A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency

Study Overview
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Brief Summary
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This will be a randomized, double-blind, placebo-controlled, parallel-group, multicenter study in adult subjects with GHD to assess the safety and efficacy of a long-acting, once weekly injection of modified hGH (MOD-4023).

Official Title
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A Phase 3, Multicenter Study Designed To Evaluate The Efficacy And Safety Of A Long Acting hGH Product (MOD-4023) In Adult Subjects With Growth Hormone Deficiency

Conditions
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Adult Growth Hormone Deficiency

Intervention / Treatment
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* Drug: MOD-4023
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women between the age of 23 to 70 years old at screening, inclusive GHD subjects as defined in the Consensus guidelines for the diagnosis and treatment of adults with GH deficiency II (2007). No r-hGH replacement therapy or use of GH secretagogues for at least 9 months with any registered or investigational r-hGH or GH secretagogue product. The IGF-I level at screening ≤-1 SDS of the age and sex normal ranges according to the central laboratory measurements Subjects who are on a stable diet and exercise regime and do not have plans to modify their diet or exercise for at least 12 months Subject had a DXA screening and the results are interpretable according to the study plan. Exclusion Criteria: Women who are pregnant or breast-feeding (at least 6 months delay from childbirth or lactation) Evidence of growth benign intracranial tumor within the last 12 months (determined by comparing a previous MRI to a new one obtained no more than 6 months prior to study entry to clarify dynamics of growth). History of any cancer. Exceptions to this exclusion criterion include resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision. Patients with GHD attributed to treatment of intracranial malignant lesions in childhood or adulthood (or, tumors) or leukemia may also be enrolled into the study provided that a recurrence-free survival period of at least 5 years is well documented in the study record. Signs of intracranial hypertension at screening Heart insufficiency, NYHA class > 2 (Appendix B) History of overt diabetes mellitus (including currently treated, well-controlled DM) defined according to the American Diabetes Association (ADA) Criteriaa. A history of gestational diabetes, resolved after childbirth, is not exclusionary. History of Acromegaly

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: MOD-4023<br> | Drug: MOD-4023<br>* Individualized once weekly dose of MOD-4023<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Once weekly administration of placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Trunk Fat Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26 |  | Baseline to 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Total Fat Mass, Expressed in Kilograms, Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26 |  | Baseline to 26 weeks | 
| Change in Lean Body Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26 |  | Baseline to 26 weeks | 
| Change in Trunk Fat Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to 52 Weeks |  | Baseline to 52 weeks | 
| Change in Trunk Fat Mass, Expressed as % Change From Baseline, Measured With Dual-energy X-ray Absorptiometry, From Baseline to 26 and 52 Weeks |  | 26 weeks to 52 weeks | 
| Trunk Fat Mass as Percentage of Total Fat Mass From Baseline to Week 26 |  | Baseline to 26 weeks | 
| Change in Biochemical Marker IGF-1 |  | Baseline to 26 weeks |