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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
202
Opko Biologics
Kiryat Gat, Israel
Change in Trunk Fat Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26
Time frame: Baseline to 26 weeks
Change in Total Fat Mass, Expressed in Kilograms, Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26
Time frame: Baseline to 26 weeks
Change in Lean Body Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to Week 26
Time frame: Baseline to 26 weeks
Change in Trunk Fat Mass, Expressed in Kilograms Measured With Dual-energy X-ray Absorptiometry, From Baseline to 52 Weeks
Time frame: 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
Time frame: 26 weeks to 52 weeks
Trunk Fat Mass as Percentage of Total Fat Mass From Baseline to Week 26
Time frame: Baseline to 26 weeks
Change in Biochemical Marker IGF-1
Time frame: Baseline to 26 weeks
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