SAT-LB12 Once-Weekly Somapacitan vs Daily Growth Hormone in Growth Hormone Deficiency: 2-Year Safety Results From Real 3, a Randomized Phase 2 Trial

Savendahl L, Rasmussen M

Journal of the Endocrine Society8 May 2020

PMCIDPMC7209577PepBankPUB-90230968

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Summary

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

Results from this study16

16 results from studies that gave the peptide. 16 results from people.

01HumanRandomized controlled trialSafety outcome
In children with GHD, pyrexia occurred in 43.8% with somapacitan 0.04/0.16 mg/kg/wk versus 7.1% with daily GH.
In plain wordsIn children with GHD, fever was more frequent with the lowest initial somapacitan sequence than daily GH.
Peptide
Somapacitan
Outcome
IncreasePyrexia
Study
n: not reported in source
Comparator
Daily GH
Outcome group
Adverse events · Whole body
Studied dose
0.04/0.16 mg/kg/wk · subcutaneous · 104 weeksAs given in this study (human).
Measurements
Pyrexia incidence
43.8%
somapacitan 0.04/0.16 mg/kg/wk group
Pyrexia incidence
7.1%
daily GH group
Source sentences
Summary
Pyrexia was more common in the OW somapacitan 0.04/0.16 mg/kg/wk (43.8%) and 0.08/0.16 mg/kg/wk (26.7%) groups vs the higher-dose OW somapacitan and daily GH groups (7.1% each).
2 context sentences(design, population, supporting numbers)
Summary · context
A phase 2, multinational, randomized, open-label, controlled trial (ClinicalTrials.gov: NCT02616562) investigated the efficacy and safety of OW somapacitan compared with daily GH (Norditropin® FlexPro®).
Summary · context
We report here safety results at 104 wks’ total treatment.
Report a problemFND-9023096805
02HumanRandomized controlled trialSafety outcome
In children with GHD, pyrexia occurred in 43.8% with somapacitan 0.04/0.16 mg/kg/wk versus 7.1% with higher-dose somapacitan.
In plain wordsIn children with GHD, fever was more frequent with the lowest initial somapacitan sequence than the higher-dose sequence.
Peptide
Somapacitan
Outcome
IncreasePyrexia
Study
n: not reported in source
Comparator
Somapacitan 0.16/0.16 mg/kg/wk
Outcome group
Adverse events · Whole body
Studied dose
0.04/0.16 mg/kg/wk · subcutaneous · 104 weeksAs given in this study (human).
Measurements
Pyrexia incidence
43.8%
somapacitan 0.04/0.16 mg/kg/wk group
Pyrexia incidence
7.1%
somapacitan 0.16/0.16 mg/kg/wk group
Source sentences
Summary
Pyrexia was more common in the OW somapacitan 0.04/0.16 mg/kg/wk (43.8%) and 0.08/0.16 mg/kg/wk (26.7%) groups vs the higher-dose OW somapacitan and daily GH groups (7.1% each).
2 context sentences(design, population, supporting numbers)
Summary · context
A phase 2, multinational, randomized, open-label, controlled trial (ClinicalTrials.gov: NCT02616562) investigated the efficacy and safety of OW somapacitan compared with daily GH (Norditropin® FlexPro®).
Summary · context
We report here safety results at 104 wks’ total treatment.
Report a problemFND-9023096806
03HumanRandomized controlled trialSafety outcome
In children with GHD, pyrexia occurred in 26.7% with somapacitan 0.08/0.16 mg/kg/wk versus 7.1% with daily GH.
In plain wordsIn children with GHD, fever was more frequent with the middle initial somapacitan sequence than daily GH.
Peptide
Somapacitan
Outcome
IncreasePyrexia
Study
n: not reported in source
Comparator
Daily GH
Outcome group
Adverse events · Whole body
Studied dose
0.08/0.16 mg/kg/wk · subcutaneous · 104 weeksAs given in this study (human).
Measurements
Pyrexia incidence
26.7%
somapacitan 0.08/0.16 mg/kg/wk group
Pyrexia incidence
7.1%
daily GH group
Source sentences
Summary
Pyrexia was more common in the OW somapacitan 0.04/0.16 mg/kg/wk (43.8%) and 0.08/0.16 mg/kg/wk (26.7%) groups vs the higher-dose OW somapacitan and daily GH groups (7.1% each).
2 context sentences(design, population, supporting numbers)
Summary · context
A phase 2, multinational, randomized, open-label, controlled trial (ClinicalTrials.gov: NCT02616562) investigated the efficacy and safety of OW somapacitan compared with daily GH (Norditropin® FlexPro®).
Summary · context
We report here safety results at 104 wks’ total treatment.
Report a problemFND-9023096807
04HumanRandomized controlled trialSafety outcome
In children with GHD, pyrexia occurred in 26.7% with somapacitan 0.08/0.16 mg/kg/wk versus 7.1% with higher-dose somapacitan.
In plain wordsIn children with GHD, fever was more frequent with the middle initial somapacitan sequence than the higher-dose sequence.
Peptide
Somapacitan
Outcome
IncreasePyrexia
Study
n: not reported in source
Comparator
Somapacitan 0.16/0.16 mg/kg/wk
Outcome group
Adverse events · Whole body
Studied dose
0.08/0.16 mg/kg/wk · subcutaneous · 104 weeksAs given in this study (human).
Measurements
Pyrexia incidence
26.7%
somapacitan 0.08/0.16 mg/kg/wk group
Pyrexia incidence
7.1%
somapacitan 0.16/0.16 mg/kg/wk group
Source sentences
Summary
Pyrexia was more common in the OW somapacitan 0.04/0.16 mg/kg/wk (43.8%) and 0.08/0.16 mg/kg/wk (26.7%) groups vs the higher-dose OW somapacitan and daily GH groups (7.1% each).
2 context sentences(design, population, supporting numbers)
Summary · context
A phase 2, multinational, randomized, open-label, controlled trial (ClinicalTrials.gov: NCT02616562) investigated the efficacy and safety of OW somapacitan compared with daily GH (Norditropin® FlexPro®).
Summary · context
We report here safety results at 104 wks’ total treatment.
Report a problemFND-9023096808
05HumanNon-randomized trialSafety outcome
In children with GHD, the somapacitan 0.04/0.16 mg/kg/wk sequence had 51 AEs affecting 75% of patients.
In plain wordsIn children with GHD, 75% had adverse events during the lowest initial somapacitan dose sequence.
Peptide
Somapacitan
Outcome
Not applicableAdverse events
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
0.04/0.16 mg/kg/wk · subcutaneous · 104 weeksAs given in this study (human).
Measurements
Number of adverse events
51 events
OW somapacitan 0.04/0.16 mg/kg/wk group, 104 weeks total treatment
Patients with adverse events
75%
OW somapacitan 0.04/0.16 mg/kg/wk group, 104 weeks total treatment
Source sentences
Summary
Number of AEs (% of patients) was as follows: OW somapacitan 0.04/0.16 mg/kg/wk, 51 (75%); 0.08/0.16 mg/kg/wk, 89 (80%); 0.16/0.16 mg/kg/wk, 89 (100%); and for daily GH, 82 (100%).
2 context sentences(design, population, supporting numbers)
Summary · context
A phase 2, multinational, randomized, open-label, controlled trial (ClinicalTrials.gov: NCT02616562) investigated the efficacy and safety of OW somapacitan compared with daily GH (Norditropin® FlexPro®).
Summary · context
We report here safety results at 104 wks’ total treatment.
Report a problemFND-9023096801
06HumanNon-randomized trialSafety outcome
In children with GHD, the somapacitan 0.08/0.16 mg/kg/wk sequence had 89 AEs affecting 80% of patients.
In plain wordsIn children with GHD, 80% had adverse events during the middle initial somapacitan dose sequence.
Peptide
Somapacitan
Outcome
Not applicableAdverse events
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
0.08/0.16 mg/kg/wk · subcutaneous · 104 weeksAs given in this study (human).
Measurements
Number of adverse events
89 events
OW somapacitan 0.08/0.16 mg/kg/wk group, 104 weeks total treatment
Patients with adverse events
80%
OW somapacitan 0.08/0.16 mg/kg/wk group, 104 weeks total treatment
Source sentences
Summary
Number of AEs (% of patients) was as follows: OW somapacitan 0.04/0.16 mg/kg/wk, 51 (75%); 0.08/0.16 mg/kg/wk, 89 (80%); 0.16/0.16 mg/kg/wk, 89 (100%); and for daily GH, 82 (100%).
2 context sentences(design, population, supporting numbers)
Summary · context
A phase 2, multinational, randomized, open-label, controlled trial (ClinicalTrials.gov: NCT02616562) investigated the efficacy and safety of OW somapacitan compared with daily GH (Norditropin® FlexPro®).
Summary · context
We report here safety results at 104 wks’ total treatment.
Report a problemFND-9023096802
07HumanNon-randomized trialSafety outcome
In children with GHD, the somapacitan 0.16/0.16 mg/kg/wk sequence had 89 AEs affecting 100% of patients.
In plain wordsIn children with GHD, 100% had adverse events during the highest somapacitan dose sequence.
Peptide
Somapacitan
Outcome
Not applicableAdverse events
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
0.16/0.16 mg/kg/wk · subcutaneous · 104 weeksAs given in this study (human).
Measurements
Number of adverse events
89 events
OW somapacitan 0.16/0.16 mg/kg/wk group, 104 weeks total treatment
Patients with adverse events
100%
OW somapacitan 0.16/0.16 mg/kg/wk group, 104 weeks total treatment
Source sentences
Summary
Number of AEs (% of patients) was as follows: OW somapacitan 0.04/0.16 mg/kg/wk, 51 (75%); 0.08/0.16 mg/kg/wk, 89 (80%); 0.16/0.16 mg/kg/wk, 89 (100%); and for daily GH, 82 (100%).
2 context sentences(design, population, supporting numbers)
Summary · context
A phase 2, multinational, randomized, open-label, controlled trial (ClinicalTrials.gov: NCT02616562) investigated the efficacy and safety of OW somapacitan compared with daily GH (Norditropin® FlexPro®).
Summary · context
We report here safety results at 104 wks’ total treatment.
Report a problemFND-9023096803
08HumanNon-randomized trialSafety outcome
In children with GHD, nasopharyngitis, influenza, allergic rhinitis and gastroenteritis were the most common adverse events across somapacitan and daily GH groups.
In plain wordsIn children with GHD, common events across somapacitan and daily GH groups included nasopharyngitis, influenza, allergic rhinitis and gastroenteritis.
Peptide
Somapacitan
Outcome
Not applicableCommon adverse event types
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · subcutaneous · 104 weeksAs given in this study (human).
Source sentences
Summary
Nasopharyngitis, influenza, allergic rhinitis and gastroenteritis were the most common AEs across all treatment groups.
2 context sentences(design, population, supporting numbers)
Summary · context
A phase 2, multinational, randomized, open-label, controlled trial (ClinicalTrials.gov: NCT02616562) investigated the efficacy and safety of OW somapacitan compared with daily GH (Norditropin® FlexPro®).
Summary · context
We report here safety results at 104 wks’ total treatment.
Report a problemFND-9023096804
09HumanNon-randomized trialSafety outcome
In children with GHD, most AEs during somapacitan and daily GH treatment were mild to moderate and unlikely treatment-related.
In plain wordsIn children with GHD, most adverse events with somapacitan and daily GH were mild to moderate.
Peptide
Somapacitan
Outcome
Not applicableAdverse event severity
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · subcutaneous · 104 weeksAs given in this study (human).
Source sentences
Summary
Most AEs were mild to moderate and unlikely related to treatment.
3 context sentences(design, population, supporting numbers)
Summary · context
Number of AEs (% of patients) was as follows: OW somapacitan 0.04/0.16 mg/kg/wk, 51 (75%); 0.08/0.16 mg/kg/wk, 89 (80%); 0.16/0.16 mg/kg/wk, 89 (100%); and for daily GH, 82 (100%).
Summary · context
A phase 2, multinational, randomized, open-label, controlled trial (ClinicalTrials.gov: NCT02616562) investigated the efficacy and safety of OW somapacitan compared with daily GH (Norditropin® FlexPro®).
Summary · context
We report here safety results at 104 wks’ total treatment.
Report a problemFND-9023096809
10HumanNon-randomized trialSafety outcome
In a child with GHD, serious generalized edema during the first 26 weeks was probably related to somapacitan; intravenous antibiotics were also given.
In plain wordsIn a child with GHD, serious swelling was probably related to somapacitan; the child also received antibiotics.
Peptide
Somapacitan
Outcome
Not applicableSerious generalized edema
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
0.16 mg/kg/wk · subcutaneousAs given in this study (human).
Source sentences
Summary
Ten serious AEs were reported in five (8.5%) children and unlikely related to treatment, except two AEs of moderate severity during the first 26 wks: generalized edema and vomiting in one child on 0.16 mg/kg/wk OW somapacitan, rated as probably related to treatment although she was also given intrav…
2 context sentences(design, population, supporting numbers)
Summary · context
A phase 2, multinational, randomized, open-label, controlled trial (ClinicalTrials.gov: NCT02616562) investigated the efficacy and safety of OW somapacitan compared with daily GH (Norditropin® FlexPro®).
Summary · context
We report here safety results at 104 wks’ total treatment.
Report a problemFND-9023096810
11HumanNon-randomized trialSafety outcome
In a child with GHD, serious vomiting during the first 26 weeks was probably related to somapacitan; intravenous antibiotics were also given.
In plain wordsIn a child with GHD, serious vomiting was probably related to somapacitan; the child also received antibiotics.
Peptide
Somapacitan
Outcome
Not applicableSerious vomiting
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
0.16 mg/kg/wk · subcutaneousAs given in this study (human).
Source sentences
Summary
Ten serious AEs were reported in five (8.5%) children and unlikely related to treatment, except two AEs of moderate severity during the first 26 wks: generalized edema and vomiting in one child on 0.16 mg/kg/wk OW somapacitan, rated as probably related to treatment although she was also given intrav…
2 context sentences(design, population, supporting numbers)
Summary · context
A phase 2, multinational, randomized, open-label, controlled trial (ClinicalTrials.gov: NCT02616562) investigated the efficacy and safety of OW somapacitan compared with daily GH (Norditropin® FlexPro®).
Summary · context
We report here safety results at 104 wks’ total treatment.
Report a problemFND-9023096811
12HumanNon-randomized trialSafety outcome
In children with GHD, two recipients of somapacitan 0.04/0.16 mg/kg/wk had injection-site reactions.
In plain wordsIn children with GHD, two recipients of the lowest initial somapacitan sequence had injection-site reactions.
Peptide
Somapacitan
Outcome
Not applicableInjection-site reactions
Study
n: not reported in source
Outcome group
Adverse events · Skin and wound
Studied dose
0.04/0.16 mg/kg/wk · subcutaneous · 104 weeksAs given in this study (human).
Measurements
Injection-site reactions
2 children
OW somapacitan 0.04/0.16 mg/kg/wk group
Source sentences
Summary
Injection-site reactions were reported in the 0.04/0.16 mg/kg/wk (n=2) and 0.16/0.16 mg/kg/wk (n=1) OW somapacitan groups and in the daily GH group (n=1).
2 context sentences(design, population, supporting numbers)
Summary · context
A phase 2, multinational, randomized, open-label, controlled trial (ClinicalTrials.gov: NCT02616562) investigated the efficacy and safety of OW somapacitan compared with daily GH (Norditropin® FlexPro®).
Summary · context
We report here safety results at 104 wks’ total treatment.
Report a problemFND-9023096812
13HumanNon-randomized trialSafety outcome
In children with GHD, one recipient of somapacitan 0.16/0.16 mg/kg/wk had injection-site reactions.
In plain wordsIn children with GHD, one recipient of the highest somapacitan sequence had injection-site reactions.
Peptide
Somapacitan
Outcome
Not applicableInjection-site reactions
Study
n: not reported in source
Outcome group
Adverse events · Skin and wound
Studied dose
0.16/0.16 mg/kg/wk · subcutaneous · 104 weeksAs given in this study (human).
Measurements
Injection-site reactions
1 children
OW somapacitan 0.16/0.16 mg/kg/wk group
Source sentences
Summary
Injection-site reactions were reported in the 0.04/0.16 mg/kg/wk (n=2) and 0.16/0.16 mg/kg/wk (n=1) OW somapacitan groups and in the daily GH group (n=1).
2 context sentences(design, population, supporting numbers)
Summary · context
A phase 2, multinational, randomized, open-label, controlled trial (ClinicalTrials.gov: NCT02616562) investigated the efficacy and safety of OW somapacitan compared with daily GH (Norditropin® FlexPro®).
Summary · context
We report here safety results at 104 wks’ total treatment.
Report a problemFND-9023096813
14HumanNon-randomized trialSafety outcome
In children with GHD, four recipients of somapacitan 0.04/0.16 mg/kg/wk had transient non-neutralizing anti-somapacitan antibodies.
In plain wordsIn children with GHD, four recipients of the lowest initial somapacitan sequence had temporary antibodies that did not neutralize treatment.
Peptide
Somapacitan
Outcome
Not applicableTransient anti-somapacitan antibodies
Study
n: not reported in source
Outcome group
Adverse events · Immune and inflammation
Studied dose
0.04/0.16 mg/kg/wk · subcutaneous · 104 weeksAs given in this study (human).
Measurements
Children with transient anti-somapacitan antibodies
4 children
OW somapacitan 0.04/0.16 mg/kg/wk group
Source sentences
Summary
Four children (0.04/0.16 mg/kg/wk) and one child (0.16/0.16 mg/kg/wk) had transient anti-somapacitan antibodies;
3 context sentences(design, population, supporting numbers)
Summary · context
All antibodies were non-neutralizing.
Summary · context
A phase 2, multinational, randomized, open-label, controlled trial (ClinicalTrials.gov: NCT02616562) investigated the efficacy and safety of OW somapacitan compared with daily GH (Norditropin® FlexPro®).
Summary · context
We report here safety results at 104 wks’ total treatment.
Report a problemFND-9023096814
15HumanNon-randomized trialSafety outcome
In children with GHD, one recipient of somapacitan 0.16/0.16 mg/kg/wk had transient non-neutralizing anti-somapacitan antibodies.
In plain wordsIn children with GHD, one recipient of the highest somapacitan sequence had temporary antibodies that did not neutralize treatment.
Peptide
Somapacitan
Outcome
Not applicableTransient anti-somapacitan antibodies
Study
n: not reported in source
Outcome group
Adverse events · Immune and inflammation
Studied dose
0.16/0.16 mg/kg/wk · subcutaneous · 104 weeksAs given in this study (human).
Measurements
Children with transient anti-somapacitan antibodies
1 children
OW somapacitan 0.16/0.16 mg/kg/wk group
Source sentences
Summary
Four children (0.04/0.16 mg/kg/wk) and one child (0.16/0.16 mg/kg/wk) had transient anti-somapacitan antibodies;
3 context sentences(design, population, supporting numbers)
Summary · context
All antibodies were non-neutralizing.
Summary · context
A phase 2, multinational, randomized, open-label, controlled trial (ClinicalTrials.gov: NCT02616562) investigated the efficacy and safety of OW somapacitan compared with daily GH (Norditropin® FlexPro®).
Summary · context
We report here safety results at 104 wks’ total treatment.
Report a problemFND-9023096815
16HumanNon-randomized trialSafety outcome
In children with GHD, one somapacitan 0.16/0.16 mg/kg/wk recipient had non-neutralizing low-titer antibodies at two consecutive visits.
In plain wordsIn children with GHD, one highest-dose somapacitan recipient had low antibody levels at two consecutive visits.
Peptide
Somapacitan
Outcome
Not applicableConsecutive low-titer anti-somapacitan antibodies
Study
n: not reported in source
Outcome group
Adverse events · Immune and inflammation
Studied dose
0.16/0.16 mg/kg/wk · subcutaneous · 104 weeksAs given in this study (human).
Measurements
Children with low-titer anti-somapacitan antibodies at two consecutive visits
1 children
OW somapacitan 0.16/0.16 mg/kg/wk group
Source sentences
Summary
one child (0.16/0.16 mg/kg/wk) had low-titer anti-somapacitan antibodies at two consecutive visits;
3 context sentences(design, population, supporting numbers)
Summary · context
All antibodies were non-neutralizing.
Summary · context
A phase 2, multinational, randomized, open-label, controlled trial (ClinicalTrials.gov: NCT02616562) investigated the efficacy and safety of OW somapacitan compared with daily GH (Norditropin® FlexPro®).
Summary · context
We report here safety results at 104 wks’ total treatment.
Report a problemFND-9023096816

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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

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Abstract

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