Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.

Adult Growth Hormone Deficiency Clinical Trial

— REAL 1  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02229851
• Other study ID #: NN8640-4054
• Secondary ID: 2013-002892-16U1
• Status: Completed
• Phase: Phase 3
• Start date: October 31, 2014
• Est. completion date: May 7, 2018

Study information

• Verified date: November 2020
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 301
• Est. completion date: May 7, 2018
• Est. primary completion date: April 21, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Years to 79 Years

Eligibility

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

Related Conditions & MeSH terms

• Adult Growth Hormone Deficiency
• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Disorder

Intervention

Drug:
• somapacitan
Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration. Extension of 44 weeks' treatment following 8 weeks of titration.
• somatropin
Administered subcutaneously (s.c., under the skin) once daily for 26 weeks following 8 weeks of titration. Re-randomisation to extension of 44 weeks' treatment following 8 weeks of titration.
• placebo
Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration.

Locations

Country	Name	City	State
Australia	Novo Nordisk Investigational Site	Blacktown	New South Wales
Australia	Novo Nordisk Investigational Site	Box Hill	Victoria
Australia	Novo Nordisk Investigational Site	Coffs Harbour	New South Wales
Australia	Novo Nordisk Investigational Site	Darlinghurst	New South Wales
Australia	Novo Nordisk Investigational Site	Nedlands	Western Australia
Australia	Novo Nordisk Investigational Site	Parkville	Victoria
Australia	Novo Nordisk Investigational Site	St Leonards	New South Wales
Australia	Novo Nordisk Investigational Site	Woolloongabba	Queensland
Brazil	Novo Nordisk Investigational Site	São Paulo	Sao Paulo
Germany	Novo Nordisk Investigational Site	Aachen
Germany	Novo Nordisk Investigational Site	Berlin
Germany	Novo Nordisk Investigational Site	Berlin
Germany	Novo Nordisk Investigational Site	Frankfurt
Germany	Novo Nordisk Investigational Site	Oldenburg
India	Novo Nordisk Investigational Site	Bangalore	Karnataka
India	Novo Nordisk Investigational Site	Chandigarh	Punjab
India	Novo Nordisk Investigational Site	Hyderabad	Telengana
India	Novo Nordisk Investigational Site	Hyderabad	Andhra Pradesh
India	Novo Nordisk Investigational Site	Kochi	Kerala
India	Novo Nordisk Investigational Site	Kolkata	West Bengal
India	Novo Nordisk Investigational Site	Mumbai	Maharashtra
India	Novo Nordisk Investigational Site	New Dehli	New Delhi
Israel	Novo Nordisk Investigational Site	Petah-Tikva
Israel	Novo Nordisk Investigational Site	Tel Hashomer
Israel	Novo Nordisk Investigational Site	Tel-Aviv
Japan	Novo Nordisk Investigational Site	Bunkyo-ku, Tokyo
Japan	Novo Nordisk Investigational Site	Chiba-shi, Chiba
Japan	Novo Nordisk Investigational Site	Fukuoka-shi, Fukuoka
Japan	Novo Nordisk Investigational Site	Hamamatsu-shi, Shizuoka
Japan	Novo Nordisk Investigational Site	Itabashi-ku, Tokyo
Japan	Novo Nordisk Investigational Site	Kagoshima
Japan	Novo Nordisk Investigational Site	Kyoto-shi Kyoto
Japan	Novo Nordisk Investigational Site	Minato-ku, Tokyo
Japan	Novo Nordisk Investigational Site	Okayama, Okayama
Japan	Novo Nordisk Investigational Site	Sagamihara-shi, Kanagawa
Japan	Novo Nordisk Investigational Site	Sapporo, Hokkaido
Japan	Novo Nordisk Investigational Site	Sappro-shi, Hokkaido
Japan	Novo Nordisk Investigational Site	Tokyo
Japan	Novo Nordisk Investigational Site	Yamagata-shi, Yamagata
Japan	Novo Nordisk Investigational Site	Yokohama, Kanagawa
Latvia	Novo Nordisk Investigational Site	Riga
Lithuania	Novo Nordisk Investigational Site	Kaunas
Lithuania	Novo Nordisk Investigational Site	Vilnius
Malaysia	Novo Nordisk Investigational Site	Kuching
Malaysia	Novo Nordisk Investigational Site	Pulau Pinang
Malaysia	Novo Nordisk Investigational Site	Putrajaya
Norway	Novo Nordisk Investigational Site	Oslo
Poland	Novo Nordisk Investigational Site	Bialystok
Poland	Novo Nordisk Investigational Site	Gdansk
Poland	Novo Nordisk Investigational Site	Krakow
Poland	Novo Nordisk Investigational Site	Warszawa
Poland	Novo Nordisk Investigational Site	Warszawa
Poland	Novo Nordisk Investigational Site	Wroclaw
Poland	Novo Nordisk Investigational Site	Wroclaw
Romania	Novo Nordisk Investigational Site	Bucuresti
Romania	Novo Nordisk Investigational Site	Cluj Napoca	Cluj
Romania	Novo Nordisk Investigational Site	Iasi
Romania	Novo Nordisk Investigational Site	Sibiu
Romania	Novo Nordisk Investigational Site	Targu Mures	Mures
Romania	Novo Nordisk Investigational Site	Timisoara
Russian Federation	Novo Nordisk Investigational Site	Kazan
Russian Federation	Novo Nordisk Investigational Site	Krasnoyarsk
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Moscow
Russian Federation	Novo Nordisk Investigational Site	Novosibirsk
Russian Federation	Novo Nordisk Investigational Site	Tomsk
South Africa	Novo Nordisk Investigational Site	Johannesburg	Gauteng
South Africa	Novo Nordisk Investigational Site	Johannesburg	Gauteng
South Africa	Novo Nordisk Investigational Site	Pretoria	Gauteng
South Africa	Novo Nordisk Investigational Site	Tygerberg	Western Cape
Sweden	Novo Nordisk Investigational Site	Göteborg
Sweden	Novo Nordisk Investigational Site	Stockholm
Sweden	Novo Nordisk Investigational Site	Uppsala
Turkey	Novo Nordisk Investigational Site	Adana
Turkey	Novo Nordisk Investigational Site	Istanbul
Turkey	Novo Nordisk Investigational Site	Istanbul
Turkey	Novo Nordisk Investigational Site	Izmir
Turkey	Novo Nordisk Investigational Site	Kocaeli
Ukraine	Novo Nordisk Investigational Site	Kiev
Ukraine	Novo Nordisk Investigational Site	Kyiv
United Kingdom	Novo Nordisk Investigational Site	Birmingham
United Kingdom	Novo Nordisk Investigational Site	Coventry
United Kingdom	Novo Nordisk Investigational Site	Exeter
United Kingdom	Novo Nordisk Investigational Site	Hull
United Kingdom	Novo Nordisk Investigational Site	Leeds
United Kingdom	Novo Nordisk Investigational Site	London
United Kingdom	Novo Nordisk Investigational Site	London
United Kingdom	Novo Nordisk Investigational Site	Manchester
United States	Novo Nordisk Investigational Site	Atlanta	Georgia
United States	Novo Nordisk Investigational Site	Aurora	Colorado
United States	Novo Nordisk Investigational Site	Baltimore	Maryland
United States	Novo Nordisk Investigational Site	Birmingham	Alabama
United States	Novo Nordisk Investigational Site	Boston	Massachusetts
United States	Novo Nordisk Investigational Site	Cleveland	Ohio
United States	Novo Nordisk Investigational Site	East Lansing	Michigan
United States	Novo Nordisk Investigational Site	El Paso	Texas
United States	Novo Nordisk Investigational Site	Federal Way	Washington
United States	Novo Nordisk Investigational Site	Houston	Texas
United States	Novo Nordisk Investigational Site	Las Vegas	Nevada
United States	Novo Nordisk Investigational Site	Los Angeles	California
United States	Novo Nordisk Investigational Site	Los Angeles	California
United States	Novo Nordisk Investigational Site	New York	New York
United States	Novo Nordisk Investigational Site	Omaha	Nebraska
United States	Novo Nordisk Investigational Site	Omaha	Nebraska
United States	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania
United States	Novo Nordisk Investigational Site	Philadelphia	Pennsylvania
United States	Novo Nordisk Investigational Site	Pittsburgh	Pennsylvania
United States	Novo Nordisk Investigational Site	Plano	Texas
United States	Novo Nordisk Investigational Site	Portland	Oregon
United States	Novo Nordisk Investigational Site	Reno	Nevada
United States	Novo Nordisk Investigational Site	Roswell	Georgia
United States	Novo Nordisk Investigational Site	Saint Louis	Missouri
United States	Novo Nordisk Investigational Site	Salt Lake City	Utah
United States	Novo Nordisk Investigational Site	San Antonio	Texas
United States	Novo Nordisk Investigational Site	Seattle	Washington
United States	Novo Nordisk Investigational Site	Shavano Park	Texas
United States	Novo Nordisk Investigational Site	Topeka	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Germany,  India,  Israel,  Japan,  Latvia,  Lithuania,  Malaysia,  Norway,  Poland,  Romania,  Russian Federation,  South Africa,  Sweden,  Turkey,  Ukraine,  United Kingdom, 

References & Publications (1)

Johannsson G, Gordon MB, Højby Rasmussen M, Håkonsson IH, Karges W, Sværke 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 A — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Week -3, week 34
Secondary	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).	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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).	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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).	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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).	Week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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).	Week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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).	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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).	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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).	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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).	week -3, week 87
Secondary	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).	week -3, week 87
Secondary	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).	week -3, week 87
Secondary	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.	Week -3, week 34
Secondary	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.	Week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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).	Week -3, week 87
Secondary	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.	Week 0, week 34
Secondary	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.	week 0, week 87
Secondary	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.	Week 0, week 34
Secondary	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.	week 0, week 87
Secondary	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.	Week 34
Secondary	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.	Week 87
Secondary	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).	Week -3, week 34
Secondary	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).	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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).	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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).	week -3, week 87
Secondary	Change in Triglycerides (Week 34)	Change in Triglycerides was measured from baseline (week -3) until the end of the main treatment period (week 34).	Week -3, week 34
Secondary	Change in Triglycerides (Week 87)	Change in Triglycerides was measured from baseline (week -3) until the end of the extension treatment period (week 87).	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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).	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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).	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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).	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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).	week -3, week 87
Secondary	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.	Weeks 0-35
Secondary	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.	Weeks 0-88
Secondary	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.	Weeks 0 to 35
Secondary	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.	Weeks 0 to 88
Secondary	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.	Weeks 0 to 35
Secondary	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.	Weeks 0 to 88
Secondary	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	Week 0 and week 35
Secondary	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	Week 0 and week 88
Secondary	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.	Week -3 and week 35
Secondary	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.	Week -3 and week 88
Secondary	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).	Week -3, week 35
Secondary	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.	Week -3, week 88
Secondary	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).	Week -3, week 35
Secondary	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).	Week -3, week 88
Secondary	Change in Pulse (Week 35)	Change in pulse was measured from baseline (week -3) until the end of the main treatment period (week 35).	Week -3, week 35
Secondary	Change in Pulse (Week 88)	Change in pulse was measured from baseline (week -3) until the end of the extension treatment period (week 88).	Week -3, week 88
Secondary	Change in Haemoglobin (Week 34)	Change in Haemoglobin was measured from baseline (week -3) until the end of the main treatment period (week 34).	Week -3, week 34
Secondary	Change in Haemoglobin (Week 87)	Change in Haemoglobin was measured from baseline (week -3) until the end of the week 87.	week -3, week 87
Secondary	Change in Haematocrit (Week 34)	Change in Haematocrit was measured from baseline (week -3) until the end of the main treatment period (week 34).	Week -3, week 34
Secondary	Change in Haematocrit (Week 87)	Change in Haematocrit was measured from baseline (week -3) until the end of the week 87.	week -3, week 87
Secondary	Change in Erythrocytes (Week 34)	Change in Erythrocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).	Week -3, week 34
Secondary	Change in Erythrocytes (Week 87)	Change in Erythrocytes was measured from baseline (week -3) until the end of the week 87.	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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.	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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.	week -3, week 87
Secondary	Change in Thrombocytes (Week 34)	Change in Thrombocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).	Week -3, week 34
Secondary	Change in Thrombocytes (Week 87)	Change in Thrombocytes was measured from baseline (week -3) until the end of the week 87.	week -3, week 87
Secondary	Change in Leucocytes (Week 34)	Change in Leucocytes was measured from baseline (week -3) until the end of the main treatment period (week 34).	Week -3, week 34
Secondary	Change in Leucocytes (Week 87)	Change in Leucocytes was measured from baseline (week -3) until the end of the week 87.	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	Change in Alanine Aminotransferase (ALT) (Week 87)	Change in ALT was measured from baseline (week -3) until the end of the week 87.	week -3, week 87
Secondary	Change in Albumin (Week 34)	Change in Albumin was measured from baseline (week -3) until the end of the main treatment period (week 34).	Week -3, week 34
Secondary	Change in Albumin (Week 87)	Change in Albumin was measured from baseline (week -3) until the end of the week 87.	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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.	Week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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).	Week -3, week 87
Secondary	Change in Bilirubin (Week 34)	Change in Bilirubin was measured from baseline (week -3) until the end of the main treatment period (week 34).	Week -3, week 34
Secondary	Change in Bilirubin (Week 87)	Change in Bilirubin was measured from baseline (week -3) until the end of the extension treatment period (week 87).	week -3, week 87
Secondary	Change in Calcium (Week 34)	Change in Calcium was measured from baseline (week -3) until the end of the main treatment period (week 34).	Week -3, week 34
Secondary	Change in Calcium (Week 87)	Change in Calcium was measured from baseline (week -3) until the end of the week 87.	week -3, week 87
Secondary	Change in Chloride (Week 34)	Change in Chloride was measured from baseline (week -3) until the end of the main treatment period (week 34).	Week -3, week 34
Secondary	Change in Chloride (Week 87)	Change in Chloride was measured from baseline (week -3) until the end of the week 87.	week -3, week 87
Secondary	Change in Creatinine (Week 34)	Change in Creatinine was measured from baseline (week -3) until the end of the main treatment period (week 34).	Week -3, week 34
Secondary	Change in Creatinine (Week 87)	Change in Creatinine was measured from baseline (week -3) until the end of the week 87.	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	Change in Creatine Kinase (Week 87)	Change in Creatine kinase was measured from baseline (week -3) until the end of the week 87.	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	Change in Gamma-glutamyl Transferase (GGT) (Week 87)	Change in GGT was measured from baseline (week -3) until the end of the week 87.	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	Change in Phosphate (Inorganic)(Week 87)	Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the week 87.	week -3, week 87
Secondary	Change in Potassium (Week 34)	Change in Potassium was measured from baseline (week -3) until the end of the main treatment period (week 34).	Week -3, week 34
Secondary	Change in Potassium (Week 87)	Change in Potassium was measured from baseline (week -3) until the end of the week 87.	week -3, week 87
Secondary	Change in Sodium (Week 34)	Change in Sodium was measured from baseline (week -3) until the end of the main treatment period (week 34).	Week -3, week 34
Secondary	Change in Sodium (Week 87)	Change in Sodium was measured from baseline (week -3) until the end of the extension treatment period (week 87).	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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).	week -3, week 87
Secondary	Change in Urea (Week 34)	Change in Urea was measured from baseline (week -3) until the end of the main treatment period (week 34).	Week -3, week 34
Secondary	Change in Urea (Week 87)	Change in Urea was measured from baseline (week -3) until the end of the extension treatment period (week 87).	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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).	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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).	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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).	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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).	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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.	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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).	week -3, week 87
Secondary	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).	Week -3, week 34
Secondary	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).	week -3, week 87

External Links

•   Clinical Trials at Novo Nordisk