Open-label Extension Study to Evaluate the Safety of Long-term Twice-monthly Administration of Somavaratan in Adult Growth Hormone Deficiency (AGHD)
Condition: Adult Growth Hormone Deficiency (AGHD)
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Intervention: somavaratan
Intervention description: Long-acting recombinant human growth hormone therapy administered subcutaneously twice-monthly
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: VRS-317; Long Acting Growth Hormone; Versartis; somavaratan; Growth Hormone Deficiency; Adult Growth Hormone Deficiency; AGHD; Growth Hormone Replacement; Growth Hormone Replacement Therapy; XTEN

Summary:

      Open-label extension study to evaluate the safety of long-term twice-monthly administration
      of somavaratan in adults with Growth Hormone Deficiency (GHD).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Female participants of childbearing potential must have negative pregnancy test and
             use appropriate contraceptive methods

          -  Documented GHD during adulthood

          -  Participants naive to somavaratan must have an IGF-1 SDS value ≤ 0 at Screening

          -  Participants taking other hormone replacement therapy must have been on a stable
             course of treatment for at least 3 months

          -  Underlying disorders responsible for the participant's GHD must have been clinically
             stable for at least 6 months

          -  Participants receiving daily rhGH injections must washout for ≥ 14 days

          -  Body mass index (BMI) (kilograms [kg]/meter square [m^2]) between 18.0 and 40.0

        Exclusion Criteria:

          -  Untreated adrenal insufficiency

          -  Recently diagnosed thyroid dysfunction which is not being treated or has not been
             stable on therapy for at least 3 months

          -  Currently taking anti-inflammatory dose of glucocorticoids that could potentially
             compromise safety or efficacy assessments

          -  Currently taking a GHRH or IGF-I product

          -  Current significant cardiovascular disease, heart insufficiency of New York Heart
             Association (NYHA) class > 2

          -  Current significant disease thought to increase risk of receiving growth hormone or
             confound assessment of study outcomes

          -  History of diabetes mellitus or inadequate glucose control

          -  Current drug or alcohol abuse

          -  Current human immunodeficiency virus (HIV) wasting syndrome (HIV testing not required)

          -  History of malignancy in adulthood (participants with a history of childhood
             malignancy that were subsequently treated with rhGH in childhood and remain GHD in
             adulthood may be enrolled)

          -  Women who are pregnant or breastfeeding

          -  Treatment with an investigational drug other than somavaratan within 30 days prior to
             Screening

          -  A significant abnormality in Screening laboratory results