Trial · NCT03878446
A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
NCT03878446, Phase 2, Active not recruiting, Novo Nordisk A/S; results first posted 2024-06-20
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day. Trials, record NCT03878446. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03878446
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Research Study in Children Born Small and Who Stayed Small. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day
- NCT number
- NCT03878446
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 62 participants, actual
- Lead sponsor
- Novo Nordisk A/S
- Conditions
- Short Stature Children Born Small for Gestational Age (SGA)
- Interventions
- Somapacitan, Norditropin®
- First posted
- 2019-03-18
- Last updated
- 2026-10-06
- Other registries' IDs
- eudract:2018-000232-10
- Results first posted
- 2024-06-20
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Height Velocity | Baseline (week 0); week 26 | Height velocity (HV) was derived from height measurements taken at baseline (week 0) and week 26 visit as: HV = (height at 26 weeks visit - height at baseline)/(time from baseline to 26 weeks visit in years). The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: from first administration and up until week 26 or last trial contact, whichever came first. |
| Secondary | Change in Ratio of Bone Age Versus Chronological Age | Baseline (week 0); week 52 | Change in ratio of bone age (years) versus chronological age (years) from baseline (week 0) to week 52 is presented. X-rays of left hand and wrist for bone age assessment according to the Greulich and Pyle atlas were taken. X-ray images were sent to a central imaging laboratory for evaluation. Chronological Age (years) was calculated as: (Date minus Date of Birth) divided by 365.25. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: from first administration and up until week 52 or last trial contact, whichever came first. |
| Secondary | Change in Height Standard Deviation Score (HSDS) | Baseline (week 0); week 26 | Change in HSDS from baseline (week 0) to week 26 is presented. HSDS was derived using Centre for Disease Control and Prevention (CDC) standards. HSDS = \[(height/population median)\^skewness - 1\]/(skewness \* population standard deviation) where skewness, median and standard deviation is given by a reference growth table for the corresponding chronological age. The range for HSDS was -10 to +10. Negative scores indicated a height below the mean height for a child with the same age and gender, whereas positive scores indicated a height above the mean height for a child with the same age and gender. Positive value in change from baseline in HSDS indicated that HSDS was better than baseline HSDS In-trial observation period: from first administration and up until week 26 or last trial contact, whichever came first. |
| Secondary | Change in Height Velocity Standard Deviation Score (HVSDS) | Baseline (week 0); week 26 | Change in HVSDS from baseline (week 0) to week 26 is presented. HVSDS was derived using Prader standards. HV SDS was calculated using the formula: HV SDS = (height velocity - mean)/standard deviation (SD), where height velocity was the height velocity variable measured, mean and SD of height velocity by gender and age for the reference population. The range for HVSDS was -10 to +10. Negative scores indicated a height velocity below the mean height velocity for a child with the same age and gender, whereas positive scores indicated a height velocity above the mean height velocity for a child with the same age and gender. Positive value in change from baseline in HVSDS indicated that HVSDS was better than baseline HVSDS. The outcome measure was evaluated based on the data from in-trial observation period. In-trial observation period: from first administration and up until week 26 or last trial contact, whichever came first. |
| Secondary | Change in Fasting Plasma Glucose | Baseline (week 0); week 26 | Change in fasting plasma glucose from baseline (week 0) to week 26 is presented. The outcome measure was evaluated based on the data from on-treatment observation period. On-treatment observation period: from first administration and up until last trial contact, week 26 or 14 days after last administration, whichever came first. |
| Secondary | Change in Homeostatic Model Assessment for Steady State Beta Cell Function (HOMA-B) | Baseline (week 0); week 26 | Change in HOMA-B from baseline (week 0) to week 26 is presented. HOMA-B is a measure of the beta cell function and was calculated as follows: HOMA-B = (20 \* fasting insulin (picomoles per liter \[pmol/L\]) \* 1/6(microunit per milliliter \[µU/mL\]))/ FPG(mmol/L)-3.5). HOMA-beta score ranges from minus infinity to infinity (no limits). Higher score means better beta-cell function for HOMA-beta. Negative change from baseline (week 0) in HOMA-B indicated a worse outcome. The outcome measure was evaluated based on the data from on-treatment observation period. On-treatment observation period: from first administration and up until last trial contact, week 26 or 14 days after last administration, whichever came first. |
| Secondary | Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | Baseline (week 0); week 26 | Change in HOMA-IR from baseline (week 0) to week 26 is presented. Insulin resistance is a condition in which cells fail to respond to normal actions of hormone in body. HOMA-IR is calculated using a participant's fasting plasma insulin and glucose levels. HOMA-IR = fasting serum insulin (micro international units per milliliter (μU/ml)) × fasting plasma glucose (millimoles per liter (mmol/l)) / 22.5. HOMA-IR scores are classified as follows: less than 1.0: considered insulin sensitive, 0.5-1.4: considered healthy, above 1.8: considered early insulin resistance; above 2.7 is considered significant insulin resistance. HOMA-IR score ranges from 0-infinity (no upper limit). Higher the score, higher the level of insulin resistance. The outcome measure was evaluated based on the data from on-treatment observation period. On-treatment observation period: from first administration and up until last trial contact, week 26 or 14 days after last administration, whichever came first. |
| Secondary | Change in Glycated Haemoglobin (HbA1c) | Baseline (week 0); week 26 | Change in HbA1c from baseline (week 0) to week 26 is presented. The outcome measure was evaluated based on the data from on-treatment observation period. On-treatment observation period: from first administration and up until last trial contact, week 26 or 14 days after last administration, whichever came first. |
| Secondary | Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS) | Baseline (week 0); week 26 | Change in IGF-I SDS from baseline (week 0) to week 26 is presented. IGF-I SDS was provided by the central laboratory; its calculation is based on the actual value of IGF-1 minus mean reference value of IGF-1 divided by reference standard deviation of IGF-1. The range for IGF-I SDS was from -10 to +10. Negative scores indicated a IGF-I below the mean IGF-I for a child with the same age and gender, whereas positive scores indicated a IGF-I above the mean IGF-I for a child with the same age and gender. Positive value in change from baseline in IGF-I SDS indicated that IGF-I SDS was higher than baseline IGF-I SDS. The outcome measure was evaluated based on the data from on-treatment observation period. On-treatment observation period: from first administration and up until last trial contact, week 26 or 14 days after last administration, whichever came first. |
| Secondary | Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) SDS | Baseline (week 0); week 26 | Change in IGFBP-3 SDS from baseline (week 0) to week 26 is presented. The range for IGFBP-3 SDS was from -10 to +10. Negative scores indicated a IGFBP-3 below the mean IGFBP-3 for a child with the same age and gender, whereas positive scores indicated a IGFBP-3 above the mean IGFBP-3 for a child with the same age and gender. Positive value in change from baseline in IGFBP-3 SDS indicated that IGFBP-3 SDS was higher than baseline IGFBP-3 SDS. The outcome measure was evaluated based on the data from on-treatment observation period. On-treatment observation period: from first administration and up until last trial contact, week 26 or 14 days after last administration, whichever came first. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Height Velocity | Baseline (week 0); week 26 | Full analysis set (FAS) included all randomized participants exposed to the trial product. | centimeter per year (cm/year) | MEAN |
| SECONDARY | Change in Ratio of Bone Age Versus Chronological Age | Baseline (week 0); week 52 | Safety anslyis set (SAS) included all randomized participants exposed to the trial product. Overall number of participants analyzed = participants with available data for this outcome measure. | ratio (bone age/chronological age) | MEAN |
| SECONDARY | Change in Height Standard Deviation Score (HSDS) | Baseline (week 0); week 26 | FAS included all randomized participants exposed to the trial product. | score on a scale | MEAN |
| SECONDARY | Change in Height Velocity Standard Deviation Score (HVSDS) | Baseline (week 0); week 26 | FAS included all randomized participants exposed to the trial product. | score on a scale | MEAN |
| SECONDARY | Change in Fasting Plasma Glucose | Baseline (week 0); week 26 | Safety analysis set (SAS) included all randomized participants exposed to trial product. | millimoles per liter (mmol/L) | MEAN |
| SECONDARY | Change in Homeostatic Model Assessment for Steady State Beta Cell Function (HOMA-B) | Baseline (week 0); week 26 | SAS included all randomized participants exposed to trial product. Overall number of participants analyzed = participants with available data for this outcome measure. | HOMA-B index | MEAN |
| SECONDARY | Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | Baseline (week 0); week 26 | SAS included all randomized participants exposed to trial product. | HOMA-IR index | MEAN |
| SECONDARY | Change in Glycated Haemoglobin (HbA1c) | Baseline (week 0); week 26 | SAS included all randomized participants exposed to trial product. Overall number of participants analyzed = participants with available data for this outcome measure. | Percentage of HbA1c | MEAN |
| SECONDARY | Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS) | Baseline (week 0); week 26 | FAS included all randomized participants exposed to the trial product. | score on a scale | MEAN |
| SECONDARY | Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) SDS | Baseline (week 0); week 26 | FAS included all randomized participants exposed to the trial product. | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group50
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Height Velocity | Norditropin 0.035 mg/kg/Day | 10.5 | Standard Deviation 2.0 | centimeter per year (cm/year) | |
| Height Velocity | Norditropin 0.067 mg/kg/Day | 11.9 | Standard Deviation 2.4 | centimeter per year (cm/year) | |
| Height Velocity | Somapacitan 0.16 mg/kg/Week | 8.9 | Standard Deviation 1.8 | centimeter per year (cm/year) | |
| Height Velocity | Somapacitan 0.20 mg/kg/Week | 11.1 | Standard Deviation 2.6 | centimeter per year (cm/year) | |
| Height Velocity | Somapacitan 0.24 mg/kg/Week | 11.2 | Standard Deviation 3.4 | centimeter per year (cm/year) | |
| Change in Ratio of Bone Age Versus Chronological Age | Norditropin 0.035 mg/kg/Day | -0.02 | Standard Deviation 0.13 | ratio (bone age/chronological age) | |
| Change in Ratio of Bone Age Versus Chronological Age | Norditropin 0.067 mg/kg/Day | 0.07 | Standard Deviation 0.16 | ratio (bone age/chronological age) | |
| Change in Ratio of Bone Age Versus Chronological Age | Somapacitan 0.16 mg/kg/Week | 0.07 | Standard Deviation 0.08 | ratio (bone age/chronological age) | |
| Change in Ratio of Bone Age Versus Chronological Age | Somapacitan 0.20 mg/kg/Week | 0.03 | Standard Deviation 0.12 | ratio (bone age/chronological age) | |
| Change in Ratio of Bone Age Versus Chronological Age | Somapacitan 0.24 mg/kg/Week | -0.00 | Standard Deviation 0.10 | ratio (bone age/chronological age) |
1 to 10 of 50Source ClinicalTrials.gov
See all 50 results by groupParticipant flow30
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Norditropin 0.035 mg/kg/Day | 12 | |
| Overall Study | STARTED | Norditropin 0.067 mg/kg/Day | 13 | |
| Overall Study | STARTED | Somapacitan 0.16 mg/kg/Week | 12 | |
| Overall Study | STARTED | Somapacitan 0.20 mg/kg/Week | 13 | |
| Overall Study | STARTED | Somapacitan 0.24 mg/kg/Week | 12 | |
| Overall Study | Safety Analysis Set (SAS) | Norditropin 0.035 mg/kg/Day | 12 | |
| Overall Study | Safety Analysis Set (SAS) | Norditropin 0.067 mg/kg/Day | 13 | |
| Overall Study | Safety Analysis Set (SAS) | Somapacitan 0.16 mg/kg/Week | 12 | |
| Overall Study | Safety Analysis Set (SAS) | Somapacitan 0.20 mg/kg/Week | 13 | |
| Overall Study | Safety Analysis Set (SAS) | Somapacitan 0.24 mg/kg/Week | 12 |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 participant flowAdverse events330
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 distension | Gastrointestinal disorders | Norditropin (0.035mg/kg/Day) | 0 | 12 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Norditropin (0.067mg/kg/Day) | 0 | 13 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Somapacitan (0.16mg/kg/Week) | 0 | 12 | 0 |
| other | Abdominal distension | Gastrointestinal disorders | Somapacitan (0.20mg/kg/Week) | 1 | 13 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Somapacitan (0.24mg/kg/Week) | 0 | 12 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Norditropin (0.035mg/kg/Day) | 0 | 12 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Norditropin (0.067mg/kg/Day) | 0 | 13 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Somapacitan (0.16mg/kg/Week) | 1 | 12 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Somapacitan (0.20mg/kg/Week) | 0 | 13 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Somapacitan (0.24mg/kg/Week) | 0 | 12 | 0 |
1 to 10 of 330Source ClinicalTrials.gov
See all 330 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Norditropin (0.035mg/kg/Day) | 0 | 12 |
| Total, all-cause mortality | Norditropin (0.067mg/kg/Day) | 0 | 13 |
| Total, all-cause mortality | Somapacitan (0.16mg/kg/Week) | 0 | 12 |
| Total, all-cause mortality | Somapacitan (0.20mg/kg/Week) | 0 | 13 |
| Total, all-cause mortality | Somapacitan (0.24mg/kg/Week) | 0 | 12 |
| Total, other adverse events | Norditropin (0.035mg/kg/Day) | 7 | 12 |
| Total, other adverse events | Norditropin (0.067mg/kg/Day) | 6 | 13 |
| Total, other adverse events | Somapacitan (0.16mg/kg/Week) | 7 | 12 |
| Total, other adverse events | Somapacitan (0.20mg/kg/Week) | 9 | 13 |
| Total, other adverse events | Somapacitan (0.24mg/kg/Week) | 8 | 12 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41614610 | DERIVED |
Source PubMed
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/NCT03878446
GET https://conductscience.org/api/trials/v1/NCT03878446/results?page=2