Trial to Compare the Efficacy and Safety of NNC0195-0092 With Placebo and Norditropin® FlexPro® in Adults With Growth Hormone Deficiency
- Conditions
- Health Condition 1: null- â?¢Growth Hormone Disorderâ?¢Adult Growth Hormone DeficiencyHealth Condition 2: E00-E89- Endocrine, nutritional and metabolic diseases
- Registration Number
- CTRI/2015/01/005458
- Lead Sponsor
- ovo Nordisk AS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 28
•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
• Confirmed diagnosis of adult growth hormone deficiency (if a subject satisfies at least one of the following criteria):
•a. Insulin tolerance test (ITT) or glucagon test: a peak GH response of less than 3 ng/mL (3 mcg/L)
•b. Growth hormone releasing hormone (GHRH) + arginine test according to body mass index (BMI): i) BMI less than 25 kg/m2, a peak GH less than 11 ng/mL (mcg/L), ii) BMI 25-30 kg/m2, a peak GH less than 8 ng/mL (8 mcg/L), iii) BMI greater than 30 kg/m2, a peak GH less than 4 ngmL (4 mcgL)
•c. Three or more pituitary hormone deficiencies at screening and insulin like growth factor - I standard deviation score (IGF-I SDS) less than -2.0
•Active malignant disease or history of malignancy. Exceptions to this exclusion criterion:
•Resected in situ carcinoma of the cervix and squamous cell or basal cell carcinoma of the skin with complete local excision
•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 subjects file
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in truncal fat percentageTimepoint: Week 0,Week 34
- Secondary Outcome Measures
Name Time Method Change in truncal fat mass (kg) <br/ ><br>Change in truncal lean body mass (kg)Timepoint: [ Time Frame: Baseline, week 34 ];Incidence of adverse events, including injection site reactions <br/ ><br>Occurrence of anti-NNC0195-0092 antibodiesTimepoint: [ Time Frame: Up to week 35 ];Incidence of adverse events, including injection site reactions <br/ ><br>Occurrence of anti-NNC0195-0092 antibodiesTimepoint: [ Time Frame: Up to week 88 ]