RF14 | LBMON195 Once-weekly Somapacitan Is Effective And Well Tolerated In Children With GH Deficiency: A Randomized Phase 3 Trial

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Journal of the Endocrine Society1 Nov 2022

PMCIDPMC9625361PepBankPUB-99967925

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Summary

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

Results from this study11

11 results from studies that gave the peptide. 11 results from people.

01HumanRandomized controlled trialEfficacy outcome
In children with GHD, height velocity was 11.2 versus 11.7 cm/year with somapacitan versus daily GH, a difference of -0.5 (95% CI -1.1 to 0.2).
In plain wordsIn children with GHD, somapacitan growth speed was numerically lower than daily GH and met the noninferiority threshold.
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/week · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Height velocity
11.2 cm/year
Somapacitan
Height velocity
11.7 cm/year
Daily GH
Treatment difference
−0.5 cm/year
Somapacitan versus daily GH
95% CI
−1.1 to 0.2 cm/year
Difference
Noninferiority threshold
−1.8 cm/year
Trial threshold
Source sentences
Summary
At week 52, the estimated mean HV was 11.2 cm/year for somapacitan compared to 11.7 cm/year for daily GH.
4 context sentences(design, population, supporting numbers)
Summary · context
The estimated treatment difference was -0.5 [95% CI -1.1 to 0.2] cm/year, confirming non-inferiority (non-inferiority threshold: -1.8 cm/year).
Summary · context
The primary endpoint was annualized height velocity (HV) after 52 weeks of treatment.
Summary · context
REAL4 is a randomised, multi-national, open labelled, and active-controlled parallel group phase 3 trial, comprising a 52-week main phase and three-year extension period (NCT03811535).
Summary · context
Two-hundred GH-treatment-naïve, prepubertal children with GHD (74.5% male) were randomly assigned in a 2: 1 ratio to receive 0.16 mg/kg/week s.c. somapacitan (n=132) or daily s.c. GH (0.034 mg/kg/day Norditropin®; n=68).
Report a problemFND-9996792501
02HumanRandomized controlled trialEfficacy outcome
In children with GHD, secondary height-related endpoints supported the somapacitan versus daily GH primary result.
In plain wordsIn children with GHD, other growth endpoints supported the main somapacitan versus daily GH result.
Peptide
Somapacitan
Outcome
Direction not reportedSecondary height-related endpoints
Study
n = 200
Comparator
Daily GH (Norditropin)
Analysis
Secondary
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
Secondary height-related endpoints supported the primary endpoint.
2 context sentences(design, population, supporting numbers)
Summary · context
REAL4 is a randomised, multi-national, open labelled, and active-controlled parallel group phase 3 trial, comprising a 52-week main phase and three-year extension period (NCT03811535).
Summary · context
Two-hundred GH-treatment-naïve, prepubertal children with GHD (74.5% male) were randomly assigned in a 2: 1 ratio to receive 0.16 mg/kg/week s.c. somapacitan (n=132) or daily s.c. GH (0.034 mg/kg/day Norditropin®; n=68).
Report a problemFND-9996792502
03HumanRandomized controlled trialEfficacy outcome
In children with GHD, IGF-I SDS increased with both treatments, with no significant difference in changes between somapacitan and daily GH.
In plain wordsIn children with GHD, IGF-I score changes were similar with somapacitan and daily GH.
Peptide
Somapacitan
Outcome
No significant changeIGF-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/week · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
Insulin-like growth factor-I standard deviation score (IGF-I SDS) showed consistent increases for both somapacitan and daily GH over the 52 weeks, with change differences from baseline not statistically significant between treatment groups.
2 context sentences(design, population, supporting numbers)
Summary · context
REAL4 is a randomised, multi-national, open labelled, and active-controlled parallel group phase 3 trial, comprising a 52-week main phase and three-year extension period (NCT03811535).
Summary · context
Two-hundred GH-treatment-naïve, prepubertal children with GHD (74.5% male) were randomly assigned in a 2: 1 ratio to receive 0.16 mg/kg/week s.c. somapacitan (n=132) or daily s.c. GH (0.034 mg/kg/day Norditropin®; n=68).
Report a problemFND-9996792503
04HumanRandomized controlled trialEfficacy outcome
In children with GHD, week 52 mean IGF-I SDS was +0.28 with somapacitan versus +0.10 with daily GH, with similar normal-range levels.
In plain wordsIn children with GHD, IGF-I scores were numerically higher with somapacitan than daily GH, but levels were described as similar.
Peptide
Somapacitan
Outcome
IncreaseIGF-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/week · subcutaneous · 52 weeksAs given in this study (human).
Measurements
IGF-I SDS
0.28 SDS
Somapacitan
IGF-I SDS
0.1 SDS
Daily GH
Normal lower limit
−2 SDS
Both groups
Normal upper limit
2 SDS
Both groups
Source sentences
Summary
At week 52, mean IGF-I SDS levels were similar between somapacitan (+0.28) and daily GH (+0.10) and within normal range (-2 to +2).
2 context sentences(design, population, supporting numbers)
Summary · context
REAL4 is a randomised, multi-national, open labelled, and active-controlled parallel group phase 3 trial, comprising a 52-week main phase and three-year extension period (NCT03811535).
Summary · context
Two-hundred GH-treatment-naïve, prepubertal children with GHD (74.5% male) were randomly assigned in a 2: 1 ratio to receive 0.16 mg/kg/week s.c. somapacitan (n=132) or daily s.c. GH (0.034 mg/kg/day Norditropin®; n=68).
Report a problemFND-9996792504
05HumanRandomized controlled trialSafety outcome
In children with GHD, injection-site reactions occurred in 5.3% with somapacitan versus 5.9% with daily GH, described as similar.
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/week · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Injection-site reactions
5.3 % of patients
Somapacitan
Injection-site reactions
5.9 % of patients
Daily GH
Source sentences
Summary
and a low number of patients reported injection-site reactions, with similar proportions for somapacitan (5.3%) and daily GH (5.9%).
2 context sentences(design, population, supporting numbers)
Summary · context
REAL4 is a randomised, multi-national, open labelled, and active-controlled parallel group phase 3 trial, comprising a 52-week main phase and three-year extension period (NCT03811535).
Summary · context
Two-hundred GH-treatment-naïve, prepubertal children with GHD (74.5% male) were randomly assigned in a 2: 1 ratio to receive 0.16 mg/kg/week s.c. somapacitan (n=132) or daily s.c. GH (0.034 mg/kg/day Norditropin®; n=68).
Report a problemFND-9996792509
06HumanRandomized controlled trialSafety outcome
In children with GHD, injection-site pain occurred in 1.5% of patients with either somapacitan or daily GH.
In plain wordsIn children with GHD, injection-site pain occurred in 1.5% with somapacitan and daily GH.
Peptide
Somapacitan
Outcome
No significant changeInjection-site pain
Study
n = 200
Comparator
Daily GH (Norditropin)
Outcome group
Pain · Skin and wound
Studied dose
0.16 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Injection-site pain
1.5 % of patients
Somapacitan
Injection-site pain
1.5 % of patients
Daily GH
Source sentences
Summary
In both treatment groups, 1.5% of patients reported injection site pain.
2 context sentences(design, population, supporting numbers)
Summary · context
REAL4 is a randomised, multi-national, open labelled, and active-controlled parallel group phase 3 trial, comprising a 52-week main phase and three-year extension period (NCT03811535).
Summary · context
Two-hundred GH-treatment-naïve, prepubertal children with GHD (74.5% male) were randomly assigned in a 2: 1 ratio to receive 0.16 mg/kg/week s.c. somapacitan (n=132) or daily s.c. GH (0.034 mg/kg/day Norditropin®; n=68).
Report a problemFND-9996792510
07HumanRandomized controlled trialOther
In children with GHD, somapacitan adherence averaged 95.8% with median 100%, versus daily GH mean 88.3% and median 96.9%.
In plain wordsIn children with GHD, mean and median adherence were higher with somapacitan than daily GH.
Peptide
Somapacitan
Outcome
IncreaseAdherence
Study
n = 200
Comparator
Daily GH (Norditropin)
Outcome group
Treatment adherence and retention · Whole body
Studied dose
0.16 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).
Measurements
Mean adherence
95.8%
Somapacitan
Median adherence
100%
Somapacitan
Mean adherence
88.3%
Daily GH
Median adherence
96.9%
Daily GH
Source sentences
Summary
The mean and median adherence for somapacitan treatment were 95.8% and 100%, respectively.
3 context sentences(design, population, supporting numbers)
Summary · context
The mean and median adherence for the daily GH group were 88.3% and 96.9%, respectively.
Summary · context
REAL4 is a randomised, multi-national, open labelled, and active-controlled parallel group phase 3 trial, comprising a 52-week main phase and three-year extension period (NCT03811535).
Summary · context
Two-hundred GH-treatment-naïve, prepubertal children with GHD (74.5% male) were randomly assigned in a 2: 1 ratio to receive 0.16 mg/kg/week s.c. somapacitan (n=132) or daily s.c. GH (0.034 mg/kg/day Norditropin®; n=68).
Report a problemFND-9996792511
08HumanNon-randomized trialSafety outcome
In children with GHD, no safety or local tolerability issues were identified with somapacitan.
In plain wordsIn children with GHD, no safety or local tolerability issues were identified with somapacitan.
Peptide
Somapacitan
Outcome
Not applicableSafety and local tolerability
Study
n = 132
Outcome group
Adverse events · Whole body
Studied dose
0.16 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
Somapacitan was well tolerated, with no safety or local tolerability issues identified.
2 context sentences(design, population, supporting numbers)
Summary · context
REAL4 is a randomised, multi-national, open labelled, and active-controlled parallel group phase 3 trial, comprising a 52-week main phase and three-year extension period (NCT03811535).
Summary · context
Two-hundred GH-treatment-naïve, prepubertal children with GHD (74.5% male) were randomly assigned in a 2: 1 ratio to receive 0.16 mg/kg/week s.c. somapacitan (n=132) or daily s.c. GH (0.034 mg/kg/day Norditropin®; n=68).
Report a problemFND-9996792505
09HumanNon-randomized trialSafety outcome
In children with GHD, somapacitan had no clinically relevant findings in changes in glucose metabolism.
In plain wordsIn children with GHD, somapacitan showed no clinically relevant changes in glucose metabolism.
Peptide
Somapacitan
Outcome
Direction not reportedGlucose metabolism
Study
n = 132
Outcome group
Glycemic control · Metabolic and weight
Studied dose
0.16 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
There were no clinically relevant findings with respect to changes in glucose metabolism,
2 context sentences(design, population, supporting numbers)
Summary · context
REAL4 is a randomised, multi-national, open labelled, and active-controlled parallel group phase 3 trial, comprising a 52-week main phase and three-year extension period (NCT03811535).
Summary · context
Two-hundred GH-treatment-naïve, prepubertal children with GHD (74.5% male) were randomly assigned in a 2: 1 ratio to receive 0.16 mg/kg/week s.c. somapacitan (n=132) or daily s.c. GH (0.034 mg/kg/day Norditropin®; n=68).
Report a problemFND-9996792506
10HumanNon-randomized trialSafety outcome
In children with GHD receiving somapacitan, no neutralizing anti-somapacitan antibodies were detected.
In plain wordsIn children with GHD receiving somapacitan, no neutralizing antibodies against somapacitan were detected.
Peptide
Somapacitan
Outcome
Not applicableNeutralizing anti-somapacitan antibodies
Study
n = 132
Outcome group
Immune response · Immune and inflammation
Studied dose
0.16 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
no neutralizing anti-somapacitan or anti-GH antibodies were detected,
2 context sentences(design, population, supporting numbers)
Summary · context
REAL4 is a randomised, multi-national, open labelled, and active-controlled parallel group phase 3 trial, comprising a 52-week main phase and three-year extension period (NCT03811535).
Summary · context
Two-hundred GH-treatment-naïve, prepubertal children with GHD (74.5% male) were randomly assigned in a 2: 1 ratio to receive 0.16 mg/kg/week s.c. somapacitan (n=132) or daily s.c. GH (0.034 mg/kg/day Norditropin®; n=68).
Report a problemFND-9996792507
11HumanNon-randomized trialSafety outcome
In children with GHD receiving somapacitan, no neutralizing anti-GH antibodies were detected.
In plain wordsIn children with GHD receiving somapacitan, no neutralizing antibodies against GH were detected.
Peptide
Somapacitan
Outcome
Not applicableNeutralizing anti-GH antibodies
Study
n = 132
Outcome group
Immune response · Immune and inflammation
Studied dose
0.16 mg/kg/week · subcutaneous · 52 weeksAs given in this study (human).
Source sentences
Summary
no neutralizing anti-somapacitan or anti-GH antibodies were detected,
2 context sentences(design, population, supporting numbers)
Summary · context
REAL4 is a randomised, multi-national, open labelled, and active-controlled parallel group phase 3 trial, comprising a 52-week main phase and three-year extension period (NCT03811535).
Summary · context
Two-hundred GH-treatment-naïve, prepubertal children with GHD (74.5% male) were randomly assigned in a 2: 1 ratio to receive 0.16 mg/kg/week s.c. somapacitan (n=132) or daily s.c. GH (0.034 mg/kg/day Norditropin®; n=68).
Report a problemFND-9996792508

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Version history

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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

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