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Study · Randomized controlled trial · n = 36 · 2025

4 results

Efficacy in Japanese adults with growth hormone deficiency receiving weekly somapacitan or daily growth hormone: results from phase 3 REAL 1 trial.

Otsuka F, Rasmussen MH, Endo T, Sværke C, Tahara S, Johannsson G

Frontiers in endocrinology7 Feb 2025Cited by 5 (Europe PMC)

PMID39991735 (opens in a new tab)PMCIDPMC11842232 (opens in a new tab)DOI10.3389/fendo.2025.1534891 (opens in a new tab)PepBankPUB-39991735
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Summary

IntroductionSomapacitan is a long-acting growth hormone (GH) derivative approved for once-weekly treatment of adult GH deficiency (AGHD). This study aimed to evaluate the efficacy and safety of somapacitan and daily GH in Japanese individuals with AGHD.MethodsThis subgroup study included the 34-week main period of the multinational, randomized, parallel-group, phase 3 trial, REAL 1 (NCT02229851). Participants received once-weekly somapacitan or daily GH (Norditropin®), both administered subcutaneously. Investigators and trial sites were blinded. A total of 36 Japanese GH-naïve individuals with AGHD were allocated to somapacitan or daily GH (excluding the placebo group of the global trial). Endpoints included change in truncal fat percentage to week 34 measured using dual-energy x-ray absorptiometry, as well as other body composition measures. Insulin-like growth factor I standard deviation score values were used for dose titration.ResultsIn total, 36 Japanese individuals were included (18 and 18 in the somapacitan and daily GH group, respectively). 35 completed the main period (34 weeks). Mean (SD) change from baseline to week 34 in truncal fat percentage was -2.23 (2.50) %-points in the somapacitan group and -2.12 (4.21) %-points in the daily GH group. Other body composition measures also improved in both groups, including reduced visceral fat and increased lean body mass. Somapacitan was well tolerated, with a safety profile similar to daily GH.ConclusionsIn Japanese treatment-naïve individuals with AGHD, once-weekly somapacitan demonstrated similar efficacy and safety to daily GH after 34 weeks of treatment. Somapacitan provides an effective alternative to daily GH in AGHD.Clinical trial registrationhttp://www.clinicaltrials.gov, identifier NCT02229851.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In Japanese adults with GH deficiency, somapacitan had a safety profile similar to daily GH.

    In plain wordsIn Japanese adults with GH deficiency, somapacitan had a safety profile similar to daily GH.

    Peptide
    Somapacitan
    Outcome
    Direction not reportedSafety profile
    Study

    n = 36

    Comparator
    Daily GH
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · subcutaneous · 34 weeksAs given in this study (human).

    Source sentences

    Summary
    Somapacitan was well tolerated, with a safety profile similar to daily GH.
    3 context sentences
    Summary · context
    This subgroup study included the 34-week main period of the multinational, randomized, parallel-group, phase 3 trial, REAL 1 (NCT02229851).
    Summary · context
    Participants received once-weekly somapacitan or daily GH (Norditropin®), both administered subcutaneously.
    Summary · context
    In total, 36 Japanese individuals were included (18 and 18 in the somapacitan and daily GH group, respectively).
  2. 02HumanNon-randomized trialEfficacy outcome

    In Japanese adults with GH deficiency, visceral fat decreased from baseline with somapacitan and daily GH.

    In plain wordsIn Japanese adults with GH deficiency, visceral fat decreased from baseline with somapacitan and daily GH.

    Peptide
    Somapacitan
    Outcome
    DecreaseVisceral fat
    Study

    n = 36

    Outcome group
    Body composition · Metabolic and weight
    Studied dose
    Dose not stated · subcutaneous · 34 weeksAs given in this study (human).

    Source sentences

    Summary
    Other body composition measures also improved in both groups, including reduced visceral fat and increased lean body mass.
    3 context sentences
    Summary · context
    This subgroup study included the 34-week main period of the multinational, randomized, parallel-group, phase 3 trial, REAL 1 (NCT02229851).
    Summary · context
    Participants received once-weekly somapacitan or daily GH (Norditropin®), both administered subcutaneously.
    Summary · context
    In total, 36 Japanese individuals were included (18 and 18 in the somapacitan and daily GH group, respectively).
  3. 03HumanNon-randomized trialEfficacy outcome

    In Japanese adults with GH deficiency, lean body mass increased from baseline with somapacitan and daily GH.

    In plain wordsIn Japanese adults with GH deficiency, lean body mass increased from baseline with somapacitan and daily GH.

    Peptide
    Somapacitan
    Outcome
    IncreaseLean body mass
    Study

    n = 36

    Outcome group
    Body composition · Metabolic and weight
    Studied dose
    Dose not stated · subcutaneous · 34 weeksAs given in this study (human).

    Source sentences

    Summary
    Other body composition measures also improved in both groups, including reduced visceral fat and increased lean body mass.
    3 context sentences
    Summary · context
    This subgroup study included the 34-week main period of the multinational, randomized, parallel-group, phase 3 trial, REAL 1 (NCT02229851).
    Summary · context
    Participants received once-weekly somapacitan or daily GH (Norditropin®), both administered subcutaneously.
    Summary · context
    In total, 36 Japanese individuals were included (18 and 18 in the somapacitan and daily GH group, respectively).
  4. 04HumanNon-randomized trialEfficacy outcome

    In Japanese adults with GH deficiency, somapacitan reduced truncal fat percentage by 2.23 percentage points from baseline at week 34.

    In plain wordsIn Japanese adults with GH deficiency, truncal fat percentage decreased from baseline with somapacitan.

    Peptide
    Somapacitan
    Outcome
    DecreaseTruncal fat percentage
    Study

    n = 18

    Outcome group
    Body composition · Metabolic and weight
    Studied dose
    Dose not stated · subcutaneous · 34 weeksAs given in this study (human).

    Measurements

    Change in truncal fat
    −2.23 percentage points
    somapacitan
    SD
    2.5 percentage points
    somapacitan

    Source sentences

    Summary
    Mean (SD) change from baseline to week 34 in truncal fat percentage was -2.23 (2.50) %-points in the somapacitan group and -2.12 (4.21) %-points in the daily GH group.
    3 context sentences
    Summary · context
    This subgroup study included the 34-week main period of the multinational, randomized, parallel-group, phase 3 trial, REAL 1 (NCT02229851).
    Summary · context
    Participants received once-weekly somapacitan or daily GH (Norditropin®), both administered subcutaneously.
    Summary · context
    In total, 36 Japanese individuals were included (18 and 18 in the somapacitan and daily GH group, respectively).

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 3Results postedNCT02229851

Trial to Compare the Efficacy and Safety of NNC0195-0092 (Somapacitan) With Placebo and Norditropin® FlexPro® (Somatropin) in Adults With Growth Hormone Deficiency.

Novo Nordisk A/Sn = 30131 Oct 2014 to 7 May 2018

Growth Hormone Disorder · Adult Growth Hormone Deficiency

Trial pageClinicalTrials.govUpdated 23 Nov 2020

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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