Somapacitan is Effective and Well Tolerated in Chinese Children with Growth Hormone Deficiency: a Randomised Controlled Phase 3 Study
Authors' conclusion
Efficacy and safety profiles were comparable for Chinese children with GHD treated with somapacitan or daily GH. Both treatments similarly reduced disease burden, while treatment burden was reduced with somapacitan.
Study context
- Population
- Treatment-naïve Chinese children with GH deficiency (GHD)randomized 2:1
- Participants
- 110 children
- Comparison
- Once-weekly somapacitan vs daily growth hormone (GH)
- Primary endpoint
- Annualized height velocity (HV; cm/year)
- Follow-up
- Week 52
Methodological detailsmulti-centre, open-labelled, active-controlled, parallel group, phase 3, non-inferiority
- Multi-centre
- Open-labelled
- Active-controlled
- Parallel group
- Phase 3
- Non-inferiority
Primary result
As reported in the abstract
Estimated mean HV
Further findings
Mean
| Outcome | Somapacitan | Daily GH |
|---|---|---|
| IGF-I SDS · week 52 | +0.5 (SD 1.4) | +0.1 (SD 1.2) |
Changes in HVSDS, HSDS, bone age and IGF-I standard deviation score (SDS) · baseline to week 52
- Similar between groups
IGF-I SDS · week 52
- Within intended reference range (−2.0 to +2.0) and comparable between groups
Disease and treatment burden · baseline to week 52
- Disease burden reduced for both treatments
- Somapacitan reduced treatment burden vs daily GH
Safety
- Injection site reactions with somapacitan
- 2.7%
- Somapacitan well tolerated; safety profile consistent with the well-known safety profile of daily GH
- No reports of injection site pain with somapacitan during the 52-week treatment period
Original publication
Somapacitan is Effective and Well Tolerated in Chinese Children with Growth Hormone Deficiency: a Randomised Controlled Phase 3 Study. Horm Res Paediatr. Published 5 May 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →