Treatment of Adults With Growth Hormone Deficiency

Inclusion Criteria:

• Male or female of at least 23 years and not more than 70 years of age

• GHD of either adult onset(AO)or Childhood onset(CO), either idiopathic or secondary topituitary disease

• Confirmed diagnosis of GHD defined

• IGF-1 SDS ≤ -1 at screening

• No exposure to rhGH within the last 6 months

• Patients with adequate adrenal function, which is confirmed by ACTH stimulation testat screening; or Patients with known secondary hypoadrenalism on adequateglucocorticoid replacement therapy

• If applicable, hormone replacement therapies for any other hormone deficiencies,adequate and stable for at least 3 months before study entry

• Women of child-bearing potential to be using a reliable method of contraception at thescreening and be willing to use it throughout the study

• A negative serum pregnancy test is required at screening for females of child-bearingpotential.

Exclusion Criteria:

• History of malignancy other than cranial tumor or leukemia causing GHD or fullytreated basal cell carcinoma

• Evidence of active malignancy

• Evidence of growth of pituitary adenoma or other intracranial tumor within the last 12months, or patients without MRI or CT data to confirm the tumor stability within thelast 12 months

• Significant hepatic dysfunction

• Chronic renal impairment

• Clinically significant pulmonary, cardiac, hepatic, renal, or neuromuscular disease

• Prader-Willi syndrome

• Acute severe illness in the last 6 months

• Benign intracranial hypertension

• Active Cushing's syndrome within the last 12 months

• Uncontrolled hypertension

• Patients with overt diabetes mellitus or evidence of persistent impaired glucosetolerance

• Severe psychiatric disease or patients who cannot understand the objective and methodsof the study or patients with current alcohol abuse

• Pregnancy or lactation

• Known hypersensitivity to any ingredient of the study drug

• Inability to undergo scanning by dual-energy X ray absorptiometry (DXA) due to a bodyweight more than 130 kg or in situ internal or external devices known to interferewith DXA scanning

• Weight reducing drugs or appetite suppressants

• Anabolic steroids other than gonadal steroid replacement therapy within 2 monthsbefore study entry

• Methylphenidate within 2 months before study entry

• Systemic corticosteroids other than in replacement doses within the 3 months beforestudy entry.

• History of non-compliance with medications, un-cooperativeness or drug abuse

• Patients participating in another study parallel to, or within 6 months prior to studyentry, or previous participation in this study

• Patients who are not able to comply with the study protocol for any reason.