Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.
Condition: Growth Hormone Disorder; Adult Growth Hormone Deficiency
MeSH terms: Dwarfism, Pituitary; Endocrine System Diseases
Intervention: somapacitan; somatropin; placebo
Intervention description: Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration. Extension of 44 weeks' treatment following 8 weeks of titration.; Administered subcutaneously (s.c., under the skin) once daily for 26 weeks following 8 weeks of titration. Re-randomisation to extension of 44 weeks' treatment following 8 weeks of titration.; Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration.
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 301.0
Sex: All
Minimum age: 23 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      This study is conducted globally. The purpose is to demonstrate the efficacy of once weekly
      dosing of NNC0195-0092 (somapacitan) compared to placebo and once-daily dosing of somatropin
      (human growth hormone, hGH) after 35 weeks of treatment in adults with growth hormone
      deficiency.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female of at least 23 years of age and not more than 79 years of age at the
             time of signing informed consent

          -  Human growth hormone (hGH) treatment naïve or no exposure to hGH or growth hormone
             (GH) secretagogues for at least 180 days prior to randomisation with any registered or
             investigational hGH or GH secretagogue product (if only used in connection with
             stimulation tests for diagnosis of growth hormone deficiency (GHD), subjects can be
             included)

          -  If applicable, hormone replacement therapies for any other hormone deficiencies,
             adequate and stable for at least 90 days prior to randomisation as judged by the
             investigator

          -  FOR ALL COUNTRIES EXCEPT JAPAN:

        Confirmed diagnosis of adult growth hormone deficiency (Subjects must satisfy one of the
        following criterion and documentation of test results must be available before
        randomisation (either from subjects' file or new test):

          1. Insulin tolerance test (ITT) or glucagon test: a peak GH response of less than 3 ng/mL
             (3 mcg/L)

          2. Growth hormone releasing hormone (GHRH) + arginine test according to body mass index
             (BMI): i) BMI less than 25 kg/m^2, a peak GH less than 11 ng/mL (11 mcg/L), ii) BMI
             25-30 kg/m^2, a peak GH less than 8 ng/mL (8 mcg/L), iii) BMI greater than 30 kg/m^2,
             a peak GH less than 4 ng/mL (4 mcg/L)

          3. Three or more pituitary hormone deficiencies and insulin like growth factor - I
             standard deviation score (IGF-I SDS) less than -2.0 - FOR JAPAN ONLY: Confirmed
             diagnosis of adult growth hormone deficiency (subjects with adult onset adult growth
             hormone deficiency (AGHD) need to satisfy at least one of the following criteria,
             subjects with a history of childhood GHD need to satisfy at least 2 of the following
             criteria):

        a. ITT test: a peak GH of less than or equal to 1.8 ng/mL (assay using recombinant GH
        standard) b. glucagon test: a peak GH of less than or equal to 1.8 ng/mL (assay using
        recombinant GH standard) c. growth hormone releasing peptide 2 (GHRP-2) tolerance test: a
        peak GH of less than or equal to 9 ng/mL (assay using recombinant GH standard)

        Exclusion Criteria:

          -  Active malignant disease or history of malignancy. Exceptions to this exclusion
             criterion: - Resection in situ carcinoma of the cervix uteri. Complete eradication of
             squamous cell or basal cell carcinoma of the skin

          -  Subjects with GHD attributed to treatment of intracranial malignant tumours or
             leukaemia, provided that a recurrence-free survival period of at least 5 years is
             documented in the subject's file