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| Name | Class |
|---|---|
| BioPartners GmbH | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LB03002 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| growth hormone | Drug | subcutaneous injection, once-weekly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Fat Mass at the end of 26-week treatment from baseline | 26 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| HJ Ji, PhD | LG Life Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oregon Health Sciences University | Portland | Oregon | United States |
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| ID | Term |
|---|---|
| D010900 | Pituitary Diseases |
| D004393 | Dwarfism, Pituitary |
| ID | Term |
|---|---|
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D013006 | Growth Hormone |
| ID | Term |
|---|---|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
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| D004700 | Endocrine System Diseases |
| D004392 | Dwarfism |
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D001849 | Bone Diseases, Endocrine |
| D007018 | Hypopituitarism |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |