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

Completed · Phase 3 · Has a placebo group

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

In brief

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).

Key facts

Study ID

NCT05171855

Run by

Ascendis Pharma Endocrinology Division A/S

People needed

220

Starts

2021-12-16

Expected to finish

2024-12-23

Last updated by the study team

2026-07-07

Who can join

Age: 23 and older, up to 81. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Diabetes mellitus if any of the following were met:
• Poorly controlled diabetes, defined as HbA1C higher than 7.5% according to central laboratory at Visit 7 in trial TCH-306
• 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

Where it is running

• Ascendis Pharma Investigational Site — Torrance, California, United States
• Ascendis Pharma Investigational Site — Chicago, Illinois, United States
• Ascendis Pharma Investigational Site — Indianapolis, Indiana, United States
• Ascendis Pharma Investigational Site — Boston, Massachusetts, United States
• Ascendis Pharma Investigational Site — Dearborn, Michigan, United States
• Ascendis Pharma Investigational Site — Rochester, Minnesota, United States
• Ascendis Pharma Investigational Site — St Louis, Missouri, United States
• Ascendis Pharma Investigational Site — Las Vegas, Nevada, United States
• Ascendis Pharma Investigational Site — Reno, Nevada, United States
• Ascendis Pharma Investigational Site — New York, New York, United States
• Ascendis Pharma Investigational Site — Portland, Oregon, United States
• Ascendis Pharma Investigational Site — Dallas, Texas, United States
• Ascendis Pharma Investigational Site — San Antonio, Texas, United States
• Ascendis Pharma Investigational Site — Seattle, Washington, United States
• Ascendis Pharma Investigational Site — Yerevan, Armenia
• Ascendis Pharma Investigational Site — Saint Leonards, New South Wales, Australia
• Ascendis Pharma Investigational Site — Sydney, New South Wales, Australia
• Ascendis Pharma Investigational Site — Box Hill, Victoria, Australia
• Ascendis Pharma Investigational Site — Fitzroy, Victoria, Australia
• Ascendis Pharma Investigational Site — Parkville, Victoria, Australia
• Ascendis Pharma Investigational Site — Perth, Western Australia, Australia
• Ascendis Pharma Investigational Site — Halifax, Nova Scotia, Canada
• Ascendis Pharma Investigational Site — Lyon, France
• Ascendis Pharma Investigational Site — Marseille, France
• Ascendis Pharma Investigational Site — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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