Trial Outcomes & Findings for A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day. (NCT NCT04970654)
NCT ID: NCT04970654
Last Updated: 2026-01-06
Results Overview
Height velocity (HV) was derived from height measurements taken at baseline (week 0) and the week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
110 participants
Primary outcome timeframe
Baseline (Week 0); Week 52
Results posted on
2026-01-06
Participant Flow
The trial was conducted at 20 sites in China.
Participants were randomized in a 2:1 ratio to receive either somapacitan or Norditropin.
Participant milestones
| Measure |
Norditropin
Participants received Norditropin 0.034 mg/kg (milligram per kilogram) subcutaneous injection once daily using PDS290 pen injector for 52 weeks.
|
Somapacitan
Participants received somapacitan 0.16 mg/kg subcutaneous injection once weekly using PDS290 pen injector for 52 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
74
|
|
Overall Study
Full Analysis Set
|
36
|
74
|
|
Overall Study
Safety Analysis Set
|
36
|
74
|
|
Overall Study
COMPLETED
|
32
|
71
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Norditropin
Participants received Norditropin 0.034 mg/kg (milligram per kilogram) subcutaneous injection once daily using PDS290 pen injector for 52 weeks.
|
Somapacitan
Participants received somapacitan 0.16 mg/kg subcutaneous injection once weekly using PDS290 pen injector for 52 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by parents/guardian
|
1
|
2
|
|
Overall Study
Unclassified
|
2
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
A Research Study in Chinese Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day.
Baseline characteristics by cohort
| Measure |
Norditropin
n=36 Participants
Participants received Norditropin 0.034 mg/kg (milligram per kilogram) subcutaneous injection once daily using PDS290 pen injector for 52 weeks.
|
Somapacitan
n=74 Participants
Participants received somapacitan 0.16 mg/kg subcutaneous injection once weekly using PDS290 pen injector for 52 weeks.
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
6.5 Years
STANDARD_DEVIATION 2.3 • n=37 Participants
|
6.6 Years
STANDARD_DEVIATION 2.1 • n=56 Participants
|
6.5 Years
STANDARD_DEVIATION 2.2 • n=82 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=37 Participants
|
9 Participants
n=56 Participants
|
15 Participants
n=82 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=37 Participants
|
65 Participants
n=56 Participants
|
95 Participants
n=82 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Asian
|
36 Participants
n=37 Participants
|
74 Participants
n=56 Participants
|
110 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=37 Participants
|
0 Participants
n=56 Participants
|
0 Participants
n=82 Participants
|
PRIMARY outcome
Timeframe: Baseline (Week 0); Week 52Population: FAS included all randomized participants. Here, Overall number of participants analysed = participants with available data for this outcome measure.
Height velocity (HV) was derived from height measurements taken at baseline (week 0) and the week 52 visit as: HV = (height at 52 weeks visit - height at baseline)/(time from baseline to 52 weeks visit in years).
Outcome measures
| Measure |
Norditropin
n=32 Participants
Participants received Norditropin 0.034 mg/kg (milligram per kilogram) subcutaneous injection once daily using PDS290 pen injector for 52 weeks.
|
Somapacitan
n=71 Participants
Participants received somapacitan 0.16 mg/kg subcutaneous injection once weekly using PDS290 pen injector for 52 weeks.
|
|---|---|---|
|
Height Velocity
|
10.5 Cm/year (centimeter per year)
Standard Deviation 2.3
|
11.0 Cm/year (centimeter per year)
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Week -2, week 52Population: FAS included all randomized participants. Here, Overall number of participants analysed = participants with available data for this outcome measure.
Change in bone age is presented from week -2 to week 52. This outcome measure was analysed based on the 'on treatment' observation period. On treatment observation period: It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first.
Outcome measures
| Measure |
Norditropin
n=32 Participants
Participants received Norditropin 0.034 mg/kg (milligram per kilogram) subcutaneous injection once daily using PDS290 pen injector for 52 weeks.
|
Somapacitan
n=68 Participants
Participants received somapacitan 0.16 mg/kg subcutaneous injection once weekly using PDS290 pen injector for 52 weeks.
|
|---|---|---|
|
Change in Bone Age
|
5.6 Years
Standard Deviation 2.2
|
5.5 Years
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Baseline (week 0), week 52Population: FAS included all randomized participants. Here, Overall number of participants analysed = participants with available data for this outcome measure.
Change in the height standard deviation score (HSDS) is presented from baseline (week 0) to week 52. HSDS was derived using Chinese general population standards. The formula to calculate HSDS is: HSDS = ((Height / M)\*\*L-1) / (L\*S). L: The sex and age-specific power in the Box-Cox transformation, M: The sex and age-specific median, S: The sex and age-specific generalized coefficient of variation. 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. This outcome measure was analysed based on the 'on treatment' observation period. On treatment observation period: It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first.
Outcome measures
| Measure |
Norditropin
n=32 Participants
Participants received Norditropin 0.034 mg/kg (milligram per kilogram) subcutaneous injection once daily using PDS290 pen injector for 52 weeks.
|
Somapacitan
n=69 Participants
Participants received somapacitan 0.16 mg/kg subcutaneous injection once weekly using PDS290 pen injector for 52 weeks.
|
|---|---|---|
|
Change in Height Standard Deviation Score
|
1.13 Score on a scale
Standard Deviation 0.48
|
1.21 Score on a scale
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: Baseline (week 0), week 52Population: FAS included all randomized participants. Here, Overall number of participants analysed = participants with available data for this outcome measure.
Change in height velocity standard deviation score (HVSDS) is presented from baseline (week 0) to week 52. HVSDS was derived using Prader standards. HVSDS was calculated using the formula: HVSDS = (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 HVSDS 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. This outcome measure was analysed based on the 'on treatment' observation period. On treatment observation period: It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first.
Outcome measures
| Measure |
Norditropin
n=32 Participants
Participants received Norditropin 0.034 mg/kg (milligram per kilogram) subcutaneous injection once daily using PDS290 pen injector for 52 weeks.
|
Somapacitan
n=69 Participants
Participants received somapacitan 0.16 mg/kg subcutaneous injection once weekly using PDS290 pen injector for 52 weeks.
|
|---|---|---|
|
Change in Height Velocity Standard Deviation Score
|
8.34 Score on a scale
Standard Deviation 3.01
|
8.96 Score on a scale
Standard Deviation 3.53
|
SECONDARY outcome
Timeframe: Baseline (week 0), week 52Population: Safety analysis set (SAS): SAS included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. Here, Overall number of participants analysed = participants with available data for this outcome measure.
Change in fasting plasma glucose is presented from baseline (week 0) to week 52. This outcome measure was analysed based on the 'on treatment' observation period. On treatment observation period: It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first.
Outcome measures
| Measure |
Norditropin
n=32 Participants
Participants received Norditropin 0.034 mg/kg (milligram per kilogram) subcutaneous injection once daily using PDS290 pen injector for 52 weeks.
|
Somapacitan
n=68 Participants
Participants received somapacitan 0.16 mg/kg subcutaneous injection once weekly using PDS290 pen injector for 52 weeks.
|
|---|---|---|
|
Change in Fasting Plasma Glucose
|
0.541 mmol/l (milimoles per liter)
Standard Deviation 0.523
|
0.304 mmol/l (milimoles per liter)
Standard Deviation 0.521
|
SECONDARY outcome
Timeframe: Baseline (week 0), week 52Population: SAS included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product. Here, Overall number of participants analysed = participants with available data for this outcome measure.
Change in glycosylated haemoglobin (HbA1c) is presented from baseline (week 0) to week 52 is presented. This outcome measure was analysed based on the 'on treatment' observation period. On treatment observation period: It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first.
Outcome measures
| Measure |
Norditropin
n=32 Participants
Participants received Norditropin 0.034 mg/kg (milligram per kilogram) subcutaneous injection once daily using PDS290 pen injector for 52 weeks.
|
Somapacitan
n=69 Participants
Participants received somapacitan 0.16 mg/kg subcutaneous injection once weekly using PDS290 pen injector for 52 weeks.
|
|---|---|---|
|
Change in HbA1c
|
0.09 Percentage (%) of HbA1c
Standard Deviation 0.31
|
0.19 Percentage (%) of HbA1c
Standard Deviation 0.25
|
SECONDARY outcome
Timeframe: Baseline (week 0), week 52Population: FAS included all randomized participants. Here, Overall number of participants analysed = participants with available data for this outcome measure.
Change in Insulin like growth factor-I (IGF-I) standard deviation score is presented from baseline (week 0) to week 52. 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. This outcome measure was analysed based on the 'on treatment' observation period. On treatment observation period: It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first.
Outcome measures
| Measure |
Norditropin
n=32 Participants
Participants received Norditropin 0.034 mg/kg (milligram per kilogram) subcutaneous injection once daily using PDS290 pen injector for 52 weeks.
|
Somapacitan
n=67 Participants
Participants received somapacitan 0.16 mg/kg subcutaneous injection once weekly using PDS290 pen injector for 52 weeks.
|
|---|---|---|
|
Change in IGF-I Standard Deviation Score
|
1.73 Score on a scale
Standard Deviation 1.00
|
2.09 Score on a scale
Standard Deviation 1.28
|
SECONDARY outcome
Timeframe: Baseline (week 0), week 52Population: FAS included all randomized participants. Here, Overall number of participants analysed = participants with available data for this outcome measure.
Change in Insulin like growth factor binding protein 3 (IGFBP-3) standard deviation score is presented from baseline (week 0) to week 52. 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. This outcome measure was analysed based on the 'on treatment' observation period. On treatment observation period: It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first.
Outcome measures
| Measure |
Norditropin
n=32 Participants
Participants received Norditropin 0.034 mg/kg (milligram per kilogram) subcutaneous injection once daily using PDS290 pen injector for 52 weeks.
|
Somapacitan
n=67 Participants
Participants received somapacitan 0.16 mg/kg subcutaneous injection once weekly using PDS290 pen injector for 52 weeks.
|
|---|---|---|
|
Change in IGFBP-3 Standard Deviation Score
|
0.93 Score on a scale
Standard Deviation 0.75
|
1.06 Score on a scale
Standard Deviation 0.87
|
Adverse Events
Norditropin
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Somapacitan
Serious events: 8 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Norditropin
n=36 participants at risk
Participants received Norditropin 0.034 mg/kg (milligram per kilogram) subcutaneous injection once daily using PDS290 pen injector for 52 weeks.
|
Somapacitan
n=74 participants at risk
Participants received somapacitan 0.16 mg/kg subcutaneous injection once weekly using PDS290 pen injector for 52 weeks.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Adenoidal hypertrophy
|
0.00%
0/36 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
1.4%
1/74 • Number of events 1 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
|
Infections and infestations
Adenovirus infection
|
0.00%
0/36 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
1.4%
1/74 • Number of events 1 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/36 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
2.7%
2/74 • Number of events 2 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/36 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
1.4%
1/74 • Number of events 1 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/36 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
1.4%
1/74 • Number of events 1 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
|
General disorders
Oedema
|
0.00%
0/36 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
1.4%
1/74 • Number of events 1 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/36 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
2.7%
2/74 • Number of events 2 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
0.00%
0/36 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
1.4%
1/74 • Number of events 1 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
|
Infections and infestations
Tonsillitis
|
2.8%
1/36 • Number of events 1 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
0.00%
0/74 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/36 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
1.4%
1/74 • Number of events 1 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
Other adverse events
| Measure |
Norditropin
n=36 participants at risk
Participants received Norditropin 0.034 mg/kg (milligram per kilogram) subcutaneous injection once daily using PDS290 pen injector for 52 weeks.
|
Somapacitan
n=74 participants at risk
Participants received somapacitan 0.16 mg/kg subcutaneous injection once weekly using PDS290 pen injector for 52 weeks.
|
|---|---|---|
|
Investigations
Blood glucose increased
|
5.6%
2/36 • Number of events 2 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
2.7%
2/74 • Number of events 3 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
|
Infections and infestations
Bronchitis
|
11.1%
4/36 • Number of events 8 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
9.5%
7/74 • Number of events 7 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
|
Infections and infestations
COVID-19
|
19.4%
7/36 • Number of events 7 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
14.9%
11/74 • Number of events 11 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
19.4%
7/36 • Number of events 12 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
16.2%
12/74 • Number of events 22 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.6%
2/36 • Number of events 2 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
4.1%
3/74 • Number of events 3 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.6%
2/36 • Number of events 2 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
5.4%
4/74 • Number of events 4 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
|
Gastrointestinal disorders
Gastritis
|
5.6%
2/36 • Number of events 2 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
2.7%
2/74 • Number of events 2 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
5.6%
2/36 • Number of events 2 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
0.00%
0/74 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
|
Infections and infestations
Influenza
|
8.3%
3/36 • Number of events 4 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
4.1%
3/74 • Number of events 3 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
|
General disorders
Influenza like illness
|
5.6%
2/36 • Number of events 2 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
0.00%
0/74 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
|
General disorders
Pyrexia
|
16.7%
6/36 • Number of events 9 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
24.3%
18/74 • Number of events 23 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
|
Infections and infestations
Respiratory tract infection
|
13.9%
5/36 • Number of events 9 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
12.2%
9/74 • Number of events 17 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
|
Infections and infestations
Rhinitis
|
8.3%
3/36 • Number of events 3 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
1.4%
1/74 • Number of events 1 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.6%
2/36 • Number of events 3 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
1.4%
1/74 • Number of events 1 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
5.6%
2/36 • Number of events 2 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
0.00%
0/74 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
|
Infections and infestations
Tonsillitis
|
2.8%
1/36 • Number of events 1 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
5.4%
4/74 • Number of events 4 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
|
Infections and infestations
Upper respiratory tract infection
|
41.7%
15/36 • Number of events 24 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
54.1%
40/74 • Number of events 74 • From baseline (week 0) to week 57
All presented AEs are TEAEs (treatment emergent adverse events). AEs with onset during the on-treatment observation period (It starts from first administration of trial product and up until last trial contact, visit 7 (52 weeks+5 days) or 14 days after last administration, whichever comes first) were considered treatment-emergent. Results are based on the SAS which included all participants randomly assigned to trial treatment and who took at least 1 dose of trial product.
|
Additional Information
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