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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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
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

Other trials in United States

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

Other trials in Japan

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

Other trials in Australia

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

Other trials in India

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

Other trials in United Kingdom

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

Other trials in Poland

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

Other trials in Romania

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

Other trials in Russia

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

Other trials in Germany

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

Other trials in Turkey (Türkiye)

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

Other trials in South Africa

Israel3 sites
  • Novo Nordisk Investigational Site

    Petah Tikva, 49100

  • Novo Nordisk Investigational Site

    Tel Aviv, 64239

  • Novo Nordisk Investigational Site

    Tel Litwinsky, 52621

Other trials in Israel

Malaysia3 sites
  • Novo Nordisk Investigational Site

    Kuching, 93586

  • Novo Nordisk Investigational Site

    Pulau Pinang, 10990

  • Novo Nordisk Investigational Site

    Putrajaya, 62250

Other trials in Malaysia

Sweden3 sites
  • Novo Nordisk Investigational Site

    Gothenburg, 413 45

  • Novo Nordisk Investigational Site

    Stockholm, 171 76

  • Novo Nordisk Investigational Site

    Uppsala, 751 85

Other trials in Sweden

Lithuania2 sites
  • Novo Nordisk Investigational Site

    Kaunas, 50009

  • Novo Nordisk Investigational Site

    Vilnius, 08661

Other trials in Lithuania

Ukraine2 sites
  • Novo Nordisk Investigational Site

    Kiev, 01021

  • Novo Nordisk Investigational Site

    Kyiv, 04114

Other trials in Ukraine

Brazil1 site
  • Novo Nordisk Investigational Site

    São Paulo, São Paulo, 01228-000

Other trials in Brazil

Latvia1 site
  • Novo Nordisk Investigational Site

    Riga, LV-1002

Other trials in Latvia

Norway1 site
  • Novo Nordisk Investigational Site

    Oslo, 0027

Other trials in Norway

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 groups in NCT02229851
Study groupRoleWhat they receive
NNC0195-0092 (somapacitan)ExperimentalNot described
Receives: Drug: somapacitan
Daily hGHActive comparatorNot described
Receives: Drug: somatropin
PlaceboPlacebo comparatorSwitch 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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

  39. 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

  40. 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

  41. 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

  42. 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

  43. 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

  44. 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

  45. 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

  46. 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

  47. 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

  48. 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

  49. 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

  50. 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

  51. 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

  52. 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

  53. 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

  54. 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

  55. 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

  56. 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

  57. 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

  58. 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

  59. 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

  60. 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

  61. 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

  62. 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

  63. 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

  64. 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

  65. 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

  66. 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

  67. 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

  68. 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

  69. 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

  70. 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

  71. 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

  72. 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

  73. 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

  74. 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

  75. 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

  76. 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

  77. 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

  78. 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

  79. 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

  80. 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

  81. 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

  82. 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

  83. 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

  84. 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

  85. 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

  86. 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

  87. 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

  88. 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

  89. 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

  90. 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

  91. 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

  92. 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

  93. 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

  94. 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

  95. 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

  96. 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

  97. 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

  98. 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

  99. 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

  100. 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

  101. 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

  102. 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

  103. 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

  104. 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

  105. 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

  106. 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

  107. 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

  108. 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

  109. 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

  110. 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

  111. 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

  112. 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

  113. 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

  114. 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

  115. 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

  116. 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

  117. 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

  118. 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

  119. 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.

  1. First posted3 Sep 2014 (estimated)
  2. Study start31 Oct 2014
  3. Primary completion21 Apr 2017
  4. Study completion7 May 2018

Resources

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)
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
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 32022863
  • Otsuka 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 39991735
  • Takahashi 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

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