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Study · Randomized controlled trial · n = 28 · 2020

8 results

SAT-091 First Report of Disease-Specific Patient-Reported Outcomes from a Randomized Phase 2 Trial of Once-Weekly Somapacitan vs Daily GH in Children with GHD

Brod M, Lee K, Rasmussen M

Journal of the Endocrine Society8 May 2020

PMCIDPMC7208886 (opens in a new tab)PepBankPUB-94538066
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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 study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In children with GHD, at week 52 the estimated treatment difference in change in emotional wellbeing score for somapacitan 0.16 mg/kg/wk versus daily GH was -9.34, exceeding the minimal important difference of 7 but not statistically significant.

    In plain wordsIn children with GHD, emotional scores numerically favored somapacitan over daily GH and exceeded the important-difference threshold, without statistical significance.

    Peptide
    Somapacitan
    Outcome
    DecreaseEmotional wellbeing score
    Study

    n = 28

    Comparator
    Daily GH
    Outcome group
    Quality of life · Mental health and mood
    Studied dose
    0.16 mg/kg/wk · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Estimated treatment difference in change from baseline
    −9.34 score points
    somapacitan 0.16 mg/kg/wk minus daily GH at week 52
    Minimal important difference
    7 score points
    Emotional wellbeing score

    Source sentences

    Summary
    For the change from baseline in GHD-CIM ObsRO score, the estimated treatment differences (ETDs) between somapacitan 0.16 mg/kg/wk and daily GH at wk 52 exceeded the MID in favor of somapacitan for the emotional wellbeing (ETD -9.34; MID 7) and social wellbeing domains (ETD -10.12; MID 5), as well as…
    3 context sentences
    Summary · context
    The somapacitan 0.16 mg/kg/wk group showed a numerical improvement over daily GH across all GHD-CIM ObsRO domains and total score, although none of the ETDs reached statistical significance.
    Summary · context
    The efficacy, safety and tolerability of somapacitan were compared with daily GH in children with GHD in a multicenter, randomized, controlled, double-blinded to dose, phase 2 trial (REAL 3, NCT02616562).
    Summary · context
    Treatment-naïve, prepubertal children with GHD were randomized 1:1:1:1 to once-weekly sc somapacitan (0.04, 0.08 or 0.16 mg/kg/week [wk]) or daily sc GH (Norditropin®; 0.034 mg/kg/day) during the 26-wk main trial period and 26-wk extension.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In children with GHD, at week 52 the estimated treatment difference in change in social wellbeing score for somapacitan 0.16 mg/kg/wk versus daily GH was -10.12, exceeding the minimal important difference of 5 but not statistically significant.

    In plain wordsIn children with GHD, social scores numerically favored somapacitan over daily GH and exceeded the important-difference threshold, without statistical significance.

    Peptide
    Somapacitan
    Outcome
    DecreaseSocial wellbeing score
    Study

    n = 28

    Comparator
    Daily GH
    Outcome group
    Quality of life · Mental health and mood
    Studied dose
    0.16 mg/kg/wk · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Estimated treatment difference in change from baseline
    −10.12 score points
    somapacitan 0.16 mg/kg/wk minus daily GH at week 52
    Minimal important difference
    5 score points
    Social wellbeing score

    Source sentences

    Summary
    For the change from baseline in GHD-CIM ObsRO score, the estimated treatment differences (ETDs) between somapacitan 0.16 mg/kg/wk and daily GH at wk 52 exceeded the MID in favor of somapacitan for the emotional wellbeing (ETD -9.34; MID 7) and social wellbeing domains (ETD -10.12; MID 5), as well as…
    3 context sentences
    Summary · context
    The somapacitan 0.16 mg/kg/wk group showed a numerical improvement over daily GH across all GHD-CIM ObsRO domains and total score, although none of the ETDs reached statistical significance.
    Summary · context
    The efficacy, safety and tolerability of somapacitan were compared with daily GH in children with GHD in a multicenter, randomized, controlled, double-blinded to dose, phase 2 trial (REAL 3, NCT02616562).
    Summary · context
    Treatment-naïve, prepubertal children with GHD were randomized 1:1:1:1 to once-weekly sc somapacitan (0.04, 0.08 or 0.16 mg/kg/week [wk]) or daily sc GH (Norditropin®; 0.034 mg/kg/day) during the 26-wk main trial period and 26-wk extension.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In children with GHD, at week 52 the estimated treatment difference in change in total score for somapacitan 0.16 mg/kg/wk versus daily GH was -7.43, exceeding the minimal important difference of 5 but not statistically significant.

    In plain wordsIn children with GHD, total scores numerically favored somapacitan over daily GH and exceeded the important-difference threshold, without statistical significance.

    Peptide
    Somapacitan
    Outcome
    DecreaseTotal GHD-CIM ObsRO score
    Study

    n = 28

    Comparator
    Daily GH
    Outcome group
    Quality of life · Whole body
    Studied dose
    0.16 mg/kg/wk · subcutaneous · 52 weeksAs given in this study (human).

    Measurements

    Estimated treatment difference in change from baseline
    −7.43 score points
    somapacitan 0.16 mg/kg/wk minus daily GH at week 52
    Minimal important difference
    5 score points
    Total GHD-CIM ObsRO score

    Source sentences

    Summary
    For the change from baseline in GHD-CIM ObsRO score, the estimated treatment differences (ETDs) between somapacitan 0.16 mg/kg/wk and daily GH at wk 52 exceeded the MID in favor of somapacitan for the emotional wellbeing (ETD -9.34; MID 7) and social wellbeing domains (ETD -10.12; MID 5), as well as…
    3 context sentences
    Summary · context
    The somapacitan 0.16 mg/kg/wk group showed a numerical improvement over daily GH across all GHD-CIM ObsRO domains and total score, although none of the ETDs reached statistical significance.
    Summary · context
    The efficacy, safety and tolerability of somapacitan were compared with daily GH in children with GHD in a multicenter, randomized, controlled, double-blinded to dose, phase 2 trial (REAL 3, NCT02616562).
    Summary · context
    Treatment-naïve, prepubertal children with GHD were randomized 1:1:1:1 to once-weekly sc somapacitan (0.04, 0.08 or 0.16 mg/kg/week [wk]) or daily sc GH (Norditropin®; 0.034 mg/kg/day) during the 26-wk main trial period and 26-wk extension.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In children with GHD, physical functioning scores numerically favored somapacitan over daily GH, without statistical significance.

    In plain wordsIn children with GHD, physical functioning scores numerically favored somapacitan over daily GH, without statistical significance.

    Peptide
    Somapacitan
    Outcome
    Direction not reportedPhysical functioning score
    Study

    n = 28

    Comparator
    Daily GH
    Outcome group
    Exercise and physical function · Whole body
    Studied dose
    0.16 mg/kg/wk · subcutaneous · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    The somapacitan 0.16 mg/kg/wk group showed a numerical improvement over daily GH across all GHD-CIM ObsRO domains and total score, although none of the ETDs reached statistical significance.
    3 context sentences
    Summary · context
    This is a new, validated questionnaire, developed according to US FDA guidance, to assess the impact of GHD on physical functioning, and social and emotional wellbeing in children aged 4 to <13 years, to be completed by caregivers.
    Summary · context
    The efficacy, safety and tolerability of somapacitan were compared with daily GH in children with GHD in a multicenter, randomized, controlled, double-blinded to dose, phase 2 trial (REAL 3, NCT02616562).
    Summary · context
    Treatment-naïve, prepubertal children with GHD were randomized 1:1:1:1 to once-weekly sc somapacitan (0.04, 0.08 or 0.16 mg/kg/week [wk]) or daily sc GH (Norditropin®; 0.034 mg/kg/day) during the 26-wk main trial period and 26-wk extension.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In children with GHD, height SDS efficacy was similar with somapacitan 0.16 mg/kg/wk and daily GH.

    In plain wordsIn children with GHD, height scores were similar with somapacitan and daily GH.

    Peptide
    Somapacitan
    Outcome
    No significant changeHeight SDS
    Study

    n: not reported in source

    Comparator
    Daily GH
    Outcome group
    Linear growth · Musculoskeletal
    Studied dose
    0.16 mg/kg/wk · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Efficacy of the 0.16 mg/kg/wk dose was similar to that of daily GH, judged by height standard deviation scores (SDS) and insulin-like growth factor-I SDS, and, at wk 52, height velocity was statistically significantly greater with somapacitan 0.16 mg/kg/wk vs daily GH.
    2 context sentences
    Summary · context
    The efficacy, safety and tolerability of somapacitan were compared with daily GH in children with GHD in a multicenter, randomized, controlled, double-blinded to dose, phase 2 trial (REAL 3, NCT02616562).
    Summary · context
    Treatment-naïve, prepubertal children with GHD were randomized 1:1:1:1 to once-weekly sc somapacitan (0.04, 0.08 or 0.16 mg/kg/week [wk]) or daily sc GH (Norditropin®; 0.034 mg/kg/day) during the 26-wk main trial period and 26-wk extension.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In children with GHD, IGF-I SDS efficacy was similar with somapacitan 0.16 mg/kg/wk and daily GH.

    In plain wordsIn children with GHD, IGF-I scores were similar with somapacitan and daily GH.

    Peptide
    Somapacitan
    Outcome
    No significant changeIGF-I SDS
    Study

    n: not reported in source

    Comparator
    Daily GH
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    0.16 mg/kg/wk · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Efficacy of the 0.16 mg/kg/wk dose was similar to that of daily GH, judged by height standard deviation scores (SDS) and insulin-like growth factor-I SDS, and, at wk 52, height velocity was statistically significantly greater with somapacitan 0.16 mg/kg/wk vs daily GH.
    2 context sentences
    Summary · context
    The efficacy, safety and tolerability of somapacitan were compared with daily GH in children with GHD in a multicenter, randomized, controlled, double-blinded to dose, phase 2 trial (REAL 3, NCT02616562).
    Summary · context
    Treatment-naïve, prepubertal children with GHD were randomized 1:1:1:1 to once-weekly sc somapacitan (0.04, 0.08 or 0.16 mg/kg/week [wk]) or daily sc GH (Norditropin®; 0.034 mg/kg/day) during the 26-wk main trial period and 26-wk extension.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In children with GHD, height velocity at week 52 was significantly greater with somapacitan 0.16 mg/kg/wk than daily GH.

    In plain wordsIn children with GHD, growth was faster with somapacitan than daily GH at week 52.

    Peptide
    Somapacitan
    Outcome
    IncreaseHeight velocity at week 52
    Study

    n: not reported in source

    Comparator
    Daily GH
    Outcome group
    Linear growth · Musculoskeletal
    Studied dose
    0.16 mg/kg/wk · subcutaneous · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Efficacy of the 0.16 mg/kg/wk dose was similar to that of daily GH, judged by height standard deviation scores (SDS) and insulin-like growth factor-I SDS, and, at wk 52, height velocity was statistically significantly greater with somapacitan 0.16 mg/kg/wk vs daily GH.
    2 context sentences
    Summary · context
    The efficacy, safety and tolerability of somapacitan were compared with daily GH in children with GHD in a multicenter, randomized, controlled, double-blinded to dose, phase 2 trial (REAL 3, NCT02616562).
    Summary · context
    Treatment-naïve, prepubertal children with GHD were randomized 1:1:1:1 to once-weekly sc somapacitan (0.04, 0.08 or 0.16 mg/kg/week [wk]) or daily sc GH (Norditropin®; 0.034 mg/kg/day) during the 26-wk main trial period and 26-wk extension.
  8. 08HumanRandomized controlled trialSafety outcome

    In children with GHD, somapacitan safety and tolerability were consistent with daily GH.

    In plain wordsIn children with GHD, somapacitan safety and tolerability were consistent with daily GH.

    Peptide
    Somapacitan
    Outcome
    No significant changeSafety and tolerability
    Study

    n: not reported in source

    Comparator
    Daily GH
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Safety and tolerability of somapacitan were consistent with the profile of daily GH.
    2 context sentences
    Summary · context
    The efficacy, safety and tolerability of somapacitan were compared with daily GH in children with GHD in a multicenter, randomized, controlled, double-blinded to dose, phase 2 trial (REAL 3, NCT02616562).
    Summary · context
    Treatment-naïve, prepubertal children with GHD were randomized 1:1:1:1 to once-weekly sc somapacitan (0.04, 0.08 or 0.16 mg/kg/week [wk]) or daily sc GH (Norditropin®; 0.034 mg/kg/day) during the 26-wk main trial period and 26-wk extension.

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.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:36 UTC

    First added · source update from Europe PMC

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Terms as the source lists them.

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