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
sites
Philadelphia, Pennsylvania 19104
2373
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Philadelphia, PA
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Atlanta, Georgia 30318
1919
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Atlanta, GA
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Aurora, Colorado 80010
824
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Aurora, CO
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Baltimore, Maryland 21229
2297
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Baltimore, MD
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Birmingham, Alabama 35215
1788
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Birmingham, AL
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Blacktown, New South Wales
?
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Blacktown,
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Boston, Massachusetts 02115
2576
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Boston, MA
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Cleveland, Ohio 44106
2032
mi
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Cleveland, OH
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East Lansing, Michigan 48824
1897
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East Lansing, MI
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El Paso, Texas 79912
681
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El Paso, TX
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Federal Way, Washington 98003
942
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Federal Way, WA
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Houston, Texas 77030
1357
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Houston, TX
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Las Vegas, Nevada 89128
213
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Las Vegas, NV
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Los Angeles, California 90027
16
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Los Angeles, CA
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New York, New York 10029
2435
mi
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New York, NY
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Omaha, Nebraska 68114
1301
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Omaha, NE
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Pittsburgh, Pennsylvania 15224
2119
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Pittsburgh, PA
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1225
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Plano, TX
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Portland, Oregon 97239
828
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Portland, OR
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389
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Reno, NV
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Roswell, Georgia 30076
1918
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Roswell, GA
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Saint Louis, Missouri 63110
1573
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Saint Louis, MO
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Salt Lake City, Utah 84132
570
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Salt Lake City, UT
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San Antonio, Texas 78224
1188
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San Antonio, TX
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Seattle, Washington 98105
961
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Seattle, WA
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Shavano Park, Texas 78231
1181
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Shavano Park, TX
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Topeka, Kansas 66606
1282
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Topeka, KS
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