Treatment of Adults With Growth Hormone Deficiency

Study Overview
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Brief Summary
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The purpose of this study is to evaluate efficacy and safety profile of a new weekly administered growth hormone preparation compared with placebo in adults with growth hormone deficiency.

Official Title
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A Phase III, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Assess Efficacy and Safety of LB03002 Administered Weekly in Adults With Growth Hormone Deficiency.

Conditions
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Pituitary Disorders, Adult Growth Hormone Deficiency

Intervention / Treatment
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* Drug: growth hormone


Participation Criteria
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Eligibility Criteria
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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 to pituitary 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 test at screening; or Patients with known secondary hypoadrenalism on adequate glucocorticoid 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 the screening and be willing to use it throughout the study A negative serum pregnancy test is required at screening for females of child-bearing potential. Exclusion Criteria: History of malignancy other than cranial tumor or leukemia causing GHD or fully treated basal cell carcinoma Evidence of active malignancy Evidence of growth of pituitary adenoma or other intracranial tumor within the last 12 months, or patients without MRI or CT data to confirm the tumor stability within the last 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 glucose tolerance Severe psychiatric disease or patients who cannot understand the objective and methods of 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 body weight more than 130 kg or in situ internal or external devices known to interfere with DXA scanning Weight reducing drugs or appetite suppressants Anabolic steroids other than gonadal steroid replacement therapy within 2 months before study entry Methylphenidate within 2 months before study entry Systemic corticosteroids other than in replacement doses within the 3 months before study 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 study entry, or previous participation in this study Patients who are not able to comply with the study protocol for any reason.

Ages Eligible for Study
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Minimum Age: 23 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LB03002<br> | Drug: growth hormone<br>* subcutaneous injection, once-weekly<br>|
| Placebo Comparator: Placebo<br> | Drug: growth hormone<br>* subcutaneous injection, once-weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Fat Mass at the end of 26-week treatment from baseline |  | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the following parameters at the end of 26-week treatment from baseline; other body composition parameters, QoL Score, Serum IGF-I, IGFBP-3 levels & SDS, Lipid profile, waist-to-hip ratio |  | 26 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Growth hormone deficiency