SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor
Research type
Research Study
Full title
SPI-62 as a Treatment for Hypercortisolism Related to a Benign Adrenal Tumor
IRAS ID
1005795
Contact name
Jamie MacPherson
Contact email
Sponsor organisation
Sparrow Pharmaceuticals, Inc.
Eudract number
2022-000748-32
Clinicaltrials.gov Identifier
Research summary
The purpose of this study is to find out about the safety and efficacy of an experimental drug called SPI-62 for the treatment of hypercortisolism that is related to a benign adrenal tumour.
SPI-62 has the potential to reduce symptoms associated with hypercortisolism by possibly reducing the amount of cortisol inside cells in different parts of the body, such as the liver, fat, and bones.The study's primary goal is to look at the possible effect of SPI-62 on blood sugar (glucose) and fat (lipid) levels, body weight, blood pressure, liver function, anxiety, mood, brain function, bone strength, and muscle strength and the assessment of side effects, if any.
Up to 150 patients will take part in this study in the Americas, Asia and Europe. Study participation will last approximately 21 weeks. There will be approximately 5 clinic visits and 2 telephone calls. Procedures will include but not limited to physical examination, questionnaires, glucose tolerance tests, DXA scans and blood tests.
Sparrow Pharmaceuticals are funding the research. The study is currently planned to run at 4 hospitals in the UK
REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
22/LO/0533
Date of REC Opinion
22 Sep 2022
REC opinion
Further Information Favourable Opinion