A Phase 3, Multicenter Study To Evaluate The Efficacy And Safety Of MOD-4023 In Adults With Growth Hormone Deficiency
Condition: Adult Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Intervention: MOD-4023; Placebo
Intervention description: Individualized once weekly dose of MOD-4023; Once weekly administration of placebo
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 202.0
Sex: All
Minimum age: 23 Years
Maximum age: 70 Years
Healthy volunteers: No

Summary:

      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).
    

Eligibility criteria:

        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