An Open Label Study of CRN00808 in Patient with Acromegaly
Research type
Research Study
Full title
AN OPEN LABEL, LONG-TERM EXTENSION STUDY TO EVALUATE THE SAFETY AND EFFICACY OF CRN00808 IN SUBJECTS WITH ACROMEGALY (ACROBAT ADVANCE)
IRAS ID
272421
Contact name
Harpal Singh Randeva
Contact email
Sponsor organisation
Crinetics Pharmaceuticals, Inc
Eudract number
2019-002193-31
Duration of Study in the UK
2 years, 0 months, 9 days
Research summary
Acromegaly is a hormonal disorder that develops when your pituitary glands produce too much growth hormone during adulthood. When this happens, your bones increase in size, including those of your hands, feet and face. These high levels of hormones can lead to a wide range of cardiovascular (heart and blood vessels issues e.g. high blood pressure), respiratory (lungs), endocrine (hormone) and metabolic (e.g. diabetes – elevated blood sugar) illnesses, as well as joint pain, weakness, and sometimes visual disturbances. This disorder usually affects middle aged adults. This is an open label extension study to check the safety and efficacy of the study drug (CRN00808) in patients with Acromegaly. The study drug (CRN00808) is being used to see if it can effectively and safely reduce the level of GH (growth hormone) in patients with acromegaly. CRN00808 will be taken once a day in the morning after overnight fasting. It will be in tablet form. The strength of the dose will vary from 10mg/day to a maximum of 40mg/day. The study will last for up to 60 weeks and has 15 planned visits. The patient will undergo procedures such as ECGs, holter monitor and taking blood. Additional assessments may need to be performed depending on the patient’s needs.
This study has 3 groups available to be enrolled into- Group 1 and Group 2 will have patients from the parent studies CRN00808-03 and CRN00808-02. Group 3 will be available for patients who have not completed a parent study but has uncontrolled acromegaly and they are not being treated with other acromegaly medications. Sites who have already taken part in the parent studies will take part in this extension study. These are NHS sites in England.REC name
East of England - Cambridge East Research Ethics Committee
REC reference
20/EE/0057
Date of REC Opinion
2 Apr 2020
REC opinion
Further Information Favourable Opinion