ATL1103 treatment in adult patients with acromegaly

• Research type

  Research Study

• Full title

  A Phase II Randomised, Open-Label, Parallel Group Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Two Subcutaneous Dosing Regimens of ATL1103 in Adult Patients with Acromegaly.

• IRAS ID

  116442

• Contact name

  Peter J Trainer

• Sponsor organisation

  Antisense Therapeutics Limited

• Eudract number

  2012-003147-30

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Acromegaly is an acquired, rare and debilitating somatic growth disorder in adults, arising from the hypersecretion of GH from pituitary tumours. This is a study to test the experimental drug ATL1103 [(a growth hormone receptor (GHR) antisense oligonucleotide (ASO)], which is being developed as a therapy for conditions where Insulin-like Growth Factor (IGF)-I and Growth Hormone (GH) are elevated, such as the growth disorder acromegaly. ATL1103 has been shown to reduce serum IGF-I and GHR mRNA levels in the liver in pre-clinical studies, as well as serum IGF-I in healthy male volunteers, and is therefore considered a valid therapy for this disease. The study is designed to evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of Two Subcutaneous Dosing Regimens of ATL1103 in Adult Patients with Acromegaly. The study will be conducted in approximately 24 adult male and female patients with acromegaly. After Screening and washout from other acromegaly drugs (if required), eligible patients will be randomised at Baseline to receive one of two dosing regimens of ATL1103 in a 1:1 ratio: Dosing Regimen 1: subcutaneous injections of ATL1103 200 mg three times in the first week (on Days 1, 4 and 7), then once weekly (on Day 4 each week) in Week 2 through to Week 13. Dosing Regimen 2: subcutaneous injections of ATL1103 200 mg three times in the first week (Day 1, 4 and 7), then twice weekly (on Days 4 and 7 each week) in Week 2 through to Week 13. The open-label treatment phase will last 13 weeks. Patients will have eight (8) visits during the treatment period and three (3) visits during the 8 week follow-up period after their final dose of study drug.

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  12/EM/0402

• Date of REC Opinion

  20 Nov 2012

• REC opinion

  Further Information Favourable Opinion