Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.



Status:Completed
Conditions:Endocrine, Endocrine
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:23 - 79
Updated:7/25/2018
Start Date:October 31, 2014
End Date:May 7, 2018

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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:

- 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

- 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 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/m^2, a peak GH less than 11 ng/mL (11 mcg/L), ii)
BMI 25-30 kg/m^2, a peak GH less than 8 ng/mL (8 mcg/L), iii) BMI greater than 30
kg/m^2, a peak GH less than 4 ng/mL (4 mcg/L)

- c. Three or more pituitary hormone deficiencies and insulin like growth factor - I
standard deviation score (IGF-I SDS) less than -2.0

- FOR JAPAN ONLY: Confirmed diagnosis of adult growth hormone deficiency (subjects with
adult onset adult growth hormone deficiency (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 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:

- 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
We found this trial at
27
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Atlanta, Georgia 30318
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Aurora, Colorado 80010
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Baltimore, Maryland 21229
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Birmingham, Alabama 35215
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Blacktown, New South Wales
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Boston, Massachusetts 02115
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Boston, MA
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Cleveland, Ohio 44106
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Cleveland, OH
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East Lansing, Michigan 48824
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El Paso, Texas 79912
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Federal Way, Washington 98003
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Houston, Texas 77030
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Las Vegas, Nevada 89128
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Los Angeles, California 90027
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New York, New York 10029
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Omaha, Nebraska 68114
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Philadelphia, Pennsylvania 19104
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Pittsburgh, Pennsylvania 15224
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Plano, TX
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Portland, Oregon 97239
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Portland, OR
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Reno, NV
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Roswell, Georgia 30076
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Saint Louis, Missouri 63110
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Salt Lake City, Utah 84132
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San Antonio, Texas 78224
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Seattle, Washington 98105
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Shavano Park, Texas 78231
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Topeka, Kansas 66606
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Topeka, KS
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