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Patient-Centric Design of the Lonapegsomatropin Auto-Injector for Growth Hormone Deficiency: Usability Validation of

Michael Lau1, Paul Erik Fabricius2, Nils Berg Madsen3

  • 1Human Factors Engineering, Insight by Nemera, Chicago, IL, USA.

Medical Devices (Auckland, N.Z.)
|June 8, 2026
PubMed

Insights

The lonapegsomatropin Auto-Injector offers a user-friendly solution for pediatric growth hormone deficiency (pGHD) treatment. This device facilitates successful weekly injections, potentially improving adherence and growth outcomes.

Area of Science:

  • Pediatric Endocrinology
  • Drug Delivery Systems
  • Patient Adherence

Background:

  • Daily human growth hormone (hGH) injections for pediatric growth hormone deficiency (pGHD) present challenges like needle anxiety.
  • These challenges can lead to poor treatment adherence and suboptimal growth outcomes.

Purpose of the Study:

  • To evaluate the usability of the lonapegsomatropin (TransCon hGH) Auto-Injector for once-weekly treatment of pGHD.
  • To assess the device's potential to minimize injection challenges and improve patient adherence.

Main Methods:

  • A usability validation study was conducted under simulated-use conditions.
  • Participants included pediatric patients with pGHD, caregivers, and healthcare providers (HCPs).
  • Simulated injections were performed by both naive and experienced individuals, with some receiving training.

Main Results:

  • All participants (135 total) successfully completed simulated injections.
  • 98% of participants felt confident using the device as intended, with or without supervision.
  • Observed use deviations were low across all participant groups (patients, caregivers, HCPs).

Conclusions:

  • The lonapegsomatropin Auto-Injector features a user-centric design for successful and confident administration.
  • The device has the potential to overcome barriers associated with growth hormone injections.
  • Improved adherence facilitated by the Auto-Injector may lead to better treatment outcomes for pGHD.
Abstract

Keywords:
auto-injectorhuman factors engineeringhuman factors validationlonapegsomatropinonce-weekly growth hormone therapypediatric growth hormone deficiency

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