A Phase 2 interventional study of Somapacitan and Norditropin® in Short Stature Children Born Small for Gestational Age (SGA), sponsored by Novo Nordisk A/S. Active, not recruiting at 95 sites in 23 countries. Open to participants aged 2 Years to 11 Years. Per ClinicalTrials.gov, last updated 2026-10-06.
Sponsored by Novo Nordisk A/S · Phase 2, Interventional, and Treatment
The study compares 2 medicines used for the treatment of children who are born small and who stayed small: somapacitan given once a week (a new medicine) and Norditropin® given once a day (the medicine doctors can already prescribe).
Participants will either get somapacitan or Norditropin® - which treatment is decided by chance. Both participants and the study doctor will know which treatment the participants get. The study will last for 5 years. Participants will take either an injection once every week or once every day.
Novo Nordisk A/S is the lead sponsor of 1,404 studies on the registry; 101 are open to participants now.
Of its 205 completed or terminated interventional studies of FDA-regulated products, 100 (49%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Pre-pubertal children, boys:
Pre-pubertal children, girls:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Same treatment in main period (26 weeks) and extension period I (26 weeks). Dosage of Somapacitan during extension period II will be determined based on the data from main phase.
Drug: Somapacitan
Same treatment in main period (26 weeks) and extension period I (26 weeks). Dosage of Somapacitan during extension period II will be determined based on the data from main phase.
Drug: Somapacitan
Same treatment in main period (26 weeks) and extension period I (26 weeks). Dosage of Somapacitan during extension period II will be determined based on the data from main phase.
Drug: Somapacitan
Same treatment in main period (26 weeks) and extension period I (26 weeks). Participants will switch to Somapacitan during extension period II. Dosage of Somapacitan during extension period II will be determined based on the data from main phase.
Drug: Norditropin®
Same treatment in main period (26 weeks) and extension period I (26 weeks). Participants will switch to Somapacitan during extension period II. Dosage of Somapacitan during extension period II will be determined based on the data from main phase.
Drug: Norditropin®
Somapacitan injected under the skin once a week.
Norditropin® injected under the skin once a day.
Height Velocity
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.
Time frame: Baseline (week 0); week 26
Change in Ratio of Bone Age Versus Chronological Age
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.
Time frame: Baseline (week 0); week 52
Change in Height Standard Deviation Score (HSDS)
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.
Time frame: Baseline (week 0); week 26
Change in Height Velocity Standard Deviation Score (HVSDS)
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.
Time frame: Baseline (week 0); week 26
Change in Fasting Plasma Glucose
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.
Time frame: Baseline (week 0); week 26
Change in Homeostatic Model Assessment for Steady State Beta Cell Function (HOMA-B)
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.
Time frame: Baseline (week 0); week 26
Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
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.
Time frame: Baseline (week 0); week 26
Change in Glycated Haemoglobin (HbA1c)
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.
Time frame: Baseline (week 0); week 26
Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS)
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.
Time frame: Baseline (week 0); week 26
Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) SDS
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.
Time frame: Baseline (week 0); week 26
The trial was conducted at 38 sites in 12 countries as follows (number of sites that screened participants/ number of sites that randomized participants): Austria (2/1), France (2/2), Hungary (1/1), India (3/3), Israel (1/1), Italy (2/2), Japan (10/10), Latvia (1/1), Russia (6/6), Thailand (2/1), Ukraine (2/2) and United States (6/5).
| Milestone | Norditropin 0.035 mg/kg/Day | Norditropin 0.067 mg/kg/Day | Somapacitan 0.16 mg/kg/Week | Somapacitan 0.20 mg/kg/Week | Somapacitan 0.24 mg/kg/Week |
|---|---|---|---|---|---|
| Started | 12 | 13 | 12 | 13 | 12 |
| Safety analysis set (sas) | 12 | 13 | 12 | 13 | 12 |
| Full analysis set (fas) | 12 | 13 | 12 | 13 | 12 |
| Per protocol analysis set | 11 | 13 | 12 | 13 | 12 |
| Completed | 11 | 13 | 12 | 13 | 12 |
| Not completed | 1 | 0 | 0 | 0 | 0 |
| Withdrew: Withdrawn by parent or guardian | 1 | 0 | 0 | 0 | 0 |
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.
| centimeter per year (cm/year) | Norditropin 0.035 mg/kg/Day | Norditropin 0.067 mg/kg/Day | Somapacitan 0.16 mg/kg/Week | Somapacitan 0.20 mg/kg/Week | Somapacitan 0.24 mg/kg/Week |
|---|---|---|---|---|---|
| Height Velocity | 10.5 ± 2.0 | 11.9 ± 2.4 | 8.9 ± 1.8 | 11.1 ± 2.6 | 11.2 ± 3.4 |
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.
| ratio (bone age/chronological age) | Norditropin 0.035 mg/kg/Day | Norditropin 0.067 mg/kg/Day | Somapacitan 0.16 mg/kg/Week | Somapacitan 0.20 mg/kg/Week | Somapacitan 0.24 mg/kg/Week |
|---|---|---|---|---|---|
| Change in Ratio of Bone Age Versus Chronological Age | -0.02 ± 0.13 | 0.07 ± 0.16 | 0.07 ± 0.08 | 0.03 ± 0.12 | -0.00 ± 0.10 |
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.
| score on a scale | Norditropin 0.035 mg/kg/Day | Norditropin 0.067 mg/kg/Day | Somapacitan 0.16 mg/kg/Week | Somapacitan 0.20 mg/kg/Week | Somapacitan 0.24 mg/kg/Week |
|---|---|---|---|---|---|
| Change in Height Standard Deviation Score (HSDS) | 0.61 ± 0.19 | 0.73 ± 0.30 | 0.41 ± 0.20 | 0.66 ± 0.29 | 0.66 ± 0.37 |
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.
| score on a scale | Norditropin 0.035 mg/kg/Day | Norditropin 0.067 mg/kg/Day | Somapacitan 0.16 mg/kg/Week | Somapacitan 0.20 mg/kg/Week | Somapacitan 0.24 mg/kg/Week |
|---|---|---|---|---|---|
| Change in Height Velocity Standard Deviation Score (HVSDS) | 6.37 ± 3.05 | 7.86 ± 1.88 | 4.03 ± 2.68 | 6.77 ± 3.35 | 7.24 ± 3.80 |
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.
| millimoles per liter (mmol/L) | Norditropin 0.035 mg/kg/Day | Norditropin 0.067 mg/kg/Day | Somapacitan 0.16 mg/kg/Week | Somapacitan 0.20 mg/kg/Week | Somapacitan 0.24 mg/kg/Week |
|---|---|---|---|---|---|
| Change in Fasting Plasma Glucose | 0.382 ± 0.500 | 0.192 ± 0.415 | 0.167 ± 0.485 | 0.200 ± 0.912 | 0.275 ± 0.693 |
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.
| HOMA-B index | Norditropin 0.035 mg/kg/Day | Norditropin 0.067 mg/kg/Day | Somapacitan 0.16 mg/kg/Week | Somapacitan 0.20 mg/kg/Week | Somapacitan 0.24 mg/kg/Week |
|---|---|---|---|---|---|
| Change in Homeostatic Model Assessment for Steady State Beta Cell Function (HOMA-B) | 6.12 ± 99.55 | 63.35 ± 46.01 | 24.53 ± 49.59 | 0.75 ± 65.08 | 51.83 ± 88.89 |
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.
| HOMA-IR index | Norditropin 0.035 mg/kg/Day | Norditropin 0.067 mg/kg/Day | Somapacitan 0.16 mg/kg/Week | Somapacitan 0.20 mg/kg/Week | Somapacitan 0.24 mg/kg/Week |
|---|---|---|---|---|---|
| Change in Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) | 0.85 ± 0.82 | 1.17 ± 0.88 | 0.40 ± 0.48 | 0.57 ± 3.07 | 1.50 ± 2.10 |
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.
| Percentage of HbA1c | Norditropin 0.035 mg/kg/Day | Norditropin 0.067 mg/kg/Day | Somapacitan 0.16 mg/kg/Week | Somapacitan 0.20 mg/kg/Week | Somapacitan 0.24 mg/kg/Week |
|---|---|---|---|---|---|
| Change in Glycated Haemoglobin (HbA1c) | -0.10 ± 0.39 | 0.03 ± 0.20 | 0.07 ± 0.15 | 0.12 ± 0.25 | 0.05 ± 0.24 |
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.
| score on a scale | Norditropin 0.035 mg/kg/Day | Norditropin 0.067 mg/kg/Day | Somapacitan 0.16 mg/kg/Week | Somapacitan 0.20 mg/kg/Week | Somapacitan 0.24 mg/kg/Week |
|---|---|---|---|---|---|
| Change in Insulin-like Growth Factor I (IGF-I) Standard Deviation Score (SDS) | 1.59 ± 0.67 | 2.13 ± 1.07 | 1.48 ± 0.90 | 1.93 ± 1.07 | 3.03 ± 1.42 |
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.
| score on a scale | Norditropin 0.035 mg/kg/Day | Norditropin 0.067 mg/kg/Day | Somapacitan 0.16 mg/kg/Week | Somapacitan 0.20 mg/kg/Week | Somapacitan 0.24 mg/kg/Week |
|---|---|---|---|---|---|
| Change in Insulin-like Growth Factor Binding Protein 3 (IGFBP-3) SDS | 0.81 ± 0.64 | 1.06 ± 0.66 | 0.77 ± 0.68 | 1.01 ± 0.80 | 1.40 ± 0.88 |
Collected over From Baseline (Week 0) to Week 52. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Norditropin (0.035mg/kg/Day) | 0/12 (0%) | 1/12 (8.3%) | 7/12 (58.3%) |
| Norditropin (0.067mg/kg/Day) | 0/13 (0%) | 0/13 (0%) | 6/13 (46.2%) |
| Somapacitan (0.16mg/kg/Week) | 0/12 (0%) | 0/12 (0%) | 7/12 (58.3%) |
| Somapacitan (0.20mg/kg/Week) | 0/13 (0%) | 1/13 (7.7%) | 9/13 (69.2%) |
| Somapacitan (0.24mg/kg/Week) | 0/12 (0%) | 0/12 (0%) | 8/12 (66.7%) |
| Event | Norditropin (0.035mg/kg/Day) | Norditropin (0.067mg/kg/Day) | Somapacitan (0.16mg/kg/Week) | Somapacitan (0.20mg/kg/Week) | Somapacitan (0.24mg/kg/Week) |
|---|---|---|---|---|---|
| Inguinal herniaGastrointestinal disorders | 1/12 | 0/13 | 0/12 | 0/13 | 0/12 |
| Type 1 diabetes mellitusMetabolism and nutrition disorders | 0/12 | 0/13 | 0/12 | 1/13 | 0/12 |
| Event | Norditropin (0.035mg/kg/Day) | Norditropin (0.067mg/kg/Day) | Somapacitan (0.16mg/kg/Week) | Somapacitan (0.20mg/kg/Week) | Somapacitan (0.24mg/kg/Week) |
|---|---|---|---|---|---|
| NasopharyngitisInfections and infestations | 1/12 | 1/13 | 3/12 | 2/13 | 3/12 |
| RhinitisInfections and infestations | 0/12 | 1/13 | 2/12 | 0/13 | 0/12 |
| VomitingGastrointestinal disorders | 0/12 | 0/13 | 2/12 | 1/13 | 1/12 |
| ContusionInjury, poisoning and procedural complications | 0/12 | 0/13 | 1/12 | 0/13 | 2/12 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/12 | 0/13 | 0/12 | 2/13 | 0/12 |
| BronchitisInfections and infestations | 0/12 | 1/13 | 0/12 | 2/13 | 0/12 |
| Upper respiratory tract infectionInfections and infestations | 0/12 | 2/13 | 0/12 | 2/13 | 0/12 |
| Abdominal painGastrointestinal disorders | 0/12 | 0/13 | 1/12 | 0/13 | 0/12 |
| AnxietyPsychiatric disorders | 1/12 | 0/13 | 0/12 | 0/13 | 0/12 |
| Behaviour disorderPsychiatric disorders | 1/12 | 0/13 | 0/12 | 0/13 | 0/12 |
Full analysis set (FAS) included all randomized participants exposed to the trial product.
| Age, Continuous(years) | Norditropin 0.035 mg/kg/Day | Norditropin 0.067 mg/kg/Day | Somapacitan 0.16 mg/kg/Week | Somapacitan 0.20 mg/kg/Week | Somapacitan 0.24 mg/kg/Week | Total |
|---|---|---|---|---|---|---|
| Mean | 6.29 ± 2.84 | 5.92 ± 2.44 | 6.13 ± 2.41 | 6.17 ± 2.21 | 6.00 ± 2.46 | 6.10 ± 2.39 |
| Sex: Female, Male(Participants) | Norditropin 0.035 mg/kg/Day | Norditropin 0.067 mg/kg/Day | Somapacitan 0.16 mg/kg/Week | Somapacitan 0.20 mg/kg/Week | Somapacitan 0.24 mg/kg/Week | Total |
|---|---|---|---|---|---|---|
| Female | 6 | 4 | 4 | 4 | 4 | 22 |
| Male | 6 | 9 | 8 | 9 | 8 | 40 |
| Ethnicity (NIH/OMB)(Participants) | Norditropin 0.035 mg/kg/Day | Norditropin 0.067 mg/kg/Day | Somapacitan 0.16 mg/kg/Week | Somapacitan 0.20 mg/kg/Week | Somapacitan 0.24 mg/kg/Week | Total |
|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 0 | 0 | 0 | 2 |
| Not Hispanic or Latino | 12 | 11 | 8 | 12 | 11 | 54 |
| Unknown or Not Reported | 0 | 0 | 4 | 1 | 1 | 6 |
| Race/Ethnicity, Customized(Participants) | Norditropin 0.035 mg/kg/Day | Norditropin 0.067 mg/kg/Day | Somapacitan 0.16 mg/kg/Week | Somapacitan 0.20 mg/kg/Week | Somapacitan 0.24 mg/kg/Week | Total |
|---|---|---|---|---|---|---|
| White | 9 | 8 | 4 | 7 | 6 | 34 |
| Asian | 3 | 5 | 6 | 4 | 6 | 24 |
| Other | 0 | 0 | 0 | 1 | 0 | 1 |
| Not reported | 0 | 0 | 2 | 1 | 0 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Data sharing details ↗ · novonordisk-trials.com
Ran from Jul 2019 to primary completion in May 2021, 22 months.
Results were first posted in Jun 2024, 3 years 1 month after primary completion. A results delay was requested in Apr 2022.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Somapacitan