Chief investigator:Jeremy Tomlinson
Sponsor:University of Oxford
Two to three percent of the UK population are prescribed steroid medication at some time in their life to treat a wide variety of conditions. Whilst steroid treatment is highly effective, it can be associated with a significant number of side effects that include weight gain, development of diabetes, high blood pressure, fat in the liver and thinning of the muscles. These side effects mimic Cushing’s syndrome which results from high levels of the steroid hormone cortisol in the body. Currently there are no treatments available to limit the side effects when steroid medication is administered.
Within metabolic tissues (liver, skeletal muscle, adipose), 11β-hydroxysteroid dehydrogenase type 1 (11β-HSD1) regenerates active steroid and magnifies its action. We believe that inhibition of 11β-HSD1 represents a novel way of limiting the unwanted metabolic side effects of steroid use without reducing the intended anti-inflammatory actions.
If this trial is successful, then we could have the potential to reduce the side effects of steroid medication when it is administered in routine clinical practice.
TICSI is a randomised, double-blind, placebo-controlled trial comparing the effects of AZD4017 (an inhibitor of 11β-HSD1) with a placebo (dummy pill), when administered together with prednisolone (a steroid medication). AZD4017 has been used in many clinical trials without problems. The TICSI trial commenced in May 2017 with recruitment expected to be completed by January 2019.
The trial Targeting Iatrogenic Cushing's Syndrome with 11ß-hydroxysteroid dehydrogenase type 1 Inhibition (TICSI) met its recruitment target by enrolling 32 participants since June 2017. The last study visit took place on 27th February 2019....[Read more...]
The first patient has been randomised into the TICSI trial.