Trial Outcomes & Findings for A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4) (NCT NCT03811535)

Results Overview

Height velocity (HV) was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

200 participants

Primary outcome timeframe

From baseline (week 0) to visit 7 (week 52)

Results posted on

2026-01-06

Participant Flow

The trial was conducted at 86 sites in 20 countries as follows (number of sites that screened participants/ number of sites that randomized participants): Austria (2/1); Canada (1/1); Denmark (1/0); France (4/4); Germany (3/2); Hungary (1/0); India (3/3); Israel (4/4); Italy (3/2); Japan (17/14); Korea (8/6); Latvia (1/1); Poland (1/1); Russia (8/8); Serbia (5/3); Slovenia (1/1); Spain (2/2); Switzerland (1/1); Thailand (2/2); Ukraine (3/3); United Kingdom (5/5); United States (23/22).

Data reported based on the main part of the trial i.e. up to week 52.

Participant milestones

Participant milestones
Measure	Norditropin Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).	Somapacitan Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
Overall Study STARTED	68	132
Overall Study COMPLETED	68	132
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Norditropin n=68 Participants Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).	Somapacitan n=132 Participants Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).	Total n=200 Participants Total of all reporting groups
Age, Continuous	6.43 years STANDARD_DEVIATION 2.42 • n=37 Participants	6.38 years STANDARD_DEVIATION 2.23 • n=56 Participants	6.40 years STANDARD_DEVIATION 2.29 • n=82 Participants
Sex: Female, Male Female	18 Participants n=37 Participants	33 Participants n=56 Participants	51 Participants n=82 Participants
Sex: Female, Male Male	50 Participants n=37 Participants	99 Participants n=56 Participants	149 Participants n=82 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=37 Participants	4 Participants n=56 Participants	5 Participants n=82 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	63 Participants n=37 Participants	119 Participants n=56 Participants	182 Participants n=82 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=37 Participants	9 Participants n=56 Participants	13 Participants n=82 Participants
Race/Ethnicity, Customized Race · White	36 Participants n=37 Participants	78 Participants n=56 Participants	114 Participants n=82 Participants
Race/Ethnicity, Customized Race · Asian	28 Participants n=37 Participants	46 Participants n=56 Participants	74 Participants n=82 Participants
Race/Ethnicity, Customized Race · Black or African American	1 Participants n=37 Participants	0 Participants n=56 Participants	1 Participants n=82 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=37 Participants	1 Participants n=56 Participants	1 Participants n=82 Participants
Race/Ethnicity, Customized Race · Not reported	3 Participants n=37 Participants	7 Participants n=56 Participants	10 Participants n=82 Participants

PRIMARY outcome

Timeframe: From baseline (week 0) to visit 7 (week 52)

Population: Full analysis set included all randomized participants.

Height velocity (HV) was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Outcome measures

Outcome measures
Measure	Norditropin n=68 Participants Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).	Somapacitan n=132 Participants Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
Height Velocity: In-trial Observation Period	11.8 centimeters per year (cm/year) Standard Deviation 2.9	11.2 centimeters per year (cm/year) Standard Deviation 2.5

PRIMARY outcome

Timeframe: From baseline (week 0) to visit 7 (week 52)

Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data.

Height velocity was derived from height measurements taken at baseline and Week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years). Data is reported for 'on-treatment' observation period. On-treatment observation period: from first administration and up until last trial contact, visit 7 or 14 days after last administration, whichever comes first.

Outcome measures

Outcome measures
Measure	Norditropin n=68 Participants Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).	Somapacitan n=131 Participants Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
Height Velocity: On-treatment Observation Period	11.8 cm/year Standard Deviation 2.9	11.2 cm/year Standard Deviation 2.5

SECONDARY outcome

Timeframe: Baseline (week -2), week 52

Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data.

Change from baseline (week -2) in bone age at week 52 is presented. X-ray images of left hand and wrist for bone age assessment according to the Greulich and Pyle atlas were taken. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Outcome measures

Outcome measures
Measure	Norditropin n=68 Participants Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).	Somapacitan n=131 Participants Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
Change in Bone Age	1.28 Years Standard Deviation 0.76	1.13 Years Standard Deviation 0.78

SECONDARY outcome

Timeframe: Baseline (week 0), week 52

Population: Full analysis set included all randomized participants.

Change from baseline (week 0) in HSDS at week 52 is presented. HSDS was derived using Centre for Disease Control and Prevention (CDC) standards. The range for HSDS was -10 to +10. Negative scores indicated a height below the mean height for a child with the same age and gender, whereas positive scores indicated a height above the mean height for a child with the same age and gender. Positive value in change from baseline in HSDS indicated that HSDS was better than baseline HSDS. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Outcome measures

Outcome measures
Measure	Norditropin n=68 Participants Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).	Somapacitan n=132 Participants Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
Change in Height Standard Deviation Score (HSDS)	1.37 Score on a scale Standard Deviation 0.69	1.21 Score on a scale Standard Deviation 0.54

SECONDARY outcome

Timeframe: Baseline (week 0), week 52

Population: Full analysis set included all randomized participants.

Change from baseline (week 0) in HV SDS at week 52 is presented. HV SDS was calculated using the formula: HV SDS = (height velocity - mean)/standard deviation (SD), where height velocity was the height velocity variable measured, mean and SD of height velocity by gender and age for the reference population. The range for HV SDS was -10 to +10. Negative scores indicated a height velocity below the mean height velocity for a child with the same age and gender, whereas positive scores indicated a height velocity above the mean height velocity for a child with the same age and gender. Positive value in change from baseline in HV SDS indicated that HV SDS was better than baseline HV SDS. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Outcome measures

Outcome measures
Measure	Norditropin n=68 Participants Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).	Somapacitan n=132 Participants Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
Change in Height Velocity Standard Deviation Score (HV SDS)	8.97 Score on a scale Standard Deviation 4.38	7.97 Score on a scale Standard Deviation 3.36

SECONDARY outcome

Timeframe: Baseline (week -2), week 52

Population: Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment. Overall Number of Participants Analyzed = participants with available data.

Change from baseline (week -2) in FPG at week 52 is presented.

Outcome measures

Outcome measures
Measure	Norditropin n=66 Participants Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).	Somapacitan n=124 Participants Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
Change in Fasting Plasma Glucose (FPG) at Week 52	0.255 Millimoles per liter (mmol/L) Standard Deviation 0.790	0.083 Millimoles per liter (mmol/L) Standard Deviation 0.567

SECONDARY outcome

Timeframe: Baseline (week -2), week 104

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (week -2), week 156

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (week -2), week 208

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (week -2), week 52

Population: Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment. Overall Number of Participants Analyzed = participants with available data.

Change from baseline (week -2) in HOMA-B at week 52 is presented. HOMA-B is a measure of the beta cell function and was calculated as follows: HOMA-B = (20 \* fasting insulin (picomoles per liter \[pmol/L\]) \* 1/6(microunit per milliliter \[µU/mL\]))/ FPG(mmol/L)-3.5). Negative change from baseline in HOMA-B indicated a worse outcome.

Outcome measures

Outcome measures
Measure	Norditropin n=58 Participants Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).	Somapacitan n=111 Participants Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
Change in Homeostatic Model Assessment Steady State Beta Cell Function (HOMA-B) at Week 52	69.24 Percentage of HOMA-B Standard Deviation 81.59	37.71 Percentage of HOMA-B Standard Deviation 59.25

SECONDARY outcome

Timeframe: Baseline (week -2), week 104

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (week -2), week 156

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (week -2), week 208

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (week -2), week 52

Population: Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment. Overall Number of Participants Analyzed = participants with available data.

Change from baseline (week -2) in HOMA-IR at week 52 is presented. HOMA-IR is an evaluation of the insulin resistance and was calculated as HOMA-IR = fasting insulin (pmol/L) \* 1/6(µU/mL) \* FPG(mmol/L) / 22.5. Positive change from baseline in HOMA-IR indicated a worse outcome.

Outcome measures

Outcome measures
Measure	Norditropin n=60 Participants Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).	Somapacitan n=114 Participants Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
Change in Homeostatic Model Assessment Insulin Resistance (HOMA-IR) at Week 52	1.03 Percentage of HOMA-IR Standard Deviation 1.12	0.60 Percentage of HOMA-IR Standard Deviation 1.13

SECONDARY outcome

Timeframe: Baseline (week -2), week 104

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (week -2), week 156

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (week -2), week 208

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (week -2), week 52

Population: Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment. Overall Number of Participants Analyzed = participants with available data.

Change from baseline (week -2) in HbA1c at week 52 is presented.

Outcome measures

Outcome measures
Measure	Norditropin n=68 Participants Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).	Somapacitan n=130 Participants Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
Change in Glycated Haemoglobin (HbA1c) at Week 52	0.11 Percentage of HbA1c Standard Deviation 0.26	0.09 Percentage of HbA1c Standard Deviation 0.22

SECONDARY outcome

Timeframe: Baseline (week -2), week 104

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (week -2), week 156

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (week -2), week 208

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (week 0), week 52

Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data.

Change from baseline (week 0) in IGF-I SDS at week 52 is presented. The range for IGF-I SDS was from -10 to +10. Negative scores indicated a IGF-I below the mean IGF-I for a child with the same age and gender, whereas positive scores indicated a IGF-I above the mean IGF-I for a child with the same age and gender. For participants with low IGF-I SDS at baseline, a positive change from baseline in IGF-I SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Outcome measures

Outcome measures
Measure	Norditropin n=67 Participants Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).	Somapacitan n=132 Participants Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS) at Week 52	2.41 Score on a scale Standard Deviation 1.09	2.32 Score on a scale Standard Deviation 1.27

SECONDARY outcome

Timeframe: Baseline (week 0), week 104

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (week 0), week 156

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (week 0), week 208

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (week 0), week 52

Population: Full analysis set included all randomized participants. Overall Number of Participants Analyzed = participants with available data.

Change from baseline (week 0) in IGFBP-3 SDS at week 52 is presented. The range for IGFBP-3 SDS was from -10 to +10. Negative scores indicated a IGFBP-3 below the mean IGFBP-3 for a child with the same age and gender, whereas positive scores indicated a IGFBP-3 above the mean IGFBP-3 for a child with the same age and gender. For participants with low IGFBP-3 SDS at baseline, a positive change from baseline in IGFBP-3 SDS indicated a better outcome. Data is reported for 'in-trial' observation period. In-trial observation period: from first administration and up until visit 7 or last trial contact, whichever comes first.

Outcome measures

Outcome measures
Measure	Norditropin n=67 Participants Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).	Somapacitan n=132 Participants Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) Standard Deviation Score (SDS) at Week 52	1.68 Score on a scale Standard Deviation 1.02	1.58 Score on a scale Standard Deviation 0.92

SECONDARY outcome

Timeframe: Baseline (week 0), week 104

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (week 0), week 156

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (week 0), week 208

Outcome measures

Outcome data not reported

Adverse Events

Norditropin

Serious events: 2 serious events

Other events: 22 other events

Deaths: 0 deaths

Somapacitan

Serious events: 6 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Norditropin n=68 participants at risk Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).	Somapacitan n=132 participants at risk Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
Respiratory, thoracic and mediastinal disorders Adenoidal hypertrophy	0.00% 0/68 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.	0.76% 1/132 • Number of events 1 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.
Endocrine disorders Adrenocortical insufficiency acute	1.5% 1/68 • Number of events 1 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.	0.00% 0/132 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/68 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.	0.76% 1/132 • Number of events 1 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.
Infections and infestations COVID-19	1.5% 1/68 • Number of events 1 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.	0.00% 0/132 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.
Congenital, familial and genetic disorders Cryptorchism	0.00% 0/68 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.	0.76% 1/132 • Number of events 1 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/68 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.	0.76% 1/132 • Number of events 1 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.
Infections and infestations Gastroenteritis	1.5% 1/68 • Number of events 1 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.	0.00% 0/132 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.
Nervous system disorders Headache	0.00% 0/68 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.	0.76% 1/132 • Number of events 1 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.
Infections and infestations Otitis media	0.00% 0/68 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.	0.76% 1/132 • Number of events 1 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.
Gastrointestinal disorders Umbilical hernia	0.00% 0/68 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.	0.76% 1/132 • Number of events 1 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.
Gastrointestinal disorders Vomiting	0.00% 0/68 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.	0.76% 1/132 • Number of events 1 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.

Other adverse events

Other adverse events
Measure	Norditropin n=68 participants at risk Participants received 0.034 milligrams/kilogram (mg/kg) norditropin subcutaneously (s.c.; under the skin) by FlexPro pen-injector once daily for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).	Somapacitan n=132 participants at risk Participants received 0.16 mg/kg somapacitan s.c. once weekly by PDS290 pen-injector for 52 weeks (main trial period). Participants completing the main trial period will receive 0.16 mg/kg somapacitan once weekly for 3 years (extension period).
Infections and infestations Bronchitis	7.4% 5/68 • Number of events 5 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.	3.0% 4/132 • Number of events 6 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.
Nervous system disorders Headache	8.8% 6/68 • Number of events 11 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.	12.1% 16/132 • Number of events 22 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.
Infections and infestations Nasopharyngitis	10.3% 7/68 • Number of events 13 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.	11.4% 15/132 • Number of events 22 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	2.9% 2/68 • Number of events 4 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.	9.1% 12/132 • Number of events 17 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.
General disorders Pyrexia	10.3% 7/68 • Number of events 12 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.	7.6% 10/132 • Number of events 14 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.
Gastrointestinal disorders Vomiting	5.9% 4/68 • Number of events 6 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.	4.5% 6/132 • Number of events 10 • From week -2 up to week 52 Safety analysis set included all randomized participants exposed to at least one dose of randomized treatment.

Additional Information

Clinical Reporting Office (2834)

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.
Publication restrictions are in place

Restriction type: OTHER