A Research Study Looking at How Safe Somapacitan is and H... | NCT05723835 | Trialant
NCT05723835
Sponsor
Novo Nordisk A/S
Status
Active, not recruiting
Last Update Posted
Jul 9, 2026Actual
Enrollment
47Actual
Phase
Phase 3
Conditions
SGA
Turner Syndrome
Noonan Syndrome
ISS
Interventions
Somapacitan
Countries
United States
Malaysia
Netherlands
Poland
South Korea
Spain
Protocol Section
Identification Module
NCT ID
NCT05723835
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
NN8640-4469
Secondary IDs
ID
Type
Description
Link
U1111-1277-9765
Other Identifier
World Health Organization (WHO)
2022-501055-87
EudraCT Number
Brief Title
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
Official Title
A Study Evaluating the Safety and Efficacy of Once-weekly Dosing of Somapacitan in a Basket Study Design in Paediatric Participants With Short Stature Either Born Small for Gestational Age or With Turner Syndrome, Noonan Syndrome or Idiopathic Short Stature
Acronym
REAL 9
Organization
Novo Nordisk A/SINDUSTRY
Status Module
Record Verification Date
Jun 2026
Overall Recruitment Status or Expanded Access Status
Active, not recruiting
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 1, 2023Actual
Primary Completion Date
Jun 7, 2024Actual
Completion Date
Oct 29, 2027Estimated
First Submitted Date
Jan 29, 2023
First Submission Date that Met QC Criteria
Jan 29, 2023
First Posted Date
Feb 13, 2023Actual
Results Waived
Not provided
Results First Submitted Date
Sep 24, 2025
Results First Submitted that Met QC Criteria
Nov 7, 2025
Results First Posted Date
Nov 21, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 16, 2026
Last Update Posted Date
Jul 9, 2026Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novo Nordisk A/SINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of this study is to find out if somapacitan is safe and how well somapacitan works in children either born small for gestational age or with Turner syndrome, Noonan syndrome or idiopathic short stature. Somapacitan is a new growth hormone medicine for treatment of low level of growth hormone. The study will last for about 3 years. During the study, the participants will be treated with somapacitan once a week. Somapacitan can be injected anytime during the day. The study doctor or nurse will show how to inject somapacitan, so that the participant knows how to do it at home.
Detailed Description
Not provided
Conditions Module
Conditions
SGA
Turner Syndrome
Noonan Syndrome
ISS
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
47Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Somapacitan
Experimental
Participants will receive Somapacitan for 26-week main phase followed by 130-week extension phase.
Drug: Somapacitan
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Somapacitan
Drug
Somapacitan 0.24 milligrams per kilograms per week (mg/kg/week) will be administered subcutaneously (s.c.) using PDS290 pen-injector.
Somapacitan
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Number of Adverse Events (AEs) Reported in Children Born Small for Gestational Age- Weeks 0 to 26
This outcome measure reported number of AEs in children with short stature for indication SGA. Children with SGA are born small for gestational age with insufficient catch-up growth by 2 years of age or older. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
From baseline (Week 0) to Week 26
Number of Adverse Events Reported for Turner Syndrome (TS)- Weeks 0 to 26
This outcome measure reported number of AEs in participants with short stature for indication TS. TS is a chromosomal disorder which leads to short stature. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
From baseline (Week 0) to Week 26
Number of Adverse Events Reported for Noonan Syndrome- Weeks 0 to 26
This outcome measure reported number of AEs in participants with short stature for indication NS which is a genetically heterogeneous developmental disorder characterized by postnatally reduced growth and other major disorders. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
From baseline (Week 0) to Week 26
Secondary Outcomes
Measure
Description
Time Frame
Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Children Born Small for Gestational Age
This outcome measure reported number of AEs possibly or probably related to somapacitan reported in children with short stature for indication SGA. Children with SGA are born small for gestational age with insufficient catch-up growth by 2 years of age or older. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Applicable to children with SGA:
Born small for gestational age (birth length below -2 SDS OR birth weight below -2 SDS OR both) (according to national standards).
Age:
- Male participants: Age equal to or above 11.0 years and below 18.0 years at screening.
- Female participants: Age equal to or above 10.0 years and below 18.0 years at screening.
Open epiphyses; defined as bone age less than (<) 14 years for females and bone age < 16 years for males.
For Growth Hormone (GH) treatment naïve participants: Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and sex at screening according to the standards of Centers for Disease Control and Prevention.
Applicable to children with TS:
• Diagnosis of TS according to local clinical practice.
Age:
- Female participants: Age equal to or above 10.0 years and below 18.0 years at screening.
Open epiphyses; defined as bone age < 14 years for females and bone age < 16 years for males.
For GH treatment naïve participants: Impaired height defined as at least 2.0 standard deviation below the mean height for chronological age and sex at screening according to the standards of Centers for Disease Control and Prevention.
For GH treatment naïve participants: Confirmed diagnosis of TS by 30-cell (or more) lymphocyte chromosomal analysis or confirmation of TS and TS mosaicism using comparative genomic hybridization (CGH)-array.
Applicable to children with NS:
Diagnosis of NS according to local clinical practice.
Age:
Male participants: Age equal to or above 11.0 years and below 18.0 years at screening.
Female participants: Age equal to or above 10.0 years and below 18.0 years at screening.
Open epiphyses; defined as bone age < 14 years for females and bone age < 16 years for males.
For GH treatment naïve participants: Clinical diagnosis of NS according to van der Burgt score list and genetic test result or confirmed mutation in any of the genes associated with NS before allocation.
Applicable to children with ISS:
Age:
- Male participants: Age equal to or above 11.0 years and below 18.0 years at screening.
- Female participants: Age equal to or above 10.0 years and below 18.0 years at screening.
Open epiphyses; defined as bone age < 14 years for females and bone age < 16 years for males.
For GH treatment naïve participants: Impaired height defined as at least 2.5 standard deviations below the mean height for chronological age and sex at screening
For GH treatment naïve participants: Normal GH secretion (GH peak above 7 ng/mL) during GH stimulation test performed within 18 months prior to screening.
For GH treatment naïve participants: Bone age not delayed more than 2 years compared to chronological age at screening.
Exclusion Criteria:
Children with suspected or confirmed growth hormone deficiency according to local practice.
Children diagnosed with diabetes mellitus or screening values from the central laboratory.
Fasting plasma glucose above or equal to 126 milligrams per deciliter (mg/dL) [7.0 millimoles per litre (mmol/L)] or
Glycated hemoglobin (HbA1c) above or equal to 6.5%.
Current inflammatory diseases requiring systemic corticosteroid treatment for longer than 2 consecutive weeks within the last 3 months prior to screening.
Children requiring inhaled glucocorticoid therapy at a dose greater than 400 micrograms per day (µg/day) of inhaled budesonide or equivalent (i.e., 250 µg/day for fluticasone propionate) for longer than 4 consecutive weeks within the last 12 months prior to screening.
History or known presence of malignancy including intracranial tumours.
Applicable to children with SGA:
• Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with height, such as, but not limited to:
Poorly controlled or uncontrolled hormonal deficiencies.
Known chromosomal aneuploidy or significant gene mutations causing medical 'syndromes' with short stature, including but not limited to Laron syndrome, Prader-Willi syndrome, Russell-Silver Syndrome, skeletal dysplasias, abnormal short stature homeobox (SHOX) gene analysis or absence of GH receptors.
Applicable to children with TS:
• Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with height, such as, but not limited to:
Known family history of skeletal dysplasia.
Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants.
Any other disorder that can cause short stature such as, but not limited to nutritional disorders, chronic systemic illness and chronic renal disease.
Mosaicism below 10%.
TS with Y-chromosome mosaicism where gonadectomy has not been performed.
New York Heart Association (NYHA) class II or above or requiring medication for any heart condition.
Applicable to children with NS:
• Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with height, such as, but not limited to:
Known family history of skeletal dysplasia.
Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants.
Any other disorder that can cause short stature such as, but not limited to nutritional disorders, chronic systemic illness and chronic renal disease.
Noonan-related disorders including but not limited to: Noonan syndrome with multiple lentigines (formerly called 'LEOPARD' syndrome), Noonan syndrome with loose anagen hair, cardiofaciocutaneous syndrome (CFC), Costello syndrome, neurofibromatosis type 1 (NF1) and Legius syndrome.
Applicable to children with ISS:
• Any known or suspected clinically significant abnormality likely to affect growth or the ability to evaluate growth with height, such as, but not limited to:
Known family history of skeletal dysplasia.
Significant spinal abnormalities including but not limited to scoliosis, kyphosis and spina bifida variants.
Any other disorder that can cause short stature such as, but not limited to nutritional disorders, chronic systemic illness and chronic renal disease.
Poorly controlled or uncontrolled hormonal deficiencies.
Known chromosomal aneuploidy or significant gene mutations causing medical 'syndromes' with short stature, including but not limited to Laron syndrome, Prader-Willi syndrome, Russell-Silver Syndrome, skeletal dysplasias, abnormal SHOX gene analysis or absence of GH receptors.
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
10 Years
Maximum Age
18 Years
Standard Ages
ChildAdult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Clinical Transparency (dept. 2834)
Novo Nordisk A/S
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Univ of AL at Birmingham_BRM
Birmingham
Alabama
35233
United States
Sutter Valley Med Fdt Ped Endo
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
A total of 47 participants with short stature either born small for gestational age(SGA), Noonan syndrome(NS), Turner syndrome(TS), or idiopathic short stature(ISS) were either treatment naïve or previously treated with growth hormone(GH) were enrolled & exposed to once weekly dosing of somapacitan 0.24 milligrams per kilogram per week(mg/kg/week).
26-week main phase is followed by 130-week extension phase I. Study was ongoing at data cut-off date(24Nov2024).
Recruitment Details
Participants were screened and assigned to treatment across 14 sites in 5 countries.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
SGA_somapacitan (GH Treatment Naïve)
Participants with small for gestational age who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
FG001
SGA_somapacitan (Previously Treated With GH)
Periods
Title
Milestones
Reasons Not Completed
Main Trial Period: Weeks 0 to 26
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Nov 19, 2024
Jun 6, 2025
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
Estimated Results First Submitted Date
Not provided
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Number of Adverse Events Reported for Idiopathic Short Stature (ISS)- Weeks 0 to 26
This outcome measure reported number of AEs in participants with short stature for indication ISS. ISS describes short children with normal GH secretion. ISS is a condition in which the height of the individual is more than 2 standard deviations below the corresponding mean height for a given age, sex and population, without evidence of systemic, endocrine, nutritional or chromosomal abnormalities. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
From baseline (Week 0) to Week 26
From baseline (Week 0) to Week 26
Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Turner Syndrome
This outcome measure reported number of AEs possibly or probably related to somapacitan reported in participants with short stature for indication TS. TS is a chromosomal disorder which leads to short stature. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
From baseline (Week 0) to Week 26
Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Noonan Syndrome
This outcome measure reported number of AEs possibly or probably related to somapacitan reported in participants with short stature for indication NS. An NS is a genetically heterogeneous developmental disorder characterized by postnatally reduced growth and other major disorders. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
From baseline (Week 0) to Week 26
Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Idiopathic Short Stature
This outcome measure reported number of AEs possibly or probably related to somapacitan in participants with short stature for indication ISS. ISS describes short children with normal GH secretion and it is a condition in which the height of the individual is more than 2 standard deviations below the corresponding mean height for a given age, sex and population, without evidence of systemic, endocrine, nutritional or chromosomal abnormalities. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
From baseline (Week 0) to Week 26
Number of Adverse Events Reported Long-term Safety for Children Born Small for Gestational Age- Weeks 0 to 156
This outcome measure reported long-term safety in terms of number of AEs in children with short stature for indication SGA. Children with SGA are born small for gestational age with insufficient catch-up growth by 2 years of age or older. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
From baseline (Week 0) to Week 156
Number of Adverse Events Reported Long-term Safety for Turner Syndrome- Weeks 0 to 156
This outcome measure reported long-term safety in terms of number of AEs in participants with short stature for indication TS. TS is a chromosomal disorder which leads to short stature. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
From baseline (Week 0) to Week 156
Number of Adverse Events Reported Long-term Safety for Noonan Syndrome- Weeks 0 to 156
This outcome measure reported long-term safety in terms of number of AEs in participants with short stature for indication NS which is a genetically heterogeneous developmental disorder characterized by postnatally reduced growth and other major disorders. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
From baseline (Week 0) to Week 156
Number of Adverse Events Reported Long-term Safety for Idiopathic Short Stature- Weeks 0 to 156
This outcome measure reported long-term safety in terms of number of AEs in participants with short stature for indication ISS. ISS describes short children with normal GH secretion. ISS is a condition in which the height of the individual is more than 2 standard deviations below the corresponding mean height for a given age, sex and population, without evidence of systemic, endocrine, nutritional or chromosomal abnormalities. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
From baseline (Week 0) to Week 156
Height Velocity Reported Children Born Small for Gestational Age
This outcome measure reported height velocity in children with short stature for indication SGA. Height velocity at week 26 was derived as: (height at 26 weeks visit - height at baseline)/ (time from baseline to 26 weeks visit in years).
From Baseline (Week 0) to Week 26
Height Velocity Reported for Turner Syndrome
This outcome measure reported height velocity in children with short stature for indication TS. Height velocity at week 26 was derived as: (height at 26 weeks visit - height at baseline)/ (time from baseline to 26 weeks visit in years).
From Baseline (Week 0) to Week 26
Height Velocity Reported for Noonan Syndrome
This outcome measure reported height velocity in children with short stature for indication NS. Height velocity at week 26 was derived as: (height at 26 weeks visit - height at baseline)/(time from baseline to 26 weeks visit in years).
From Baseline (Week 0) to Week 26
Height Velocity Reported for Idiopathic Short Stature
This outcome measure reported height velocity in children with short stature for indication ISS. Height velocity at week 26 was derived as: (height at 26 weeks visit - height at baseline)/ (time from baseline to 26 weeks visit in years).
From Baseline (Week 0) to Week 26
Change in Height Standard Deviation Scores (SDS) Reported for Children Born Small for Gestational Age
This outcome measure reported height standard deviation scores in children with short stature for indication SGA. Height SDS at Week 26 was derived as the Height SDS value at baseline (Week 0) subtracted from the Height SDS value at Week 26. Height SDS is derived as: Height SDSi = ({[Heighti/population median]^Skewness}-1)/(Skewness∗population SD); where i indicates the visit and SD indicates the standard deviation (SD). The population median and standard deviation are the ones corresponding to the age at visit i. The population median and standard deviation and skewness are based on reference data. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height. The positive score indicates that the value is closer to or above the reference population compared to baseline.
Baseline (Week 0), Week 26
Change in Height Standard Deviation Scores Reported for Turner Syndrome
This outcome measure reported height standard deviation scores in children with short stature for indication TS. Height SDS at Week 26 was derived as the Height SDS value at baseline (Week 0) subtracted from the Height SDS value at Week 26. Height SDS is derived as: Height SDSi = ({[Heighti/population median]^Skewness}-1)/(Skewness∗population SD); where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The population median and standard deviation and skewness are based on reference data. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height. The positive score indicates that the value is closer to or above the reference population compared to baseline.
Baseline (Week 0), Week 26
Change in Height Standard Deviation Scores Reported for Noonan Syndrome
This outcome measure reported height standard deviation scores in children with short stature for indication NS. Height SDS at Week 26 was derived as the Height SDS value at baseline (Week 0) subtracted from the Height SDS value at Week 26. Height SDS is derived as: Height SDSi = ({[Heighti/population median]^Skewness}-1)/(Skewness∗population SD); where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The population median and standard deviation and skewness are based on reference data. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height. The positive score indicates that the value is closer to or above the reference population compared to baseline.
Baseline (Week 0), Week 26
Change in Height Standard Deviation Scores Reported for Idiopathic Short Stature
This outcome measure reported height standard deviation scores in children with short stature for indication ISS. Height SDS at Week 26 was derived as the Height SDS value at baseline (Week 0) subtracted from the Height SDS value at Week 26. Height SDS is derived as: Height SDSi = ({[Heighti/population median]^Skewness}-1)/(Skewness∗population SD); where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The population median and standard deviation and skewness are based on reference data. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height. The positive score indicates that the value is closer to or above the reference population compared to baseline.
Baseline (Week 0), Week 26
Change in Height Velocity Standard Deviation Scores Reported Separately for Children Born Small for Gestational Age
This outcome measure reported change in height velocity SDS in children with short stature for indication SGA. Change in height velocity SDS at week 26 was calculated as the height velocity SDS value at baseline Week 0 subtracted from the height velocity SDS value at Week 26. Height Velocity SDS is derived as: HV SDSi = (HVi - population mean HV)/population SD; where i indicates the visit. The population mean and standard deviation corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height velocity. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Baseline (Week 0), Week 26
Change in Height Velocity Standard Deviation Scores Reported Separately for Turner Syndrome
This outcome measure reported change in height velocity SDS in children with short stature for indication TS. Change in height velocity SDS at week 26 was calculated as the height velocity SDS value at baseline (Week 0) subtracted from the height velocity SDS value at Week 26. Height Velocity SDS is derived as: HV SDSi = (HVi - population mean HV)/population SD; where i indicates the visit. The population mean and standard deviation corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height velocity. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Baseline (Week 0), Week 26
Change in Height Velocity Standard Deviation Scores Reported for Noonan Syndrome
This outcome measure reported change in height velocity SDS in children with short stature for indication NS. Change in height velocity SDS at Week 26 was the Height Velocity SDS value at baseline (Week 0) subtracted from the Height Velocity SDS value at Week 26. Height Velocity SDS is derived as: HV SDSi = (HVi - population mean HV)/population SD; where i indicates the visit. The population mean and standard deviation corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height velocity. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Baseline (Week 0), Week 26
Change in Height Velocity Standard Deviation Scores Reported Separately for Idiopathic Short Stature
This outcome measure reported change in height velocity SDS in children with short stature for indication ISS. Change in height velocity SDS at Week 26 was the Height Velocity SDS value at baseline (Week 0) subtracted from the Height Velocity SDS value at Week 26. Height Velocity SDS is derived as: HV SDSi = (HVi - population mean HV)/population SD; where i indicates the visit. The population mean and standard deviation corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height velocity. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Baseline (Week 0), Week 26
Change in Insulin-like Growth Factor 1 (IGF-1) Standard Deviation Score Reported for Children Born Small for Gestational Age
This outcome measure reported change in IGF-1 SDS in children with short stature for indication SGA. Change in IGF-I SDS was derived as IGF-1 SDS value at baseline Week 0 subtracted from the IGF-I SDS value at Week 26. IGF-I SDS is derived as: IGF - I SDSi = ({[IGF - I i]/population median}^Skewness - 1)/ Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGF-1. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Baseline (Week 0), Week 26
Change in Insulin-like Growth Factor 1 Standard Deviation Score Reported for Turner Syndrome
This outcome measure reported change in IGF-1 SDS in children with short stature for indication TS. Change in IGF-I SDS was derived as IGF-1 SDS value at baseline Week 0 subtracted from the IGF-I SDS value at Week 26. IGF-I SDS is derived as: IGF - I SDSi = ({[IGF - I i]/population median}^Skewness - 1)/ Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGF-1. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Baseline (Week 0), Week 26
Change in Insulin-like Growth Factor 1 Standard Deviation Score Reported for Noonan Syndrome
This outcome measure reported change in IGF-1 SDS in children with short stature for indication NS. Change in IGF-I SDS was derived as IGF-1 SDS value at baseline Week 0 subtracted from the IGF-I SDS value at Week 26. IGF-I SDS is derived as: IGF - I SDSi = ({[IGF - I i]/population median}^Skewness - 1)/ Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGF-1. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Baseline (Week 0), Week 26
Change in Insulin-like Growth Factor 1 Standard Deviation Score Reported Separately for Idiopathic Short Stature
This outcome measure reported change in IGF-1 SDS in children with short stature for indication ISS. Change in IGF-I SDS was derived as IGF-1 SDS value at baseline Week 0 subtracted from the IGF-I SDS value at Week 26. IGF-I SDS is derived as: IGF - I SDSi = ({[IGF - I i]/population median}^Skewness - 1)/ Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGF-1. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Baseline (Week 0), Week 26
Change in Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) SDS Reported for Children Born Small for Gestational Age
This outcome measure reported change in IGFBP-3 scores in children with short stature for indication SGA. Change in IGFBP-3 SCS at Week 26 was derived as the IGFBP-3 SDS value at baseline Week 0 subtracted from IGFBP-3 SDS value at Week 26. IGFBP-3 SDS is derived as: IGFBP - 3 SDSi = ({[IGFBP - 3 i/population median]^Skewness} - 1)/Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGFBP-3. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Baseline (week 0), Week 26
Change in Insulin-like Growth Factor Binding Protein-3 SDS Reported for Turner Syndrome
This outcome measure reported change in IGFBP-3 scores in children with short stature for indication TS. Change in IGFBP-3 SCS at Week 26 was derived as the IGFBP-3 SDS value at baseline Week 0 subtracted from IGFBP-3 SDS value at Week 26. IGFBP-3 SDS is derived as: IGFBP - 3 SDSi = ({[IGFBP - 3 i/population median]^Skewness} - 1)/Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGFBP-3. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Baseline (Week 0), Week 26
Change in Insulin-like Growth Factor Binding Protein-3 SDS Reported for Noonan Syndrome
This outcome measure reported change in IGFBP-3 scores in children with short stature for indication NS. Change in IGFBP-3 SCS at Week 26 was derived as the IGFBP-3 SDS value at baseline Week 0 subtracted from IGFBP-3 SDS value at Week 26. IGFBP-3 SDS is derived as: IGFBP - 3 SDSi = ({[IGFBP - 3 i/population median]^Skewness} - 1)/Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGFBP-3. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Baseline (Week 0), Week 26
Change in Insulin-like Growth Factor Binding Protein-3 SDS Reported for Idiopathic Short Stature
This outcome measure reported change in IGFBP-3 scores in children with short stature for indication ISS. Change in IGFBP-3 SCS at Week 26 was derived as the IGFBP-3 SDS value at baseline Week 0 subtracted from IGFBP-3 SDS value at Week 26. IGFBP-3 SDS is derived as: IGFBP - 3 SDSi = ({[IGFBP - 3 i/population median]^Skewness} - 1)/Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGFBP-3. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Baseline (Week 0), Week 26
Weekly Average Somapacitan Concentration (Cavg) Reported for Children Born Small for Gestational Age
The steady state pharmacokinetics in terms of Cavg was evaluated for once-weekly somapacitan in children born small for gestational age who were either naïve or non-naïve to GH treatment.
Weeks 4, 8, 13, 20 and 26
Weekly Average Somapacitan Concentration (Cavg) Reported for Turner Syndrome
The steady state pharmacokinetics in terms of Cavg was evaluated for once-weekly somapacitan in children with Turner Syndrome who were either naïve or non-naïve to GH treatment.
Weeks 4, 8, 13, 20 and 26
Weekly Average Somapacitan Concentration (Cavg) Reported for Noonan Syndrome
The steady state pharmacokinetics in terms of Cavg was evaluated for once-weekly somapacitan in children with Noonan Syndrome who were either naïve or non-naïve to GH treatment.
Weeks 4, 8, 13, 20 and 26
Weekly Average Somapacitan Concentration (Cavg) Reported for Idiopathic Short Stature
The steady state pharmacokinetics in terms of Cavg was evaluated for once-weekly somapacitan in children with idiopathic short stature who were either naïve or non-naïve to GH treatment.
Weeks 4, 8, 13, 20 and 26
Sacramento
California
95821
United States
Rocky Mt Ped and Endo
Centennial
Colorado
80112
United States
Childrens National Medical Ctr
Washington D.C.
District of Columbia
20010-2978
United States
Rocky Mt Clin Res, LLC
Idaho Falls
Idaho
83404-7596
United States
Children's Minnesota
Saint Paul
Minnesota
55102
United States
University Malaya Medical Centre
Lembah Pantai
Kuala Lumpur
59100
Malaysia
University Technology MARA (UiTM) - Sg Buloh
Bandar Puncak Alam
Selangor
42300
Malaysia
Erasmus MC
Rotterdam
3015 GD
Netherlands
Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
Rzeszów
Podkarpackie Voivodeship
35-301
Poland
UCK, Klinika Pediatrii, Diabetologii i Endokrynologii,
Gdansk
80-952
Poland
Instytut Centrum Zdrowia Matki Polki
Lodz
93-338
Poland
Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
Rzeszów
35-301
Poland
SPSK nr 1 im. prof.S.Szyszko w Zabrzu
Zabrze
41-800
Poland
Pusan National University Yangsan Hospital
Yangsan
Gyeongsangnam-do
50612
South Korea
Asan Medical Center
Seoul
05505
South Korea
Pusan National University Yangsan Hospital
Yangsan
50612
South Korea
Hospital Vall d'Hebron
Barcelona
08035
Spain
Participants with small for gestational age who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
FG002
TS_somapacitan (GH Treatment Naïve)
Participants with Turner syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
FG003
TS_somapacitan (Previously Treated With GH)
Participants with Turner syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
FG004
NS_somapacitan (GH Treatment Naïve)
Participants with Noonan syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
FG005
NS_somapacitan (Previously Treated With GH)
Participants with Noonan syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
FG006
ISS_somapacitan (GH Treatment Naïve)
Participants with idiopathic short stature who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
FG007
ISS_somapacitan (Previously Treated With GH)
Participants with idiopathic short stature who were were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
FG0004 subjects
FG0018 subjects
FG0023 subjects
FG0038 subjects
FG0046 subjects
FG0057 subjects
FG0062 subjects
FG0079 subjects
Full Analysis Set (FAS)
FG0004 subjects
FG0018 subjects
FG0023 subjects
FG0038 subjects
FG0046 subjects
FG0057 subjects
FG0062 subjects
FG0079 subjects
Safety Analysis Set (SAS)
FG0004 subjects
FG0018 subjects
FG0023 subjects
FG0038 subjects
FG0046 subjects
FG0057 subjects
FG0062 subjects
FG0079 subjects
COMPLETED
FG0004 subjects
FG0018 subjects
FG0023 subjects
FG0038 subjects
FG0046 subjects
FG0057 subjects
FG0062 subjects
FG0079 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Extension I Period: Weeks 39 Upto 156
Type
Comment
Milestone Data
STARTED
FG0004 subjects
FG0018 subjects
FG0023 subjects
FG0038 subjects
FG0046 subjects
FG0057 subjects
FG0062 subjects
FG0079 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0004 subjects
FG0018 subjects
FG0023 subjects
FG0038 subjects
FG004
Type
Comment
Reasons
Study is ongoing, data is reported till data cut-off 24 Nov 2024
FG0004 subjects
FG0018 subjects
FG0023 subjects
FG003
Full analysis set included all participants assigned to study intervention.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
SGA_somapacitan (GH Treatment Naïve)
Participants with small for gestational age who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
BG001
SGA_somapacitan (Previously Treated With GH)
Participants with small for gestational age who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
BG002
TS_somapacitan (GH Treatment Naïve)
Participants with Turner syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
BG003
TS_somapacitan (Previously Treated With GH)
Participants with Turner syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
BG004
NS_somapacitan (GH Treatment Naïve)
Participants with Noonan syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
BG005
NS_somapacitan (Previously Treated With GH)
Participants with Noonan syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
BG006
ISS_somapacitan (GH Treatment Naïve)
Participants with idiopathic short stature who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
BG007
ISS_somapacitan (Previously Treated With GH)
Participants with idiopathic short stature who were were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG0004
BG0018
BG0023
BG0038
BG0046
BG0057
BG0062
BG0079
BG00847
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00012.50± 2.08
BG00111.75± 1.67
BG00210.67± 1.15
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0002
BG0013
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0010
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Number of Adverse Events (AEs) Reported in Children Born Small for Gestational Age- Weeks 0 to 26
This outcome measure reported number of AEs in children with short stature for indication SGA. Children with SGA are born small for gestational age with insufficient catch-up growth by 2 years of age or older. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Safety analysis set included all participants who were exposed to study treatment.
Posted
Number
Events
From baseline (Week 0) to Week 26
ID
Title
Description
OG000
SGA_somapacitan (GH Treatment Naïve)
Participants with small for gestational age who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
SGA_somapacitan (Previously Treated With GH)
Participants with small for gestational age who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Units
Counts
Participants
OG0004
OG0018
Title
Denominators
Categories
Title
Measurements
OG0004
OG00110
Primary
Number of Adverse Events Reported for Turner Syndrome (TS)- Weeks 0 to 26
This outcome measure reported number of AEs in participants with short stature for indication TS. TS is a chromosomal disorder which leads to short stature. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Safety analysis set included all participants who were exposed to study treatment.
Posted
Number
Events
From baseline (Week 0) to Week 26
ID
Title
Description
OG000
TS_somapacitan (GH Treatment Naïve)
Participants with Turner syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
TS_somapacitan (Previously Treated With GH)
Participants with Turner syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Primary
Number of Adverse Events Reported for Noonan Syndrome- Weeks 0 to 26
This outcome measure reported number of AEs in participants with short stature for indication NS which is a genetically heterogeneous developmental disorder characterized by postnatally reduced growth and other major disorders. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Safety analysis set included all participants who were exposed to study treatment.
Posted
Number
Events
From baseline (Week 0) to Week 26
ID
Title
Description
OG000
NS_somapacitan (GH Treatment Naïve)
Participants with Noonan syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
NS_somapacitan (Previously Treated With GH)
Participants with Noonan syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Primary
Number of Adverse Events Reported for Idiopathic Short Stature (ISS)- Weeks 0 to 26
This outcome measure reported number of AEs in participants with short stature for indication ISS. ISS describes short children with normal GH secretion. ISS is a condition in which the height of the individual is more than 2 standard deviations below the corresponding mean height for a given age, sex and population, without evidence of systemic, endocrine, nutritional or chromosomal abnormalities. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Safety analysis set included all participants who were exposed to study treatment.
Posted
Number
Events
From baseline (Week 0) to Week 26
ID
Title
Description
OG000
ISS_somapacitan (GH Treatment Naïve)
Participants with idiopathic short stature who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
ISS_somapacitan (Previously Treated With GH)
Participants with idiopathic short stature who were were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Secondary
Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Children Born Small for Gestational Age
This outcome measure reported number of AEs possibly or probably related to somapacitan reported in children with short stature for indication SGA. Children with SGA are born small for gestational age with insufficient catch-up growth by 2 years of age or older. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Safety analysis set included all participants who were exposed to study treatment.
Posted
Number
Events
From baseline (Week 0) to Week 26
ID
Title
Description
OG000
SGA_somapacitan (GH Treatment Naïve)
Participants with small for gestational age who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
SGA_somapacitan (Previously Treated With GH)
Participants with small for gestational age who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Secondary
Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Turner Syndrome
This outcome measure reported number of AEs possibly or probably related to somapacitan reported in participants with short stature for indication TS. TS is a chromosomal disorder which leads to short stature. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Safety analysis set included all participants who were exposed to study treatment.
Posted
Number
Events
From baseline (Week 0) to Week 26
ID
Title
Description
OG000
TS_somapacitan (GH Treatment Naïve)
Participants with Turner syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
TS_somapacitan (Previously Treated With GH)
Participants with Turner syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Secondary
Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Noonan Syndrome
This outcome measure reported number of AEs possibly or probably related to somapacitan reported in participants with short stature for indication NS. An NS is a genetically heterogeneous developmental disorder characterized by postnatally reduced growth and other major disorders. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Safety analysis set included all participants who were exposed to study treatment.
Posted
Number
Events
From baseline (Week 0) to Week 26
ID
Title
Description
OG000
NS_somapacitan (GH Treatment Naïve)
Participants with Noonan syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
NS_somapacitan (Previously Treated With GH)
Participants with Noonan syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Secondary
Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Idiopathic Short Stature
This outcome measure reported number of AEs possibly or probably related to somapacitan in participants with short stature for indication ISS. ISS describes short children with normal GH secretion and it is a condition in which the height of the individual is more than 2 standard deviations below the corresponding mean height for a given age, sex and population, without evidence of systemic, endocrine, nutritional or chromosomal abnormalities. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Safety analysis set included all participants who were exposed to study treatment.
Posted
Number
Events
From baseline (Week 0) to Week 26
ID
Title
Description
OG000
ISS_somapacitan (GH Treatment Naïve)
Participants with idiopathic short stature who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
ISS_somapacitan (Previously Treated With GH)
Participants with idiopathic short stature who were were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Secondary
Number of Adverse Events Reported Long-term Safety for Children Born Small for Gestational Age- Weeks 0 to 156
This outcome measure reported long-term safety in terms of number of AEs in children with short stature for indication SGA. Children with SGA are born small for gestational age with insufficient catch-up growth by 2 years of age or older. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Not Posted
Dec 2027
From baseline (Week 0) to Week 156
Participants
Secondary
Number of Adverse Events Reported Long-term Safety for Turner Syndrome- Weeks 0 to 156
This outcome measure reported long-term safety in terms of number of AEs in participants with short stature for indication TS. TS is a chromosomal disorder which leads to short stature. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Not Posted
Dec 2027
From baseline (Week 0) to Week 156
Participants
Secondary
Number of Adverse Events Reported Long-term Safety for Noonan Syndrome- Weeks 0 to 156
This outcome measure reported long-term safety in terms of number of AEs in participants with short stature for indication NS which is a genetically heterogeneous developmental disorder characterized by postnatally reduced growth and other major disorders. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Not Posted
Dec 2027
From baseline (Week 0) to Week 156
Participants
Secondary
Number of Adverse Events Reported Long-term Safety for Idiopathic Short Stature- Weeks 0 to 156
This outcome measure reported long-term safety in terms of number of AEs in participants with short stature for indication ISS. ISS describes short children with normal GH secretion. ISS is a condition in which the height of the individual is more than 2 standard deviations below the corresponding mean height for a given age, sex and population, without evidence of systemic, endocrine, nutritional or chromosomal abnormalities. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment.
Not Posted
Dec 2027
From baseline (Week 0) to Week 156
Participants
Secondary
Height Velocity Reported Children Born Small for Gestational Age
This outcome measure reported height velocity in children with short stature for indication SGA. Height velocity at week 26 was derived as: (height at 26 weeks visit - height at baseline)/ (time from baseline to 26 weeks visit in years).
Full analysis set included all participants assigned to study intervention.
Posted
Mean
Standard Deviation
centimeters per year (cm/year)
From Baseline (Week 0) to Week 26
ID
Title
Description
OG000
SGA_somapacitan (GH Treatment Naïve)
Participants with small for gestational age who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
SGA_somapacitan (Previously Treated With GH)
Participants with small for gestational age who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Units
Counts
Participants
Secondary
Height Velocity Reported for Turner Syndrome
This outcome measure reported height velocity in children with short stature for indication TS. Height velocity at week 26 was derived as: (height at 26 weeks visit - height at baseline)/ (time from baseline to 26 weeks visit in years).
Full analysis set included all participants assigned to study intervention.
Posted
Mean
Standard Deviation
cm/year
From Baseline (Week 0) to Week 26
ID
Title
Description
OG000
TS_somapacitan (GH Treatment Naïve)
Participants with Turner syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
TS_somapacitan (Previously Treated With GH)
Participants with Turner syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Units
Counts
Participants
Secondary
Height Velocity Reported for Noonan Syndrome
This outcome measure reported height velocity in children with short stature for indication NS. Height velocity at week 26 was derived as: (height at 26 weeks visit - height at baseline)/(time from baseline to 26 weeks visit in years).
Full analysis set included all participants assigned to study intervention.
Posted
Mean
Standard Deviation
cm/year
From Baseline (Week 0) to Week 26
ID
Title
Description
OG000
NS_somapacitan (GH Treatment Naïve)
Participants with Noonan syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
NS_somapacitan (Previously Treated With GH)
Participants with Noonan syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Units
Counts
Participants
Secondary
Height Velocity Reported for Idiopathic Short Stature
This outcome measure reported height velocity in children with short stature for indication ISS. Height velocity at week 26 was derived as: (height at 26 weeks visit - height at baseline)/ (time from baseline to 26 weeks visit in years).
Full analysis set included all participants assigned to study intervention.
Posted
Mean
Standard Deviation
cm/year
From Baseline (Week 0) to Week 26
ID
Title
Description
OG000
ISS_somapacitan (GH Treatment Naïve)
Participants with idiopathic short stature who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
ISS_somapacitan (Previously Treated With GH)
Participants with idiopathic short stature who were were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Units
Counts
Participants
Secondary
Change in Height Standard Deviation Scores (SDS) Reported for Children Born Small for Gestational Age
This outcome measure reported height standard deviation scores in children with short stature for indication SGA. Height SDS at Week 26 was derived as the Height SDS value at baseline (Week 0) subtracted from the Height SDS value at Week 26. Height SDS is derived as: Height SDSi = ({[Heighti/population median]^Skewness}-1)/(Skewness∗population SD); where i indicates the visit and SD indicates the standard deviation (SD). The population median and standard deviation are the ones corresponding to the age at visit i. The population median and standard deviation and skewness are based on reference data. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height. The positive score indicates that the value is closer to or above the reference population compared to baseline.
Full analysis set included all participants assigned to study intervention.
Posted
Mean
Standard Deviation
standard deviation score
Baseline (Week 0), Week 26
ID
Title
Description
OG000
SGA_somapacitan (GH Treatment Naïve)
Participants with small for gestational age who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
SGA_somapacitan (Previously Treated With GH)
Participants with small for gestational age who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Secondary
Change in Height Standard Deviation Scores Reported for Turner Syndrome
This outcome measure reported height standard deviation scores in children with short stature for indication TS. Height SDS at Week 26 was derived as the Height SDS value at baseline (Week 0) subtracted from the Height SDS value at Week 26. Height SDS is derived as: Height SDSi = ({[Heighti/population median]^Skewness}-1)/(Skewness∗population SD); where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The population median and standard deviation and skewness are based on reference data. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height. The positive score indicates that the value is closer to or above the reference population compared to baseline.
Full analysis set included all participants assigned to study intervention.
Posted
Mean
Standard Deviation
standard deviation score
Baseline (Week 0), Week 26
ID
Title
Description
OG000
TS_somapacitan (GH Treatment Naïve)
Participants with Turner syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
TS_somapacitan (Previously Treated With GH)
Participants with Turner syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Secondary
Change in Height Standard Deviation Scores Reported for Noonan Syndrome
This outcome measure reported height standard deviation scores in children with short stature for indication NS. Height SDS at Week 26 was derived as the Height SDS value at baseline (Week 0) subtracted from the Height SDS value at Week 26. Height SDS is derived as: Height SDSi = ({[Heighti/population median]^Skewness}-1)/(Skewness∗population SD); where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The population median and standard deviation and skewness are based on reference data. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height. The positive score indicates that the value is closer to or above the reference population compared to baseline.
Full analysis set included all participants assigned to study intervention.
Posted
Mean
Standard Deviation
standard deviation score
Baseline (Week 0), Week 26
ID
Title
Description
OG000
NS_somapacitan (GH Treatment Naïve)
Participants with Noonan syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
NS_somapacitan (Previously Treated With GH)
Participants with Noonan syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Secondary
Change in Height Standard Deviation Scores Reported for Idiopathic Short Stature
This outcome measure reported height standard deviation scores in children with short stature for indication ISS. Height SDS at Week 26 was derived as the Height SDS value at baseline (Week 0) subtracted from the Height SDS value at Week 26. Height SDS is derived as: Height SDSi = ({[Heighti/population median]^Skewness}-1)/(Skewness∗population SD); where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The population median and standard deviation and skewness are based on reference data. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height. The positive score indicates that the value is closer to or above the reference population compared to baseline.
Full analysis set included all participants assigned to study intervention.
Posted
Mean
Standard Deviation
standard deviation score
Baseline (Week 0), Week 26
ID
Title
Description
OG000
ISS_somapacitan (GH Treatment Naïve)
Participants with idiopathic short stature who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
ISS_somapacitan (Previously Treated With GH)
Participants with idiopathic short stature who were were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Secondary
Change in Height Velocity Standard Deviation Scores Reported Separately for Children Born Small for Gestational Age
This outcome measure reported change in height velocity SDS in children with short stature for indication SGA. Change in height velocity SDS at week 26 was calculated as the height velocity SDS value at baseline Week 0 subtracted from the height velocity SDS value at Week 26. Height Velocity SDS is derived as: HV SDSi = (HVi - population mean HV)/population SD; where i indicates the visit. The population mean and standard deviation corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height velocity. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Full analysis set included all participants assigned to study intervention.
Posted
Mean
Standard Deviation
standard deviation score
Baseline (Week 0), Week 26
ID
Title
Description
OG000
SGA_somapacitan (GH Treatment Naïve)
Participants with small for gestational age who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
SGA_somapacitan (Previously Treated With GH)
Participants with small for gestational age who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Secondary
Change in Height Velocity Standard Deviation Scores Reported Separately for Turner Syndrome
This outcome measure reported change in height velocity SDS in children with short stature for indication TS. Change in height velocity SDS at week 26 was calculated as the height velocity SDS value at baseline (Week 0) subtracted from the height velocity SDS value at Week 26. Height Velocity SDS is derived as: HV SDSi = (HVi - population mean HV)/population SD; where i indicates the visit. The population mean and standard deviation corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height velocity. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Full analysis set included all participants assigned to study intervention.
Posted
Mean
Standard Deviation
standard deviation score
Baseline (Week 0), Week 26
ID
Title
Description
OG000
TS_somapacitan (GH Treatment Naïve)
TS_somapacitan (GH Treatment Naïve) Participants with Turner syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
TS_somapacitan (Previously Treated With GH)
Participants with Turner syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Secondary
Change in Height Velocity Standard Deviation Scores Reported for Noonan Syndrome
This outcome measure reported change in height velocity SDS in children with short stature for indication NS. Change in height velocity SDS at Week 26 was the Height Velocity SDS value at baseline (Week 0) subtracted from the Height Velocity SDS value at Week 26. Height Velocity SDS is derived as: HV SDSi = (HVi - population mean HV)/population SD; where i indicates the visit. The population mean and standard deviation corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height velocity. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Full analysis set included all participants assigned to study intervention.
Posted
Mean
Standard Deviation
standard deviation score
Baseline (Week 0), Week 26
ID
Title
Description
OG000
NS_somapacitan (GH Treatment Naïve)
Participants with Noonan syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
NS_somapacitan (Previously Treated With GH)
Participants with Noonan syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Secondary
Change in Height Velocity Standard Deviation Scores Reported Separately for Idiopathic Short Stature
This outcome measure reported change in height velocity SDS in children with short stature for indication ISS. Change in height velocity SDS at Week 26 was the Height Velocity SDS value at baseline (Week 0) subtracted from the Height Velocity SDS value at Week 26. Height Velocity SDS is derived as: HV SDSi = (HVi - population mean HV)/population SD; where i indicates the visit. The population mean and standard deviation corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater height velocity. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Full analysis set included all participants assigned to study intervention.
Posted
Mean
Standard Deviation
standard deviation score
Baseline (Week 0), Week 26
ID
Title
Description
OG000
ISS_somapacitan (GH Treatment Naïve)
Participants with idiopathic short stature who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
ISS_somapacitan (Previously Treated With GH)
Participants with idiopathic short stature who were were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Secondary
Change in Insulin-like Growth Factor 1 (IGF-1) Standard Deviation Score Reported for Children Born Small for Gestational Age
This outcome measure reported change in IGF-1 SDS in children with short stature for indication SGA. Change in IGF-I SDS was derived as IGF-1 SDS value at baseline Week 0 subtracted from the IGF-I SDS value at Week 26. IGF-I SDS is derived as: IGF - I SDSi = ({[IGF - I i]/population median}^Skewness - 1)/ Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGF-1. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Full analysis set included all participants assigned to study intervention.
Posted
Mean
Standard Deviation
standard deviation score
Baseline (Week 0), Week 26
ID
Title
Description
OG000
SGA_somapacitan (GH Treatment Naïve)
Participants with small for gestational age who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
SGA_somapacitan (Previously Treated With GH)
Participants with small for gestational age who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Secondary
Change in Insulin-like Growth Factor 1 Standard Deviation Score Reported for Turner Syndrome
This outcome measure reported change in IGF-1 SDS in children with short stature for indication TS. Change in IGF-I SDS was derived as IGF-1 SDS value at baseline Week 0 subtracted from the IGF-I SDS value at Week 26. IGF-I SDS is derived as: IGF - I SDSi = ({[IGF - I i]/population median}^Skewness - 1)/ Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGF-1. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Full analysis set included all participants assigned to study intervention.
Posted
Mean
Standard Deviation
standard deviation score
Baseline (Week 0), Week 26
ID
Title
Description
OG000
TS_somapacitan (GH Treatment Naïve)
TS_somapacitan (GH Treatment Naïve) Participants with Turner syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
TS_somapacitan (Previously Treated With GH)
Participants with Turner syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Secondary
Change in Insulin-like Growth Factor 1 Standard Deviation Score Reported for Noonan Syndrome
This outcome measure reported change in IGF-1 SDS in children with short stature for indication NS. Change in IGF-I SDS was derived as IGF-1 SDS value at baseline Week 0 subtracted from the IGF-I SDS value at Week 26. IGF-I SDS is derived as: IGF - I SDSi = ({[IGF - I i]/population median}^Skewness - 1)/ Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGF-1. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Full analysis set included all participants assigned to study intervention.
Posted
Mean
Standard Deviation
standard deviation score
Baseline (Week 0), Week 26
ID
Title
Description
OG000
NS_somapacitan (GH Treatment Naïve)
Participants with Noonan syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
NS_somapacitan (Previously Treated With GH)
Participants with Noonan syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Secondary
Change in Insulin-like Growth Factor 1 Standard Deviation Score Reported Separately for Idiopathic Short Stature
This outcome measure reported change in IGF-1 SDS in children with short stature for indication ISS. Change in IGF-I SDS was derived as IGF-1 SDS value at baseline Week 0 subtracted from the IGF-I SDS value at Week 26. IGF-I SDS is derived as: IGF - I SDSi = ({[IGF - I i]/population median}^Skewness - 1)/ Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGF-1. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Full analysis set included all participants assigned to study intervention.
Posted
Mean
Standard Deviation
standard deviation score
Baseline (Week 0), Week 26
ID
Title
Description
OG000
ISS_somapacitan (GH Treatment Naïve)
Participants with idiopathic short stature who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
ISS_somapacitan (Previously Treated With GH)
Participants with idiopathic short stature who were were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Secondary
Change in Insulin-like Growth Factor Binding Protein-3 (IGFBP-3) SDS Reported for Children Born Small for Gestational Age
This outcome measure reported change in IGFBP-3 scores in children with short stature for indication SGA. Change in IGFBP-3 SCS at Week 26 was derived as the IGFBP-3 SDS value at baseline Week 0 subtracted from IGFBP-3 SDS value at Week 26. IGFBP-3 SDS is derived as: IGFBP - 3 SDSi = ({[IGFBP - 3 i/population median]^Skewness} - 1)/Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGFBP-3. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Full analysis set included all participants assigned to study intervention.
Posted
Mean
Standard Deviation
standard deviation score
Baseline (week 0), Week 26
ID
Title
Description
OG000
SGA_somapacitan (GH Treatment Naïve)
Participants with small for gestational age who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
SGA_somapacitan (Previously Treated With GH)
Participants with small for gestational age who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Secondary
Change in Insulin-like Growth Factor Binding Protein-3 SDS Reported for Turner Syndrome
This outcome measure reported change in IGFBP-3 scores in children with short stature for indication TS. Change in IGFBP-3 SCS at Week 26 was derived as the IGFBP-3 SDS value at baseline Week 0 subtracted from IGFBP-3 SDS value at Week 26. IGFBP-3 SDS is derived as: IGFBP - 3 SDSi = ({[IGFBP - 3 i/population median]^Skewness} - 1)/Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGFBP-3. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Full analysis set included all participants assigned to study intervention. Here 'Number of participants analysed' signifies number of participants with available data for particular timepoint.
Posted
Mean
Standard Deviation
standard deviation score
Baseline (Week 0), Week 26
ID
Title
Description
OG000
TS_somapacitan (GH Treatment Naïve)
TS_somapacitan (GH Treatment Naïve) Participants with Turner syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
TS_somapacitan (Previously Treated With GH)
Participants with Turner syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Secondary
Change in Insulin-like Growth Factor Binding Protein-3 SDS Reported for Noonan Syndrome
This outcome measure reported change in IGFBP-3 scores in children with short stature for indication NS. Change in IGFBP-3 SCS at Week 26 was derived as the IGFBP-3 SDS value at baseline Week 0 subtracted from IGFBP-3 SDS value at Week 26. IGFBP-3 SDS is derived as: IGFBP - 3 SDSi = ({[IGFBP - 3 i/population median]^Skewness} - 1)/Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGFBP-3. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Full analysis set included all participants assigned to study intervention.
Posted
Mean
Standard Deviation
standard deviation score
Baseline (Week 0), Week 26
ID
Title
Description
OG000
NS_somapacitan (GH Treatment Naïve)
Participants with Noonan syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
NS_somapacitan (Previously Treated With GH)
Participants with Noonan syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Secondary
Change in Insulin-like Growth Factor Binding Protein-3 SDS Reported for Idiopathic Short Stature
This outcome measure reported change in IGFBP-3 scores in children with short stature for indication ISS. Change in IGFBP-3 SCS at Week 26 was derived as the IGFBP-3 SDS value at baseline Week 0 subtracted from IGFBP-3 SDS value at Week 26. IGFBP-3 SDS is derived as: IGFBP - 3 SDSi = ({[IGFBP - 3 i/population median]^Skewness} - 1)/Skewness ∗ population SD; where i indicates the visit. The population median and standard deviation are the ones corresponding to the age at visit i. The score ranges from -10 (minimum) to +10 (maximum), where the greater value indicated greater IGFBP-3. The positive score indicated that the value is closer to or above the reference population compared to baseline.
Full analysis set included all participants assigned to study intervention.
Posted
Mean
Standard Deviation
standard deviation score
Baseline (Week 0), Week 26
ID
Title
Description
OG000
ISS_somapacitan (GH Treatment Naïve)
Participants with idiopathic short stature who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
ISS_somapacitan (Previously Treated With GH)
Participants with idiopathic short stature who were were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Secondary
Weekly Average Somapacitan Concentration (Cavg) Reported for Children Born Small for Gestational Age
The steady state pharmacokinetics in terms of Cavg was evaluated for once-weekly somapacitan in children born small for gestational age who were either naïve or non-naïve to GH treatment.
Full analysis set included all participants assigned to study intervention.
Posted
Mean
Standard Deviation
nanograms per milliliter (ng/mL)
Weeks 4, 8, 13, 20 and 26
ID
Title
Description
OG000
SGA_somapacitan (GH Treatment Naïve)
Participants with small for gestational age who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
SGA_somapacitan (Previously Treated With GH)
Participants with small for gestational age who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Units
Counts
Participants
Secondary
Weekly Average Somapacitan Concentration (Cavg) Reported for Turner Syndrome
The steady state pharmacokinetics in terms of Cavg was evaluated for once-weekly somapacitan in children with Turner Syndrome who were either naïve or non-naïve to GH treatment.
Full analysis set included all participants assigned to study intervention.
Posted
Mean
Standard Deviation
nanograms per milliliter (ng/mL)
Weeks 4, 8, 13, 20 and 26
ID
Title
Description
OG000
TS_somapacitan (GH Treatment Naïve)
Participants with Turner syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
TS_somapacitan (Previously Treated With GH)
Participants with Turner syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Units
Counts
Participants
Secondary
Weekly Average Somapacitan Concentration (Cavg) Reported for Noonan Syndrome
The steady state pharmacokinetics in terms of Cavg was evaluated for once-weekly somapacitan in children with Noonan Syndrome who were either naïve or non-naïve to GH treatment.
Full analysis set included all participants assigned to study intervention.
Posted
Mean
Standard Deviation
nanograms per milliliter (ng/mL)
Weeks 4, 8, 13, 20 and 26
ID
Title
Description
OG000
NS_somapacitan (GH Treatment Naïve)
Participants with Noonan syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
NS_somapacitan (Previously Treated With GH)
Participants with Noonan syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Units
Counts
Participants
Secondary
Weekly Average Somapacitan Concentration (Cavg) Reported for Idiopathic Short Stature
The steady state pharmacokinetics in terms of Cavg was evaluated for once-weekly somapacitan in children with idiopathic short stature who were either naïve or non-naïve to GH treatment.
Full analysis set included all participants assigned to study intervention. Here, 'Number Analyzed' signifies number of participants with available data for particular timepoint.
Posted
Mean
Standard Deviation
nanograms per milliliter (ng/mL)
Weeks 4, 8, 13, 20 and 26
ID
Title
Description
OG000
ISS_somapacitan (GH Treatment Naïve)
Participants with idiopathic short stature who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
OG001
ISS_somapacitan (Previously Treated With GH)
Participants with idiopathic short stature who were were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
Units
Counts
Time Frame
From Baseline (Week 0) up to Week 94 (approximately, Data cut off date: 24Nov2024)
Description
An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of study drug, whether or not considered related to the study treatment. An AE can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease (new or exacerbated) temporally associated with the use of an study treatment. Safety analysis set included all participants who were exposed to study treatment.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
SGA_somapacitan (GH Treatment Naïve)
Participants with small for gestational age who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
0
4
0
4
3
4
EG001
SGA_somapacitan (Previously Treated With GH)
Participants with small for gestational age who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
0
8
1
8
5
8
EG002
TS_somapacitan (GH Treatment Naïve)
Participants with Turner syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
0
3
0
3
2
3
EG003
TS_somapacitan (Previously Treated With GH)
Participants with Turner syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
0
8
1
8
7
8
EG004
NS_somapacitan (GH Treatment Naïve)
Participants with Noonan syndrome who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
0
6
0
6
4
6
EG005
NS_somapacitan (Previously Treated With GH)
Participants with Noonan syndrome who were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
0
7
0
7
6
7
EG006
ISS_somapacitan (GH Treatment Naïve)
Participants with idiopathic short stature who were treatment naïve subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
0
2
0
2
2
2
EG007
ISS_somapacitan (Previously Treated With GH)
Participants with idiopathic short stature who were were previously treated with GH, subcutaneously received a dose of 0.24 mg/kg/week somapacitan once weekly for 26-week main phase followed by an ongoing 130-week extension phase I.
0
9
1
9
8
9
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Conduction disorder
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG0031 events1 affected8 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected2 at risk
EG0070 events0 affected9 at risk
Constipation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Gastrointestinal microorganism overgrowth
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Abdominal pain
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected3 at risk
EG0030 events0 affected8 at risk
EG0040 events0 affected6 at risk
EG0050 events0 affected7 at risk
EG0060 events0 affected2 at risk
EG0073 events1 affected9 at risk
Abdominal pain upper
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Accidental overdose
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Accidental underdose
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Acne
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected3 at risk
EG003
Aortic valve incompetence
Cardiac disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Asthma exercise induced
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Avulsion fracture
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Blood thyroid stimulating hormone increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected3 at risk
EG003
COVID-19
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Cardiac imaging procedure abnormal
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Chest pain
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Coccydynia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Concussion
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Constipation
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Contusion
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Costochondritis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Diarrhoea
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Dysuria
Renal and urinary disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Ear infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Ear swelling
Ear and labyrinth disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Erythema infectiosum
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected3 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Fatigue
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Fungal skin infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Groin pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Headache
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0013 events1 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Influenza
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0022 events1 affected3 at risk
EG003
Ingrowing nail
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Injection site bruising
General disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Insulin-like growth factor increased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Intellectual disability
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected3 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Lethargy
Nervous system disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Ligament sprain
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Limb injury
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Lipodystrophy acquired
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Medication error
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Molluscum contagiosum
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Muscle strain
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Myopia
Eye disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected3 at risk
EG003
Norovirus infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Odynophagia
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Onychomycosis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Osteitis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Otitis media acute
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Pneumonia viral
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Precocious puberty
Endocrine disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Product administration error
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Productive cough
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Pyrexia
General disorders
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Respiratory syncytial virus infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Rhinorrhoea
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Scarlet fever
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Scoliosis
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Seasonal allergy
Immune system disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Serum ferritin decreased
Investigations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Sports injury
Injury, poisoning and procedural complications
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Tendon pain
Musculoskeletal and connective tissue disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0001 events1 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Viral pharyngitis
Infections and infestations
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0011 events1 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0021 events1 affected3 at risk
EG003
Wheezing
Respiratory, thoracic and mediastinal disorders
MedDRA 27.1
Systematic Assessment
EG0000 events0 affected4 at risk
EG0010 events0 affected8 at risk
EG0020 events0 affected3 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
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.
Female Urogenital Diseases and Pregnancy Complications
D000091642
Urogenital Diseases
D058533
Sex Chromosome Disorders of Sex Development
D052801
Male Urogenital Diseases
D006330
Heart Defects, Congenital
D018376
Cardiovascular Abnormalities
D002318
Cardiovascular Diseases
D006331
Heart Diseases
D000013
Congenital Abnormalities
D009358
Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D025064
Sex Chromosome Disorders
D025063
Chromosome Disorders
D030342
Genetic Diseases, Inborn
D006058
Gonadal Disorders
D004700
Endocrine System Diseases
D019465
Craniofacial Abnormalities
D009139
Musculoskeletal Abnormalities
D009140
Musculoskeletal Diseases
D003240
Connective Tissue Diseases
D017437
Skin and Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C000718308
somapacitan
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
6 subjects
FG0057 subjects
FG0062 subjects
FG0079 subjects
8 subjects
FG0046 subjects
FG0057 subjects
FG0062 subjects
FG0079 subjects
11.00
± 1.20
BG00412.67± 2.07
BG00512.29± 1.50
BG00614.50± 0.71
BG00711.44± 1.24
BG00811.87± 1.67
3
BG0038
BG0042
BG0052
BG0060
BG0076
BG00826
Male
BG0002
BG0015
BG0020
BG0030
BG0044
BG0055
BG0062
BG0073
BG00821
0
BG0032
BG0040
BG0050
BG0060
BG0070
BG0082
Not Hispanic or Latino
BG0004
BG0018
BG0023
BG0036
BG0046
BG0057
BG0062
BG0079
BG00845
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
0
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Asian
BG0002
BG0011
BG0021
BG0031
BG0041
BG0051
BG0061
BG0073
BG00811
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Black or African American
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
White
BG0002
BG0017
BG0022
BG0037
BG0045
BG0056
BG0061
BG0076
BG00836
More than one race
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
BG0080
Units
Counts
Participants
OG0003
OG0018
Title
Denominators
Categories
Title
Measurements
OG0004
OG00118
Units
Counts
Participants
OG0006
OG0017
Title
Denominators
Categories
Title
Measurements
OG00013
OG00111
Units
Counts
Participants
OG0002
OG0019
Title
Denominators
Categories
Title
Measurements
OG0009
OG00122
Units
Counts
Participants
OG0004
OG0018
Title
Denominators
Categories
Title
Measurements
OG0001
OG0011
Units
Counts
Participants
OG0003
OG0018
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
Units
Counts
Participants
OG0006
OG0017
Title
Denominators
Categories
Title
Measurements
OG0003
OG0012
Units
Counts
Participants
OG0002
OG0019
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011
OG0004
OG0018
Title
Denominators
Categories
Title
Measurements
OG00011.3± 3.8
OG0019.5± 2.0
OG0003
OG0018
Title
Denominators
Categories
Title
Measurements
OG00010.2± 2.2
OG0015.8± 2.0
OG0006
OG0017
Title
Denominators
Categories
Title
Measurements
OG0009.1± 2.3
OG0016.4± 2.0
OG0002
OG0019
Title
Denominators
Categories
Title
Measurements
OG0009.2± 3.5
OG0017.9± 2.4
Units
Counts
Participants
OG0004
OG0018
Title
Denominators
Categories
Title
Measurements
OG0000.50± 0.21
OG0010.24± 0.13
Units
Counts
Participants
OG0003
OG0018
Title
Denominators
Categories
Title
Measurements
OG0000.40± 0.30
OG0010.00± 0.23
Units
Counts
Participants
OG0006
OG0017
Title
Denominators
Categories
Title
Measurements
OG0000.35± 0.26
OG0010.11± 0.14
Units
Counts
Participants
OG0002
OG0019
Title
Denominators
Categories
Title
Measurements
OG0000.22± 0.15
OG0010.14± 0.18
Units
Counts
Participants
OG0004
OG0018
Title
Denominators
Categories
Title
Measurements
OG0003.53± 2.49
OG0011.04± 1.18
Units
Counts
Participants
OG0003
OG0018
Title
Denominators
Categories
Title
Measurements
OG0003.45± 1.41
OG001-0.48± 1.84
Units
Counts
Participants
OG0006
OG0017
Title
Denominators
Categories
Title
Measurements
OG0003.43± 2.75
OG0010.22± 0.93
Units
Counts
Participants
OG0002
OG0019
Title
Denominators
Categories
Title
Measurements
OG0002.89± 0.85
OG001-0.32± 1.90
Units
Counts
Participants
OG0004
OG0018
Title
Denominators
Categories
Title
Measurements
OG0001.61± 1.52
OG0011.39± 1.14
Units
Counts
Participants
OG0003
OG0018
Title
Denominators
Categories
Title
Measurements
OG0000.88± 0.43
OG001-0.09± 1.52
Units
Counts
Participants
OG0006
OG0017
Title
Denominators
Categories
Title
Measurements
OG0001.01± 1.38
OG0012.23± 1.87
Units
Counts
Participants
OG0002
OG0019
Title
Denominators
Categories
Title
Measurements
OG0002.79± 0.52
OG0011.66± 1.28
Units
Counts
Participants
OG0004
OG0018
Title
Denominators
Categories
Title
Measurements
OG0000.69± 0.93
OG0011.22± 1.00
Units
Counts
Participants
OG0003
OG0017
Title
Denominators
Categories
Title
Measurements
OG0000.39± 0.48
OG0010.05± 1.45
Units
Counts
Participants
OG0006
OG0017
Title
Denominators
Categories
Title
Measurements
OG0000.66± 0.97
OG0010.67± 1.08
Units
Counts
Participants
OG0002
OG0019
Title
Denominators
Categories
Title
Measurements
OG0001.22± 0.18
OG0011.08± 1.43
OG0004
OG0018
Title
Denominators
Categories
Week 4
Title
Measurements
OG000518.948± 58.993
OG001339.226± 205.265
Week 8
Title
Measurements
OG0001.800± 0.857
OG0012.204± 0.556
Week 13
Title
Measurements
OG00062.280± 92.161
OG00178.530± 79.022
Week 20
Title
Measurements
OG0002.345± 1.331
OG0014.123± 3.263
Week 26
Title
Measurements
OG0005.928± 4.904
OG0018.364± 5.075
OG0003
OG0018
Title
Denominators
Categories
Week 4
Title
Measurements
OG000287.777± 191.086
OG001384.130± 252.372
Week 8
Title
Measurements
OG0002.187± 0.335
OG0013.285± 2.018
Week 13
Title
Measurements
OG00075.400± 125.123
OG00193.753± 162.274
Week 20
Title
Measurements
OG0002.487± 1.232
OG0012.871± 1.018
Week 26
Title
Measurements
OG0004.363± 2.890
OG0018.574± 5.304
OG0006
OG0017
Title
Denominators
Categories
Week 4
Title
Measurements
OG000249.278± 225.237
OG001254.626± 175.518
Week 8
Title
Measurements
OG0003.102± 2.197
OG00131.343± 58.845
Week 13
Title
Measurements
OG000102.647± 164.113
OG001134.501± 188.934
Week 20
Title
Measurements
OG00034.043± 69.759
OG0013.869± 2.376
Week 26
Title
Measurements
OG00013.057± 22.222
OG00142.834± 58.984
Participants
OG0002
OG0019
Title
Denominators
Categories
Week 4
ParticipantsOG0002
ParticipantsOG0019
Title
Measurements
OG000344.415± 313.128
OG001401.444± 178.512
Week 8
ParticipantsOG0002
ParticipantsOG0019
Title
Measurements
OG0009.535± 0.940
OG001
Week 13
ParticipantsOG0002
ParticipantsOG0019
Title
Measurements
OG000403.525± 156.235
OG001
Week 20
ParticipantsOG0002
ParticipantsOG0019
Title
Measurements
OG0007.070± 3.564
OG001
Week 26
ParticipantsOG0001
ParticipantsOG0019
Title
Measurements
OG00016.630± NASince only a single participant was assessed in this arm, the standard deviation could not be calculated and is reported as 'Not Applicable'.