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Study · Randomized controlled trial · n = 62 · 2020

12 results

MON-265 Once-Weekly Somapacitan in Japanese Adults with GH Deficiency Was Well Tolerated, with Similar Efficacy to Daily GH: A Randomized Trial

Otsuka F, Takahashi Y, Tahara S, Rasmussen M, Ogawa Y, Takano K

Journal of the Endocrine Society8 May 2020

PMCIDPMC7209108 (opens in a new tab)PepBankPUB-97117870
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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 study12

12 results from studies that gave the peptide. 12 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In Japanese adults with GHD, AE rates were similar with somapacitan and daily GH: 312.7 versus 309.8 per 100 patient-years.

    In plain wordsIn Japanese adults with GHD, adverse event rates were similar with somapacitan and daily GH.

    Peptide
    Somapacitan
    Outcome
    No significant changeAdverse event rate
    Study

    n = 62

    Comparator
    Daily GH
    Analysis
    Primary
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Measurements

    Adverse event rate
    312.7 per 100 patient-years
    once-weekly somapacitan arm
    Adverse event rate
    309.8 per 100 patient-years
    daily GH arm

    Source sentences

    Summary
    Rate of AEs per 100 patient-years was similar between treatment arms (309.8 for daily GH, 312.7 for once-weekly somapacitan); most AEs were mild (97.9% and 93.1%, respectively) and none were severe.
    3 context sentences
    Summary · context
    The objective of this trial was to evaluate the safety, efficacy and treatment satisfaction of once-weekly somapacitan compared with daily GH (Norditropin®) over 52 weeks in Japanese patients with adult GH deficiency (AGHD).
    Summary · context
    This was a phase 3, multicenter, randomized, open-label, parallel-group, active-controlled trial (NCT03075644).
    Summary · context
    Patients previously treated with human GH were randomized 1:3 to either daily GH or somapacitan, respectively, to undergo 20 weeks of dose titration and 32 weeks of fixed-dose treatment.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Japanese adults with GHD, VAT did not differ significantly between somapacitan and daily GH (estimated difference -1.74 cm2).

    In plain wordsIn Japanese adults with GHD, visceral fat did not differ significantly between somapacitan and daily GH.

    Peptide
    Somapacitan
    Outcome
    No significant changeVisceral adipose tissue
    Study

    n: not reported in source

    Comparator
    Daily GH
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Measurements

    Estimated treatment difference
    −1.74 cm²
    somapacitan minus daily GH at week 52
    95% confidence interval
    −18.13 to 14.66 cm²
    somapacitan minus daily GH at week 52

    Source sentences

    Summary
    No significant differences in VAT, SAT and TAT were seen in both treatment groups after 52 weeks (estimated difference, somapacitan – daily GH [95% CI]): –1.74 [–18.13; 14.66], –11.53 [–35.54; 12.48], and –12.85 [–47.31; 21.62] cm2, respectively.
    3 context sentences
    Summary · context
    The objective of this trial was to evaluate the safety, efficacy and treatment satisfaction of once-weekly somapacitan compared with daily GH (Norditropin®) over 52 weeks in Japanese patients with adult GH deficiency (AGHD).
    Summary · context
    This was a phase 3, multicenter, randomized, open-label, parallel-group, active-controlled trial (NCT03075644).
    Summary · context
    Patients previously treated with human GH were randomized 1:3 to either daily GH or somapacitan, respectively, to undergo 20 weeks of dose titration and 32 weeks of fixed-dose treatment.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In Japanese adults with GHD, SAT did not differ significantly between somapacitan and daily GH (estimated difference -11.53 cm2).

    In plain wordsIn Japanese adults with GHD, subcutaneous fat did not differ significantly between somapacitan and daily GH.

    Peptide
    Somapacitan
    Outcome
    No significant changeSubcutaneous adipose tissue
    Study

    n: not reported in source

    Comparator
    Daily GH
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Measurements

    Estimated treatment difference
    −11.53 cm²
    somapacitan minus daily GH at week 52
    95% confidence interval
    −35.54 to 12.48 cm²
    somapacitan minus daily GH at week 52

    Source sentences

    Summary
    No significant differences in VAT, SAT and TAT were seen in both treatment groups after 52 weeks (estimated difference, somapacitan – daily GH [95% CI]): –1.74 [–18.13; 14.66], –11.53 [–35.54; 12.48], and –12.85 [–47.31; 21.62] cm2, respectively.
    3 context sentences
    Summary · context
    The objective of this trial was to evaluate the safety, efficacy and treatment satisfaction of once-weekly somapacitan compared with daily GH (Norditropin®) over 52 weeks in Japanese patients with adult GH deficiency (AGHD).
    Summary · context
    This was a phase 3, multicenter, randomized, open-label, parallel-group, active-controlled trial (NCT03075644).
    Summary · context
    Patients previously treated with human GH were randomized 1:3 to either daily GH or somapacitan, respectively, to undergo 20 weeks of dose titration and 32 weeks of fixed-dose treatment.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In Japanese adults with GHD, TAT did not differ significantly between somapacitan and daily GH (estimated difference -12.85 cm2).

    In plain wordsIn Japanese adults with GHD, total fat did not differ significantly between somapacitan and daily GH.

    Peptide
    Somapacitan
    Outcome
    No significant changeTotal adipose tissue
    Study

    n: not reported in source

    Comparator
    Daily GH
    Analysis
    Secondary
    Outcome group
    Body weight · Metabolic and weight
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Measurements

    Estimated treatment difference
    −12.85 cm²
    somapacitan minus daily GH at week 52
    95% confidence interval
    −47.31 to 21.62 cm²
    somapacitan minus daily GH at week 52

    Source sentences

    Summary
    No significant differences in VAT, SAT and TAT were seen in both treatment groups after 52 weeks (estimated difference, somapacitan – daily GH [95% CI]): –1.74 [–18.13; 14.66], –11.53 [–35.54; 12.48], and –12.85 [–47.31; 21.62] cm2, respectively.
    3 context sentences
    Summary · context
    The objective of this trial was to evaluate the safety, efficacy and treatment satisfaction of once-weekly somapacitan compared with daily GH (Norditropin®) over 52 weeks in Japanese patients with adult GH deficiency (AGHD).
    Summary · context
    This was a phase 3, multicenter, randomized, open-label, parallel-group, active-controlled trial (NCT03075644).
    Summary · context
    Patients previously treated with human GH were randomized 1:3 to either daily GH or somapacitan, respectively, to undergo 20 weeks of dose titration and 32 weeks of fixed-dose treatment.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In Japanese adults with GHD, effectiveness scores favored somapacitan over daily GH by 4.87, without statistical significance.

    In plain wordsIn Japanese adults with GHD, effectiveness scores numerically favored somapacitan over daily GH, without statistical significance.

    Peptide
    Somapacitan
    Outcome
    IncreaseTSQM-9 effectiveness
    Study

    n: not reported in source

    Comparator
    Daily GH
    Analysis
    Secondary
    Outcome group
    Patient-reported outcomes · Whole body
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Measurements

    Estimated treatment difference
    4.87 score points
    somapacitan minus daily GH
    95% confidence interval
    −3.46 to 13.2 score points
    somapacitan minus daily GH

    Source sentences

    Summary
    TSQM-9 scores were not significantly different between treatments, but showed a tendency in favor of somapacitan (estimated difference [95% CI]): 4.87 [–3.46; 13.20] for effectiveness, 6.79 [–1.04; 14.61] for convenience, and 6.88 [–1.08; 14.85] for overall satisfaction.
    3 context sentences
    Summary · context
    The objective of this trial was to evaluate the safety, efficacy and treatment satisfaction of once-weekly somapacitan compared with daily GH (Norditropin®) over 52 weeks in Japanese patients with adult GH deficiency (AGHD).
    Summary · context
    This was a phase 3, multicenter, randomized, open-label, parallel-group, active-controlled trial (NCT03075644).
    Summary · context
    Patients previously treated with human GH were randomized 1:3 to either daily GH or somapacitan, respectively, to undergo 20 weeks of dose titration and 32 weeks of fixed-dose treatment.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In Japanese adults with GHD, convenience scores favored somapacitan over daily GH by 6.79, without statistical significance.

    In plain wordsIn Japanese adults with GHD, convenience scores numerically favored somapacitan over daily GH, without statistical significance.

    Peptide
    Somapacitan
    Outcome
    IncreaseTSQM-9 convenience
    Study

    n: not reported in source

    Comparator
    Daily GH
    Analysis
    Secondary
    Outcome group
    Patient-reported outcomes · Whole body
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Measurements

    Estimated treatment difference
    6.79 score points
    somapacitan minus daily GH
    95% confidence interval
    −1.04 to 14.61 score points
    somapacitan minus daily GH

    Source sentences

    Summary
    TSQM-9 scores were not significantly different between treatments, but showed a tendency in favor of somapacitan (estimated difference [95% CI]): 4.87 [–3.46; 13.20] for effectiveness, 6.79 [–1.04; 14.61] for convenience, and 6.88 [–1.08; 14.85] for overall satisfaction.
    3 context sentences
    Summary · context
    The objective of this trial was to evaluate the safety, efficacy and treatment satisfaction of once-weekly somapacitan compared with daily GH (Norditropin®) over 52 weeks in Japanese patients with adult GH deficiency (AGHD).
    Summary · context
    This was a phase 3, multicenter, randomized, open-label, parallel-group, active-controlled trial (NCT03075644).
    Summary · context
    Patients previously treated with human GH were randomized 1:3 to either daily GH or somapacitan, respectively, to undergo 20 weeks of dose titration and 32 weeks of fixed-dose treatment.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In Japanese adults with GHD, overall satisfaction favored somapacitan over daily GH by 6.88, without statistical significance.

    In plain wordsIn Japanese adults with GHD, overall satisfaction numerically favored somapacitan over daily GH, without statistical significance.

    Peptide
    Somapacitan
    Outcome
    IncreaseTSQM-9 overall satisfaction
    Study

    n: not reported in source

    Comparator
    Daily GH
    Analysis
    Secondary
    Outcome group
    Patient-reported outcomes · Whole body
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Measurements

    Estimated treatment difference
    6.88 score points
    somapacitan minus daily GH
    95% confidence interval
    −1.08 to 14.85 score points
    somapacitan minus daily GH

    Source sentences

    Summary
    TSQM-9 scores were not significantly different between treatments, but showed a tendency in favor of somapacitan (estimated difference [95% CI]): 4.87 [–3.46; 13.20] for effectiveness, 6.79 [–1.04; 14.61] for convenience, and 6.88 [–1.08; 14.85] for overall satisfaction.
    3 context sentences
    Summary · context
    The objective of this trial was to evaluate the safety, efficacy and treatment satisfaction of once-weekly somapacitan compared with daily GH (Norditropin®) over 52 weeks in Japanese patients with adult GH deficiency (AGHD).
    Summary · context
    This was a phase 3, multicenter, randomized, open-label, parallel-group, active-controlled trial (NCT03075644).
    Summary · context
    Patients previously treated with human GH were randomized 1:3 to either daily GH or somapacitan, respectively, to undergo 20 weeks of dose titration and 32 weeks of fixed-dose treatment.
  8. 08HumanNon-randomized trialSafety outcome

    In Japanese adults with GHD, no anti-somapacitan antibodies were detected during treatment.

    In plain wordsIn Japanese adults with GHD, no antibodies against somapacitan were detected.

    Peptide
    Somapacitan
    Outcome
    Not applicableAnti-somapacitan antibodies
    Study

    n = 46

    Analysis
    Secondary
    Outcome group
    Adverse events · Immune and inflammation
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    No anti-somapacitan antibodies were detected during treatment.
    3 context sentences
    Summary · context
    The objective of this trial was to evaluate the safety, efficacy and treatment satisfaction of once-weekly somapacitan compared with daily GH (Norditropin®) over 52 weeks in Japanese patients with adult GH deficiency (AGHD).
    Summary · context
    This was a phase 3, multicenter, randomized, open-label, parallel-group, active-controlled trial (NCT03075644).
    Summary · context
    Patients previously treated with human GH were randomized 1:3 to either daily GH or somapacitan, respectively, to undergo 20 weeks of dose titration and 32 weeks of fixed-dose treatment.
  9. 09HumanNon-randomized trialSafety outcome

    In Japanese adults with GHD, four serious AEs occurred with somapacitan, all considered unlikely treatment-related.

    In plain wordsIn Japanese adults with GHD, four serious adverse events with somapacitan were considered unlikely treatment-related.

    Peptide
    Somapacitan
    Outcome
    Not applicableSerious adverse events
    Study

    n = 46

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Measurements

    Serious adverse events
    4 events
    somapacitan arm

    Source sentences

    Summary
    Four AEs in the somapacitan arm were serious; all were considered unlikely related to treatment.
    3 context sentences
    Summary · context
    The objective of this trial was to evaluate the safety, efficacy and treatment satisfaction of once-weekly somapacitan compared with daily GH (Norditropin®) over 52 weeks in Japanese patients with adult GH deficiency (AGHD).
    Summary · context
    This was a phase 3, multicenter, randomized, open-label, parallel-group, active-controlled trial (NCT03075644).
    Summary · context
    Patients previously treated with human GH were randomized 1:3 to either daily GH or somapacitan, respectively, to undergo 20 weeks of dose titration and 32 weeks of fixed-dose treatment.
  10. 10HumanNon-randomized trialSafety outcome

    In Japanese adults with GHD, 93.1% of AEs with somapacitan were mild.

    In plain wordsIn Japanese adults with GHD, most adverse events with somapacitan were mild.

    Peptide
    Somapacitan
    Outcome
    Not applicableMild adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Measurements

    Share of adverse events that were mild
    93.1%
    once-weekly somapacitan arm

    Source sentences

    Summary
    Rate of AEs per 100 patient-years was similar between treatment arms (309.8 for daily GH, 312.7 for once-weekly somapacitan); most AEs were mild (97.9% and 93.1%, respectively) and none were severe.
    3 context sentences
    Summary · context
    The objective of this trial was to evaluate the safety, efficacy and treatment satisfaction of once-weekly somapacitan compared with daily GH (Norditropin®) over 52 weeks in Japanese patients with adult GH deficiency (AGHD).
    Summary · context
    This was a phase 3, multicenter, randomized, open-label, parallel-group, active-controlled trial (NCT03075644).
    Summary · context
    Patients previously treated with human GH were randomized 1:3 to either daily GH or somapacitan, respectively, to undergo 20 weeks of dose titration and 32 weeks of fixed-dose treatment.
  11. 11HumanNon-randomized trialSafety outcome

    In Japanese adults with GHD, no severe AEs occurred with somapacitan or daily GH.

    In plain wordsIn Japanese adults with GHD, no severe adverse events occurred with somapacitan or daily GH.

    Peptide
    Somapacitan
    Outcome
    Not applicableSevere adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Rate of AEs per 100 patient-years was similar between treatment arms (309.8 for daily GH, 312.7 for once-weekly somapacitan); most AEs were mild (97.9% and 93.1%, respectively) and none were severe.
    3 context sentences
    Summary · context
    The objective of this trial was to evaluate the safety, efficacy and treatment satisfaction of once-weekly somapacitan compared with daily GH (Norditropin®) over 52 weeks in Japanese patients with adult GH deficiency (AGHD).
    Summary · context
    This was a phase 3, multicenter, randomized, open-label, parallel-group, active-controlled trial (NCT03075644).
    Summary · context
    Patients previously treated with human GH were randomized 1:3 to either daily GH or somapacitan, respectively, to undergo 20 weeks of dose titration and 32 weeks of fixed-dose treatment.
  12. 12HumanNon-randomized trialEfficacy outcome

    In Japanese adults with GHD, mean IGF-I SDS was maintained from baseline with somapacitan and daily GH.

    In plain wordsIn Japanese adults with GHD, IGF-I scores remained at baseline levels with somapacitan and daily GH.

    Peptide
    Somapacitan
    Outcome
    No significant changeIGF-I SDS maintenance
    Study

    n: not reported in source

    Comparator
    Baseline
    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    Dose not stated · 52 weeksAs given in this study (human).

    Source sentences

    Summary
    Mean insulin-like growth factor-I standard deviation score (IGF-I SDS) at baseline was maintained with both treatments.
    3 context sentences
    Summary · context
    The objective of this trial was to evaluate the safety, efficacy and treatment satisfaction of once-weekly somapacitan compared with daily GH (Norditropin®) over 52 weeks in Japanese patients with adult GH deficiency (AGHD).
    Summary · context
    This was a phase 3, multicenter, randomized, open-label, parallel-group, active-controlled trial (NCT03075644).
    Summary · context
    Patients previously treated with human GH were randomized 1:3 to either daily GH or somapacitan, respectively, to undergo 20 weeks of dose titration and 32 weeks of fixed-dose treatment.

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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