Once-weekly somapacitan enhances linear growth in girls with Turner syndrome: a randomized controlled phase 3 study.

Mauras N, Boettcher C, Højby M, Soltysik K, Jorge AAL, Kashimada K, Linglart A, Luo X, Murray PG, Backeljauw P

The Journal of clinical endocrinology and metabolism1 Aug 2026

PMID42538806DOI10.1210/clinem/dgag309PepBankPUB-42538806

Publisher page PubMedAsk about this study

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: Publisher copyright. 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 girls with Turner syndrome, somapacitan height velocity was 9.0 versus 9.5 cm/year with daily GH; non-inferiority was confirmed.
In plain wordsIn girls with Turner syndrome, growth velocity was lower with somapacitan than daily GH, but met non-inferiority criteria.
Peptide
Somapacitan
Outcome
DecreaseHeight velocity at week 52
Study
n = 105
Comparator
Daily GH 0.050 mg/kg/day
Analysis
Primary
Outcome group
Linear growth · Endocrine and hormones
Studied dose
0.24 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Height velocity
9 cm/year
somapacitan
SD
1.6 cm/year
somapacitan
Height velocity
9.5 cm/year
daily GH
SD
2.2 cm/year
daily GH
ETD
−0.8 cm/year
somapacitan versus daily GH
95% CI
−1.57 to −0.11 cm/year
ETD
Source sentences
Summary
At week 52, mean observed HV was 9.0 (1.6) vs. 9.5 (2.2) cm/year for somapacitan and daily GH, respectively (ETD = -0.8 [-1.57; -0.11]95%CI).
3 context sentences(design, population, supporting numbers)
Summary · context
Non-inferiority for once-weekly somapacitan vs. daily GH for the primary endpoint, HV at week 52, was confirmed.
Summary · context
In total, 105 treatment-naïve, prepubertal girls with TS (aged 2.5-10 years), were randomized and exposed.
Summary · context
Participants were assigned 2:1 to somapacitan, 0.24 mg/kg/week, or daily GH 0.050 mg/kg/day, administered subcutaneously.
Report a problemFND-4253880601
02HumanRandomized controlled trialEfficacy outcome
In girls with Turner syndrome, mean IGF-I score at week 52 was +1.71 with somapacitan versus +1.95 with daily GH.
In plain wordsIn girls with Turner syndrome, IGF-I scores were numerically lower with somapacitan than daily GH at week 52.
Peptide
Somapacitan
Outcome
DecreaseIGF-I score at week 52
Study
n = 105
Comparator
Daily GH 0.050 mg/kg/day
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.24 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Mean IGF-I SDS
1.71
somapacitan
SD
1.38
somapacitan
Mean IGF-I SDS
1.95
daily GH
SD
1.11
daily GH
Source sentences
Summary
At week 52, mean (SD) IGF-I SDS was +1.71 (1.38) vs. + 1.95 (1.11) for somapacitan and daily GH, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
In total, 105 treatment-naïve, prepubertal girls with TS (aged 2.5-10 years), were randomized and exposed.
Summary · context
Participants were assigned 2:1 to somapacitan, 0.24 mg/kg/week, or daily GH 0.050 mg/kg/day, administered subcutaneously.
Report a problemFND-4253880603
03HumanRandomized controlled trialSafety outcome
In girls with Turner syndrome, somapacitan and daily GH had similar safety profiles.
In plain wordsIn girls with Turner syndrome, safety profiles were similar with somapacitan and daily GH.
Peptide
Somapacitan
Outcome
Direction not reportedSafety profile
Study
n = 105
Comparator
Daily GH 0.050 mg/kg/day
Outcome group
Adverse events · Whole body
Studied dose
0.24 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
Safety profiles were similar between groups.
2 context sentences(design, population, supporting numbers)
Summary · context
In total, 105 treatment-naïve, prepubertal girls with TS (aged 2.5-10 years), were randomized and exposed.
Summary · context
Participants were assigned 2:1 to somapacitan, 0.24 mg/kg/week, or daily GH 0.050 mg/kg/day, administered subcutaneously.
Report a problemFND-4253880604
04HumanNon-randomized trialSafety outcome
In girls with Turner syndrome, no participants discontinued somapacitan or daily GH because of adverse events.
In plain wordsIn girls with Turner syndrome, no participants stopped somapacitan or daily GH because of adverse events.
Peptide
Somapacitan
Outcome
Not applicableDiscontinuation due to adverse events
Study
n = 105
Outcome group
Adverse events · Whole body
Studied dose
0.24 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
No participants discontinued trial product due to adverse events.
2 context sentences(design, population, supporting numbers)
Summary · context
In total, 105 treatment-naïve, prepubertal girls with TS (aged 2.5-10 years), were randomized and exposed.
Summary · context
Participants were assigned 2:1 to somapacitan, 0.24 mg/kg/week, or daily GH 0.050 mg/kg/day, administered subcutaneously.
Report a problemFND-4253880605
05HumanNon-randomized trialEfficacy outcome
In girls with Turner syndrome, IGF-I scores increased with somapacitan, as they did with daily GH.
In plain wordsIn girls with Turner syndrome, IGF-I scores increased with somapacitan, as with daily GH.
Peptide
Somapacitan
Outcome
IncreaseIGF-I score change
Study
n: not reported in source
Comparator
Baseline
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.24 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
IGF-I SD score (SDS) increased in both groups.
2 context sentences(design, population, supporting numbers)
Summary · context
In total, 105 treatment-naïve, prepubertal girls with TS (aged 2.5-10 years), were randomized and exposed.
Summary · context
Participants were assigned 2:1 to somapacitan, 0.24 mg/kg/week, or daily GH 0.050 mg/kg/day, administered subcutaneously.
Report a problemFND-4253880602

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

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.

Publication types

Journal Article

Keywords

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