by the body does not work properly. Semaglutide has been administered to over 1200 clinical trial participants.

    This clinical trial is a phase 1, open-label, healthy volunteer, drug-drug interaction study that will look at how the drug levels of furosemide and rosuvastatin in the body are affected by oral semaglutide and a compound called SNAC (sodium N-(8-2-hydroxybenzoyl)amino)). SNAC is able to increase the way the body absorbs (takes into the blood stream) semaglutide. The study will also look at the safety and tolerability of oral semaglutide when given with rosuvastatin and furosemide. 36 healthy participants are expected to complete the trial.

  • REC name

    London - Brent Research Ethics Committee

  • REC reference

    16/LO/1890

  • Date of REC Opinion

    25 Nov 2016

  • REC opinion

    Further Information Favourable Opinion