growth hormone deficiency in adults MedDRA version: 8.0 Level: PT Classification code 10056438
Conditions
Sponsors
LG Life Science Ltd.
BioPartners
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female over 18 years of age and linear growth completed as confirmed by a bone age of >18 years for those =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) History of proliferative diabetic retinopathy. 2) History of malignancy other than i) cranial tumor or leukemia causing GHD or ii) fully treated basal cell carcinoma. 3) Evidence of active malignancy. 4) Evidence of growth of pituitary adenoma or other intracranial tumor within the last 12 months. 5) Significant hepatic dysfunction (persistent elevation of alanine transaminase [ALT] or aspartate transaminase [AST] >2 x upper limit of normal). 6) Chronic renal impairment (serum creatinine >1.6 mg/dL). 7) Clinically significant pulmonary, cardiac, hepatic, renal, or neuromuscular disease. 8) Prader-Willi syndrome. 9) Acute severe illness in the last 6 months. 10) Benign intracranial hypertension. 11) Active Cushing’s syndrome within the last 12 months. 12) Active acromegaly within the past 12 months. 13) Uncontrolled hypertension. 14) Patients with overt diabetes mellitus (fasting glucose level >126 mg/dL) or evidence of persistent impaired glucose tolerance (fasting glucose level >100 mg/dL at screening and history of impaired glucose tolerance in the source documents. If a fasting glucose level >100 mg/dL is detected at screening but there is no history of impaired glucose tolerance, then an additional test will be done at least 1 week later to exclude any false or temporary impaired glucose tolerance. If a normal result is obtained from the additional test, the patient will be considered eligible for the study). 15) Severe psychiatric disease or patients who cannot understand the objective and methods of the study or patients with current alcohol abuse. 16) Pregnancy or lactation. 17) Known hypersensitivity to any ingredient of the study drug: rhGH, sodium hyaluronate, lecithin, dibasic sodium phosphate, monobasic sodium phosphate, medium chain triglycerides. 18) Inability to undergo scanning by dual-energy X-ray absorptiometry (DXA) due to a body weight more than 130 kg or in situ internal or external devices known to interfere with DXA scanning 19) Weight reducing drugs or appetite suppressants (a 6-month withdrawal period is required unless it can be documented that no weight loss occurred with these drugs, in which case a 3-month withdrawal period is sufficient). 20) Anabolic steroids other than gonadal steroid replacement therapy within 2 months before study entry. 21) Methylphenidate within 2 months before study entry 22) Systemic corticosteroids other than in replacement doses within the 3 months before study entry. Temporary adjustment of glucocorticoids, as appropriate, is acceptable. 23) History of non-compliance with medications, un-cooperativeness or drug abuse. 24) Patients participating in another study parallel to, or within 6 months prior to study entry, or previous participation in this study. 25) Patients who are not able to comply with the study protocol for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate a clinical superiority of LB03002 over placebo in terms of improvement in fat mass (FM) in adult patients with GHD.;Secondary Objective: The secondary objectives are to determine the efficacy of LB03002 over placebo. Safety and tolerability features of LB03002 will be evaluated.;Primary end point(s): Primary efficacy endpoint: The primary efficacy endpoint will be the FM change at Visit 8 (4±1 days after dose 26) from baseline. Safety endpoints: * Incidence of adverse events; * Incidence of anti-human growth hormone antibody formation after 26 weeks of treatment; * Incidence of anti-Saccharomyces cerevisiae antibody formation after 26 weeks of treatment; * Local tolerability assessment by investigator and patients; * Glucose homeostasis parameters (fasting glucose, fasting insulin and fasting glycosylated hemoglobin); * Thyroid function tests (total triiodothyronin, free thyroxin, thyroid stimulating hormone); * Lipid panel tests (total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol, triglycerides); * Adrenal function test (serum cortisol, adrenocorticotropic hormone stimulation test); * Laboratory safety parameters * Vital signs; * Physical examination. | — |
Countries
Austria, Czech Republic, Germany, Spain, Sweden, United Kingdom
Outcome results
None listed