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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02229851




Registration number
NCT02229851
Ethics application status
Date submitted
26/08/2014
Date registered
3/09/2014
Date last updated
12/11/2019

Titles & IDs
Public title
Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.
Scientific title
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
Secondary ID [1] 0 0
2013-002892-16
Secondary ID [2] 0 0
NN8640-4054
Universal Trial Number (UTN)
Trial acronym
REAL 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Growth Hormone Disorder 0 0
Adult Growth Hormone Deficiency 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - somapacitan
Treatment: Drugs - somatropin
Treatment: Drugs - placebo

Experimental: NNC0195-0092 (somapacitan) -

Active Comparator: Daily hGH -

Placebo Comparator: Placebo - Switch to NNC0195-0092 (somapacitan) treatment in the extension period.


Treatment: Drugs: somapacitan
Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration. Extension of 44 weeks' treatment following 8 weeks of titration.

Treatment: Drugs: somatropin
Administered subcutaneously (s.c., under the skin) once daily for 26 weeks following 8 weeks of titration. Re-randomisation to extension of 44 weeks' treatment following 8 weeks of titration.

Treatment: Drugs: placebo
Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in truncal fat percentage
Timepoint [1] 0 0
Baseline, week 34
Secondary outcome [1] 0 0
Change in truncal fat mass (kg)
Timepoint [1] 0 0
Baseline, week 34
Secondary outcome [2] 0 0
Change in truncal lean body mass (kg)
Timepoint [2] 0 0
Baseline, week 34
Secondary outcome [3] 0 0
Incidence of adverse events, including injection site reactions
Timepoint [3] 0 0
Up to week 35
Secondary outcome [4] 0 0
Incidence of adverse events, including injection site reactions
Timepoint [4] 0 0
Up to week 88
Secondary outcome [5] 0 0
Occurrence of anti-NNC0195-0092 (somapacitan) antibodies
Timepoint [5] 0 0
Up to week 35
Secondary outcome [6] 0 0
Occurrence of anti-NNC0195-0092 (somapacitan) antibodies
Timepoint [6] 0 0
Up to week 88

Eligibility
Key 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):

1. Insulin tolerance test (ITT) or glucagon test: a peak GH response of less than 3 ng/mL
(3 mcg/L)

2. 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)

3. 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)
Minimum age
23 Years
Maximum age
79 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Blacktown
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Coffs Harbour
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Darlinghurst
Recruitment hospital [4] 0 0
Novo Nordisk Investigational Site - St Leonards
Recruitment hospital [5] 0 0
Novo Nordisk Investigational Site - Woolloongabba
Recruitment hospital [6] 0 0
Novo Nordisk Investigational Site - Box Hill
Recruitment hospital [7] 0 0
Novo Nordisk Investigational Site - Parkville
Recruitment hospital [8] 0 0
Novo Nordisk Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2450 - Coffs Harbour
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
2065 - St Leonards
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [6] 0 0
3128 - Box Hill
Recruitment postcode(s) [7] 0 0
3052 - Parkville
Recruitment postcode(s) [8] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
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California
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Colorado
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Georgia
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Kansas
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Maryland
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Massachusetts
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Michigan
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Missouri
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Nebraska
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Nevada
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New York
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Ohio
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Oregon
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Pennsylvania
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Texas
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United States of America
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Utah
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United States of America
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Washington
Country [19] 0 0
Brazil
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Sao Paulo
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Germany
State/province [20] 0 0
Aachen
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Germany
State/province [21] 0 0
Berlin
Country [22] 0 0
Germany
State/province [22] 0 0
Frankfurt
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Germany
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Oldenburg
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India
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Andhra Pradesh
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India
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Karnataka
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India
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Kerala
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India
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Maharashtra
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India
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New Delhi
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India
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Punjab
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India
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West Bengal
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Israel
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Petah-Tikva
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Israel
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Tel Hashomer
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Israel
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Tel-Aviv
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Japan
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Bunkyo-ku, Tokyo
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Japan
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Chiba-shi, Chiba
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Japan
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Fukuoka-shi, Fukuoka
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Japan
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Hamamatsu-shi, Shizuoka
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Itabashi-ku, Tokyo
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Kagoshima
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Kyoto-shi Kyoto
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Minato-ku, Tokyo
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Minato?ku, Tokyo
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Okayama, Okayama
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Sagamihara-shi, Kanagawa
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Sapporo, Hokkaido
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Sappro-shi, Hokkaido
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Tokyo
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Bialystok
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Gdansk
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Wroclaw
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Romania
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Cluj
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Mures
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Romania
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Bucuresti
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Iasi
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Romania
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Sibiu
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Romania
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Timisoara
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Russian Federation
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Kazan
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Krasnoyarsk
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Moscow
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Novosibirsk
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Tomsk
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South Africa
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Gauteng
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Western Cape
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Sweden
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Göteborg
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Stockholm
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Uppsala
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Adana
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Istanbul
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Izmir
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Ukraine
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Kiev
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Ukraine
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Kyiv
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United Kingdom
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Birmingham
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Coventry
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Exeter
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Hull
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Leeds
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London
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United Kingdom
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Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02229851
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Reporting Anchor and Disclosure' (1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications