Weekly Somapacitan is Effective and Well Tolerated in Children With GH Deficiency: The Randomized Phase 3 REAL4 Trial.

Miller BS, Blair JC, Rasmussen MH, Maniatis A, Kildemoes RJ, Mori J, Polak M, Bang RB, Böttcher V, Stagi S, Horikawa R

The Journal of clinical endocrinology and metabolism1 Nov 2022Cited by 65 (Europe PMC)

PMID36062966PMCIDPMC9693810DOI10.1210/clinem/dgac513PepBankPUB-36062966

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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

01HumanRandomized controlled trialEfficacy outcome
In children with GHD, week 52 height velocity was 11.2 cm/y with somapacitan versus 11.7 cm/y with daily GH, confirming noninferiority.
In plain wordsIn children with GHD, growth speed was numerically lower with somapacitan than daily GH, within the trial's noninferiority limit.
Peptide
Somapacitan
Outcome
DecreaseHeight velocity at week 52
Study
n = 200
Comparator
Daily GH (Norditropin)
Analysis
Primary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16 mg/kg/wk · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Height velocity
11.2 cm/y
Somapacitan
Height velocity
11.7 cm/y
Daily GH
Source sentences
Summary
Estimated mean HV at week 52 was 11.2 and 11.7 cm/y for somapacitan and daily GH, respectively.
5 context sentences(design, population, supporting numbers)
Summary · context
Noninferiority was confirmed.
Summary · context
The primary endpoint was annualized height velocity (HV; cm/y) at week 52.
Summary · context
REAL4 is a randomised, multinational, open-labeled, active-controlled parallel group phase 3 trial, comprising a 52-week main trial and 3-year extension (NCT03811535).
Summary · context
200 treatment-naïve patients were randomized and exposed.
Summary · context
Patients were randomized 2:1 to somapacitan (0.16 mg/kg/wk) or daily GH (Norditropin; 0.034 mg/kg/d), administered subcutaneously.
Report a problemFND-3606296601
02HumanRandomized controlled trialEfficacy outcome
In children with GHD, height velocity SDS changes through week 52 were similar with somapacitan and daily GH.
In plain wordsIn children with GHD, growth speed score changes were similar with somapacitan and daily GH.
Peptide
Somapacitan
Outcome
Direction not reportedHeight velocity SDS change
Study
n = 200
Comparator
Daily GH (Norditropin)
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16 mg/kg/wk · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
Changes in HV SDS, height SDS, bone age, and IGF-I SDS from baseline to week 52 were similar between treatment groups.
3 context sentences(design, population, supporting numbers)
Summary · context
REAL4 is a randomised, multinational, open-labeled, active-controlled parallel group phase 3 trial, comprising a 52-week main trial and 3-year extension (NCT03811535).
Summary · context
200 treatment-naïve patients were randomized and exposed.
Summary · context
Patients were randomized 2:1 to somapacitan (0.16 mg/kg/wk) or daily GH (Norditropin; 0.034 mg/kg/d), administered subcutaneously.
Report a problemFND-3606296602
03HumanRandomized controlled trialEfficacy outcome
In children with GHD, height SDS changes through week 52 were similar with somapacitan and daily GH.
In plain wordsIn children with GHD, height score changes were similar with somapacitan and daily GH.
Peptide
Somapacitan
Outcome
Direction not reportedHeight SDS change
Study
n = 200
Comparator
Daily GH (Norditropin)
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16 mg/kg/wk · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
Changes in HV SDS, height SDS, bone age, and IGF-I SDS from baseline to week 52 were similar between treatment groups.
3 context sentences(design, population, supporting numbers)
Summary · context
REAL4 is a randomised, multinational, open-labeled, active-controlled parallel group phase 3 trial, comprising a 52-week main trial and 3-year extension (NCT03811535).
Summary · context
200 treatment-naïve patients were randomized and exposed.
Summary · context
Patients were randomized 2:1 to somapacitan (0.16 mg/kg/wk) or daily GH (Norditropin; 0.034 mg/kg/d), administered subcutaneously.
Report a problemFND-3606296603
04HumanRandomized controlled trialEfficacy outcome
In children with GHD, bone age changes through week 52 were similar with somapacitan and daily GH.
In plain wordsIn children with GHD, bone age changes were similar with somapacitan and daily GH.
Peptide
Somapacitan
Outcome
Direction not reportedBone age change
Study
n = 200
Comparator
Daily GH (Norditropin)
Outcome group
Bone and joint · Musculoskeletal
Studied dose
0.16 mg/kg/wk · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
Changes in HV SDS, height SDS, bone age, and IGF-I SDS from baseline to week 52 were similar between treatment groups.
3 context sentences(design, population, supporting numbers)
Summary · context
REAL4 is a randomised, multinational, open-labeled, active-controlled parallel group phase 3 trial, comprising a 52-week main trial and 3-year extension (NCT03811535).
Summary · context
200 treatment-naïve patients were randomized and exposed.
Summary · context
Patients were randomized 2:1 to somapacitan (0.16 mg/kg/wk) or daily GH (Norditropin; 0.034 mg/kg/d), administered subcutaneously.
Report a problemFND-3606296604
05HumanRandomized controlled trialEfficacy outcome
In children with GHD, IGF-I SDS changes through week 52 were similar with somapacitan and daily GH.
In plain wordsIn children with GHD, IGF-I score changes were similar with somapacitan and daily GH.
Peptide
Somapacitan
Outcome
Direction not reportedIGF-I SDS change
Study
n = 200
Comparator
Daily GH (Norditropin)
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16 mg/kg/wk · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
Changes in HV SDS, height SDS, bone age, and IGF-I SDS from baseline to week 52 were similar between treatment groups.
3 context sentences(design, population, supporting numbers)
Summary · context
REAL4 is a randomised, multinational, open-labeled, active-controlled parallel group phase 3 trial, comprising a 52-week main trial and 3-year extension (NCT03811535).
Summary · context
200 treatment-naïve patients were randomized and exposed.
Summary · context
Patients were randomized 2:1 to somapacitan (0.16 mg/kg/wk) or daily GH (Norditropin; 0.034 mg/kg/d), administered subcutaneously.
Report a problemFND-3606296605
06HumanRandomized controlled trialEfficacy outcome
In children with GHD, week 52 mean IGF-I SDS was similar with somapacitan and daily GH and within the normal range (-2 to +2).
In plain wordsIn children with GHD, IGF-I scores were similar and within the normal range with somapacitan and daily GH.
Peptide
Somapacitan
Outcome
Direction not reportedIGF-I SDS at week 52
Study
n = 200
Comparator
Daily GH (Norditropin)
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16 mg/kg/wk · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
At week 52, mean IGF-I SDS values were similar between treatment groups and within normal range (-2 to +2).
3 context sentences(design, population, supporting numbers)
Summary · context
REAL4 is a randomised, multinational, open-labeled, active-controlled parallel group phase 3 trial, comprising a 52-week main trial and 3-year extension (NCT03811535).
Summary · context
200 treatment-naïve patients were randomized and exposed.
Summary · context
Patients were randomized 2:1 to somapacitan (0.16 mg/kg/wk) or daily GH (Norditropin; 0.034 mg/kg/d), administered subcutaneously.
Report a problemFND-3606296606
07HumanRandomized controlled trialSafety outcome
In children with GHD, injection-site reactions occurred in 5.3% with somapacitan versus 5.9% with daily GH.
In plain wordsIn children with GHD, injection-site reactions occurred in 5.3% with somapacitan and 5.9% with daily GH.
Peptide
Somapacitan
Outcome
DecreaseInjection-site reactions
Study
n = 200
Comparator
Daily GH (Norditropin)
Outcome group
Adverse events · Skin and wound
Studied dose
0.16 mg/kg/wk · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Injection-site reactions
5.3%
Somapacitan
Injection-site reactions
5.9%
Daily GH
Source sentences
Summary
Low proportions of injection-site reactions were reported for somapacitan (5.3%) and daily GH (5.9%).
3 context sentences(design, population, supporting numbers)
Summary · context
REAL4 is a randomised, multinational, open-labeled, active-controlled parallel group phase 3 trial, comprising a 52-week main trial and 3-year extension (NCT03811535).
Summary · context
200 treatment-naïve patients were randomized and exposed.
Summary · context
Patients were randomized 2:1 to somapacitan (0.16 mg/kg/wk) or daily GH (Norditropin; 0.034 mg/kg/d), administered subcutaneously.
Report a problemFND-3606296608
08HumanRandomized controlled trialEfficacy outcome
In children with GHD, somapacitan reduced treatment burden more than daily GH through week 52.
In plain wordsIn children with GHD, somapacitan reduced treatment burden more than daily GH.
Peptide
Somapacitan
Outcome
DecreaseTreatment burden reduction
Study
n = 200
Comparator
Daily GH (Norditropin)
Outcome group
Device usability · Whole body
Studied dose
0.16 mg/kg/wk · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
Both treatments similarly reduced disease burden from baseline to week 52, whereas a greater treatment burden reduction was observed for somapacitan.
3 context sentences(design, population, supporting numbers)
Summary · context
REAL4 is a randomised, multinational, open-labeled, active-controlled parallel group phase 3 trial, comprising a 52-week main trial and 3-year extension (NCT03811535).
Summary · context
200 treatment-naïve patients were randomized and exposed.
Summary · context
Patients were randomized 2:1 to somapacitan (0.16 mg/kg/wk) or daily GH (Norditropin; 0.034 mg/kg/d), administered subcutaneously.
Report a problemFND-3606296610
09HumanNon-randomized trialEfficacy outcome
In children with GHD, disease burden fell from baseline to week 52 with both somapacitan and daily GH, to a similar degree.
In plain wordsIn children with GHD, disease burden fell from baseline with both somapacitan and daily GH, to a similar degree.
Peptide
Somapacitan
Outcome
DecreaseDisease burden reduction
Study
n = 200
Comparator
Baseline
Outcome group
Disease Burden · Whole body
Studied dose
0.16 mg/kg/wk · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
Both treatments similarly reduced disease burden from baseline to week 52, whereas a greater treatment burden reduction was observed for somapacitan.
3 context sentences(design, population, supporting numbers)
Summary · context
REAL4 is a randomised, multinational, open-labeled, active-controlled parallel group phase 3 trial, comprising a 52-week main trial and 3-year extension (NCT03811535).
Summary · context
200 treatment-naïve patients were randomized and exposed.
Summary · context
Patients were randomized 2:1 to somapacitan (0.16 mg/kg/wk) or daily GH (Norditropin; 0.034 mg/kg/d), administered subcutaneously.
Report a problemFND-3606296609
10HumanNon-randomized trialSafety outcome
In children with GHD, somapacitan safety was consistent with the known daily GH profile.
In plain wordsIn children with GHD, somapacitan had a safety profile consistent with daily GH.
Peptide
Somapacitan
Outcome
Direction not reportedSafety profile
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
0.16 mg/kg/wk · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
Safety of somapacitan was consistent with the well-known daily GH profile.
3 context sentences(design, population, supporting numbers)
Summary · context
REAL4 is a randomised, multinational, open-labeled, active-controlled parallel group phase 3 trial, comprising a 52-week main trial and 3-year extension (NCT03811535).
Summary · context
200 treatment-naïve patients were randomized and exposed.
Summary · context
Patients were randomized 2:1 to somapacitan (0.16 mg/kg/wk) or daily GH (Norditropin; 0.034 mg/kg/d), administered subcutaneously.
Report a problemFND-3606296607

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT03811535

A Research Study in Children With a Low Level of Hormone to Grow. Treatment is Somapacitan Once a Week Compared to Norditropin® Once a Day (REAL4)

Novo Nordisk A/Sn = 20020 May 2019 to 30 Sept 2025

Growth Hormone Deficiency in Children

Trial page ClinicalTrials.govUpdated 22 Oct 2026

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:36 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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