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Somapacitan, a once-weekly reversible albumin-binding GH derivative, in children with GH deficiency : a randomized dose-escalation trial

(2017) CLINICAL ENDOCRINOLOGY. 87(4). p.350-358
Author
Organization
Abstract
ObjectiveTo evaluate the safety, local tolerability, pharmacodynamics and pharmacokinetics of escalating single doses of once-weekly somapacitan, a reversible, albumin-binding GH derivative, vs once-daily GH in children with GH deficiency (GHD). DesignPhase 1, randomized, open-label, active-controlled, dose-escalation trial (NCT01973244). PatientsThirty-two prepubertal GH-treated children with GHD were sequentially randomized 3:1 within each of four cohorts to a single dose of somapacitan (0.02, 0.04, 0.08 and 0.16mg/kg; n=6 each), or once-daily Norditropin((R)) SimpleXx((R)) (0.03mg/kg; n=2 each) for 7days. MeasurementsPharmacokinetic and pharmacodynamic profiles were assessed. ResultsAdverse events were all mild, and there were no apparent treatment-dependent patterns in type or frequency. Four mild transient injection site reactions were reported in three of 24 children treated with somapacitan. No antisomapacitan/anti-human growth hormone (hGH) antibodies were detected. Mean serum concentrations of somapacitan increased in a dose-dependent but nonlinear manner: maximum concentration ranged from 21.8ng/mL (0.02mg/kg dose) to 458.4ng/mL (0.16mg/kg dose). IGF-I and IGFBP-3, and change from baseline in IGF-I standard deviation score (SDS) and IGFBP-3 SDS, increased dose dependently; greatest changes in SDS values were seen for 0.16mg/kg. IGF-I SDS values were between -2 and +2 SDS, except for peak IGF-I SDS with 0.08mg/kg somapacitan. Postdosing, IGF-I SDS remained above baseline levels for at least 1week. ConclusionsSingle doses of once-weekly somapacitan (0.02-0.16mg/kg) were well tolerated in children with GHD, with IGF-I profiles supporting a once-weekly treatment profile. No clinically significant safety/tolerability signals or immunogenicity concerns were identified.
Keywords
growth hormone, growth hormone deficiency, IGF-I, long-acting growth hormone, ACTING GROWTH-HORMONE, DOUBLE-BLIND, SAFETY, EFFICACY, INSULIN, MULTICENTER, POSSESSES, VRS-317

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Citation

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MLA
Battelino, Tadej, et al. “Somapacitan, a Once-Weekly Reversible Albumin-Binding GH Derivative, in Children with GH Deficiency : A Randomized Dose-Escalation Trial.” CLINICAL ENDOCRINOLOGY, vol. 87, no. 4, 2017, pp. 350–58, doi:10.1111/cen.13409.
APA
Battelino, T., Rasmussen, M. H., De Schepper, J., Zuckerman-Levin, N., Gucev, Z., Sävendahl, L., & the NN8640-4042 Study Group, [missing]. (2017). Somapacitan, a once-weekly reversible albumin-binding GH derivative, in children with GH deficiency : a randomized dose-escalation trial. CLINICAL ENDOCRINOLOGY, 87(4), 350–358. https://doi.org/10.1111/cen.13409
Chicago author-date
Battelino, Tadej, Michael Højby Rasmussen, Jean De Schepper, Nehama Zuckerman-Levin, Zoran Gucev, Lars Sävendahl, and [missing] the NN8640-4042 Study Group. 2017. “Somapacitan, a Once-Weekly Reversible Albumin-Binding GH Derivative, in Children with GH Deficiency : A Randomized Dose-Escalation Trial.” CLINICAL ENDOCRINOLOGY 87 (4): 350–58. https://doi.org/10.1111/cen.13409.
Chicago author-date (all authors)
Battelino, Tadej, Michael Højby Rasmussen, Jean De Schepper, Nehama Zuckerman-Levin, Zoran Gucev, Lars Sävendahl, and [missing] the NN8640-4042 Study Group. 2017. “Somapacitan, a Once-Weekly Reversible Albumin-Binding GH Derivative, in Children with GH Deficiency : A Randomized Dose-Escalation Trial.” CLINICAL ENDOCRINOLOGY 87 (4): 350–358. doi:10.1111/cen.13409.
Vancouver
1.
Battelino T, Rasmussen MH, De Schepper J, Zuckerman-Levin N, Gucev Z, Sävendahl L, et al. Somapacitan, a once-weekly reversible albumin-binding GH derivative, in children with GH deficiency : a randomized dose-escalation trial. CLINICAL ENDOCRINOLOGY. 2017;87(4):350–8.
IEEE
[1]
T. Battelino et al., “Somapacitan, a once-weekly reversible albumin-binding GH derivative, in children with GH deficiency : a randomized dose-escalation trial,” CLINICAL ENDOCRINOLOGY, vol. 87, no. 4, pp. 350–358, 2017.
@article{8714278,
  abstract     = {{ObjectiveTo evaluate the safety, local tolerability, pharmacodynamics and pharmacokinetics of escalating single doses of once-weekly somapacitan, a reversible, albumin-binding GH derivative, vs once-daily GH in children with GH deficiency (GHD).

DesignPhase 1, randomized, open-label, active-controlled, dose-escalation trial (NCT01973244).

PatientsThirty-two prepubertal GH-treated children with GHD were sequentially randomized 3:1 within each of four cohorts to a single dose of somapacitan (0.02, 0.04, 0.08 and 0.16mg/kg; n=6 each), or once-daily Norditropin((R)) SimpleXx((R)) (0.03mg/kg; n=2 each) for 7days.

MeasurementsPharmacokinetic and pharmacodynamic profiles were assessed.

ResultsAdverse events were all mild, and there were no apparent treatment-dependent patterns in type or frequency. Four mild transient injection site reactions were reported in three of 24 children treated with somapacitan. No antisomapacitan/anti-human growth hormone (hGH) antibodies were detected. Mean serum concentrations of somapacitan increased in a dose-dependent but nonlinear manner: maximum concentration ranged from 21.8ng/mL (0.02mg/kg dose) to 458.4ng/mL (0.16mg/kg dose). IGF-I and IGFBP-3, and change from baseline in IGF-I standard deviation score (SDS) and IGFBP-3 SDS, increased dose dependently; greatest changes in SDS values were seen for 0.16mg/kg. IGF-I SDS values were between -2 and +2 SDS, except for peak IGF-I SDS with 0.08mg/kg somapacitan. Postdosing, IGF-I SDS remained above baseline levels for at least 1week.

ConclusionsSingle doses of once-weekly somapacitan (0.02-0.16mg/kg) were well tolerated in children with GHD, with IGF-I profiles supporting a once-weekly treatment profile. No clinically significant safety/tolerability signals or immunogenicity concerns were identified.}},
  author       = {{Battelino, Tadej and Rasmussen, Michael Højby and De Schepper, Jean and Zuckerman-Levin, Nehama and Gucev, Zoran and Sävendahl, Lars and the NN8640-4042 Study Group, [missing]}},
  issn         = {{0300-0664}},
  journal      = {{CLINICAL ENDOCRINOLOGY}},
  keywords     = {{growth hormone,growth hormone deficiency,IGF-I,long-acting growth hormone,ACTING GROWTH-HORMONE,DOUBLE-BLIND,SAFETY,EFFICACY,INSULIN,MULTICENTER,POSSESSES,VRS-317}},
  language     = {{eng}},
  number       = {{4}},
  pages        = {{350--358}},
  title        = {{Somapacitan, a once-weekly reversible albumin-binding GH derivative, in children with GH deficiency : a randomized dose-escalation trial}},
  url          = {{http://doi.org/10.1111/cen.13409}},
  volume       = {{87}},
  year         = {{2017}},
}

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