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Study · Randomized controlled trial · 2020

5 results

Once-weekly Somapacitan is Effective and Well Tolerated in Adults with GH Deficiency: A Randomized Phase 3 Trial.

Johannsson G, Gordon MB, Højby Rasmussen M, Håkonsson IH, Karges W, Sværke C, Tahara S, Takano K, Biller BMK

The Journal of clinical endocrinology and metabolism1 Apr 2020Cited by 65 (Europe PMC)

PMID32022863 (opens in a new tab)PMCIDPMC7076631 (opens in a new tab)DOI10.1210/clinem/dgaa049 (opens in a new tab)PepBankPUB-32022863
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Summary

ContextGrowth hormone (GH) replacement requires daily GH injections, which is burdensome for some adult patients with GH deficiency (AGHD).ObjectiveTo demonstrate efficacy and safety of somapacitan, a once-weekly reversible albumin-binding GH derivative, versus placebo in AGHD.DesignRandomized, parallel-group, placebo-controlled (double-blind) and active-controlled (open-label) phase 3 trial, REAL 1 (NCT02229851).SettingClinics in 17 countries.PatientsTreatment-naïve patients with AGHD (n = 301 main study period, 272 extension period); 257 patients completed the trial.InterventionsPatients were randomized 2:2:1 to once-weekly somapacitan, daily GH, or once-weekly placebo for 34 weeks (main period). During the 52-week extension period, patients continued treatment with somapacitan or daily GH.Main outcome measuresBody composition measured using dual-energy x-ray absorptiometry (DXA). The primary endpoint was change in truncal fat percentage to week 34. Insulin-like growth factor 1 (IGF-I) standard deviation score (SDS) values were used to dose titrate.ResultsAt 34 weeks, somapacitan significantly reduced truncal fat percentage (estimated difference: -1.53% [-2.68; -0.38]; P = 0.0090), demonstrating superiority compared with placebo, and it improved other body composition parameters (including visceral fat and lean body mass) and IGF-I SDS. At 86 weeks, improvements were maintained with both somapacitan and daily GH. Somapacitan was well tolerated, with similar adverse events (including injection-site reactions) compared with daily GH.ConclusionsIn AGHD patients, somapacitan administered once weekly demonstrated superiority over placebo, and the overall treatment effects and safety of somapacitan were in accordance with known effects and safety of GH replacement for up to 86 weeks of treatment. Somapacitan may provide an effective alternative to daily GH in AGHD. A short visual summary of our work is available (1).
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study5

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with GH deficiency, somapacitan reduced truncal fat percentage versus placebo at 34 weeks (estimated difference -1.53%, P = 0.0090).

    In plain wordsIn adults with GH deficiency, somapacitan reduced trunk fat more than placebo.

    Peptide
    Somapacitan
    Outcome
    DecreaseTruncal fat percentage
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 34 weeksAs given in this study (human).

    Measurements

    Estimated truncal fat percentage difference
    −1.53%
    versus placebo at 34 weeks
    95% confidence interval
    −2.68 to −0.38%
    versus placebo at 34 weeks

    Source sentences

    Summary
    At 34 weeks, somapacitan significantly reduced truncal fat percentage (estimated difference: -1.53% [-2.68; -0.38]; P = 0.0090), demonstrating superiority compared with placebo, and it improved other body composition parameters (including visceral fat and lean body mass) and IGF-I SDS.
    3 context sentences
    Summary · context
    Randomized, parallel-group, placebo-controlled (double-blind) and active-controlled (open-label) phase 3 trial, REAL 1 (NCT02229851).
    Summary · context
    Treatment-naïve patients with AGHD (n = 301 main study period, 272 extension period); 257 patients completed the trial.
    Summary · context
    Patients were randomized 2:2:1 to once-weekly somapacitan, daily GH, or once-weekly placebo for 34 weeks (main period).
  2. 02HumanRandomized controlled trialSafety outcome

    In adults with GH deficiency, somapacitan had similar adverse events to daily GH.

    In plain wordsIn adults with GH deficiency, adverse events were similar with somapacitan and daily GH.

    Peptide
    Somapacitan
    Outcome
    No significant changeAdverse events
    Study

    n: not reported in source

    Comparator
    Daily GH
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Somapacitan was well tolerated, with similar adverse events (including injection-site reactions) compared with daily GH.
    3 context sentences
    Summary · context
    Randomized, parallel-group, placebo-controlled (double-blind) and active-controlled (open-label) phase 3 trial, REAL 1 (NCT02229851).
    Summary · context
    Treatment-naïve patients with AGHD (n = 301 main study period, 272 extension period); 257 patients completed the trial.
    Summary · context
    Patients were randomized 2:2:1 to once-weekly somapacitan, daily GH, or once-weekly placebo for 34 weeks (main period).
  3. 03HumanRandomized controlled trialSafety outcome

    In adults with GH deficiency, injection-site reactions were similar with somapacitan and daily GH.

    In plain wordsIn adults with GH deficiency, injection-site reactions were similar with somapacitan and daily GH.

    Peptide
    Somapacitan
    Outcome
    No significant changeInjection-site reactions
    Study

    n: not reported in source

    Comparator
    Daily GH
    Outcome group
    Adverse events · Skin and wound
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Somapacitan was well tolerated, with similar adverse events (including injection-site reactions) compared with daily GH.
    3 context sentences
    Summary · context
    Randomized, parallel-group, placebo-controlled (double-blind) and active-controlled (open-label) phase 3 trial, REAL 1 (NCT02229851).
    Summary · context
    Treatment-naïve patients with AGHD (n = 301 main study period, 272 extension period); 257 patients completed the trial.
    Summary · context
    Patients were randomized 2:2:1 to once-weekly somapacitan, daily GH, or once-weekly placebo for 34 weeks (main period).
  4. 04HumanNon-randomized trialEfficacy outcome

    In adults with GH deficiency, somapacitan improved other body composition parameters, including visceral fat and lean body mass, and IGF-I SDS at 34 weeks.

    In plain wordsIn adults with GH deficiency, somapacitan improved other body composition measures and IGF-I scores at 34 weeks.

    Peptide
    Somapacitan
    Outcome
    Direction not reportedOther body composition parameters and IGF-I SDS
    Study

    n: not reported in source

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

    Source sentences

    Summary
    At 34 weeks, somapacitan significantly reduced truncal fat percentage (estimated difference: -1.53% [-2.68; -0.38]; P = 0.0090), demonstrating superiority compared with placebo, and it improved other body composition parameters (including visceral fat and lean body mass) and IGF-I SDS.
    3 context sentences
    Summary · context
    Randomized, parallel-group, placebo-controlled (double-blind) and active-controlled (open-label) phase 3 trial, REAL 1 (NCT02229851).
    Summary · context
    Treatment-naïve patients with AGHD (n = 301 main study period, 272 extension period); 257 patients completed the trial.
    Summary · context
    Patients were randomized 2:2:1 to once-weekly somapacitan, daily GH, or once-weekly placebo for 34 weeks (main period).
  5. 05HumanNon-randomized trialEfficacy outcome

    In adults with GH deficiency, improvements with somapacitan persisted at 86 weeks, as they did with daily GH.

    In plain wordsIn adults with GH deficiency, improvements persisted with somapacitan and daily GH at 86 weeks.

    Peptide
    Somapacitan
    Outcome
    Not applicableMaintenance of improvements at 86 weeks
    Study

    n: not reported in source

    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated

    Source sentences

    Summary
    At 86 weeks, improvements were maintained with both somapacitan and daily GH.
    4 context sentences
    Summary · context
    During the 52-week extension period, patients continued treatment with somapacitan or daily GH.
    Summary · context
    Randomized, parallel-group, placebo-controlled (double-blind) and active-controlled (open-label) phase 3 trial, REAL 1 (NCT02229851).
    Summary · context
    Treatment-naïve patients with AGHD (n = 301 main study period, 272 extension period); 257 patients completed the trial.
    Summary · context
    Patients were randomized 2:2:1 to once-weekly somapacitan, daily GH, or once-weekly placebo for 34 weeks (main period).

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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