Trial · NCT05723835
A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
NCT05723835, Phase 3, Active not recruiting, Novo Nordisk A/S; results first posted 2025-11-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9. Trials, record NCT05723835. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05723835
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Research Study Looking at How Safe Somapacitan is and How Well it Works in Children Who Need Help to Grow - REAL 9
- NCT number
- NCT05723835
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 47 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- SGA, Turner Syndrome, Noonan Syndrome, ISS
- Interventions
- Somapacitan
- First posted
- 2023-02-13
- Last updated
- 2026-08-13
- Results first posted
- 2025-11-21
Source ClinicalTrials.gov
Registered outcomes36
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Adverse Events (AEs) Reported in Children Born Small for Gestational Age- Weeks 0 to 26 | From baseline (Week 0) to Week 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. |
| Primary | Number of Adverse Events Reported for Turner Syndrome (TS)- Weeks 0 to 26 | From baseline (Week 0) to Week 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. |
| Primary | Number of Adverse Events Reported for Noonan Syndrome- Weeks 0 to 26 | From baseline (Week 0) to Week 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. |
| Primary | Number of Adverse Events Reported for Idiopathic Short Stature (ISS)- Weeks 0 to 26 | From baseline (Week 0) to Week 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. |
| Secondary | Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Children Born Small for Gestational Age | From baseline (Week 0) to Week 26 | 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. |
| Secondary | Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Turner Syndrome | From baseline (Week 0) to Week 26 | 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. |
| Secondary | Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Noonan Syndrome | From baseline (Week 0) to Week 26 | 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. |
| Secondary | Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Idiopathic Short Stature | From baseline (Week 0) to Week 26 | 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. |
| Secondary | Number of Adverse Events Reported Long-term Safety for Children Born Small for Gestational Age- Weeks 0 to 156 | From baseline (Week 0) to Week 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. |
| Secondary | Number of Adverse Events Reported Long-term Safety for Turner Syndrome- Weeks 0 to 156 | From baseline (Week 0) to Week 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. |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 registered outcomesOutcomes36
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Adverse Events (AEs) Reported in Children Born Small for Gestational Age- Weeks 0 to 26 | From baseline (Week 0) to Week 26 | Safety analysis set included all participants who were exposed to study treatment. | Events | NUMBER |
| PRIMARY | Number of Adverse Events Reported for Turner Syndrome (TS)- Weeks 0 to 26 | From baseline (Week 0) to Week 26 | Safety analysis set included all participants who were exposed to study treatment. | Events | NUMBER |
| PRIMARY | Number of Adverse Events Reported for Noonan Syndrome- Weeks 0 to 26 | From baseline (Week 0) to Week 26 | Safety analysis set included all participants who were exposed to study treatment. | Events | NUMBER |
| PRIMARY | Number of Adverse Events Reported for Idiopathic Short Stature (ISS)- Weeks 0 to 26 | From baseline (Week 0) to Week 26 | Safety analysis set included all participants who were exposed to study treatment. | Events | NUMBER |
| SECONDARY | Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Children Born Small for Gestational Age | From baseline (Week 0) to Week 26 | Safety analysis set included all participants who were exposed to study treatment. | Events | NUMBER |
| SECONDARY | Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Turner Syndrome | From baseline (Week 0) to Week 26 | Safety analysis set included all participants who were exposed to study treatment. | Events | NUMBER |
| SECONDARY | Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Noonan Syndrome | From baseline (Week 0) to Week 26 | Safety analysis set included all participants who were exposed to study treatment. | Events | NUMBER |
| SECONDARY | Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Idiopathic Short Stature | From baseline (Week 0) to Week 26 | Safety analysis set included all participants who were exposed to study treatment. | Events | NUMBER |
| SECONDARY | Number of Adverse Events Reported Long-term Safety for Children Born Small for Gestational Age- Weeks 0 to 156 | From baseline (Week 0) to Week 156 | |||
| SECONDARY | Number of Adverse Events Reported Long-term Safety for Turner Syndrome- Weeks 0 to 156 | From baseline (Week 0) to Week 156 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 outcomesResults by group96
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Adverse Events (AEs) Reported in Children Born Small for Gestational Age- Weeks 0 to 26 | SGA_somapacitan (GH Treatment Naïve) | 4 | Events | ||
| Number of Adverse Events (AEs) Reported in Children Born Small for Gestational Age- Weeks 0 to 26 | SGA_somapacitan (Previously Treated With GH) | 10 | Events | ||
| Number of Adverse Events Reported for Turner Syndrome (TS)- Weeks 0 to 26 | TS_somapacitan (GH Treatment Naïve) | 4 | Events | ||
| Number of Adverse Events Reported for Turner Syndrome (TS)- Weeks 0 to 26 | TS_somapacitan (Previously Treated With GH) | 18 | Events | ||
| Number of Adverse Events Reported for Noonan Syndrome- Weeks 0 to 26 | NS_somapacitan (GH Treatment Naïve) | 13 | Events | ||
| Number of Adverse Events Reported for Noonan Syndrome- Weeks 0 to 26 | NS_somapacitan (Previously Treated With GH) | 11 | Events | ||
| Number of Adverse Events Reported for Idiopathic Short Stature (ISS)- Weeks 0 to 26 | ISS_somapacitan (GH Treatment Naïve) | 9 | Events | ||
| Number of Adverse Events Reported for Idiopathic Short Stature (ISS)- Weeks 0 to 26 | ISS_somapacitan (Previously Treated With GH) | 22 | Events | ||
| Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Children Born Small for Gestational Age | SGA_somapacitan (GH Treatment Naïve) | 1 | Events | ||
| Number of Adverse Events Possibly or Probably Related to Somapacitan Reported for Children Born Small for Gestational Age | SGA_somapacitan (Previously Treated With GH) | 1 | Events |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow64
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Trial Period: Weeks 0 to 26 | STARTED | SGA_somapacitan (GH Treatment Naïve) | 4 | |
| Main Trial Period: Weeks 0 to 26 | STARTED | SGA_somapacitan (Previously Treated With GH) | 8 | |
| Main Trial Period: Weeks 0 to 26 | STARTED | TS_somapacitan (GH Treatment Naïve) | 3 | |
| Main Trial Period: Weeks 0 to 26 | STARTED | TS_somapacitan (Previously Treated With GH) | 8 | |
| Main Trial Period: Weeks 0 to 26 | STARTED | NS_somapacitan (GH Treatment Naïve) | 6 | |
| Main Trial Period: Weeks 0 to 26 | STARTED | NS_somapacitan (Previously Treated With GH) | 7 | |
| Main Trial Period: Weeks 0 to 26 | STARTED | ISS_somapacitan (GH Treatment Naïve) | 2 | |
| Main Trial Period: Weeks 0 to 26 | STARTED | ISS_somapacitan (Previously Treated With GH) | 9 | |
| Main Trial Period: Weeks 0 to 26 | Full Analysis Set (FAS) | SGA_somapacitan (GH Treatment Naïve) | 4 | |
| Main Trial Period: Weeks 0 to 26 | Full Analysis Set (FAS) | SGA_somapacitan (Previously Treated With GH) | 8 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 participant flowAdverse events672
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal pain | Gastrointestinal disorders | SGA_somapacitan (GH Treatment Naïve) | 0 | 4 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | SGA_somapacitan (Previously Treated With GH) | 1 | 8 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | TS_somapacitan (GH Treatment Naïve) | 0 | 3 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | TS_somapacitan (Previously Treated With GH) | 0 | 8 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | NS_somapacitan (GH Treatment Naïve) | 0 | 6 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | NS_somapacitan (Previously Treated With GH) | 0 | 7 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | ISS_somapacitan (GH Treatment Naïve) | 0 | 2 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | ISS_somapacitan (Previously Treated With GH) | 1 | 9 | 3 |
| other | Abdominal pain upper | Gastrointestinal disorders | SGA_somapacitan (GH Treatment Naïve) | 0 | 4 | 0 |
| other | Abdominal pain upper | Gastrointestinal disorders | SGA_somapacitan (Previously Treated With GH) | 0 | 8 | 0 |
1 to 10 of 672Source ClinicalTrials.gov
See all 672 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SGA_somapacitan (GH Treatment Naïve) | 0 | 4 |
| Total, all-cause mortality | SGA_somapacitan (Previously Treated With GH) | 0 | 8 |
| Total, all-cause mortality | TS_somapacitan (GH Treatment Naïve) | 0 | 3 |
| Total, all-cause mortality | TS_somapacitan (Previously Treated With GH) | 0 | 8 |
| Total, all-cause mortality | NS_somapacitan (GH Treatment Naïve) | 0 | 6 |
| Total, all-cause mortality | NS_somapacitan (Previously Treated With GH) | 0 | 7 |
| Total, all-cause mortality | ISS_somapacitan (GH Treatment Naïve) | 0 | 2 |
| Total, all-cause mortality | ISS_somapacitan (Previously Treated With GH) | 0 | 9 |
| Total, other adverse events | SGA_somapacitan (GH Treatment Naïve) | 3 | 4 |
| Total, other adverse events | SGA_somapacitan (Previously Treated With GH) | 5 | 8 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05723835
GET https://conductscience.org/api/trials/v1/NCT05723835/registered?page=2