A trial to compare the efficacy and safety of once weekly dosing of NNC0195-0092 with once weekly dosing of placebo and daily Norditropin® FlexPro® in adults with growth hormone deficiency

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 280

Inclusion Criteria

1. 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
2. hGH treatment naïve or no exposure to hGH or 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 GHD, subjects can be included)
3. 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

4. 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):
a. Insulin tolerance test (ITT) or glucagon test: a peak GH response of < 3 ng/mL (3 µg/L)
b. Growth hormone releasing hormone (GHRH) + arginine test according to body mass index (BMI)
i. BMI< 25 kg/m^2, a peak GH < 11 ng/mL (µg/L)
ii. BMI 25–30 kg/m^2, a peak GH < 8 ng/mL (8 µg/L)
iii. BMI > 30 kg/m^2, a peak GH < 4 ng/mL (4 µg/L )
c. Three or more pituitary hormone deficiencies and IGF-I SDS < -2.0

FOR JAPAN ONLY: Confirmed diagnosis of adult growth hormone deficiency (subjects with adult onset 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 = 1.8 ng/mL (assay using recombinant GH standard)
b. glucagon test: a peak GH of = 1.8 ng/mL (assay using recombinant GH standard)
c. GHRP-2 tolerance test: a peak GH of = 9 ng/mL (assay using recombinant GH standard)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 230
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

1. Active malignant disease or history of malignancy. Exceptions to this exclusion criterion:
- Resection of 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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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