Safety, Tolerability and Efficacy of Weekly TV-1106 in Adults With Growth Hormone Deficiency

Inclusion Criteria:

- Patient agrees to provide written informed consent and to comply with the study
protocol after reading the informed consent and discussing the study with the
investigator.

- Males and females between 23 and 65 years of age must have a confirmed diagnosis of
adult GHD, either adult onset (AO) GHD due to hypothalamic-pituitary disease or
childhood onset (CO) GHD that is either idiopathic or due to hypothalamic-pituitary
disease or due to genetic causes.

- Diagnosis of GH deficiency must be confirmed by documented (medical records)
diagnostic testing.

- Patients should have been treated with a stable dose of daily rhGH for at least 3
months prior to screening.

- Other criteria apply.

Exclusion Criteria:

- Patients with history or clinical evidence of active or chronic diseases that could
confound results of the study or put the subject at undue risk as determined by the
investigator.

- Patients with known active malignancy

- Patients with history of malignancy other than intracranial tumor causing GHD
(excluding surgically cured basal cell or squamous cell cancer of the skin with
documented 6 month remission)

- Patients with evidence of pituitary adenoma or other intracranial tumor within 12
months of enrollment, which is on day 0 (baseline, Visit 3)

- Patients without magnetic resonance imaging (MRI) or computerized tomography (CT) data
to document tumor stability within the 12 months prior to enrollment, which is on day
0 (baseline, Visit 3)

- 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.

- Other criteria apply.