An OLE Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in adults with GHD
Research type
Research Study
Full title
A Multicenter, Open-Label, Extension Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults with Growth Hormone Deficiency
IRAS ID
1007604
Contact name
Michael Beckert
Contact email
Sponsor organisation
Ascendis Pharma Endocrinology Division A/S
Eudract number
2021-004313-39
Clinicaltrials.gov Identifier
Research summary
Adult growth hormone deficiency (GHD) means the insufficient production of growth hormone (i.e. somatropin) in the body, which has complex effects on the bones, the muscles, on fat and sugar metabolism, cardiac and mental condition as well.
Standard treatment for GHD is replacement of growth hormone, which means daily injections of growth hormone products.
Ascendis Pharma Endocrinology Division A/S, a Danish pharmaceutical company (the Sponsor of this trial) developed a novel treatment for this condition. It is called lonapegsomatropin and has the same active ingredient (growth hormone) as other currently available products for GHD treatment but has been adapted to have a longer action in the body, so it is suitable for weekly (instead of daily) administration. Up to now, it has been investigated in >400 people, and it has been shown to be safe and well tolerated.
The study is conducted to learn more about the long-term efficacy and safety of lonapegsomatropin in adults with GHD previously treated in trial TCH-306. During the visit 7 in study TCH-306 following completion of the treatment period, the participants will be given an option to join the TCH-306 extension study if the investigator following medical evaluation determines that the participant might benefit from continuing to receive lonapegsomatropin once-weekly and the participant would want to continue to take the study drug. Participants will be initiated on a low dose, and the dose will slowly be increased to avoid adverse reactions as much as possible (Dose Titration Period) until the target maintenance dose is reached (Dose Maintenance Period). The total treatment period will be 52 weeks, after which participants will return to the clinic 2 weeks after discontinuing study medication for a follow-up safety visit and 4 to 5 weeks after the last dose of study medication for a couple of assessments that include antibody assessment and pregnancy test for females of childbearing potential.REC name
Wales REC 3
REC reference
23/WA/0167
Date of REC Opinion
8 Aug 2023
REC opinion
Further Information Favourable Opinion