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Study · Randomized controlled trial · n = 92 · 2018

6 results

Safety and convenience of once-weekly somapacitan in adult GH deficiency: a 26-week randomized, controlled trial.

Johannsson G, Feldt-Rasmussen U, Håkonsson IH, Biering H, Rodien P, Tahara S, Toogood A, Rasmussen MH

European journal of endocrinology2 Mar 2018Cited by 56 (Europe PMC)

PMID29500310 (opens in a new tab)PMCIDPMC5920019 (opens in a new tab)DOI10.1530/eje-17-1073 (opens in a new tab)PepBankPUB-29500310
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Summary

ObjectiveSomapacitan is a reversible albumin-binding growth hormone (GH) derivative, developed for once-weekly administration. This study aimed to evaluate the safety of once-weekly somapacitan vs once-daily Norditropin®. Local tolerability and treatment satisfaction were also assessed.Design26-week randomized, controlled phase 3 safety and tolerability trial in six countries (Nbib2382939).MethodsMale or female patients aged 18-79 years with adult GH deficiency (AGHD), treated with once-daily GH for ≥6 months, were randomized to once-weekly somapacitan (n = 61) or once-daily Norditropin (n = 31) administered subcutaneously by pen. Both treatments were dose titrated for 8 weeks to achieve insulin-like growth factor I (IGF-I) standard deviation score (SDS) levels within the normal range, and then administered at a fixed dose. Outcome measures were adverse events (AEs), including injection site reactions; occurrence of anti-somapacitan/anti-GH antibodies and change in treatment satisfaction, assessed using the Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9).ResultsMean IGF-I SDS remained between 0 and 2 SDS throughout the trial in both groups. AEs were mostly mild or moderate and transient in nature. The most common AEs were nasopharyngitis, headache and fatigue in both groups. More than 1500 somapacitan injections were administered and no clinically significant injection site reactions were reported. No anti-somapacitan or anti-GH antibodies were detected. The TSQM-9 score for convenience increased significantly more with somapacitan vs Norditropin (P = 0.0171).ConclusionsIn this 26-week trial in patients with AGHD, somapacitan was well tolerated and no safety issues were identified. Once-weekly somapacitan was reported to be more convenient than once-daily Norditropin.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In adults with GHD, convenience scores increased significantly more with somapacitan than Norditropin (P = 0.0171).

    In plain wordsIn adults with GHD, convenience scores improved more with somapacitan than Norditropin.

    Peptide
    Somapacitan
    Outcome
    IncreaseTSQM-9 convenience
    Study

    n = 92

    Comparator
    Norditropin
    Outcome group
    Patient-reported outcomes · Whole body
    Studied dose
    Dose not stated · subcutaneous · 26 weeksAs given in this study (human).

    Measurements

    P value
    0.0171 unitless
    TSQM-9 convenience, somapacitan vs Norditropin

    Source sentences

    Summary
    The TSQM-9 score for convenience increased significantly more with somapacitan vs Norditropin (P = 0.0171).
    2 context sentences
    Summary · context
    26-week randomized, controlled phase 3 safety and tolerability trial in six countries (Nbib2382939).
    Summary · context
    Male or female patients aged 18-79 years with adult GH deficiency (AGHD), treated with once-daily GH for ≥6 months, were randomized to once-weekly somapacitan (n = 61) or once-daily Norditropin (n = 31) administered subcutaneously by pen.
  2. 02HumanNon-randomized trialEfficacy outcome

    In adults with GHD, mean IGF-I SDS remained between 0 and 2 with somapacitan and daily GH throughout the trial.

    In plain wordsIn adults with GHD, mean IGF-I scores remained between 0 and 2 with somapacitan and daily GH.

    Peptide
    Somapacitan
    Outcome
    Not applicableMean IGF-I SDS
    Study

    n = 61

    Outcome group
    Growth hormone and IGF-1 · Endocrine and hormones
    Studied dose
    Dose not stated · subcutaneous · 26 weeksAs given in this study (human).

    Measurements

    Mean IGF-I SDS
    0 to 2 SDS
    throughout the trial, both groups

    Source sentences

    Summary
    Mean IGF-I SDS remained between 0 and 2 SDS throughout the trial in both groups.
    2 context sentences
    Summary · context
    26-week randomized, controlled phase 3 safety and tolerability trial in six countries (Nbib2382939).
    Summary · context
    Male or female patients aged 18-79 years with adult GH deficiency (AGHD), treated with once-daily GH for ≥6 months, were randomized to once-weekly somapacitan (n = 61) or once-daily Norditropin (n = 31) administered subcutaneously by pen.
  3. 03HumanNon-randomized trialSafety outcome

    In adults with GHD, nasopharyngitis, headache and fatigue were the most common adverse events in both somapacitan and daily GH groups.

    In plain wordsIn adults with GHD, nasopharyngitis, headache and fatigue were the most common adverse events with somapacitan and daily GH.

    Peptide
    Somapacitan
    Outcome
    Not applicableCommon adverse event types
    Study

    n = 61

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · subcutaneous · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    The most common AEs were nasopharyngitis, headache and fatigue in both groups.
    2 context sentences
    Summary · context
    26-week randomized, controlled phase 3 safety and tolerability trial in six countries (Nbib2382939).
    Summary · context
    Male or female patients aged 18-79 years with adult GH deficiency (AGHD), treated with once-daily GH for ≥6 months, were randomized to once-weekly somapacitan (n = 61) or once-daily Norditropin (n = 31) administered subcutaneously by pen.
  4. 04HumanNon-randomized trialSafety outcome

    In adults with GHD, no clinically significant injection-site reactions occurred after more than 1500 somapacitan injections.

    In plain wordsIn adults with GHD, no clinically significant injection-site reactions occurred after more than 1500 somapacitan injections.

    Peptide
    Somapacitan
    Outcome
    Not applicableClinically significant injection-site reactions
    Study

    n = 61

    Outcome group
    Adverse events · Skin and wound
    Studied dose
    Dose not stated · subcutaneous · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    More than 1500 somapacitan injections were administered and no clinically significant injection site reactions were reported.
    2 context sentences
    Summary · context
    26-week randomized, controlled phase 3 safety and tolerability trial in six countries (Nbib2382939).
    Summary · context
    Male or female patients aged 18-79 years with adult GH deficiency (AGHD), treated with once-daily GH for ≥6 months, were randomized to once-weekly somapacitan (n = 61) or once-daily Norditropin (n = 31) administered subcutaneously by pen.
  5. 05HumanNon-randomized trialSafety outcome

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

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

    Peptide
    Somapacitan
    Outcome
    Not applicableAnti-somapacitan antibodies
    Study

    n = 61

    Outcome group
    Adverse events · Immune and inflammation
    Studied dose
    Dose not stated · subcutaneous · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    No anti-somapacitan or anti-GH antibodies were detected.
    2 context sentences
    Summary · context
    26-week randomized, controlled phase 3 safety and tolerability trial in six countries (Nbib2382939).
    Summary · context
    Male or female patients aged 18-79 years with adult GH deficiency (AGHD), treated with once-daily GH for ≥6 months, were randomized to once-weekly somapacitan (n = 61) or once-daily Norditropin (n = 31) administered subcutaneously by pen.
  6. 06HumanNon-randomized trialSafety outcome

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

    In plain wordsIn adults with GHD, no antibodies against growth hormone were detected during somapacitan treatment.

    Peptide
    Somapacitan
    Outcome
    Not applicableAnti-GH antibodies
    Study

    n = 61

    Outcome group
    Adverse events · Immune and inflammation
    Studied dose
    Dose not stated · subcutaneous · 26 weeksAs given in this study (human).

    Source sentences

    Summary
    No anti-somapacitan or anti-GH antibodies were detected.
    2 context sentences
    Summary · context
    26-week randomized, controlled phase 3 safety and tolerability trial in six countries (Nbib2382939).
    Summary · context
    Male or female patients aged 18-79 years with adult GH deficiency (AGHD), treated with once-daily GH for ≥6 months, were randomized to once-weekly somapacitan (n = 61) or once-daily Norditropin (n = 31) administered subcutaneously by pen.

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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