Efficacy and safety of lonapegsomatropin in adults with GHD, v 1.0

• Research type

  Research Study

• Full title

  foresiGHt: A multicenter, randomized, parallel-arm, placebo-controlled (double-blind)and active-controlled (open-label) trial to compare the efficacy and safety of once-weekly lonapegsomatropin with placebo and a daily somatropin product in adults with growth hormone deficiency

• IRAS ID

  289266

• Contact name

  Michael Beckert

• Contact email

  mb@ascendispharma.com

• Sponsor organisation

  Ascendis Pharma Endocrinology Division A/S

• Eudract number

  2020-000929-42

• Clinicaltrials.gov Identifier

  NCT04615273

• Duration of Study in the UK

  1 years, 11 months, 0 days

• Research summary

  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 tolerability, safety and efficacy of lonapegsomatropin and its effects on patients’ GHD condition and quality of life.
  Approximately 240 adults (23-75 years) with diagnosed GHD will be involved in 27 countries worldwide in qualified Endocrinology Departments of hospitals.
  After a thorough medical check-up (screening) the Endocrinologist Investigator deems the patient’s suitability for the trial through several eligibility criteria. Suitable patients will be randomly assigned to receive weekly lonapegsomatropin (the investigational drug), weekly placebo (inactive drug) or daily somatropin (standard therapy) and they have to attend up to 7 visits to the site. The total duration of the study is up to 48 weeks for a patient, during this time patients are closely monitored for safety and well-being. The assessments include but not limited to scans to determine body composition (DXA scan), blood draws for laboratory tests, ECG, vital signs measurements, physical examinations and questionnaires related to quality of life.

  Summary of Results
  N/A

• REC name

  Wales REC 3

• REC reference

  21/WA/0002

• Date of REC Opinion

  31 Mar 2021

• REC opinion

  Further Information Favourable Opinion