Growth Hormone DisorderPhase 3REAL 1NCT02229851
Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.
A Phase 3 study testing somapacitan and somatropin in people with Growth Hormone Disorder and Adult Growth Hormone Deficiency, run by Novo Nordisk A/S at 117 sites in 19 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 23 to 79 years
- Conditions the study is for
- Growth Hormone Disorder, Adult Growth Hormone Deficiency
- What is being tested?
- somapacitan and somatropin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 301 participants
- Where
- 117 sitesin 19 countries
- Study dates
- 31 Oct 2014to 7 May 2018
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
- Insulin tolerance test (ITT) or glucagon test: a peak GH response of less than 3 ng/mL (3 mcg/L)
Show all 9Show fewer
- 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)
- 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):
- 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)
Who cannot join
- 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
Trial locations and contacts
117 sites in 19 countries.
117 sites in 19 countries
United States29 sites
Novo Nordisk Investigational Site
Atlanta, Georgia, 30318
Novo Nordisk Investigational Site
Aurora, Colorado, 80045
Novo Nordisk Investigational Site
Baltimore, Maryland, 21205
Novo Nordisk Investigational Site
Birmingham, Alabama, 35233
Novo Nordisk Investigational Site
Boston, Massachusetts, 02114
Novo Nordisk Investigational Site
Cleveland, Ohio, 44195
Novo Nordisk Investigational Site
East Lansing, Michigan, 48824
Novo Nordisk Investigational Site
El Paso, Texas, 79935
Novo Nordisk Investigational Site
Federal Way, Washington, 98003
Novo Nordisk Investigational Site
Houston, Texas, 77030
Novo Nordisk Investigational Site
Las Vegas, Nevada, 89128
Novo Nordisk Investigational Site
Los Angeles, California, 90033
Novo Nordisk Investigational Site
Los Angeles, California, 90095
Novo Nordisk Investigational Site
New York, New York, 10032
Novo Nordisk Investigational Site
Omaha, Nebraska, 68105
Novo Nordisk Investigational Site
Omaha, Nebraska, 68198-4120
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19104
Novo Nordisk Investigational Site
Philadelphia, Pennsylvania, 19107
Novo Nordisk Investigational Site
Pittsburgh, Pennsylvania, 15212
Novo Nordisk Investigational Site
Plano, Texas, 75093
Novo Nordisk Investigational Site
Portland, Oregon, 97239
Novo Nordisk Investigational Site
Reno, Nevada, 89511
Novo Nordisk Investigational Site
Roswell, Georgia, 30076
Novo Nordisk Investigational Site
Salt Lake City, Utah, 84103
Novo Nordisk Investigational Site
San Antonio, Texas, 78229
Novo Nordisk Investigational Site
Seattle, Washington, 98122-5789
Novo Nordisk Investigational Site
Shavano Park, Texas, 78231
Novo Nordisk Investigational Site
St Louis, Missouri, 63110
Novo Nordisk Investigational Site
Topeka, Kansas, 66606
Japan15 sites
Novo Nordisk Investigational Site
Bunkyo-ku, Tokyo, 113-8603
Novo Nordisk Investigational Site
Chiba-shi, Chiba, 260-8677
Novo Nordisk Investigational Site
Fukuoka-shi, Fukuoka, 812-8582
Novo Nordisk Investigational Site
Hamamatsu-shi, Shizuoka, 431-3192
Novo Nordisk Investigational Site
Itabashi-ku, Tokyo, 173-8606
Novo Nordisk Investigational Site
Kagoshima, 890-8520
Novo Nordisk Investigational Site
Kyoto-shi Kyoto, 612-8555
Novo Nordisk Investigational Site
Minato-ku, Tokyo, 105-8470
Novo Nordisk Investigational Site
Okayama, Okayama, 700-8558
Novo Nordisk Investigational Site
Sagamihara-shi, Kanagawa, 252-0375
Novo Nordisk Investigational Site
Sapporo, Hokkaido, 060-8648
Novo Nordisk Investigational Site
Sappro-shi, Hokkaido, 060 8648
Novo Nordisk Investigational Site
Tokyo, 134-0088
Novo Nordisk Investigational Site
Yamagata-shi, Yamagata, 990-9585
Novo Nordisk Investigational Site
Yokohama, Kanagawa, 222-0036
Australia8 sites
Novo Nordisk Investigational Site
Blacktown, New South Wales, 2148
Novo Nordisk Investigational Site
Box Hill, Victoria, 3128
Novo Nordisk Investigational Site
Coffs Harbour, New South Wales, 2450
Novo Nordisk Investigational Site
Darlinghurst, New South Wales, 2010
Novo Nordisk Investigational Site
Nedlands, Western Australia, 6009
Novo Nordisk Investigational Site
Parkville, Victoria, 3052
Novo Nordisk Investigational Site
St Leonards, New South Wales, 2065
Novo Nordisk Investigational Site
Woolloongabba, Queensland, 4102
India8 sites
Novo Nordisk Investigational Site
Bangalore, Karnataka, 560034
Novo Nordisk Investigational Site
Chandigarh, Punjab, 160012
Novo Nordisk Investigational Site
Hyderabad, Andhra Pradesh, 500034
Novo Nordisk Investigational Site
Hyderabad, Telangana, 500033
Novo Nordisk Investigational Site
Kochi, Kerala, 682041
Novo Nordisk Investigational Site
Kolkata, West Bengal, 700032
Novo Nordisk Investigational Site
Mumbai, Maharashtra, 400008
Novo Nordisk Investigational Site
New Dehli, New Delhi, 110029
United Kingdom8 sites
Novo Nordisk Investigational Site
Birmingham, B15 2TH
Novo Nordisk Investigational Site
Coventry, CV2 2DX
Novo Nordisk Investigational Site
Exeter, EX2 5DW
Novo Nordisk Investigational Site
Hull, HU3 2RW
Novo Nordisk Investigational Site
Leeds, LS9 7TF
Novo Nordisk Investigational Site
London, EC1A 7BE
Novo Nordisk Investigational Site
London, SE5 9RS
Novo Nordisk Investigational Site
Manchester, M20 4BX
Poland7 sites
Novo Nordisk Investigational Site
Bialystok, 15-879
Novo Nordisk Investigational Site
Gdansk, 80-952
Novo Nordisk Investigational Site
Krakow, 31-455
Novo Nordisk Investigational Site
Warsaw, 02-507
Novo Nordisk Investigational Site
Warsaw, 04-141
Novo Nordisk Investigational Site
Wroclaw, 50-311
Novo Nordisk Investigational Site
Wroclaw, 50-367
Romania6 sites
Novo Nordisk Investigational Site
Bucharest, 011863
Novo Nordisk Investigational Site
Cluj-Napoca, Cluj, 400349
Novo Nordisk Investigational Site
Iași, 700111
Novo Nordisk Investigational Site
Sibiu, 550166
Novo Nordisk Investigational Site
Târgu Mureş, Mureș County, 540142
Novo Nordisk Investigational Site
Timișoara, 300736
Russia6 sites
Novo Nordisk Investigational Site
Kazan', 420061
Novo Nordisk Investigational Site
Krasnoyarsk, 660022
Novo Nordisk Investigational Site
Moscow, 117036
Novo Nordisk Investigational Site
Moscow, 119435
Novo Nordisk Investigational Site
Novosibirsk, 630099
Novo Nordisk Investigational Site
Tomsk, 634050
Germany5 sites
Novo Nordisk Investigational Site
Aachen, 52074
Novo Nordisk Investigational Site
Berlin, 10117
Novo Nordisk Investigational Site
Berlin, 13352
Novo Nordisk Investigational Site
Frankfurt, 60596
Novo Nordisk Investigational Site
Oldenburg, 26122
Turkey (Türkiye)5 sites
Novo Nordisk Investigational Site
Adana, 01130
Novo Nordisk Investigational Site
Istanbul, 34098
Novo Nordisk Investigational Site
Istanbul, 34390
Novo Nordisk Investigational Site
Izmir, 35100
Novo Nordisk Investigational Site
Kocaeli, 41380
South Africa4 sites
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 2013
Novo Nordisk Investigational Site
Johannesburg, Gauteng, 2193
Novo Nordisk Investigational Site
Pretoria, Gauteng, 0044
Novo Nordisk Investigational Site
Tygerberg, Western Cape, 7505
Israel3 sites
Novo Nordisk Investigational Site
Petah Tikva, 49100
Novo Nordisk Investigational Site
Tel Aviv, 64239
Novo Nordisk Investigational Site
Tel Litwinsky, 52621
Malaysia3 sites
Novo Nordisk Investigational Site
Kuching, 93586
Novo Nordisk Investigational Site
Pulau Pinang, 10990
Novo Nordisk Investigational Site
Putrajaya, 62250
Sweden3 sites
Novo Nordisk Investigational Site
Gothenburg, 413 45
Novo Nordisk Investigational Site
Stockholm, 171 76
Novo Nordisk Investigational Site
Uppsala, 751 85
Lithuania2 sites
Novo Nordisk Investigational Site
Kaunas, 50009
Novo Nordisk Investigational Site
Vilnius, 08661
Ukraine2 sites
Novo Nordisk Investigational Site
Kiev, 01021
Novo Nordisk Investigational Site
Kyiv, 04114
About this study
Official 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
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.
- Being tested
- somapacitan, somatropin, placebo
- Medical subject headings
- Dwarfism, Pituitary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
somapacitanDrug
Also called NNC0195-0092
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.
somatropinDrug
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.
placeboDrug
Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration.
| Study group | Role | What they receive |
|---|---|---|
| NNC0195-0092 (somapacitan) | Experimental | Not described Receives: Drug: somapacitan |
| Daily hGH | Active comparator | Not described Receives: Drug: somatropin |
| Placebo | Placebo comparator | Switch to NNC0195-0092 (somapacitan) treatment in the extension period. Receives: Drug: somapacitan; Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Truncal Fat Percentage (Week 34)
Change in Truncal fat percentage was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Secondary outcomes (119)
Change in Truncal Fat Percentage (Week 87)
Change in Truncal fat percentage was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Change in Truncal Fat Mass (Week 34)
Change in Truncal fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Truncal Fat Mass (Week 87)
Change in Truncal fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Change in Truncal Lean Body Mass (Week 34)
Change in Truncal lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Truncal Lean Body Mass (Week 87)
Change in Truncal lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Change in Total Fat Mass (Week 34)
Change in Total fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Total Fat Mass (Week 87)
Change in total fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: Week -3, week 87
Change in Visceral Adipose Tissue (Week 34)
Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Visceral Adipose Tissue (Week 87)
Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: Week -3, week 87
Change in Android Fat Mass (Week 34)
Change in Android fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Android Fat Mass (Week 87)
Change in Android fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Change in Gynoid Fat Mass (Week 34)
Change in Gynoid fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Gynoid Fat Mass (Week 87)
Change in Gynoid fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Change in Appendicular Skeletal Muscle Mass (Week 34)
Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Appendicular Skeletal Muscle Mass (Week 87)
Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Change in Lean Body Mass (Week 34)
Change in Lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Lean Body Mass (Week 87)
Change in Lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Change in Bone Mineral Content (Week 87)
Change in Bone mineral content was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Change in Bone Mineral Density (Week 87)
Change in Bone mineral density was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Change in IGF-I SDS (Week 34)
Change in insulin-like growth factor (IGF-I) standard deviation scores (SDS) was measured from baseline (week -3) until the end of the main treatment period (week 34). A higher score reflects a better outcome.
Measured: Week -3, week 34
Change in IGF-I SDS (Week 87)
Change in IGF-I SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87). A higher score reflects a better outcome.
Measured: Week -3, week 87
Change in IGFBP 3 SDS (Week 34)
Change in insulin like growth factor binding protein 3 (IGFBP 3) SDS was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in IGFBP 3 SDS (Week 87)
Change in IGFBP 3 SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: Week -3, week 87
Change in TRIM-AGHD (Total and Domain Scores) (Week 34)
Change in treatment-related impact measure - adult growth hormone deficiency (TRIM-AGHD) scores (total and domain scores) was measured from baseline (week 0) until the end of the main treatment period (week 34). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome.
Measured: Week 0, week 34
Change in TRIM-AGHD (Total and Domain Scores) (Week 87)
Change in TRIM-AGHD (total and domain scores) was measured from baseline (week 0) until the end of the extension treatment period (week 87). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome.
Measured: week 0, week 87
Change in SF-36v2 (Summary and Domain Scores) (Week 34)
SF-36v2™ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.
Measured: Week 0, week 34
Change in SF-36v2 (Summary and Domain Scores) (Week 87)
SF-36v2™ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline.
Measured: week 0, week 87
TSQM-9 Scores (Domain Scores) (Week 34)
Scores from the TSQM-9 scale were calculated at the end of the main treatment period (week 34). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100.
Measured: Week 34
TSQM-9 Scores (Domain Scores) (Week 87)
Scores from the TSQM-9 scale were calculated at the end of the extension treatment period (week 87). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100.
Measured: Week 87
Change in Total Cholesterol (Week 34)
Change in Total cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Total Cholesterol (Week 87)
Change in Total cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Change in HDL-cholesterol (Week 34)
Change in High-density lipoprotein (HDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in HDL-cholesterol (Week 87)
Change in HDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Change in LDL-cholesterol (Week 34)
Change in Low-density lipoprotein (LDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in LDL-cholesterol (Week 87)
Change in LDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Change in Triglycerides (Week 34)
Change in Triglycerides was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Triglycerides (Week 87)
Change in Triglycerides was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Change in Hs-CRP (Week 34)
Change in high-sensitivity C-reactive protein (hs-CRP) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Hs-CRP (Week 87)
Change in hs-CRP was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Change in IL-6 (Week 34)
Change in Interleukin 6 (IL-6) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in IL-6 (Week 87)
Change in IL-6 was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Change in Body Weight (Week 34)
Change in body weight was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Body Weight (Week 87)
Change in body weight was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Change in Waist Circumference (Week 34)
Change in waist circumference was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Waist Circumference (Week 87)
Change in waist circumference was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Number of Adverse Events (Weeks 0-35)
Number of adverse events from baseline (week 0) until the end of week 35 were reported. This endpoint shows number of treatment-emergent adverse events (TEAEs), including the injection site reactions.
Measured: Weeks 0-35
Number of Adverse Events (Weeks 0-88)
Number of adverse events from baseline (week 0) until the end of week 88 were reported. This endpoint shows the number of TEAEs along with the injection site reactions.
Measured: Weeks 0-88
Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-35)
Number of participants with anti-NNC0195-0092 antibodies at week 35 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies.
Measured: Weeks 0 to 35
Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-88)
Number of participants with anti-NNC0195-0092 antibodies at week 88 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies.
Measured: Weeks 0 to 88
Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-35)
Incidence of technical complaints were recorded from baseline (week 0) until week 35.
Measured: Weeks 0 to 35
Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-88)
Incidence of technical complaints were recorded from baseline (week 0) until week 88.
Measured: Weeks 0 to 88
Change in Physical Examination During Exposure to Trial Product (Week 35)
Change in physical examination from baseline (week 0) until the end of the main treatment period (week 35) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central \& Peripheral nervous sys. 7) Skin 8) Lymph node palpation
Measured: Week 0 and week 35
Change in Physical Examination During Exposure to Trial Product (Week 88)
Change in physical examination from baseline (week 0) until the end of the extension period (week 88) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central \& Peripheral nervous sys. 7) Skin 8) Lymph node palpation
Measured: Week 0 and week 88
Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35)
Change in Electrocardiogram (ECG) evaluation from baseline (week -3) until the end of the main treatment period (week 35) was reported.
Measured: Week -3 and week 35
Change in ECG Evaluation During Exposure to Trial Product (Week 88)
Change in ECG evaluation from baseline (week 0) until the end of the extension period (Week 88) was reported.
Measured: Week -3 and week 88
Change in Diastolic Blood Pressure (Week 35)
Change in diastolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).
Measured: Week -3, week 35
Change in Diastolic Blood Pressure (Week 88)
Change in diastolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period week 88.
Measured: Week -3, week 88
Change in Systolic Blood Pressure (Week 35)
Change in systolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35).
Measured: Week -3, week 35
Change in Systolic Blood Pressure (Week 88)
Change in systolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period (week 88).
Measured: Week -3, week 88
Change in Pulse (Week 35)
Change in pulse was measured from baseline (week -3) until the end of the main treatment period (week 35).
Measured: Week -3, week 35
Change in Pulse (Week 88)
Change in pulse was measured from baseline (week -3) until the end of the extension treatment period (week 88).
Measured: Week -3, week 88
Change in Haemoglobin (Week 34)
Change in Haemoglobin was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Haemoglobin (Week 87)
Change in Haemoglobin was measured from baseline (week -3) until the end of the week 87.
Measured: week -3, week 87
Change in Haematocrit (Week 34)
Change in Haematocrit was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Haematocrit (Week 87)
Change in Haematocrit was measured from baseline (week -3) until the end of the week 87.
Measured: week -3, week 87
Change in Erythrocytes (Week 34)
Change in Erythrocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Erythrocytes (Week 87)
Change in Erythrocytes was measured from baseline (week -3) until the end of the week 87.
Measured: week -3, week 87
Change in Mean Corpuscular Volume (MCV) (Week 34)
Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Mean Corpuscular Volume (MCV) (Week 87)
Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the week 87.
Measured: week -3, week 87
Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 34)
Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 87)
Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the week 87.
Measured: week -3, week 87
Change in Thrombocytes (Week 34)
Change in Thrombocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Thrombocytes (Week 87)
Change in Thrombocytes was measured from baseline (week -3) until the end of the week 87.
Measured: week -3, week 87
Change in Leucocytes (Week 34)
Change in Leucocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Leucocytes (Week 87)
Change in Leucocytes was measured from baseline (week -3) until the end of the week 87.
Measured: week -3, week 87
Change in Alanine Aminotransferase (ALT) (Week 34)
Change in ALT was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Alanine Aminotransferase (ALT) (Week 87)
Change in ALT was measured from baseline (week -3) until the end of the week 87.
Measured: week -3, week 87
Change in Albumin (Week 34)
Change in Albumin was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Albumin (Week 87)
Change in Albumin was measured from baseline (week -3) until the end of the week 87.
Measured: week -3, week 87
Change in Alkaline Phosphatase (ALP) (Week 34)
Change in Alkaline phosphatase (ALP) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Alkaline Phosphatase (AP) (Week 87)
Change in Alkaline phosphatase (AP) was measured from baseline (week -3) until the end of the week 87.
Measured: Week -3, week 87
Change in Aspartate Aminotransferase (AST) (Week 34)
Change in AST was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Aspartate Aminotransferase (AST) (Week 87)
Change in AST was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: Week -3, week 87
Change in Bilirubin (Week 34)
Change in Bilirubin was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Bilirubin (Week 87)
Change in Bilirubin was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Change in Calcium (Week 34)
Change in Calcium was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Calcium (Week 87)
Change in Calcium was measured from baseline (week -3) until the end of the week 87.
Measured: week -3, week 87
Change in Chloride (Week 34)
Change in Chloride was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Chloride (Week 87)
Change in Chloride was measured from baseline (week -3) until the end of the week 87.
Measured: week -3, week 87
Change in Creatinine (Week 34)
Change in Creatinine was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Creatinine (Week 87)
Change in Creatinine was measured from baseline (week -3) until the end of the week 87.
Measured: week -3, week 87
Change in Creatine Kinase (Week 34)
Change in Creatine kinase was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Creatine Kinase (Week 87)
Change in Creatine kinase was measured from baseline (week -3) until the end of the week 87.
Measured: week -3, week 87
Change in Gamma-glutamyl Transferase (GGT) (Week 34)
Change in GGT was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Gamma-glutamyl Transferase (GGT) (Week 87)
Change in GGT was measured from baseline (week -3) until the end of the week 87.
Measured: week -3, week 87
Change in Phosphate (Inorganic) (Week 34)
Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Phosphate (Inorganic)(Week 87)
Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the week 87.
Measured: week -3, week 87
Change in Potassium (Week 34)
Change in Potassium was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Potassium (Week 87)
Change in Potassium was measured from baseline (week -3) until the end of the week 87.
Measured: week -3, week 87
Change in Sodium (Week 34)
Change in Sodium was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Sodium (Week 87)
Change in Sodium was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Change in Total Protein (Week 34)
Change in total protein was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Total Protein (Week 87)
Change in total protein was measured from baseline (week -3) until the end of extension treatment period (week 87).
Measured: week -3, week 87
Change in Urea (Week 34)
Change in Urea was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Urea (Week 87)
Change in Urea was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Change in Uric Acid (Week 34)
Change in Uric acid was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Uric Acid (Week 87)
Change in Uric acid was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Change in Estimated Glomerular Filtration Rate (GFR) Creatinine (CKD-EPI) (Week 34)
Change in Estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Estimated GFR Creatinine (CKD-EPI) (Week 87)
Change in estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Change in Fasting Plasma Glucose (Week 34)
Change in Fasting plasma glucosewas measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Fasting Plasma Glucose (Week 87)
Change in Fasting plasma glucose was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Change in Fasting Insulin (Week 34)
Change in Fasting insulin was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Fasting Insulin (Week 87)
Change in Fasting insulin was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Change in Steady State Beta Cell Function (%B) (Week 34)
Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Steady State Beta Cell Function (%B) (Week 87)
Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the week 87.
Measured: week -3, week 87
Change in Insulin Resistance (IR %) (Week 34)
Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Insulin Resistance (IR %) (Week 87)
Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Change in Glycated Haemoglobin (HbA1c) (%) (Week 34)
Change in Glycated haemoglobin (HbA1c) (%) was measured from baseline (week -3) until the end of the main treatment period (week 34).
Measured: Week -3, week 34
Change in Glycated Haemoglobin (HbA1c) (%) (Week 87)
Change in Glycated haemoglobin (HbA1c) was measured from baseline (week -3) until the end of the extension treatment period (week 87).
Measured: week -3, week 87
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2014 (estimated)
- Study start31 Oct 2014
- Primary completion21 Apr 2017
- Study completion7 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Growth Hormone DisorderStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 301 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor and Disclosure' (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02229851
- Sponsor's protocol ID
- NN8640-4054
- Other IDs
- 2013-002892-16, U1111-1145-0211, JapicCTI-152767
- Acronym
- REAL 1
- Status last verified
- Nov 2020
- First submitted
- 26 Aug 2014
- Last updated
- 23 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Publications
Johannsson G, Gordon MB, Hojby Rasmussen M, Hakonsson IH, Karges W, Svaerke C, Tahara S, Takano K, Biller BMK. Once-weekly Somapacitan is Effective and Well Tolerated in Adults with GH Deficiency: A Randomized Phase 3 Trial. J Clin Endocrinol Metab. 2020 Apr 1;105(4):e1358-76. doi: 10.1210/clinem/dgaa049.
PubMed 32022863Otsuka F, Rasmussen MH, Endo T, Svaerke C, Tahara S, Johannsson G. Efficacy in Japanese adults with growth hormone deficiency receiving weekly somapacitan or daily growth hormone: results from phase 3 REAL 1 trial. Front Endocrinol (Lausanne). 2025 Feb 7;16:1534891. doi: 10.3389/fendo.2025.1534891. eCollection 2025.
PubMed 39991735Takahashi Y, Biller BMK, Fukuoka H, Ho KKY, Rasmussen MH, Nedjatian N, Svaerke C, Yuen KCJ, Johannsson G. Weekly somapacitan had no adverse effects on glucose metabolism in adults with growth hormone deficiency. Pituitary. 2023 Feb;26(1):57-72. doi: 10.1007/s11102-022-01283-3. Epub 2022 Nov 15.
PubMed 36380045