Trial Outcomes & Findings for A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency (NCT NCT03075644)

Last Updated: 2020-11-23

Results Overview

An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which did not necessarily have a causal relationship with the treatment. Rate of AEs per 100 patient years at risk with onset after the first administration of trial product and up until end of the trial (53 weeks) or 14 days after last trial drug administration, whichever came first, are presented.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

62 participants

Primary outcome timeframe

Weeks 0-53

Results posted on

2020-11-23

Participant Flow

The trial was conducted at 12 sites in Japan.

Participants were randomised in a 3:1 manner to receive either somapacitan or Norditropin®.

Participant milestones

Participant milestones
Measure	Norditropin® Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Overall Study STARTED	16	46
Overall Study Full Analysis Set (FAS)	16	46
Overall Study Safety Analysis Set (SAS)	16	46
Overall Study COMPLETED	15	45
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Norditropin® Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Norditropin® n=16 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=46 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.	Total n=62 Participants Total of all reporting groups
Age, Continuous	49.3 years STANDARD_DEVIATION 11.5 • n=5 Participants	54.1 years STANDARD_DEVIATION 12.1 • n=7 Participants	52.8 years STANDARD_DEVIATION 12.1 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	22 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants	24 Participants n=7 Participants	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants	46 Participants n=7 Participants	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	16 Participants n=5 Participants	46 Participants n=7 Participants	62 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Weeks 0-53

Population: Safety analysis set (SAS) which comprised all randomised participants who received at least one dose of randomised treatment.

Outcome measures

Outcome measures
Measure	Norditropin® n=16 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=46 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Incidence of Adverse Events, Including Injection Site Reactions	309.8 Event rate per 100 patient years	312.7 Event rate per 100 patient years

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.

Cross-sectional total adipose tissue compartments (TAT) were determined by quantitative computed tomography (CT) scans. Change from baseline (week 0) to end of treatment period (52 weeks) in cross-sectional TAT compartments is presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=14 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=43 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Change in Cross-sectional Total Adipose Tissue Compartments	7.450 Square centimeters (cm^2) Standard Deviation 32.177	-7.091 Square centimeters (cm^2) Standard Deviation 58.893

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.

Subcutaneous adipose tissue compartments (SAT) was determined by quantitative CT scans. Change from baseline (week 0) to end of treatment period (52 weeks) in SAT compartments is presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=14 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=43 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Change in Subcutaneous Adipose Tissue Compartments	6.779 cm^2 Standard Deviation 22.900	-5.033 cm^2 Standard Deviation 40.735

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.

Intra-abdominal or visceral adipose tissue (VAT) compartments was determined by quantitative CT scans. Change from baseline (week 0) to end of treatment period (52 weeks) in VAT compartments is presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=14 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=45 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Change in Intra-abdominal or Visceral Adipose Tissue Compartments	0.671 cm^2 Standard Deviation 15.284	-2.618 cm^2 Standard Deviation 29.123

SECONDARY outcome

Timeframe: Week 0, week 52

Population: FAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.

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 effectiveness of the medication, convenience and global satisfaction of treatment. 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. Change in TSQM-9 scores from baseline (week 0) to week 52 are presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=14 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=45 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Change in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores Effectiveness	3.6 Score on a scale Standard Deviation 16.2	7.9 Score on a scale Standard Deviation 17.5
Change in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores Convenience	8.7 Score on a scale Standard Deviation 9.9	13.3 Score on a scale Standard Deviation 17.3
Change in Treatment Satisfaction Questionnaire for Medication (TSQM-9) Scores Global satisfaction	3.1 Score on a scale Standard Deviation 11.1	10.0 Score on a scale Standard Deviation 16.8

SECONDARY outcome

Timeframe: Week 0, week 52

Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of randomised treatment. Number Analyzed = number of participants with available data.

Physical examination parameters were evaluated for head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system, gastrointestinal system, incl. mouth; musculoskeletal system; nervous system (central and peripheral); skin; and lymph node palpation. The investigator evaluated the findings from the physical examination and classifies them as normal, abnormal not clinically significant (NCS) and abnormal clinically significant (CS). Results are presented for week 0 and week 52.

Outcome measures

Outcome measures
Measure	Norditropin® n=16 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=46 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Change in Physical Examination Week 0: Respiratory system · Normal	16 Participants	46 Participants
Change in Physical Examination Week 0: Respiratory system · Abnormal NCS	0 Participants	0 Participants
Change in Physical Examination Week 0: Respiratory system · Abnormal CS	0 Participants	0 Participants
Change in Physical Examination Week 0: Head, ears, eyes, nose, throat, neck · Normal	15 Participants	45 Participants
Change in Physical Examination Week 0: Head, ears, eyes, nose, throat, neck · Abnormal NCS	0 Participants	1 Participants
Change in Physical Examination Week 0: Head, ears, eyes, nose, throat, neck · Abnormal CS	1 Participants	0 Participants
Change in Physical Examination Week 52: Head, ears, eyes, nose, throat, neck · Normal	14 Participants	43 Participants
Change in Physical Examination Week 52: Head, ears, eyes, nose, throat, neck · Abnormal NCS	0 Participants	1 Participants
Change in Physical Examination Week 52: Head, ears, eyes, nose, throat, neck · Abnormal CS	1 Participants	1 Participants
Change in Physical Examination Week 52: Respiratory system · Normal	15 Participants	45 Participants
Change in Physical Examination Week 52: Respiratory system · Abnormal NCS	0 Participants	0 Participants
Change in Physical Examination Week 52: Respiratory system · Abnormal CS	0 Participants	0 Participants
Change in Physical Examination Week 0: Cardiovascular system · Normal	16 Participants	46 Participants
Change in Physical Examination Week 0: Cardiovascular system · Abnormal NCS	0 Participants	0 Participants
Change in Physical Examination Week 0: Cardiovascular system · Abnormal CS	0 Participants	0 Participants
Change in Physical Examination Week 52: Cardiovascular system · Normal	15 Participants	44 Participants
Change in Physical Examination Week 52: Cardiovascular system · Abnormal NCS	0 Participants	1 Participants
Change in Physical Examination Week 52: Cardiovascular system · Abnormal CS	0 Participants	0 Participants
Change in Physical Examination Week 0: Gastrointestinal system · Normal	15 Participants	46 Participants
Change in Physical Examination Week 0: Gastrointestinal system · Abnormal NCS	1 Participants	0 Participants
Change in Physical Examination Week 0: Gastrointestinal system · Abnormal CS	0 Participants	0 Participants
Change in Physical Examination Week 52: Gastrointestinal system · Normal	15 Participants	45 Participants
Change in Physical Examination Week 52: Gastrointestinal system · Abnormal NCS	0 Participants	0 Participants
Change in Physical Examination Week 52: Gastrointestinal system · Abnormal CS	0 Participants	0 Participants
Change in Physical Examination Week 0: Musculoskeletal system · Normal	16 Participants	45 Participants
Change in Physical Examination Week 0: Musculoskeletal system · Abnormal NCS	0 Participants	1 Participants
Change in Physical Examination Week 0: Musculoskeletal system · Abnormal CS	0 Participants	0 Participants
Change in Physical Examination Week 52: Musculoskeletal system · Normal	15 Participants	43 Participants
Change in Physical Examination Week 52: Musculoskeletal system · Abnormal NCS	0 Participants	0 Participants
Change in Physical Examination Week 52: Musculoskeletal system · Abnormal CS	0 Participants	2 Participants
Change in Physical Examination Week 0: Nervous system · Normal	16 Participants	46 Participants
Change in Physical Examination Week 0: Nervous system · Abnormal NCS	0 Participants	0 Participants
Change in Physical Examination Week 0: Nervous system · Abnormal CS	0 Participants	0 Participants
Change in Physical Examination Week 52: Nervous system · Normal	15 Participants	45 Participants
Change in Physical Examination Week 52: Nervous system · Abnormal NCS	0 Participants	0 Participants
Change in Physical Examination Week 52: Nervous system · Abnormal CS	0 Participants	0 Participants
Change in Physical Examination Week 0: Skin · Normal	16 Participants	46 Participants
Change in Physical Examination Week 0: Skin · Abnormal NCS	0 Participants	0 Participants
Change in Physical Examination Week 0: Skin · Abnormal CS	0 Participants	0 Participants
Change in Physical Examination Week 52: Skin · Normal	15 Participants	44 Participants
Change in Physical Examination Week 52: Skin · Abnormal NCS	0 Participants	1 Participants
Change in Physical Examination Week 52: Skin · Abnormal CS	0 Participants	0 Participants
Change in Physical Examination Week 0: Lymph node palpation · Normal	16 Participants	44 Participants
Change in Physical Examination Week 0: Lymph node palpation · Abnormal NCS	0 Participants	2 Participants
Change in Physical Examination Week 0: Lymph node palpation · Abnormal CS	0 Participants	0 Participants
Change in Physical Examination Week 52: Lymph node palpation · Normal	15 Participants	45 Participants
Change in Physical Examination Week 52: Lymph node palpation · Abnormal NCS	0 Participants	0 Participants
Change in Physical Examination Week 52: Lymph node palpation · Abnormal CS	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week -3, week 52

Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.

Change from baseline (week -3) in body weight at week 52 is presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=14 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=45 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Change in Body Weight	0.66 Kilogram (Kg) Standard Deviation 2.50	-0.29 Kilogram (Kg) Standard Deviation 3.49

SECONDARY outcome

Timeframe: Week 0, week 52

Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in systolic blood pressure (SBP) and diastolic blood pressure (DBP) at week 52 is presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=14 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=45 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Change in SBP and DBP SBP	-3.1 Millimeters of mercury (mmHg) Standard Deviation 14.8	-3.3 Millimeters of mercury (mmHg) Standard Deviation 11.7
Change in SBP and DBP DBP	1.1 Millimeters of mercury (mmHg) Standard Deviation 9.7	0.9 Millimeters of mercury (mmHg) Standard Deviation 8.7

SECONDARY outcome

Timeframe: Week 0, week 52

Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.

Change from baseline (week 0) in pulse at week 52 is presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=14 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=45 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Change in Pulse	-1.1 Beats per minute Standard Deviation 7.5	1.4 Beats per minute Standard Deviation 8.9

SECONDARY outcome

Timeframe: Week -3, week 52

The ECG was assessed by the investigator at baseline (week -3) and week 52 and categorised as normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at week -3 and week 52 are presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=16 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=46 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Change in ECG week -3 · Normal	16 Participants	39 Participants
Change in ECG week -3 · Abnormal NCS	0 Participants	7 Participants
Change in ECG week -3 · Abnormal CS	0 Participants	0 Participants
Change in ECG week 52 · Normal	15 Participants	37 Participants
Change in ECG week 52 · Abnormal NCS	0 Participants	8 Participants
Change in ECG week 52 · Abnormal CS	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week -3, week 52

Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.

Change from baseline (week -3) in haemoglobin at week 52 is presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=14 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=45 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Change in Haematology: Haemoglobin	-2.071 Grams/liter (g/L) Standard Deviation 7.790	0.311 Grams/liter (g/L) Standard Deviation 6.026

SECONDARY outcome

Timeframe: Week -3, week 52

Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.

Change from baseline (week -3) in haematocrit at week 52 is presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=14 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=45 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Change in Haematology: Haematocrit	-0.64 Percentage point of haematocrit Standard Deviation 2.76	0.04 Percentage point of haematocrit Standard Deviation 2.31

SECONDARY outcome

Timeframe: Week -3, week 52

Change from baseline (week -3) in thrombocytes and leucocytes at week 52 is presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=16 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=46 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Change in Haematology: Thrombocytes, Leucocytes Thrombocytes	0.1 10^9 cells/L Standard Deviation 27.7	5.7 10^9 cells/L Standard Deviation 33.5
Change in Haematology: Thrombocytes, Leucocytes Leucocytes	-0.29 10^9 cells/L Standard Deviation 1.01	-0.50 10^9 cells/L Standard Deviation 1.43

SECONDARY outcome

Timeframe: Week -3, week 52

Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.

Change from baseline (week -3) in erythrocytes at week 52 is presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=14 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=45 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Change in Haematology: Erythrocytes	-0.086 cells per picoliter Standard Deviation 0.271	-0.007 cells per picoliter Standard Deviation 0.228

SECONDARY outcome

Timeframe: Week -3, week 52

Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.

Change from baseline (week -3) in mean corpuscular volume at week 52 is presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=14 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=45 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Change in Haematology: Mean Corpuscular Volume	0.00 Femtoliters (fL) Standard Deviation 2.45	0.29 Femtoliters (fL) Standard Deviation 1.91

SECONDARY outcome

Timeframe: Week -3, week 52

Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.

Change from baseline (week -3) in mean corpuscular haemoglobin concentration at week 52 is presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=14 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=45 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Change in Haematology: Mean Corpuscular Haemoglobin Concentration	0.04 Millimoles per liter (mmol/L) Standard Deviation 0.47	0.05 Millimoles per liter (mmol/L) Standard Deviation 0.45

SECONDARY outcome

Timeframe: Week -3, week 52

Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.

Change from baseline (week -3) in creatinine, uric acid, and bilirubin (total) at week 52 is presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=14 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=45 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Change in Biochemistry: Creatinine, Uric Acid, and Bilirubin (Total) Creatinine	1.4 Micromoles per liter (umol/L) Standard Deviation 7.8	1.0 Micromoles per liter (umol/L) Standard Deviation 7.4
Change in Biochemistry: Creatinine, Uric Acid, and Bilirubin (Total) Uric acid	25.9 Micromoles per liter (umol/L) Standard Deviation 41.9	6.7 Micromoles per liter (umol/L) Standard Deviation 49.9
Change in Biochemistry: Creatinine, Uric Acid, and Bilirubin (Total) Total bilirubin	-0.21 Micromoles per liter (umol/L) Standard Deviation 5.21	0.56 Micromoles per liter (umol/L) Standard Deviation 3.81

SECONDARY outcome

Timeframe: Week -3, week 52

Population: SAS which comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.

Change from baseline (week -3) in creatinine kinase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) and gamma-glutamyl transferase (GGT) at week 52 is presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=14 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=45 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT Creatinine kinase	-10.4 Units per liter (U/L) Standard Deviation 66.8	6.8 Units per liter (U/L) Standard Deviation 261.3
Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT ALT	-4.9 Units per liter (U/L) Standard Deviation 13.4	-1.6 Units per liter (U/L) Standard Deviation 9.4
Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT AST	-3.2 Units per liter (U/L) Standard Deviation 10.3	-1.4 Units per liter (U/L) Standard Deviation 7.2
Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT ALP	-9.1 Units per liter (U/L) Standard Deviation 11.0	-0.7 Units per liter (U/L) Standard Deviation 11.4
Change in Biochemistry: Creatinine Kinase, ALT, AST, ALP and GGT GGT	-9.4 Units per liter (U/L) Standard Deviation 19.2	-0.6 Units per liter (U/L) Standard Deviation 6.6

SECONDARY outcome

Timeframe: Week -3, week 52

Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.

Change from baseline (week -3) in urea, sodium, potassium, chloride, phosphate (inorganic), calcium (total) (mmol/L) at week 52 is presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=14 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=45 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total) Total calcium	-0.067 mmol/L Standard Deviation 0.068	-0.051 mmol/L Standard Deviation 0.082
Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total) Urea	0.29 mmol/L Standard Deviation 0.83	0.71 mmol/L Standard Deviation 1.29
Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total) Sodium	-0.3 mmol/L Standard Deviation 1.9	0.2 mmol/L Standard Deviation 2.8
Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total) Potassium	-0.04 mmol/L Standard Deviation 0.29	0.04 mmol/L Standard Deviation 0.34
Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total) Chloride	0.4 mmol/L Standard Deviation 2.8	0.6 mmol/L Standard Deviation 2.9
Change in Biochemistry: Urea, Sodium, Potassium, Chloride, Phosphate (Inorganic), Calcium (Total) Inorganic phosphate	0.000 mmol/L Standard Deviation 0.185	0.028 mmol/L Standard Deviation 0.172

SECONDARY outcome

Timeframe: Week -3, week 52

Change from baseline (week -3) in total protein and albumin at week 52 is presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=14 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=45 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Change in Biochemistry: Total Protein and Albumin Total protein	-0.6 Grams/liter (g/L) Standard Deviation 3.7	1.4 Grams/liter (g/L) Standard Deviation 3.1
Change in Biochemistry: Total Protein and Albumin Albumin	0.3 Grams/liter (g/L) Standard Deviation 2.8	1.3 Grams/liter (g/L) Standard Deviation 2.4

SECONDARY outcome

Timeframe: Week -3, week 52

Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.

Estimated glomerular filtration rate (eGFR) creatinine (measured in milliliters per minute per 1.73 square meters \[mL/min/1.73m\^2\]) was evaluated using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula. Change from baseline (week -3) in eGFR at week 52 is presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=14 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=45 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Change in Biochemistry: eGFR Creatinine	-1.4 mL/min/1.73m^2 Standard Deviation 7.1	-1.4 mL/min/1.73m^2 Standard Deviation 6.2

SECONDARY outcome

Timeframe: Week -3, week 52

Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.

Change from baseline (week -3) in glycosylated haemoglobin (HbA1c) at week 52 is presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=14 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=45 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Change in HbA1c	-0.04 Percentage point of HbA1c Standard Deviation 0.22	-0.07 Percentage point of HbA1c Standard Deviation 0.21

SECONDARY outcome

Timeframe: Week -3, week 52

Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.

Change from baseline (week -3) in fasting plasma glucose (FPG) (mmol/L) at week 52 is presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=14 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=45 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Change in FPG	0.014 mmol/L Standard Deviation 0.442	0.089 mmol/L Standard Deviation 0.453

SECONDARY outcome

Timeframe: Week -3, week 52

Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.

Change from baseline (week -3) in fasting insulin at week 52 is presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=14 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=45 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Change in Fasting Insulin	-16.7 Picomoles per liter (pmol/L) Standard Deviation 54.1	-8.7 Picomoles per liter (pmol/L) Standard Deviation 44.7

SECONDARY outcome

Timeframe: Week -3, week 52

Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.

Change from baseline (week -3) in steady state beta cell function (%B) at week 52 is presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=12 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=39 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Change in Steady State Beta Cell Function	-23.58 Percentage of beta cell function (%B) Standard Deviation 69.76	-19.06 Percentage of beta cell function (%B) Standard Deviation 65.61

SECONDARY outcome

Timeframe: Week -3, week 52

Population: SAS comprised all randomised participants who received at least one dose of randomised treatment. Overall number of participants analyzed = number of participants with available data.

Change from baseline (week -3) in insulin resistance (IR) (Homeostatic model assessment (HOMA) estimates) at week 52 is presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=14 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=45 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Change in Insulin Resistance	-0.60 Percentage (%) of IR Standard Deviation 2.03	-0.25 Percentage (%) of IR Standard Deviation 1.70

SECONDARY outcome

Timeframe: Weeks 0 - 53

Number of participants with anti-somapacitan antibodies at baseline (week 0) and week 53 are presented. This outcome measure is applicable only for the treatment arm "Somapacitan".

Outcome measures

Outcome measures
Measure	Norditropin® n=46 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Occurrence of Anti-somapacitan Antibodies Week 0	0 Participants	—
Occurrence of Anti-somapacitan Antibodies Week 53	0 Participants	—

SECONDARY outcome

Timeframe: Weeks 0 - 53

Number of participants with anti-human growth hormone (hGH) antibodies at baseline (week 0) and week 53 are presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=16 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=46 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Occurrence of Anti-hGH Antibodies Week 0	0 Participants	1 Participants
Occurrence of Anti-hGH Antibodies Week 53	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Weeks 0 - 53

Population: Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of randomised treatment.

A technical complaint was any written, electronic, or oral communication that alleged product (medicine or device) defects. Number of partipants who reported technical complaints during the course of the trial are presented.

Outcome measures

Outcome measures
Measure	Norditropin® n=16 Participants Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=46 Participants Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Incidence of Clinical Technical Complaints	1 Participants	0 Participants

Adverse Events

Norditropin®

Serious events: 0 serious events

Other events: 11 other events

Deaths: 0 deaths

Somapacitan

Serious events: 4 serious events

Other events: 33 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Norditropin® n=16 participants at risk Participants were to receive a subcutaneous (s.c.) injection of Norditropin® once daily for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on insulin like growth factor-I standard deviation score (IGF-I SDS) values. The starting dose was 0.2 milligrams per day (mg/day) for participants between 18 and 60 years of age; 0.3 mg/day for females on oral oestrogen irrespective of age; and 0.1 mg/day for participants older than 60 years. The maximum daily dose of Norditropin® was 1.0 milligram (mg).	Somapacitan n=46 participants at risk Participants were to receive a s.c. injection of somapacitan once weekly for 52 weeks (20 weeks of dose titration and 32 weeks of fixed dose treatment). The dose was titrated every fourth week starting from week 4 based on IGF-I SDS values. The starting dose was 1.5 milligrams per week (mg/week) for participants between 18 and 60 years of age; 2.0 mg/week for females on oral oestrogen irrespective of age; and 1.0 mg/week for participants older than 60 years. The maximum weekly dose of somapacitan was 8 mg.
Infections and infestations Gastroenteritis	0.00% 0/16 • Weeks 0 - 53 All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 14 days after the last day of trial product administration. Results are based on the SAS which comprised all randomised participants who received at least one dose of randomised treatment.	2.2% 1/46 • Number of events 1 • Weeks 0 - 53 All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 14 days after the last day of trial product administration. Results are based on the SAS which comprised all randomised participants who received at least one dose of randomised treatment.
Injury, poisoning and procedural complications Head injury	0.00% 0/16 • Weeks 0 - 53 All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 14 days after the last day of trial product administration. Results are based on the SAS which comprised all randomised participants who received at least one dose of randomised treatment.	2.2% 1/46 • Number of events 1 • Weeks 0 - 53 All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 14 days after the last day of trial product administration. Results are based on the SAS which comprised all randomised participants who received at least one dose of randomised treatment.
Gastrointestinal disorders Inguinal hernia	0.00% 0/16 • Weeks 0 - 53 All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 14 days after the last day of trial product administration. Results are based on the SAS which comprised all randomised participants who received at least one dose of randomised treatment.	2.2% 1/46 • Number of events 1 • Weeks 0 - 53 All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 14 days after the last day of trial product administration. Results are based on the SAS which comprised all randomised participants who received at least one dose of randomised treatment.
Gastrointestinal disorders Large intestine polyp	0.00% 0/16 • Weeks 0 - 53 All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 14 days after the last day of trial product administration. Results are based on the SAS which comprised all randomised participants who received at least one dose of randomised treatment.	2.2% 1/46 • Number of events 1 • Weeks 0 - 53 All presented AEs are TEAEs. A TEAE was defined as an event that had onset date on or after the first day of exposure to trial product and no later than 14 days after the last day of trial product administration. Results are based on the SAS which comprised all randomised participants who received at least one dose of randomised treatment.

Other adverse events

Additional Information

Clinical Reporting Anchor and Disclosure (1452)

Novo Nordisk A/S

Phone: (+1) 866-867-7178

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
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Restriction type: OTHER