Study to Assess Safety and Tolerability in Adults With Growth Hormone-Deficiency (GHD)

Study Overview
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Brief Summary
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This study assesses the safety and tolerability of weekly TV-1106 compared to daily rhGH in adults with GHD who have previously been treated with rhGH.

Official Title
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A Phase 3, Multicenter, Randomized, Open-Label, Comparator-Controlled Study to Assess Safety and Tolerability of Weekly TV-1106 Compared to Daily rhGH (Genotropin(R)) in Adults With Growth Hormone-Deficiency

Conditions
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Growth Hormone Deficiency

Intervention / Treatment
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* Drug: TV-1106
* Drug: dGH


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: males and females 18 years of age or over diagnosis of adult GHD for at least 6 months, or patients who have hypopituitarism from surgical resection treated with a stable dose of daily rhGH for at least 3 months prior to screening stable, adequate doses of replacement hormones (adrenal, thyroid, estrogen, testosterone, vasopressin) for at least 3 months prior to screening Other criteria apply, please contact the investigator for more information Exclusion Criteria: 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) d. 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 year. patients with type 1 diabetes mellitus oror poorly controlled type 2 diabetes mellitus as indicated by a glycated hemoglobin (HbA1c) ≥8% patients using weight reducing agents or appetite suppressants Other criteria apply, please contact the investigator for more information

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TV-1106<br>TV-1106 to be injected once weekly. | Drug: TV-1106<br>* The volume necessary to provide the required weekly dose will be calculated by the investigator; dose will be adjusted for IGF-I in the normal range.<br>* Other names: rhGH;|
| Active Comparator: dGH<br>dGH to be given as daily injections. | Drug: dGH<br>* The dose levels of dGH will be the same as the stable rhGH dose taken prior to the study.<br>* Other names: Somatropin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with adverse events | Safety of TV-1106 compared to reference drug | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Insulin-like Growth Factor 1 Standard Deviation Score |  | Baseline, Weeks: 4, 8, 12, 16, 24, 36, 48 |