A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy, Safety and Tolerability Study of TV-1106 in Growth Hormone-Deficient Adults Who Are Not Current Users of rhGH Treatment
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy, Safety and Tolerability Study of TV-1106 in Growth Hormone-Deficient Adults Who Are Not Current Users of rhGH Treatment
The primary objective of this study is to determine the efficacy of 6 months of treatment with TV-1106 compared with placebo on body fat composition.
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
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
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