An extension study to check the safety of once weekly lonapegsomatropin when given for a long time in adults with growth hormone deficiency.

Phase 1

• Conditions: Adult Growth Hormone Deficiency (AGHD); MedDRA version: 20.0Level: PTClassification code 10056438Term: Growth hormone deficiencySystem Organ Class: 10014698 - Endocrine disorders; Therapeutic area: Diseases [C] - Hormonal diseases [C19]

• Registration Number: EUCTR2021-004313-39-IT
• Lead Sponsor: Ascendis Pharma Endocrinology Division A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-30
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Signing of the trial specific informed consent.
2. Completion of the treatment period and Visit 7 assessments of trial TCH-306, including collection and upload of Visit 7 DXA scan.
3. Fundoscopy at Visit 7 in trial TCH-306 without signs/symptoms of intracranial hypertension or diabetic retinopathy stage 2 / moderate or above.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 195
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 45

Exclusion Criteria

1. Diabetes mellitus if any of the following are met:
a. Poorly controlled diabetes, defined as HbA1C higher than 7.5% according to central laboratory at Visit 6 in trial TCH-306
b. Use of diabetes mellitus drugs other than metformin and/or dipeptidyl peptidase-4 (DPP-4) inhibitors
2. Active malignant disease or history of malignancy. Exceptions are:
a. Resection of in situ carcinoma of the cervix uteri
b. Complete eradication of squamous cell or basal cell carcinoma of the skin
3. Known history of hypersensitivity and/or idiosyncrasy to the investigational product (somatropin or excipients)
4. Female who is pregnant, plans to become pregnant, or is breastfeeding
5. 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 this protocol
6. 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 this protocol
7. 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
8. eGFR <60 mL/min/1.73m² determined based on Modification of Diet in Renal Disease (MDRD) equation using serum creatinine from the central laboratory at screening
9. Hepatic transaminases (ie, AST or ALT) >3 times the upper limit of normal according to the central laboratory at screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified