Efficacy and Safety of Weekly Somatrogon vs Daily Somatropin in Children With Growth Hormone Deficiency: A Phase 3 Study.

Deal CL, Steelman J, Vlachopapadopoulou E, Stawerska R, Silverman LA, Phillip M, Kim HS, Ko C, Malievskiy O, Cara JF, Roland CL, Taylor CT and 4 more

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Valluri SR, Wajnrajch MP, Pastrak A, Miller BS

The Journal of clinical endocrinology and metabolism1 Jun 2022Cited by 95 (Europe PMC)

PMID35405011PMCIDPMC9202717DOI10.1210/clinem/dgac220PepBankPUB-35405011

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Summary

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

Results from this study5

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In children with GHD, somatropin height velocity was 9.78 versus 10.10 cm/year with somatrogon, which met the -1.8 cm/year noninferiority margin.
In plain wordsIn children with growth hormone deficiency, height velocity was 9.78 cm/year with somatropin versus 10.10 cm/year with somatrogon.
Peptide
HGH (somatotropin)
Outcome
Not applicableAnnualized height velocity at month 12
Study
n = 228
Comparator
Once-weekly somatrogon 0.66 mg/kg/week
Analysis
Primary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.24 mg/kg/week once daily · 12 monthsAs given in this study (human).
Measurements
Height velocity
9.78 cm/year
somatropin at month 12
Treatment difference
0.33 cm/year
somatrogon minus somatropin
Treatment difference 95% CI lower bound
−0.24 cm/year
somatrogon minus somatropin
Treatment difference 95% CI upper bound
0.89 cm/year
somatrogon minus somatropin
Source sentences
Summary
HV at month 12 was 10.10 cm/year for somatrogon-treated subjects and 9.78 cm/year for somatropin-treated subjects, with a treatment difference (somatrogon-somatropin) of 0.33 (95% CI: -0.24, 0.89).
4 context sentences(design, population, supporting numbers)
Summary · context
The lower bound of the 2-sided 95% CI was higher than the prespecified noninferiority margin (-1.8 cm/year), demonstrating noninferiority of once-weekly somatrogon vs daily somatropin.
Summary · context
In this 12-month, open-label, randomized, active-controlled, parallel-group, phase 3 study, participants were randomized 1:1 to receive once-weekly somatrogon (0.66 mg/kg/week) or once-daily somatropin (0.24 mg/kg/week) for 12 months.
Summary · context
A total of 228 prepubertal children (boys aged 3-11 years, girls aged 3-10 years) with GHD, impaired height and height velocity (HV), and no prior rhGH treatment were randomized and 224 received ≥1 dose of study treatment (somatrogon: 109; somatropin: 115).
Summary · context
The primary endpoint was annualized HV at month 12.
Report a problemFND-3540501101
02HumanRandomized controlled trialEfficacy outcome
In children with growth hormone deficiency, height velocity at month 6 was similar with somatropin and somatrogon.
In plain wordsIn children with growth hormone deficiency, height velocity at month 6 was similar with somatropin and somatrogon.
Peptide
HGH (somatotropin)
Outcome
No significant changeHeight velocity at month 6
Study
n = 228
Comparator
Once-weekly somatrogon 0.66 mg/kg/week
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.24 mg/kg/week once daily · 12 monthsAs given in this study (human).
Source sentences
Summary
HV at month 6 and change in height standard deviation score at months 6 and 12 were similar between both treatment groups.
2 context sentences(design, population, supporting numbers)
Summary · context
In this 12-month, open-label, randomized, active-controlled, parallel-group, phase 3 study, participants were randomized 1:1 to receive once-weekly somatrogon (0.66 mg/kg/week) or once-daily somatropin (0.24 mg/kg/week) for 12 months.
Summary · context
A total of 228 prepubertal children (boys aged 3-11 years, girls aged 3-10 years) with GHD, impaired height and height velocity (HV), and no prior rhGH treatment were randomized and 224 received ≥1 dose of study treatment (somatrogon: 109; somatropin: 115).
Report a problemFND-3540501102
03HumanRandomized controlled trialEfficacy outcome
In children with growth hormone deficiency, height score change at month 6 was similar with somatropin and somatrogon.
In plain wordsIn children with growth hormone deficiency, height score change at month 6 was similar with somatropin and somatrogon.
Peptide
HGH (somatotropin)
Outcome
No significant changeHeight standard deviation score change at month 6
Study
n = 228
Comparator
Once-weekly somatrogon 0.66 mg/kg/week
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.24 mg/kg/week once daily · 12 monthsAs given in this study (human).
Source sentences
Summary
HV at month 6 and change in height standard deviation score at months 6 and 12 were similar between both treatment groups.
2 context sentences(design, population, supporting numbers)
Summary · context
In this 12-month, open-label, randomized, active-controlled, parallel-group, phase 3 study, participants were randomized 1:1 to receive once-weekly somatrogon (0.66 mg/kg/week) or once-daily somatropin (0.24 mg/kg/week) for 12 months.
Summary · context
A total of 228 prepubertal children (boys aged 3-11 years, girls aged 3-10 years) with GHD, impaired height and height velocity (HV), and no prior rhGH treatment were randomized and 224 received ≥1 dose of study treatment (somatrogon: 109; somatropin: 115).
Report a problemFND-3540501103
04HumanRandomized controlled trialEfficacy outcome
In children with growth hormone deficiency, height score change at month 12 was similar with somatropin and somatrogon.
In plain wordsIn children with growth hormone deficiency, height score change at month 12 was similar with somatropin and somatrogon.
Peptide
HGH (somatotropin)
Outcome
No significant changeHeight standard deviation score change at month 12
Study
n = 228
Comparator
Once-weekly somatrogon 0.66 mg/kg/week
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.24 mg/kg/week once daily · 12 monthsAs given in this study (human).
Source sentences
Summary
HV at month 6 and change in height standard deviation score at months 6 and 12 were similar between both treatment groups.
2 context sentences(design, population, supporting numbers)
Summary · context
In this 12-month, open-label, randomized, active-controlled, parallel-group, phase 3 study, participants were randomized 1:1 to receive once-weekly somatrogon (0.66 mg/kg/week) or once-daily somatropin (0.24 mg/kg/week) for 12 months.
Summary · context
A total of 228 prepubertal children (boys aged 3-11 years, girls aged 3-10 years) with GHD, impaired height and height velocity (HV), and no prior rhGH treatment were randomized and 224 received ≥1 dose of study treatment (somatrogon: 109; somatropin: 115).
Report a problemFND-3540501104
05HumanRandomized controlled trialSafety outcome
In children with growth hormone deficiency, mild to moderate treatment-emergent adverse events occurred in 79.1% with somatropin versus 78.9% with somatrogon.
In plain wordsIn children with growth hormone deficiency, mild to moderate adverse event proportions were similar with somatropin and somatrogon.
Peptide
HGH (somatotropin)
Outcome
No significant changeMild to moderate treatment-emergent adverse events
Study
n = 224
Comparator
Once-weekly somatrogon 0.66 mg/kg/week
Outcome group
Adverse events · Whole body
Studied dose
0.24 mg/kg/week once daily · 12 monthsAs given in this study (human).
Measurements
Treatment-emergent adverse events
79.1%
somatropin
Source sentences
Summary
Both treatments were well tolerated, with a similar percentage of subjects experiencing mild to moderate treatment-emergent adverse events in both groups (somatrogon: 78.9%, somatropin: 79.1%).
2 context sentences(design, population, supporting numbers)
Summary · context
In this 12-month, open-label, randomized, active-controlled, parallel-group, phase 3 study, participants were randomized 1:1 to receive once-weekly somatrogon (0.66 mg/kg/week) or once-daily somatropin (0.24 mg/kg/week) for 12 months.
Summary · context
A total of 228 prepubertal children (boys aged 3-11 years, girls aged 3-10 years) with GHD, impaired height and height velocity (HV), and no prior rhGH treatment were randomized and 224 received ≥1 dose of study treatment (somatrogon: 109; somatropin: 115).
Report a problemFND-3540501105

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 postedNCT02968004

Safety and Efficacy Phase 3 Study of Long-acting hGH (MOD-4023) in Growth Hormone Deficient Children

OPKO Health, Inc.n = 224Dec 2016 to May 2024

Pediatric Growth Hormone Deficiency

Trial page ClinicalTrials.govUpdated 20 Jul 2025

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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