Study of TV-1106 in Growth Hormone-Deficient Adults

Inclusion:

- males and females 18 years of age or over

- diagnosis of adult growth hormone deficiency (GHD) for at least 6 months, or patients
who have hypopituitarism from surgical resection

- no history of exposure to any rhGH within the past 12 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:

- 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)

- 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 1 year

- patients with type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus
as indicated by a glycated hemoglobin (HBA1c) of ≥8%

- patients using weight reducing agents or appetite suppressants

- women who are pregnant or nursing, or planning pregnancy during the study period

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