Dissecting the Contribution of glucocorticoid metabolism in Mild Autonomous Cortisol Secretion (MACS): a randomised controlled trial of the 11ß-HSD1 inhibitor SPI-62

A diagram showing the plan of visits for the DC-MACS study

STUDY OVERVIEW

Mild autonomous cortisol secretion (MACS) is a condition where benign adrenal tumours produce excess cortisol, a ‘stress hormone’. This affects about 300,000 people aged over 70 years in the UK, leading to medical problems such as diabetes, poor bone health, and heart disease. Currently, there are no approved treatments for MACS.

DC-MACS will investigate the efficacy of SPI-62, a drug hypothesised to improve the signs of MACS, and the adverse effects associated with prescribed corticosteroids by stopping the body’s ability of making even more cortisol in peripheral tissues.

STUDY DESIGN

This is a randomised, double-blind, placebo-controlled trial, which will involve 40 participants, each participating for a total duration of 20 weeks, including pre-treatment, treatment and follow-up periods. The study is structured into 5 to 7 participant visits and 2 follow-up telephone calls. The treatment phase spans 12 weeks, and involves taking 6 mg study tablet per day. Assessments occur at: baseline, week 4, week 8, and week 12.

All trial activities will be performed at the OCDEM clinical research unit (CRU) based at the Churchill hospital and at Sheffield Teaching Hospital.

AIMS

Primary

To determine if SPI-62 compared to placebo can improve glucose metabolism in people with MACS

Secondary

To investigate if SPI-62 improves bone health, brain function, quality of life, blood pressure, liver health, body composition, cholesterol levels, and steroid levels compared to a placebo in people with MACS. In addition, the trial will determine the safety tolerability of SPI-62.