Study to Assess Safety and Tolerability in Adults With Growth Hormone-Deficiency (GHD)

A Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH (Genotropin(R)) in Adults With Growth Hormone-Deficiency

This study assesses the safety and tolerability of weekly TV-1106 compared to daily rhGH in adults with GHD who have previously been treated with rhGH.

Inclusion Criteria:

• males and females 18 years of age or over

• diagnosis of adult GHD for at least 6 months, or patients who have hypopituitarism from surgical resection

• treated with a stable dose of daily rhGH for at least 3 months prior to screening

• stable, adequate doses of replacement hormones (adrenal, thyroid, estrogen, testosterone, vasopressin) for at least 3 months prior to screening

  • Other criteria apply, please contact the investigator for more information

Exclusion Criteria:

• patients with acute or chronic conditions or diseases that could confound results of the study or put the patient at undue risk as determined by the investigator

• Presence of contraindications to rhGH treatment

• patients who have participated in another clinical trial with a new chemical/biological entity within 3 months of screening

• patients with known active malignancy (excluding surgically removed basal cell carcinoma or carcinoma in situ of cervix) d. patients with a previously treated pituitary tumor with evidence of tumor progression in the past year

• patients with a new diagnosis of pituitary adenoma or other intracranial tumor within 12 months of screening

• presence of Prader-Willi syndrome, Turner's syndrome, untreated adrenal insufficiency, active acromegaly in the past 5 years, or active Cushing's syndrome in the past year.

• patients with type 1 diabetes mellitus oror poorly controlled type 2 diabetes mellitus as indicated by a glycated hemoglobin (HbA1c) ≥8%

• patients using weight reducing agents or appetite suppressants

  • Other criteria apply, please contact the investigator for more information