RF26 | PMON334 Once-Weekly Somapacitan in Growth Hormone Deficiency: 4-Year Efficacy and Safety Results from REAL 3, a Randomised Controlled Phase 2 Trial

The source lists no authors.

Journal of the Endocrine Society1 Nov 2022

PMCIDPMC9625284PepBankPUB-97751067

Read at source Source pageAsk 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: CC BY-NC-ND. Results still quote short attributed sentences.

Results from this study17

17 results from studies that gave the peptide. 17 results from people.

01HumanNon-randomized trialSafety outcome
In children continuing or switching to somapacitan, each adverse event other than nasopharyngitis occurred in <10% of either group.
In plain wordsIn children continuing or switching to somapacitan, each other adverse event affected fewer than 10% of either group.
Peptide
Somapacitan
Outcome
Not applicableOther adverse event frequencies
Study
n = 50
Outcome group
Adverse events · Whole body
Studied dose
0.16 mg/kg/weekAs given in this study (human).
Measurements
Frequency of each other adverse event
< 10 % of patients
Either group
Source sentences
Summary
The most common AE was nasopharyngitis, occurring in four patients (10.3%) in the somapacitan/somapacitan group and one patient (9.1%) in the daily GH/somapacitan group; all other AEs occurred in <10% of patients in either group.
2 context sentences(design, population, supporting numbers)
Summary · context
In a further, ongoing 4-year long-term safety extension, patients treated with somapacitan remained on somapacitan (somapacitan/somapacitan, n=39) and all patients on daily GH switched to somapacitan 0.16 mg/kg/week (daily GH/somapacitan, n=11).
Summary · context
Here, we present efficacy and safety results from the first year of the 4-year long-term safety extension.
Report a problemFND-9775106712
02HumanNon-randomized trialSafety outcome
In children receiving somapacitan during year 4, most adverse events were mild or moderate and unlikely related to GH treatment.
In plain wordsIn children receiving somapacitan, most adverse events were mild or moderate and unlikely related to GH treatment.
Peptide
Somapacitan
Outcome
Not applicableAdverse event severity and attribution
Study
n = 50
Outcome group
Adverse events · Whole body
Studied dose
0.16 mg/kg/weekAs given in this study (human).
Source sentences
Summary
Most AEs were mild or moderate and unlikely related to GH treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
In a further, ongoing 4-year long-term safety extension, patients treated with somapacitan remained on somapacitan (somapacitan/somapacitan, n=39) and all patients on daily GH switched to somapacitan 0.16 mg/kg/week (daily GH/somapacitan, n=11).
Summary · context
Here, we present efficacy and safety results from the first year of the 4-year long-term safety extension.
Report a problemFND-9775106713
03HumanNon-randomized trialSafety outcome
In children continuing or switching to somapacitan, no serious adverse events were reported during year 4.
In plain wordsIn children continuing or switching to somapacitan, no serious adverse events were reported during year 4.
Peptide
Somapacitan
Outcome
Not applicableSerious adverse events
Study
n = 50
Outcome group
Adverse events · Whole body
Studied dose
0.16 mg/kg/weekAs given in this study (human).
Source sentences
Summary
No serious AEs were reported in year 4.
2 context sentences(design, population, supporting numbers)
Summary · context
In a further, ongoing 4-year long-term safety extension, patients treated with somapacitan remained on somapacitan (somapacitan/somapacitan, n=39) and all patients on daily GH switched to somapacitan 0.16 mg/kg/week (daily GH/somapacitan, n=11).
Summary · context
Here, we present efficacy and safety results from the first year of the 4-year long-term safety extension.
Report a problemFND-9775106715
04HumanNon-randomized trialEfficacy outcome
In children continuing somapacitan, height velocity fell from 8.3 (SD 1.7) cm/year at year 3 to 7.4 (1.6) at year 4.
In plain wordsIn children continuing somapacitan, growth speed was lower at year 4 than year 3.
Peptide
Somapacitan
Outcome
DecreaseHeight velocity, continued group
Study
n = 39
Comparator
Year 3 in continued somapacitan group
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16 mg/kg/weekAs given in this study (human).
Measurements
Mean height velocity, year 4
7.4 cm/year
Somapacitan/somapacitan group, SD 1.6
Mean height velocity, year 3
8.3 cm/year
Somapacitan/somapacitan group, SD 1.7
Source sentences
Summary
At year 4, the mean (SD) height velocity (HV) was 7.4 (1.6) cm/year for the somapacitan/somapacitan group and 6.6 (1.6) cm/year for the daily GH/somapacitan group, compared with 8.3 (1.7) and 7.6 (2.0) cm/year for the somapacitan/somapacitan and daily GH groups, respectively, at year 3.
2 context sentences(design, population, supporting numbers)
Summary · context
In a further, ongoing 4-year long-term safety extension, patients treated with somapacitan remained on somapacitan (somapacitan/somapacitan, n=39) and all patients on daily GH switched to somapacitan 0.16 mg/kg/week (daily GH/somapacitan, n=11).
Summary · context
Here, we present efficacy and safety results from the first year of the 4-year long-term safety extension.
Report a problemFND-9775106701
05HumanNon-randomized trialEfficacy outcome
In children continuing somapacitan, year 4 mean height velocity SDS was 1.55 (SD 1.70).
In plain wordsIn children continuing somapacitan, the year 4 mean growth speed score was 1.55.
Peptide
Somapacitan
Outcome
Not applicableHeight velocity SDS, continued group
Study
n = 39
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16 mg/kg/weekAs given in this study (human).
Measurements
Mean height velocity SDS, year 4
1.55 SDS
Somapacitan/somapacitan group, SD 1.70
Source sentences
Summary
The mean (SD) HV standard deviation score (SDS) was 1.55 (1.70) for the somapacitan/somapacitan group and 0.88 (1.61) for the daily GH/somapacitan group,
2 context sentences(design, population, supporting numbers)
Summary · context
In a further, ongoing 4-year long-term safety extension, patients treated with somapacitan remained on somapacitan (somapacitan/somapacitan, n=39) and all patients on daily GH switched to somapacitan 0.16 mg/kg/week (daily GH/somapacitan, n=11).
Summary · context
Here, we present efficacy and safety results from the first year of the 4-year long-term safety extension.
Report a problemFND-9775106703
06HumanNon-randomized trialEfficacy outcome
In children continuing somapacitan, mean height SDS increased by 2.85 (SD 1.25) from baseline at year 4.
In plain wordsIn children continuing somapacitan, height scores increased from baseline by year 4.
Peptide
Somapacitan
Outcome
IncreaseHeight SDS change, continued group
Study
n = 39
Comparator
Baseline
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16 mg/kg/weekAs given in this study (human).
Measurements
Mean change in height SDS from baseline
2.85 SDS
Somapacitan/somapacitan group, SD 1.25
Source sentences
Summary
and the mean (SD) change in height SDS from baseline was 2.85 (1.25) and 2.28 (0.97), respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
In a further, ongoing 4-year long-term safety extension, patients treated with somapacitan remained on somapacitan (somapacitan/somapacitan, n=39) and all patients on daily GH switched to somapacitan 0.16 mg/kg/week (daily GH/somapacitan, n=11).
Summary · context
Here, we present efficacy and safety results from the first year of the 4-year long-term safety extension.
Report a problemFND-9775106705
07HumanNon-randomized trialEfficacy outcome
In children continuing somapacitan, mean year 4 IGF-I SDS was 1.29 (SD 1.23).
In plain wordsIn children continuing somapacitan, the mean year 4 IGF-I score was 1.29.
Peptide
Somapacitan
Outcome
Not applicableIGF-I SDS, continued group
Study
n = 39
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16 mg/kg/weekAs given in this study (human).
Measurements
Mean IGF-I SDS, year 4
1.29 SDS
Somapacitan/somapacitan group, SD 1.23
Source sentences
Summary
The mean (SD) insulin-like growth factor-I SDS at year 4 was 1.29 (1.23) and 0.94 (1.60) for the somapacitan/somapacitan and daily GH/somapacitan groups, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
In a further, ongoing 4-year long-term safety extension, patients treated with somapacitan remained on somapacitan (somapacitan/somapacitan, n=39) and all patients on daily GH switched to somapacitan 0.16 mg/kg/week (daily GH/somapacitan, n=11).
Summary · context
Here, we present efficacy and safety results from the first year of the 4-year long-term safety extension.
Report a problemFND-9775106706
08HumanNon-randomized trialSafety outcome
During year 4 in children continuing somapacitan, 20 patients (51.3%) experienced 84 adverse events.
In plain wordsDuring year 4 in children continuing somapacitan, 20 patients experienced 84 adverse events.
Peptide
Somapacitan
Outcome
Not applicableAdverse events, continued group
Study
n = 39
Outcome group
Adverse events · Whole body
Studied dose
0.16 mg/kg/weekAs given in this study (human).
Measurements
Patients with adverse events, year 4
20 patients
Somapacitan/somapacitan group
Proportion with adverse events, year 4
51.3%
Somapacitan/somapacitan group
Adverse events, year 4
84 events
Somapacitan/somapacitan group
Source sentences
Summary
During year 4, 20 patients (51.3%) experienced 84 adverse events (AEs) in the somapacitan/somapacitan group, and eight patients (72.7%) experienced 12 AEs in the daily GH/somapacitan group.
2 context sentences(design, population, supporting numbers)
Summary · context
In a further, ongoing 4-year long-term safety extension, patients treated with somapacitan remained on somapacitan (somapacitan/somapacitan, n=39) and all patients on daily GH switched to somapacitan 0.16 mg/kg/week (daily GH/somapacitan, n=11).
Summary · context
Here, we present efficacy and safety results from the first year of the 4-year long-term safety extension.
Report a problemFND-9775106708
09HumanNon-randomized trialSafety outcome
During year 4 in children continuing somapacitan, four patients (10.3%) had nasopharyngitis.
In plain wordsDuring year 4 in children continuing somapacitan, four patients had nasopharyngitis.
Peptide
Somapacitan
Outcome
Not applicableNasopharyngitis, continued group
Study
n = 39
Outcome group
Adverse events · Respiratory
Studied dose
0.16 mg/kg/weekAs given in this study (human).
Measurements
Patients with nasopharyngitis, year 4
4 patients
Somapacitan/somapacitan group
Proportion with nasopharyngitis, year 4
10.3%
Somapacitan/somapacitan group
Source sentences
Summary
The most common AE was nasopharyngitis, occurring in four patients (10.3%) in the somapacitan/somapacitan group and one patient (9.1%) in the daily GH/somapacitan group; all other AEs occurred in <10% of patients in either group.
2 context sentences(design, population, supporting numbers)
Summary · context
In a further, ongoing 4-year long-term safety extension, patients treated with somapacitan remained on somapacitan (somapacitan/somapacitan, n=39) and all patients on daily GH switched to somapacitan 0.16 mg/kg/week (daily GH/somapacitan, n=11).
Summary · context
Here, we present efficacy and safety results from the first year of the 4-year long-term safety extension.
Report a problemFND-9775106710
10HumanNon-randomized trialSafety outcome
In children continuing somapacitan, one severe adverse event required surgery for elbow fracture.
In plain wordsIn children continuing somapacitan, one severe adverse event involved surgery for an elbow fracture.
Peptide
Somapacitan
Outcome
Not applicableSevere elbow fracture event
Study
n = 39
Outcome group
Adverse events · Musculoskeletal
Studied dose
0.16 mg/kg/weekAs given in this study (human).
Measurements
Severe adverse events
1 events
Somapacitan/somapacitan group
Source sentences
Summary
One severe AE (surgery for elbow fracture) occurred in the somapacitan/somapacitan group.
2 context sentences(design, population, supporting numbers)
Summary · context
In a further, ongoing 4-year long-term safety extension, patients treated with somapacitan remained on somapacitan (somapacitan/somapacitan, n=39) and all patients on daily GH switched to somapacitan 0.16 mg/kg/week (daily GH/somapacitan, n=11).
Summary · context
Here, we present efficacy and safety results from the first year of the 4-year long-term safety extension.
Report a problemFND-9775106714
11HumanNon-randomized trialSafety outcome
In children continuing somapacitan, one patient experienced five injection-site reactions since the year 3 report.
In plain wordsIn children continuing somapacitan, one patient experienced five injection-site reactions since the year 3 report.
Peptide
Somapacitan
Outcome
Not applicableInjection-site reactions, continued group
Study
n = 39
Outcome group
Adverse events · Skin and wound
Studied dose
0.16 mg/kg/weekAs given in this study (human).
Measurements
Patients with injection-site reactions
1 patients
Somapacitan/somapacitan group
Injection-site reactions
5 reactions
Somapacitan/somapacitan group
Source sentences
Summary
Since previously reported in year 3, one patient in the somapacitan/somapacitan group experienced five injection-site reactions; none occurred in the daily GH/somapacitan group.
2 context sentences(design, population, supporting numbers)
Summary · context
In a further, ongoing 4-year long-term safety extension, patients treated with somapacitan remained on somapacitan (somapacitan/somapacitan, n=39) and all patients on daily GH switched to somapacitan 0.16 mg/kg/week (daily GH/somapacitan, n=11).
Summary · context
Here, we present efficacy and safety results from the first year of the 4-year long-term safety extension.
Report a problemFND-9775106716
12HumanNon-randomized trialEfficacy outcome
In children switching to somapacitan, height velocity fell from 7.6 (SD 2.0) cm/year at year 3 to 6.6 (1.6) at year 4.
In plain wordsIn children switching to somapacitan, growth speed was lower at year 4 than during daily GH at year 3.
Peptide
Somapacitan
Outcome
DecreaseHeight velocity, switched group
Study
n = 11
Comparator
Year 3 during daily GH
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16 mg/kg/week · 1 yearAs given in this study (human).
Measurements
Mean height velocity, year 4
6.6 cm/year
Daily GH/somapacitan group, SD 1.6
Mean height velocity, year 3
7.6 cm/year
Daily GH group, SD 2.0
Source sentences
Summary
At year 4, the mean (SD) height velocity (HV) was 7.4 (1.6) cm/year for the somapacitan/somapacitan group and 6.6 (1.6) cm/year for the daily GH/somapacitan group, compared with 8.3 (1.7) and 7.6 (2.0) cm/year for the somapacitan/somapacitan and daily GH groups, respectively, at year 3.
2 context sentences(design, population, supporting numbers)
Summary · context
In a further, ongoing 4-year long-term safety extension, patients treated with somapacitan remained on somapacitan (somapacitan/somapacitan, n=39) and all patients on daily GH switched to somapacitan 0.16 mg/kg/week (daily GH/somapacitan, n=11).
Summary · context
Here, we present efficacy and safety results from the first year of the 4-year long-term safety extension.
Report a problemFND-9775106702
13HumanNon-randomized trialEfficacy outcome
In children switching to somapacitan, year 4 mean height velocity SDS was 0.88 (SD 1.61).
In plain wordsIn children switching to somapacitan, the year 4 mean growth speed score was 0.88.
Peptide
Somapacitan
Outcome
Not applicableHeight velocity SDS, switched group
Study
n = 11
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16 mg/kg/week · 1 yearAs given in this study (human).
Measurements
Mean height velocity SDS, year 4
0.88 SDS
Daily GH/somapacitan group, SD 1.61
Source sentences
Summary
The mean (SD) HV standard deviation score (SDS) was 1.55 (1.70) for the somapacitan/somapacitan group and 0.88 (1.61) for the daily GH/somapacitan group,
2 context sentences(design, population, supporting numbers)
Summary · context
In a further, ongoing 4-year long-term safety extension, patients treated with somapacitan remained on somapacitan (somapacitan/somapacitan, n=39) and all patients on daily GH switched to somapacitan 0.16 mg/kg/week (daily GH/somapacitan, n=11).
Summary · context
Here, we present efficacy and safety results from the first year of the 4-year long-term safety extension.
Report a problemFND-9775106704
14HumanNon-randomized trialEfficacy outcome
In children switching to somapacitan, mean year 4 IGF-I SDS was 0.94 (SD 1.60).
In plain wordsIn children switching to somapacitan, the mean year 4 IGF-I score was 0.94.
Peptide
Somapacitan
Outcome
Not applicableIGF-I SDS, switched group
Study
n = 11
Outcome group
Growth hormone and IGF-1 · Endocrine and hormones
Studied dose
0.16 mg/kg/week · 1 yearAs given in this study (human).
Measurements
Mean IGF-I SDS, year 4
0.94 SDS
Daily GH/somapacitan group, SD 1.60
Source sentences
Summary
The mean (SD) insulin-like growth factor-I SDS at year 4 was 1.29 (1.23) and 0.94 (1.60) for the somapacitan/somapacitan and daily GH/somapacitan groups, respectively.
2 context sentences(design, population, supporting numbers)
Summary · context
In a further, ongoing 4-year long-term safety extension, patients treated with somapacitan remained on somapacitan (somapacitan/somapacitan, n=39) and all patients on daily GH switched to somapacitan 0.16 mg/kg/week (daily GH/somapacitan, n=11).
Summary · context
Here, we present efficacy and safety results from the first year of the 4-year long-term safety extension.
Report a problemFND-9775106707
15HumanNon-randomized trialSafety outcome
During year 4 in children switching to somapacitan, eight patients (72.7%) experienced 12 adverse events.
In plain wordsDuring year 4 in children switching to somapacitan, eight patients experienced 12 adverse events.
Peptide
Somapacitan
Outcome
Not applicableAdverse events, switched group
Study
n = 11
Outcome group
Adverse events · Whole body
Studied dose
0.16 mg/kg/week · 1 yearAs given in this study (human).
Measurements
Patients with adverse events, year 4
8 patients
Daily GH/somapacitan group
Proportion with adverse events, year 4
72.7%
Daily GH/somapacitan group
Adverse events, year 4
12 events
Daily GH/somapacitan group
Source sentences
Summary
During year 4, 20 patients (51.3%) experienced 84 adverse events (AEs) in the somapacitan/somapacitan group, and eight patients (72.7%) experienced 12 AEs in the daily GH/somapacitan group.
2 context sentences(design, population, supporting numbers)
Summary · context
In a further, ongoing 4-year long-term safety extension, patients treated with somapacitan remained on somapacitan (somapacitan/somapacitan, n=39) and all patients on daily GH switched to somapacitan 0.16 mg/kg/week (daily GH/somapacitan, n=11).
Summary · context
Here, we present efficacy and safety results from the first year of the 4-year long-term safety extension.
Report a problemFND-9775106709
16HumanNon-randomized trialSafety outcome
During year 4 in children switching to somapacitan, one patient (9.1%) had nasopharyngitis.
In plain wordsDuring year 4 in children switching to somapacitan, one patient had nasopharyngitis.
Peptide
Somapacitan
Outcome
Not applicableNasopharyngitis, switched group
Study
n = 11
Outcome group
Adverse events · Respiratory
Studied dose
0.16 mg/kg/week · 1 yearAs given in this study (human).
Measurements
Patients with nasopharyngitis, year 4
1 patients
Daily GH/somapacitan group
Proportion with nasopharyngitis, year 4
9.1%
Daily GH/somapacitan group
Source sentences
Summary
The most common AE was nasopharyngitis, occurring in four patients (10.3%) in the somapacitan/somapacitan group and one patient (9.1%) in the daily GH/somapacitan group; all other AEs occurred in <10% of patients in either group.
2 context sentences(design, population, supporting numbers)
Summary · context
In a further, ongoing 4-year long-term safety extension, patients treated with somapacitan remained on somapacitan (somapacitan/somapacitan, n=39) and all patients on daily GH switched to somapacitan 0.16 mg/kg/week (daily GH/somapacitan, n=11).
Summary · context
Here, we present efficacy and safety results from the first year of the 4-year long-term safety extension.
Report a problemFND-9775106711
17HumanNon-randomized trialSafety outcome
In children switching from daily GH to somapacitan, no injection-site reactions occurred since the year 3 report.
In plain wordsIn children switching to somapacitan, no injection-site reactions occurred since the year 3 report.
Peptide
Somapacitan
Outcome
Not applicableInjection-site reactions, switched group
Study
n = 11
Outcome group
Adverse events · Skin and wound
Studied dose
0.16 mg/kg/weekAs given in this study (human).
Source sentences
Summary
Since previously reported in year 3, one patient in the somapacitan/somapacitan group experienced five injection-site reactions; none occurred in the daily GH/somapacitan group.
2 context sentences(design, population, supporting numbers)
Summary · context
In a further, ongoing 4-year long-term safety extension, patients treated with somapacitan remained on somapacitan (somapacitan/somapacitan, n=39) and all patients on daily GH switched to somapacitan 0.16 mg/kg/week (daily GH/somapacitan, n=11).
Summary · context
Here, we present efficacy and safety results from the first year of the 4-year long-term safety extension.
Report a problemFND-9775106717

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

Abstract

PepBank is a research reference. Talk to a doctor before you use any peptide.