Similar safety and efficacy in previously treated adults with growth hormone deficiency randomized to once-weekly somapacitan or daily growth hormone.

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

Clinical endocrinology14 Aug 2020Cited by 34 (Europe PMC)

PMID32603494PMCIDPMC7689735DOI10.1111/cen.14273PepBankPUB-32603494

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Summary

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Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialSafety outcome
In Japanese adults with GH deficiency, AE rates were similar with somapacitan and daily GH: 312.7 versus 309.8 per 100 patient-years.
In plain wordsIn Japanese adults with GH deficiency, 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
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 arms (somapacitan, 312.7; daily GH, 309.8).
2 context sentences(design, population, supporting numbers)
Summary · context
Phase 3, multicentre, randomized, parallel-group, open-label, active-controlled trial (NCT03075644).
Summary · context
Previously GH-treated Japanese patients with AGHD were randomized 3:1 to somapacitan (n = 46) or daily GH (n = 16) for 20 weeks' dose titration and 32 weeks' fixed-dose treatment.
Report a problemFND-3260349402
02HumanRandomized controlled trialEfficacy outcome
In Japanese adults with GH deficiency, the VAT difference for somapacitan versus daily GH was -1.74 cm², without statistical significance.
In plain wordsIn Japanese adults with GH deficiency, visceral fat was numerically lower with somapacitan than daily GH, without statistical significance.
Peptide
Somapacitan
Outcome
DecreaseVisceral 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 were observed between arms for change from baseline to week 52 in VAT, SAT or TAT (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).
2 context sentences(design, population, supporting numbers)
Summary · context
Phase 3, multicentre, randomized, parallel-group, open-label, active-controlled trial (NCT03075644).
Summary · context
Previously GH-treated Japanese patients with AGHD were randomized 3:1 to somapacitan (n = 46) or daily GH (n = 16) for 20 weeks' dose titration and 32 weeks' fixed-dose treatment.
Report a problemFND-3260349405
03HumanRandomized controlled trialEfficacy outcome
In Japanese adults with GH deficiency, the SAT difference for somapacitan versus daily GH was -11.53 cm², without statistical significance.
In plain wordsIn Japanese adults with GH deficiency, subcutaneous fat was numerically lower with somapacitan than daily GH, without statistical significance.
Peptide
Somapacitan
Outcome
DecreaseSubcutaneous 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 were observed between arms for change from baseline to week 52 in VAT, SAT or TAT (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).
2 context sentences(design, population, supporting numbers)
Summary · context
Phase 3, multicentre, randomized, parallel-group, open-label, active-controlled trial (NCT03075644).
Summary · context
Previously GH-treated Japanese patients with AGHD were randomized 3:1 to somapacitan (n = 46) or daily GH (n = 16) for 20 weeks' dose titration and 32 weeks' fixed-dose treatment.
Report a problemFND-3260349406
04HumanRandomized controlled trialEfficacy outcome
In Japanese adults with GH deficiency, the TAT difference for somapacitan versus daily GH was -12.85 cm², without statistical significance.
In plain wordsIn Japanese adults with GH deficiency, total fat was numerically lower with somapacitan than daily GH, without statistical significance.
Peptide
Somapacitan
Outcome
DecreaseTotal 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 were observed between arms for change from baseline to week 52 in VAT, SAT or TAT (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).
2 context sentences(design, population, supporting numbers)
Summary · context
Phase 3, multicentre, randomized, parallel-group, open-label, active-controlled trial (NCT03075644).
Summary · context
Previously GH-treated Japanese patients with AGHD were randomized 3:1 to somapacitan (n = 46) or daily GH (n = 16) for 20 weeks' dose titration and 32 weeks' fixed-dose treatment.
Report a problemFND-3260349407
05HumanNon-randomized trialOther
In Japanese adults with GH deficiency, mean prescribed somapacitan dose after titration was 1.780 mg/week (SD 1.058).
In plain wordsIn Japanese adults with GH deficiency, the mean somapacitan dose after titration was 1.780 mg/week.
Peptide
Somapacitan
Outcome
Not applicablePrescribed dose after titration
Study
n = 46
Outcome group
Drug Dosing · Pharmacology
Studied dose
mean 1.780 mg/week after titration (SD 1.058) · 52 weeksAs given in this study (human).
Measurements
Mean prescribed somapacitan dose after titration
1.78 mg/week
somapacitan arm
Standard deviation of prescribed dose
1.058 mg/week
somapacitan arm
Source sentences
Summary
Mean (SD) prescribed doses after titration were 1.780 (1.058) mg/week for somapacitan and 0.197 (0.083) mg/day for daily GH.
2 context sentences(design, population, supporting numbers)
Summary · context
Phase 3, multicentre, randomized, parallel-group, open-label, active-controlled trial (NCT03075644).
Summary · context
Previously GH-treated Japanese patients with AGHD were randomized 3:1 to somapacitan (n = 46) or daily GH (n = 16) for 20 weeks' dose titration and 32 weeks' fixed-dose treatment.
Report a problemFND-3260349401
06HumanNon-randomized trialSafety outcome
In Japanese adults with GH deficiency, four serious AEs occurred with somapacitan, none considered treatment-related.
In plain wordsIn Japanese adults with GH deficiency, somapacitan recipients had four serious adverse events, none considered 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; none were considered treatment-related.
2 context sentences(design, population, supporting numbers)
Summary · context
Phase 3, multicentre, randomized, parallel-group, open-label, active-controlled trial (NCT03075644).
Summary · context
Previously GH-treated Japanese patients with AGHD were randomized 3:1 to somapacitan (n = 46) or daily GH (n = 16) for 20 weeks' dose titration and 32 weeks' fixed-dose treatment.
Report a problemFND-3260349403
07HumanNon-randomized trialEfficacy outcome
In Japanese adults with GH deficiency, mean IGF-I SDS remained at baseline levels with somapacitan and daily GH.
In plain wordsIn Japanese adults with GH deficiency, mean 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) was maintained from baseline in both arms.
2 context sentences(design, population, supporting numbers)
Summary · context
Phase 3, multicentre, randomized, parallel-group, open-label, active-controlled trial (NCT03075644).
Summary · context
Previously GH-treated Japanese patients with AGHD were randomized 3:1 to somapacitan (n = 46) or daily GH (n = 16) for 20 weeks' dose titration and 32 weeks' fixed-dose treatment.
Report a problemFND-3260349404

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 postedNCT03075644

A Trial to Evaluate the Safety of Once Weekly Dosing of Somapacitan (NNC0195-0092) and Daily Norditropin® FlexPro® for 52 Weeks in Previously Human Growth Hormone Treated Japanese Adults With Growth Hormone Deficiency

Novo Nordisk A/Sn = 623 Mar 2017 to 4 Oct 2018

Growth Hormone Disorder · Adult Growth Hormone Deficiency

Trial page ClinicalTrials.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.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
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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