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A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency
A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency

NCT05171855

CompletedPhase 3

Sponsor: Ascendis Pharma Endocrinology Division A/S

Conditions: Adult Growth Hormone Deficiency, Endocrine System Diseases, Hormone Deficiency

Interventions: Lonapegsomatropin

Countries: United States, Armenia, Australia, Canada, France, Georgia, Germany, Greece

This was a phase 3 open-label multicenter extension study designed to evaluate the long-term safety and efficacy of Lonapegsomatropin administered once-weekly. The study participants were adults (males and females) with confirmed growth hormone deficiency (GHD) having completed the treatment period in study TCH-306 (foresiGHt; NCT04615273).

Eligibility overview

Sex: ALL

Age: 23 Years to 81 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion Criteria:

* Signing of the trial specific informed consent
* Completion of the treatment period and Visit 7 assessments of trial TCH-306, including collection and upload of Visit 7 dual-X-ray-absorptiometry (DXA) scan
* Fundoscopy at Visit 7 in trial TCH-306 without signs/symptoms of intracranial hypertension or diabetic retinopathy stage 2 / moderate or above

Exclusion Criteria:

* Diabetes mellitus if any of the following were met:

  1. Poorly controlled diabetes, defined as HbA1C higher than 7.5% according to central laboratory at Visit 7 in trial TCH-306
  2. Use of diabetes mellitus drugs other than metformin and/or dipeptidyl peptidase-4 (DPP-4) inhibitors
* Active malignant disease or history of malignancy.
* Known history of hypersensitivity and/or idiosyncrasy to the investigational product (somatropin or excipients)
* Female who was pregnant, plans to become pregnant, or was breastfeeding
* Female participant of childbearing potential (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile) not willing throughout the trial to use contraceptives as required by local law or practice. Details included in Appendix 4/section 10.4 of the protocol
* Male participant not willing throughout the trial to use contraceptives as required by local law or practice. Details included in Appendix 4/ section 10.4 of the protocol
* Any disease or condition that, in the judgement of the investigator, may make the participant unlikely to comply with the requirements of the protocol or any condition that presents undue risk from the investigational product or trial procedures
Locations (85)
  • Phoenix, Arizona, United States
  • Torrance, California, United States
  • Chicago, Illinois, United States
  • Indianapolis, Indiana, United States
  • Boston, Massachusetts, United States
  • Dearborn, Michigan, United States
  • Rochester, Minnesota, United States
  • St Louis, Missouri, United States
  • Las Vegas, Nevada, United States
  • Reno, Nevada, United States
  • New York, New York, United States
  • Portland, Oregon, United States
  • Dallas, Texas, United States
  • San Antonio, Texas, United States
  • Seattle, Washington, United States
  • Yerevan, Armenia
  • Saint Leonards, New South Wales, Australia
  • Sydney, New South Wales, Australia
  • Box Hill, Victoria, Australia
  • Fitzroy, Victoria, Australia
  • Parkville, Victoria, Australia
  • Perth, Western Australia, Australia
  • Halifax, Nova Scotia, Canada
  • Lyon, France
  • Marseille, France
  • Nantes, France
  • Tbilisi, Georgia
  • Tbilisi, Georgia
  • München, Germany
  • Athens, Greece
  • + 55 more on CT.gov