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

Phase 1

Conditions: Growth hormone deficiency in adults
MedDRA version: 19.0Level: PTClassification code 10056438Term: Growth hormone deficiencySystem Organ Class: 10014698 - Endocrine disorders
Therapeutic area: Diseases [C] - Hormonal diseases [C19]

Registration Number: EUCTR2013-002892-16-SE

Lead Sponsor: ovo Nordisk A/S

Brief Summary: Not available

Detailed Description: Not available

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
Main Objective: To demonstrate the efficacy of once weekly dosing of NNC0195-0092 compared to placebo after 34 weeks of treatment in adults with growth hormone deficiency;Secondary Objective: 1. To evaluate the clinical safety of once weekly dosing of NNC0195-0092 during 34 weeks of treatment in adults with growth hormone deficiency<br>2. To evaluate the efficacy and safety of NNC0195-0092 for up to 86 weeks of treatment in adults with growth hormone deficiency (i.e. during the main and extension periods of the trial);Primary end point(s): Change in truncal fat percentage;Timepoint(s) of evaluation of this end point: From baseline to end of main treatment period (Week 34)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Key secondary endpoints for efficacy<br>Changes in the following key variables will be used to address the primary objective:<br>1. Change in truncal fat mass (kg)<br>2. Change in truncal lean body mass (kg)<br><br>Key secondary endpoints for safety<br>The following key endpoints will be used to support the secondary objectives of evaluation of safety:<br>3. Incidence of adverse events, including injection site reactions<br>4. Occurrence of anti-NNC0195-0092 antibodies;Timepoint(s) of evaluation of this end point: 1. + 2. From baseline to end of main treatment period (Week 34)<br>3. + 4. In both the main trial period (up to week 35) and extension trial period (up to week 88) (including follow-up visits/washout periods)

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