A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled (Double Blind) and Active-controlled (Open) Trial to Compare the Efficacy and Safety of Once Weekly Dosing of NNC0195-0092 (Somapacitan) With Once Weekly Dosing of Placebo and Daily Norditropin® FlexPro® in Adults With Growth Hormone Deficiency for 35 Weeks, Followed by a 53-week Open-label Extension Period
A Multicentre, Multinational, Randomised, Parallel-group, Placebo-controlled (Double Blind) and Active-controlled (Open) Trial to Compare the Efficacy and Safety of Once Weekly Dosing of NNC0195-0092 (Somapacitan) With Once Weekly Dosing of Placebo and Daily Norditropin® FlexPro® in Adults With Growth Hormone Deficiency for 35 Weeks, Followed by a 53-week Open-label Extension Period
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.
Inclusion Criteria:
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. 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:
Hyderabad, Andhra Pradesh 500034, India
New Dehli, New Delhi 110029, India
Chandigarh, Punjab 160012, India
Bunkyo-ku, Tokyo, 113-8603, Japan
Chiba-shi, Chiba, 260-8677, Japan
Fukuoka-shi, Fukuoka, 812-8582, Japan
Hamamatsu-shi, Shizuoka, 431-3192, Japan
Kyoto-shi Kyoto, 612-8555, Japan
Minato-ku, Tokyo, 105-8470, Japan
Okayama, Okayama, 700-8558, Japan
Sappro-shi, Hokkaido, 060 8648, Japan
Yamagata-shi, Yamagata, 990-9585, Japan
Yokohama, Kanagawa, 222-0036, Japan
Tygerberg, Western Cape 7505, South Africa