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Study · Randomized controlled trial · n = 110 · 2026

7 results

Somapacitan Is Effective and Well Tolerated in Chinese Children with Growth Hormone Deficiency: A Randomized Controlled Phase 3 Study.

Fu J, Cheng X, Højby M, Gong C, Leunbach TL, Li Y, Wei H, Zhu Y, Zhang Y, Zhong Y

Hormone research in paediatrics5 May 2025Cited by 9 (Europe PMC)

PMID40324364 (opens in a new tab)PMCIDPMC12129415 (opens in a new tab)DOI10.1159/000545786 (opens in a new tab)PepBankPUB-40324364
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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. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In Chinese children with GHD, mean height velocity at week 52 was 11.0 cm/year with somapacitan versus 10.4 with daily GH, meeting non-inferiority.

    In plain wordsIn Chinese children with GHD, height velocity was 11.0 cm/year with somapacitan versus 10.4 with daily GH at week 52.

    Peptide
    Somapacitan
    Outcome
    IncreaseHeight velocity at week 52
    Study

    n = 110

    Comparator
    Daily GH (Norditropin; 0.034 mg/kg/day)
    Analysis
    Primary
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    0.16 mg/kg/week · 52 weeksAs given in this study (human).

    Measurements

    Estimated mean annualized height velocity
    11 cm/year
    somapacitan, week 52
    Estimated mean annualized height velocity
    10.4 cm/year
    daily GH, week 52

    Source sentences

    Summary
    Estimated mean HV at week 52 was 11.0 and 10.4 cm/year for somapacitan and daily GH, respectively.
    4 context sentences
    Summary · context
    Non-inferiority of somapacitan compared to daily GH was confirmed.
    Summary · context
    Annualized height velocity (HV; cm/year) at week 52 was the primary measurement.
    Summary · context
    REAL6 is a randomized, multi-centre, open-labelled, active-controlled parallel group phase 3 trial (NCT04970654) investigating once-weekly somapacitan, a reversible albumin-binding growth hormone (GH) derivative, in Chinese children with GH deficiency (GHD).
    Summary · context
    110 treatment-naïve patients were randomized 2:1 to somapacitan (0.16 mg/kg/week) or daily GH (Norditropin®; 0.034 mg/kg/day) for 52 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Chinese children with GHD, changes in HVSDS, HSDS, bone age, and IGF-I SDS were similar with somapacitan and daily GH at week 52.

    In plain wordsIn Chinese children with GHD, growth and hormone score changes were similar with somapacitan and daily GH at week 52.

    Peptide
    Somapacitan
    Outcome
    No significant changeChanges in HVSDS, HSDS, bone age, and IGF-I SDS
    Study

    n = 110

    Comparator
    Daily GH (Norditropin; 0.034 mg/kg/day)
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    0.16 mg/kg/week · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Changes in HVSDS, HSDS, bone age, and IGF-I SDS from baseline to week 52 were similar between groups.
    2 context sentences
    Summary · context
    REAL6 is a randomized, multi-centre, open-labelled, active-controlled parallel group phase 3 trial (NCT04970654) investigating once-weekly somapacitan, a reversible albumin-binding growth hormone (GH) derivative, in Chinese children with GH deficiency (GHD).
    Summary · context
    110 treatment-naïve patients were randomized 2:1 to somapacitan (0.16 mg/kg/week) or daily GH (Norditropin®; 0.034 mg/kg/day) for 52 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In Chinese children with GHD, mean IGF-I SDS at week 52 was +0.5 (SD 1.4) with somapacitan versus +0.1 (1.2) with daily GH, described as comparable.

    In plain wordsIn Chinese children with GHD, IGF-I scores were comparable: +0.5 with somapacitan versus +0.1 with daily GH at week 52.

    Peptide
    Somapacitan
    Outcome
    IncreaseIGF-I SDS at week 52
    Study

    n = 110

    Comparator
    Daily GH (Norditropin; 0.034 mg/kg/day)
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    0.16 mg/kg/week · 52 weeksAs given in this study (human).

    Measurements

    IGF-I SDS, mean
    0.5 SDS
    somapacitan, week 52
    IGF-I SDS, SD
    1.4 SDS
    somapacitan, week 52
    IGF-I SDS, mean
    0.1 SDS
    daily GH, week 52
    IGF-I SDS, SD
    1.2 SDS
    daily GH, week 52

    Source sentences

    Summary
    At week 52, mean (SD) IGF-I SDS was within intended reference range (-2.0 to +2.0) and comparable between groups: +0.5 (1.4) for somapacitan versus +0.1 (1.2) for daily GH.
    2 context sentences
    Summary · context
    REAL6 is a randomized, multi-centre, open-labelled, active-controlled parallel group phase 3 trial (NCT04970654) investigating once-weekly somapacitan, a reversible albumin-binding growth hormone (GH) derivative, in Chinese children with GH deficiency (GHD).
    Summary · context
    110 treatment-naïve patients were randomized 2:1 to somapacitan (0.16 mg/kg/week) or daily GH (Norditropin®; 0.034 mg/kg/day) for 52 weeks.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In Chinese children with GHD, somapacitan reduced treatment burden compared with daily GH.

    In plain wordsIn Chinese children with GHD, somapacitan reduced treatment burden compared with daily GH.

    Peptide
    Somapacitan
    Outcome
    DecreaseTreatment burden
    Study

    n = 110

    Comparator
    Daily GH (Norditropin; 0.034 mg/kg/day)
    Outcome group
    Patterns of use · Whole body
    Studied dose
    0.16 mg/kg/week · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Somapacitan reduced treatment burden compared to daily GH.
    2 context sentences
    Summary · context
    REAL6 is a randomized, multi-centre, open-labelled, active-controlled parallel group phase 3 trial (NCT04970654) investigating once-weekly somapacitan, a reversible albumin-binding growth hormone (GH) derivative, in Chinese children with GH deficiency (GHD).
    Summary · context
    110 treatment-naïve patients were randomized 2:1 to somapacitan (0.16 mg/kg/week) or daily GH (Norditropin®; 0.034 mg/kg/day) for 52 weeks.
  5. 05HumanNon-randomized trialSafety outcome

    In Chinese children with GHD, somapacitan was well tolerated, with a safety profile consistent with daily GH.

    In plain wordsIn Chinese children with GHD, somapacitan was well tolerated, with a safety profile consistent with daily GH.

    Peptide
    Somapacitan
    Outcome
    Not applicableOverall tolerability
    Study

    n: not reported in source

    Comparator
    Well-known safety profile of daily GH
    Outcome group
    Adverse events · Whole body
    Studied dose
    0.16 mg/kg/week · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Somapacitan was well tolerated with a safety profile consistent with the well-known safety profile of daily GH.
    2 context sentences
    Summary · context
    REAL6 is a randomized, multi-centre, open-labelled, active-controlled parallel group phase 3 trial (NCT04970654) investigating once-weekly somapacitan, a reversible albumin-binding growth hormone (GH) derivative, in Chinese children with GH deficiency (GHD).
    Summary · context
    110 treatment-naïve patients were randomized 2:1 to somapacitan (0.16 mg/kg/week) or daily GH (Norditropin®; 0.034 mg/kg/day) for 52 weeks.
  6. 06HumanNon-randomized trialSafety outcome

    In Chinese children with GHD receiving somapacitan, injection site reactions occurred in 2.7% during the 52-week treatment period.

    In plain wordsIn Chinese children with GHD receiving somapacitan, 2.7% had injection site reactions during 52 weeks.

    Peptide
    Somapacitan
    Outcome
    Not applicableInjection-site reactions
    Study

    n: not reported in source

    Outcome group
    Adverse events · Skin and wound
    Studied dose
    0.16 mg/kg/week · 52 weeksAs given in this study (human).

    Measurements

    Injection site reactions
    2.7%
    somapacitan, 52-week treatment period

    Source sentences

    Summary
    A low proportion of injection site reactions were reported for somapacitan (2.7%), with no reports of injection site pain during the 52-week treatment period.
    2 context sentences
    Summary · context
    REAL6 is a randomized, multi-centre, open-labelled, active-controlled parallel group phase 3 trial (NCT04970654) investigating once-weekly somapacitan, a reversible albumin-binding growth hormone (GH) derivative, in Chinese children with GH deficiency (GHD).
    Summary · context
    110 treatment-naïve patients were randomized 2:1 to somapacitan (0.16 mg/kg/week) or daily GH (Norditropin®; 0.034 mg/kg/day) for 52 weeks.
  7. 07HumanNon-randomized trialSafety outcome

    No injection site pain was reported in Chinese children with GHD receiving somapacitan during 52 weeks.

    In plain wordsNo injection site pain was reported in Chinese children with GHD receiving somapacitan during 52 weeks.

    Peptide
    Somapacitan
    Outcome
    Not applicableInjection-site pain
    Study

    n: not reported in source

    Outcome group
    Adverse events · Skin and wound
    Studied dose
    0.16 mg/kg/week · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    A low proportion of injection site reactions were reported for somapacitan (2.7%), with no reports of injection site pain during the 52-week treatment period.
    2 context sentences
    Summary · context
    REAL6 is a randomized, multi-centre, open-labelled, active-controlled parallel group phase 3 trial (NCT04970654) investigating once-weekly somapacitan, a reversible albumin-binding growth hormone (GH) derivative, in Chinese children with GH deficiency (GHD).
    Summary · context
    110 treatment-naïve patients were randomized 2:1 to somapacitan (0.16 mg/kg/week) or daily GH (Norditropin®; 0.034 mg/kg/day) for 52 weeks.

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

Subjects

Terms as the source lists them.

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