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

Ascendis Pharma

Status and phase

Completed

Phase 3

Conditions

Hormone Deficiency

Adult Growth Hormone Deficiency

Endocrine System Diseases

Treatments

Drug: Lonapegsomatropin

Study type

Interventional

Funder types

Industry

Identifiers

NCT05171855

TCH-306EXT

Details and patient eligibility

About

This is 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 are adults (males and females) with confirmed growth hormone deficiency (GHD) having completed the treatment period in study TCH-306 (foresiGHt).

Enrollment

233 patients

Sex

All

Ages

23 to 81 years old

Volunteers

No Healthy Volunteers

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 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 are met:
1. Poorly controlled diabetes, defined as HbA1C higher than 7.5% according to central laboratory at Visit 6 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. Exceptions are:
1. Resection of in situ carcinoma of the cervix uteri
2. Complete eradication of squamous cell or basal cell carcinoma of the skin
Known history of hypersensitivity and/or idiosyncrasy to the investigational product (somatropin or excipients)
Female who is pregnant, plans to become pregnant, or is 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