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Somapacitan in children with idiopathic short stature: a randomized controlled phase 3 study

M Jennifer Abuzzahab1, Andrew Dauber2, Michael Højby3

  • 1Department of Endocrinology, The McNeely Pediatric Diabetes Center, Children's Minnesota, St. Paul, MN 55102, United States.

European Journal of Endocrinology
|February 19, 2026
PubMed

Insights

Once-weekly somapacitan demonstrated similar efficacy and safety to daily growth hormone (GH) injections in children with idiopathic short stature (ISS). This long-acting GH option offers a potentially reduced treatment burden for pediatric patients.

Area of Science:

  • Pediatric Endocrinology
  • Pharmacology
  • Clinical Trials

Background:

  • Daily growth hormone (GH) injections are standard for idiopathic short stature (ISS), but treatment burden is substantial.
  • Long-acting formulations aim to improve adherence and reduce the impact of daily injections.

Purpose of the Study:

  • To evaluate the efficacy and safety of once-weekly somapacitan compared to daily GH in children with ISS.
  • To assess patient-reported outcomes associated with the new treatment regimen.

Main Methods:

  • A global, Phase 3, randomized, open-label, active-controlled study (REAL8) involving 88 treatment-naive children with ISS.
  • Participants were randomized to receive either once-weekly somapacitan (0.24 mg/kg/week) or daily GH (0.050 mg/kg/day) subcutaneously for 52 weeks.

Main Results:

  • Mean height velocity at 52 weeks was comparable between groups (somapacitan: 10.2 cm/year, daily GH: 10.6 cm/year), confirming non-inferiority.
  • Similar safety profiles were observed, with most adverse events being mild and unrelated to the study product.
  • Patient-reported outcome measures indicated a favorable treatment burden for somapacitan.

Conclusions:

  • Once-weekly somapacitan is a safe and effective alternative to daily GH for children with ISS.
  • The favorable patient-reported outcomes suggest a potentially improved treatment experience.
  • This study supports once-weekly somapacitan as a viable future treatment option for pediatric ISS.
Abstract

Keywords:
growth hormone therapyidiopathic short staturelong-acting growth hormonesomapacitan

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