Clinical trial NCT02229851: Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Growth Hormone Disorder
Adult Growth Hormone Deficiency
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-09-03
Enrollment: 301
Sex: ALL
Minimum age (years): 23
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

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

Primary outcomes:
measure: Change in Truncal Fat Percentage (Week 34)
timeFrame: Week -3, week 34
Secondary outcomes:
measure: Change in Truncal Fat Percentage (Week 87)
timeFrame: week -3, week 87
measure: Change in Truncal Fat Mass (Week 34)
timeFrame: Week -3, week 34
measure: Change in Truncal Fat Mass (Week 87)
timeFrame: week -3, week 87
measure: Change in Truncal Lean Body Mass (Week 34)
timeFrame: Week -3, week 34
measure: Change in Truncal Lean Body Mass (Week 87)
timeFrame: week -3, week 87
measure: Change in Total Fat Mass (Week 34)
timeFrame: Week -3, week 34
measure: Change in Total Fat Mass (Week 87)
timeFrame: Week -3, week 87
measure: Change in Visceral Adipose Tissue (Week 34)
timeFrame: Week -3, week 34
measure: Change in Visceral Adipose Tissue (Week 87)
timeFrame: Week -3, week 87
measure: Change in Android Fat Mass (Week 34)
timeFrame: Week -3, week 34
measure: Change in Android Fat Mass (Week 87)
timeFrame: week -3, week 87
measure: Change in Gynoid Fat Mass (Week 34)
timeFrame: Week -3, week 34
measure: Change in Gynoid Fat Mass (Week 87)
timeFrame: week -3, week 87
measure: Change in Appendicular Skeletal Muscle Mass (Week 34)
timeFrame: Week -3, week 34
measure: Change in Appendicular Skeletal Muscle Mass (Week 87)
timeFrame: week -3, week 87
measure: Change in Lean Body Mass (Week 34)
timeFrame: Week -3, week 34
measure: Change in Lean Body Mass (Week 87)
timeFrame: week -3, week 87
measure: Change in Bone Mineral Content (Week 87)
timeFrame: week -3, week 87
measure: Change in Bone Mineral Density (Week 87)
timeFrame: week -3, week 87
measure: Change in IGF-I SDS (Week 34)
timeFrame: Week -3, week 34
measure: Change in IGF-I SDS (Week 87)
timeFrame: Week -3, week 87
measure: Change in IGFBP 3 SDS (Week 34)
timeFrame: Week -3, week 34
measure: Change in IGFBP 3 SDS (Week 87)
timeFrame: Week -3, week 87
measure: Change in TRIM-AGHD (Total and Domain Scores) (Week 34)
timeFrame: Week 0, week 34
measure: Change in TRIM-AGHD (Total and Domain Scores) (Week 87)
timeFrame: week 0, week 87
measure: Change in SF-36v2 (Summary and Domain Scores) (Week 34)
timeFrame: Week 0, week 34
measure: Change in SF-36v2 (Summary and Domain Scores) (Week 87)
timeFrame: week 0, week 87
measure: TSQM-9 Scores (Domain Scores) (Week 34)
timeFrame: Week 34
measure: TSQM-9 Scores (Domain Scores) (Week 87)
timeFrame: Week 87
measure: Change in Total Cholesterol (Week 34)
timeFrame: Week -3, week 34
measure: Change in Total Cholesterol (Week 87)
timeFrame: week -3, week 87
measure: Change in HDL-cholesterol (Week 34)
timeFrame: Week -3, week 34
measure: Change in HDL-cholesterol (Week 87)
timeFrame: week -3, week 87
measure: Change in LDL-cholesterol (Week 34)
timeFrame: Week -3, week 34
measure: Change in LDL-cholesterol (Week 87)
timeFrame: week -3, week 87
measure: Change in Triglycerides (Week 34)
timeFrame: Week -3, week 34
measure: Change in Triglycerides (Week 87)
timeFrame: week -3, week 87
measure: Change in Hs-CRP (Week 34)
timeFrame: Week -3, week 34
measure: Change in Hs-CRP (Week 87)
timeFrame: week -3, week 87
measure: Change in IL-6 (Week 34)
timeFrame: Week -3, week 34
measure: Change in IL-6 (Week 87)
timeFrame: week -3, week 87
measure: Change in Body Weight (Week 34)
timeFrame: Week -3, week 34
measure: Change in Body Weight (Week 87)
timeFrame: week -3, week 87
measure: Change in Waist Circumference (Week 34)
timeFrame: Week -3, week 34
measure: Change in Waist Circumference (Week 87)
timeFrame: week -3, week 87
measure: Number of Adverse Events (Weeks 0-35)
timeFrame: Weeks 0-35
measure: Number of Adverse Events (Weeks 0-88)
timeFrame: Weeks 0-88
measure: Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-35)
timeFrame: Weeks 0 to 35
measure: Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-88)
timeFrame: Weeks 0 to 88
measure: Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-35)
timeFrame: Weeks 0 to 35
measure: Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-88)
timeFrame: Weeks 0 to 88
measure: Change in Physical Examination During Exposure to Trial Product (Week 35)
timeFrame: Week 0 and week 35
measure: Change in Physical Examination During Exposure to Trial Product (Week 88)
timeFrame: Week 0 and week 88
measure: Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35)
timeFrame: Week -3 and week 35
measure: Change in ECG Evaluation During Exposure to Trial Product (Week 88)
timeFrame: Week -3 and week 88
measure: Change in Diastolic Blood Pressure (Week 35)
timeFrame: Week -3, week 35
measure: Change in Diastolic Blood Pressure (Week 88)
timeFrame: Week -3, week 88
measure: Change in Systolic Blood Pressure (Week 35)
timeFrame: Week -3, week 35
measure: Change in Systolic Blood Pressure (Week 88)
timeFrame: Week -3, week 88
measure: Change in Pulse (Week 35)
timeFrame: Week -3, week 35
measure: Change in Pulse (Week 88)
timeFrame: Week -3, week 88
measure: Change in Haemoglobin (Week 34)
timeFrame: Week -3, week 34
measure: Change in Haemoglobin (Week 87)
timeFrame: week -3, week 87
measure: Change in Haematocrit (Week 34)
timeFrame: Week -3, week 34
measure: Change in Haematocrit (Week 87)
timeFrame: week -3, week 87
measure: Change in Erythrocytes (Week 34)
timeFrame: Week -3, week 34
measure: Change in Erythrocytes (Week 87)
timeFrame: week -3, week 87
measure: Change in Mean Corpuscular Volume (MCV) (Week 34)
timeFrame: Week -3, week 34
measure: Change in Mean Corpuscular Volume (MCV) (Week 87)
timeFrame: week -3, week 87
measure: Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 34)
timeFrame: Week -3, week 34
measure: Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 87)
timeFrame: week -3, week 87
measure: Change in Thrombocytes (Week 34)
timeFrame: Week -3, week 34
measure: Change in Thrombocytes (Week 87)
timeFrame: week -3, week 87
measure: Change in Leucocytes (Week 34)
timeFrame: Week -3, week 34
measure: Change in Leucocytes (Week 87)
timeFrame: week -3, week 87
measure: Change in Alanine Aminotransferase (ALT) (Week 34)
timeFrame: Week -3, week 34
measure: Change in Alanine Aminotransferase (ALT) (Week 87)
timeFrame: week -3, week 87
measure: Change in Albumin (Week 34)
timeFrame: Week -3, week 34
measure: Change in Albumin (Week 87)
timeFrame: week -3, week 87
measure: Change in Alkaline Phosphatase (ALP) (Week 34)
timeFrame: Week -3, week 34
measure: Change in Alkaline Phosphatase (AP) (Week 87)
timeFrame: Week -3, week 87
measure: Change in Aspartate Aminotransferase (AST) (Week 34)
timeFrame: Week -3, week 34
measure: Change in Aspartate Aminotransferase (AST) (Week 87)
timeFrame: Week -3, week 87
measure: Change in Bilirubin (Week 34)
timeFrame: Week -3, week 34
measure: Change in Bilirubin (Week 87)
timeFrame: week -3, week 87
measure: Change in Calcium (Week 34)
timeFrame: Week -3, week 34
measure: Change in Calcium (Week 87)
timeFrame: week -3, week 87
measure: Change in Chloride (Week 34)
timeFrame: Week -3, week 34
measure: Change in Chloride (Week 87)
timeFrame: week -3, week 87
measure: Change in Creatinine (Week 34)
timeFrame: Week -3, week 34
measure: Change in Creatinine (Week 87)
timeFrame: week -3, week 87
measure: Change in Creatine Kinase (Week 34)
timeFrame: Week -3, week 34
measure: Change in Creatine Kinase (Week 87)
timeFrame: week -3, week 87
measure: Change in Gamma-glutamyl Transferase (GGT) (Week 34)
timeFrame: Week -3, week 34
measure: Change in Gamma-glutamyl Transferase (GGT) (Week 87)
timeFrame: week -3, week 87
measure: Change in Phosphate (Inorganic) (Week 34)
timeFrame: Week -3, week 34
measure: Change in Phosphate (Inorganic)(Week 87)
timeFrame: week -3, week 87
measure: Change in Potassium (Week 34)
timeFrame: Week -3, week 34
measure: Change in Potassium (Week 87)
timeFrame: week -3, week 87
measure: Change in Sodium (Week 34)
timeFrame: Week -3, week 34
measure: Change in Sodium (Week 87)
timeFrame: week -3, week 87
measure: Change in Total Protein (Week 34)
timeFrame: Week -3, week 34
measure: Change in Total Protein (Week 87)
timeFrame: week -3, week 87
measure: Change in Urea (Week 34)
timeFrame: Week -3, week 34
measure: Change in Urea (Week 87)
timeFrame: week -3, week 87
measure: Change in Uric Acid (Week 34)
timeFrame: Week -3, week 34
measure: Change in Uric Acid (Week 87)
timeFrame: week -3, week 87
measure: Change in Estimated Glomerular Filtration Rate (GFR) Creatinine (CKD-EPI) (Week 34)
timeFrame: Week -3, week 34
measure: Change in Estimated GFR Creatinine (CKD-EPI) (Week 87)
timeFrame: week -3, week 87
measure: Change in Fasting Plasma Glucose (Week 34)
timeFrame: Week -3, week 34
measure: Change in Fasting Plasma Glucose (Week 87)
timeFrame: week -3, week 87
measure: Change in Fasting Insulin (Week 34)
timeFrame: Week -3, week 34
measure: Change in Fasting Insulin (Week 87)
timeFrame: week -3, week 87
measure: Change in Steady State Beta Cell Function (%B) (Week 34)
timeFrame: Week -3, week 34
measure: Change in Steady State Beta Cell Function (%B) (Week 87)
timeFrame: week -3, week 87
measure: Change in Insulin Resistance (IR %) (Week 34)
timeFrame: Week -3, week 34
measure: Change in Insulin Resistance (IR %) (Week 87)
timeFrame: week -3, week 87
measure: Change in Glycated Haemoglobin (HbA1c) (%) (Week 34)
timeFrame: Week -3, week 34
measure: Change in Glycated Haemoglobin (HbA1c) (%) (Week 87)
timeFrame: week -3, week 87
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Novo Nordisk Investigational Site
state: Alabama
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Los Angeles
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Aurora
country: United States
facility: Novo Nordisk Investigational Site
state: Colorado
city: Atlanta
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Roswell
country: United States
facility: Novo Nordisk Investigational Site
state: Georgia
city: Topeka
country: United States
facility: Novo Nordisk Investigational Site
state: Kansas
city: Baltimore
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: Boston
country: United States
facility: Novo Nordisk Investigational Site
state: Massachusetts
city: East Lansing
country: United States
facility: Novo Nordisk Investigational Site
state: Michigan
city: Saint Louis
country: United States
facility: Novo Nordisk Investigational Site
state: Missouri
city: Omaha
country: United States
facility: Novo Nordisk Investigational Site
state: Nebraska
city: Omaha
country: United States
facility: Novo Nordisk Investigational Site
state: Nebraska
city: Las Vegas
country: United States
facility: Novo Nordisk Investigational Site
state: Nevada
city: Reno
country: United States
facility: Novo Nordisk Investigational Site
state: Nevada
city: New York
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Cleveland
country: United States
facility: Novo Nordisk Investigational Site
state: Ohio
city: Portland
country: United States
facility: Novo Nordisk Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Novo Nordisk Investigational Site
state: Pennsylvania
city: El Paso
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Plano
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Shavano Park
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Novo Nordisk Investigational Site
state: Utah
city: Federal Way
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Seattle
country: United States
facility: Novo Nordisk Investigational Site
state: Washington
city: Blacktown
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Coffs Harbour
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Darlinghurst
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: St Leonards
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Woolloongabba
country: Australia
facility: Novo Nordisk Investigational Site
state: Queensland
city: Box Hill
country: Australia
facility: Novo Nordisk Investigational Site
state: Victoria
city: Parkville
country: Australia
facility: Novo Nordisk Investigational Site
state: Victoria
city: Nedlands
country: Australia
facility: Novo Nordisk Investigational Site
state: Western Australia
city: São Paulo
country: Brazil
facility: Novo Nordisk Investigational Site
state: Sao Paulo
city: Aachen
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Frankfurt
country: Germany
facility: Novo Nordisk Investigational Site
city: Oldenburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Hyderabad
country: India
facility: Novo Nordisk Investigational Site
state: Andhra Pradesh
city: Bangalore
country: India
facility: Novo Nordisk Investigational Site
state: Karnataka
city: Kochi
country: India
facility: Novo Nordisk Investigational Site
state: Kerala
city: Mumbai
country: India
facility: Novo Nordisk Investigational Site
state: Maharashtra
city: New Dehli
country: India
facility: Novo Nordisk Investigational Site
state: New Delhi
city: Chandigarh
country: India
facility: Novo Nordisk Investigational Site
state: Punjab
city: Hyderabad
country: India
facility: Novo Nordisk Investigational Site
state: Telengana
city: Kolkata
country: India
facility: Novo Nordisk Investigational Site
state: West Bengal
city: Petah-Tikva
country: Israel
facility: Novo Nordisk Investigational Site
city: Tel Hashomer
country: Israel
facility: Novo Nordisk Investigational Site
city: Tel-Aviv
country: Israel
facility: Novo Nordisk Investigational Site
city: Bunkyo-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Chiba-shi, Chiba
country: Japan
facility: Novo Nordisk Investigational Site
city: Fukuoka-shi, Fukuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Hamamatsu-shi, Shizuoka
country: Japan
facility: Novo Nordisk Investigational Site
city: Itabashi-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Kagoshima
country: Japan
facility: Novo Nordisk Investigational Site
city: Kyoto-shi Kyoto
country: Japan
facility: Novo Nordisk Investigational Site
city: Minato-ku, Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Okayama, Okayama
country: Japan
facility: Novo Nordisk Investigational Site
city: Sagamihara-shi, Kanagawa
country: Japan
facility: Novo Nordisk Investigational Site
city: Sapporo, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Sappro-shi, Hokkaido
country: Japan
facility: Novo Nordisk Investigational Site
city: Tokyo
country: Japan
facility: Novo Nordisk Investigational Site
city: Yamagata-shi, Yamagata
country: Japan
facility: Novo Nordisk Investigational Site
city: Yokohama, Kanagawa
country: Japan
facility: Novo Nordisk Investigational Site
city: Riga
country: Latvia
facility: Novo Nordisk Investigational Site
city: Kaunas
country: Lithuania
facility: Novo Nordisk Investigational Site
city: Vilnius
country: Lithuania
facility: Novo Nordisk Investigational Site
city: Kuching
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Pulau Pinang
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Putrajaya
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Oslo
country: Norway
facility: Novo Nordisk Investigational Site
city: Bialystok
country: Poland
facility: Novo Nordisk Investigational Site
city: Gdansk
country: Poland
facility: Novo Nordisk Investigational Site
city: Krakow
country: Poland
facility: Novo Nordisk Investigational Site
city: Warszawa
country: Poland
facility: Novo Nordisk Investigational Site
city: Warszawa
country: Poland
facility: Novo Nordisk Investigational Site
city: Wroclaw
country: Poland
facility: Novo Nordisk Investigational Site
city: Wroclaw
country: Poland
facility: Novo Nordisk Investigational Site
city: Cluj Napoca
country: Romania
facility: Novo Nordisk Investigational Site
state: Cluj
city: Targu Mures
country: Romania
facility: Novo Nordisk Investigational Site
state: Mures
city: Bucuresti
country: Romania
facility: Novo Nordisk Investigational Site
city: Iasi
country: Romania
facility: Novo Nordisk Investigational Site
city: Sibiu
country: Romania
facility: Novo Nordisk Investigational Site
city: Timisoara
country: Romania
facility: Novo Nordisk Investigational Site
city: Kazan
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Krasnoyarsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Moscow
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Novosibirsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Tomsk
country: Russian Federation
facility: Novo Nordisk Investigational Site
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Johannesburg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Pretoria
country: South Africa
facility: Novo Nordisk Investigational Site
state: Gauteng
city: Tygerberg
country: South Africa
facility: Novo Nordisk Investigational Site
state: Western Cape
city: Göteborg
country: Sweden
facility: Novo Nordisk Investigational Site
city: Stockholm
country: Sweden
facility: Novo Nordisk Investigational Site
city: Uppsala
country: Sweden
facility: Novo Nordisk Investigational Site
city: Adana
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Istanbul
country: Turkey
facility: Novo Nordisk Investigational Site
city: Izmir
country: Turkey
facility: Novo Nordisk Investigational Site
city: Kocaeli
country: Turkey
facility: Novo Nordisk Investigational Site
city: Kiev
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Kyiv
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Birmingham
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Coventry
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Exeter
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Hull
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Leeds
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Manchester
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Reporting Anchor and Disclosure' (1452)
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.