Growth hormone deficiency in adults MedDRA version: 19.1 Level: PT Classification code 10056438 Term: Growth hormone deficiency System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Product Code: NNC0195-0092 PDS290 10 mg-1.5 ml
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: N/A
CAS Number: 133857
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
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 30 kg/m^2, a peak GH =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;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 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 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key secondary endpoints for efficacy Changes in the following key variables will be used to address the primary objective: 1. Change in truncal fat mass (kg) 2. Change in truncal lean body mass (kg) Key secondary endpoints for safety The following key endpoints will be used to support the secondary objectives of evaluation of safety: 3. Incidence of adverse events, including injection site reactions 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) 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) | — |
Countries
Australia, Brazil, European Union, Germany, India, Japan, Latvia, Lithuania, Malaysia, Russian Federation, South Africa, Sweden, Turkey, Ukraine, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed