Adult Growth Hormone Deficiency (AGHD) MedDRA version: 20.0 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders
Conditions
Sponsors
Ascendis Pharma Endocrinology Division A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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 3 times the upper limit of normal according to the central laboratory at screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of once-weekly lonapegsomatropin in adults with GHD previously treated in trial TCH-306.;Secondary Objective: 1. To evaluate the efficacy of once-weekly lonapegsomatropin in adults with GHD. 2. To evaluate the pharmacodynamics (PD) of once-weekly lonapegsomatropin in adults with GHD. 3. To evaluate the pharmacokinetics (PK) of once-weekly lonapegsomatropin in adults with GHD.;Primary end point(s): • Adverse events (AEs) • Laboratory values • Vital signs • Immunogenicity • 12-lead electrocardiogram (ECGs) • Fundoscopy;Timepoint(s) of evaluation of this end point: throughout the treatment period of 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy endpoints (as assessed by dual-X-rayabsorptiometry (DXA): • Trunk percent fat • Trunk fat mass • Total body lean mass PD endpoints: • IGF-1 values and IGF-1 SDS PK endpoints: • hGH, lonapegsomatropin, and mPEG values;Timepoint(s) of evaluation of this end point: Efficacy endpoints At week 52 PD endpoints throughout the treatment period of 52 weeks PK endpoints from week 17 to week 52 | — |
Countries
Armenia, Australia, Belarus, Bulgaria, Canada, Denmark, France, Georgia, Germany, Greece, Israel, Italy, Japan, Netherlands, New Zealand, Poland, Romania, Russian Federation, Serbia, Slovakia, Spain, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactClinical Trial Information Desk
Ascendis Pharma A/S
Outcome results
None listed