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Study · Randomized controlled trial · 2022

5 results

Effective GH Replacement With Once-weekly Somapacitan vs Daily GH in Children with GHD: 3-year Results From REAL 3.

Sävendahl L, Battelino T, Højby Rasmussen M, Brod M, Saenger P, Horikawa R

The Journal of clinical endocrinology and metabolism1 Apr 2022Cited by 47 (Europe PMC)

PMID34964458 (opens in a new tab)PMCIDPMC9016428 (opens in a new tab)DOI10.1210/clinem/dgab928 (opens in a new tab)PepBankPUB-34964458
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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 study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In children with GHD, the estimated year-3 height velocity difference for somapacitan 0.16/0.16 mg/kg/wk versus daily GH was 0.8 cm/y (95% CI -0.4 to 2.1).

    In plain wordsIn children with GHD, growth speed was numerically higher with somapacitan than daily GH, but the confidence interval included no difference.

    Peptide
    Somapacitan
    Outcome
    IncreaseHeight velocity at year 3
    Study

    n: not reported in source

    Comparator
    Daily GH
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    0.16/0.16 mg/kg/wk · subcutaneous · 156 weeksAs given in this study (human).

    Measurements

    Height velocity treatment difference
    0.8 cm/y
    Somapacitan versus daily GH
    95% CI
    −0.4 to 2.1 cm/y
    Treatment difference

    Source sentences

    Summary
    The estimated treatment difference (95% CI) in HV for somapacitan 0.16/0.16 mg/kg/wk vs daily GH at year 3 was 0.8 cm/y (-0.4 to 2.1).
    3 context sentences
    Summary · context
    A multicenter, randomized, controlled, phase 2 study comparing somapacitan and once-daily GH for 156 weeks (NCT02616562).
    Summary · context
    Fifty-nine children with GHD randomized (1:1:1:1) and exposed to treatment.
    Summary · context
    Patients received somapacitan (0.04 [n = 14], 0.08 [n = 15], or 0.16 [n = 14] mg/kg/wk) or daily GH (n = 14) (0.034 mg/kg/d, equivalent to 0.238 mg/kg/wk) subcutaneously during the first year, after which all patients on somapacitan received 0.16 mg/kg/wk.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In children with GHD, height velocity SDS change to year 3 was comparable with somapacitan and daily GH.

    In plain wordsIn children with GHD, growth speed score changes were similar with somapacitan and daily GH.

    Peptide
    Somapacitan
    Outcome
    Direction not reportedHeight velocity SDS change, highest dose
    Study

    n: not reported in source

    Comparator
    Daily GH
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    0.16/0.16 mg/kg/wk · subcutaneous · 156 weeksAs given in this study (human).

    Source sentences

    Summary
    Change in HVSDS from baseline to year 3 was comparable between somapacitan 0.16/0.16 mg/kg/wk, the pooled somapacitan groups, and daily GH.
    3 context sentences
    Summary · context
    A multicenter, randomized, controlled, phase 2 study comparing somapacitan and once-daily GH for 156 weeks (NCT02616562).
    Summary · context
    Fifty-nine children with GHD randomized (1:1:1:1) and exposed to treatment.
    Summary · context
    Patients received somapacitan (0.04 [n = 14], 0.08 [n = 15], or 0.16 [n = 14] mg/kg/wk) or daily GH (n = 14) (0.034 mg/kg/d, equivalent to 0.238 mg/kg/wk) subcutaneously during the first year, after which all patients on somapacitan received 0.16 mg/kg/wk.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In children with GHD, height velocity SDS change to year 3 was comparable with pooled somapacitan doses and daily GH.

    In plain wordsIn children with GHD, growth speed score changes were similar with pooled somapacitan doses and daily GH.

    Peptide
    Somapacitan
    Outcome
    Direction not reportedHeight velocity SDS change, pooled doses
    Study

    n: not reported in source

    Comparator
    Daily GH
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    0.04, 0.08 or 0.16 mg/kg/wk during the first year, then 0.16 mg/kg/wk · subcutaneous · 156 weeksAs given in this study (human).

    Source sentences

    Summary
    Change in HVSDS from baseline to year 3 was comparable between somapacitan 0.16/0.16 mg/kg/wk, the pooled somapacitan groups, and daily GH.
    3 context sentences
    Summary · context
    A multicenter, randomized, controlled, phase 2 study comparing somapacitan and once-daily GH for 156 weeks (NCT02616562).
    Summary · context
    Fifty-nine children with GHD randomized (1:1:1:1) and exposed to treatment.
    Summary · context
    Patients received somapacitan (0.04 [n = 14], 0.08 [n = 15], or 0.16 [n = 14] mg/kg/wk) or daily GH (n = 14) (0.034 mg/kg/d, equivalent to 0.238 mg/kg/wk) subcutaneously during the first year, after which all patients on somapacitan received 0.16 mg/kg/wk.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In children with GHD, mean height SDS at year 3 was similar with pooled somapacitan doses and daily GH.

    In plain wordsIn children with GHD, height scores were similar with pooled somapacitan doses and daily GH at year 3.

    Peptide
    Somapacitan
    Outcome
    Direction not reportedHeight SDS at year 3
    Study

    n: not reported in source

    Comparator
    Daily GH
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    0.04, 0.08 or 0.16 mg/kg/wk during the first year, then 0.16 mg/kg/wk · subcutaneous · 156 weeksAs given in this study (human).

    Source sentences

    Summary
    At year 3, mean HSDS was similar for the pooled somapacitan groups and daily GH.
    3 context sentences
    Summary · context
    A multicenter, randomized, controlled, phase 2 study comparing somapacitan and once-daily GH for 156 weeks (NCT02616562).
    Summary · context
    Fifty-nine children with GHD randomized (1:1:1:1) and exposed to treatment.
    Summary · context
    Patients received somapacitan (0.04 [n = 14], 0.08 [n = 15], or 0.16 [n = 14] mg/kg/wk) or daily GH (n = 14) (0.034 mg/kg/d, equivalent to 0.238 mg/kg/wk) subcutaneously during the first year, after which all patients on somapacitan received 0.16 mg/kg/wk.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In children with GHD, mean IGF-I SDS change to year 3 was similar with somapacitan and daily GH.

    In plain wordsIn children with GHD, IGF-I score changes were similar with somapacitan and daily GH at year 3.

    Peptide
    Somapacitan
    Outcome
    Direction not reportedIGF-I SDS change
    Study

    n: not reported in source

    Comparator
    Daily GH
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    Somapacitan 0.04, 0.08 or 0.16 mg/kg/wk during the first year, then 0.16 mg/kg/wk; daily GH 0.034 mg/kg/d during the first year · subcutaneous · 156 weeksAs given in this study (human).

    Source sentences

    Summary
    Change from baseline to year 3 in mean IGF-I SDS was similar across treatments.
    3 context sentences
    Summary · context
    A multicenter, randomized, controlled, phase 2 study comparing somapacitan and once-daily GH for 156 weeks (NCT02616562).
    Summary · context
    Fifty-nine children with GHD randomized (1:1:1:1) and exposed to treatment.
    Summary · context
    Patients received somapacitan (0.04 [n = 14], 0.08 [n = 15], or 0.16 [n = 14] mg/kg/wk) or daily GH (n = 14) (0.034 mg/kg/d, equivalent to 0.238 mg/kg/wk) subcutaneously during the first year, after which all patients on somapacitan received 0.16 mg/kg/wk.

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2Results postedNCT02616562

Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency

Novo Nordisk A/Sn = 7631 Mar 2016 to 26 Sept 2024

Growth Hormone Disorder · Growth Hormone Deficiency in Children

Trial pageClinicalTrials.govUpdated 16 Jan 2026

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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