Efficacy and safety of once-weekly somatrogon in adults with growth hormone deficiency: a randomized phase 3 study
Authors' conclusion
Somatrogon significantly improved several body composition parameters and was well tolerated overall in adults with GHD.
Study context
- Population
- Adults with GHD198 received treatment
- Participants
- 202 adults
- Comparison
- Once-weekly somatrogon vs placebo
- Somatrogonn = 133
- Placebon = 65reference
- Primary endpoint
- Change in trunk fat mass (FM)
- Follow-up
- Baseline-Week 26
Methodological detailsphase 3, double-blind, placebo-controlled, randomized 2:1, 26-week open-label extension (OLE) and multi-year OLE
- Phase 3
- Double-blind
- Placebo-controlled
- Randomized 2:1
- 26-week OLE and multi-year OLE
Primary result
As reported in the abstract
Change in trunk FM · baseline to Week 26
Somatrogon
−0.37
kg
Placebo
0.03
kg
P = 0.0821
Secondary outcomes
Total fat mass (FM) · Week 26
- No significant difference between somatrogon and placebo in total FM
Lean body mass (LBM), trunk FM as % of total FM, and 3 post-hoc supplemental endpoints (percent trunk FM relative to total trunk mass, trunk LBM, appendicular skeletal muscle mass)
- Somatrogon significantly improved LBM, trunk FM as % of total FM and the 3 supplemental endpoints
- Supplemental endpoints post-hoc
IGF-I SDS
- Mean IGF-I SDS normalized following somatrogon initiation
Safety
Adverse events (AEs)
- AE incidence similar between groups, most mild to moderate
Original publication
Efficacy and safety of once-weekly somatrogon in adults with growth hormone deficiency: a randomized phase 3 study. Pituitary. Published 25 March 2026. doi:10.
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