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June 7, 2024
TOPLINE:
The once-weekly hormone therapy shows continued efficacy and tolerability for up to 3 years, according to new data from an extended phase 3 trial.
METHODOLOGY:
- REAL4 is a randomized, open-label, multinational, phase 3 trial of once-weekly somapacitan (Novo Nordisk).
- Children with growth hormone deficiency (GHD) were assigned either once-weekly somapacitan (0.16 mg/kg) or once-daily GH (Norditropin® 0.034 mg/kg) for 52 weeks
- After 1 year, the once-daily group was switched to once-weekly somapacitan, and both groups were followed for 2 additional years.
- Primary endpoints were height velocity (HV), HV standard deviation score (SDS), height SDS, and bone age.
TAKEAWAY:
- 125 participants in the somapacitan continued treatment group and 63 participants in the switch group completed 3 years of treatment.
- Growth improvements were similar between the two groups: At year 3, average HV was 7.4 cm/yr in the continued treatment group and 7.8 cm/yr in the switch group.
- Mean body mass index remained in healthy range for both groups, and no safety or tolerability issues were identified.
- No neutralizing antibodies were detected.
IN PRACTICE:
“Once-weekly somapacitan showed sustained efficacy and tolerability for 3 years, as well as for 2 years following the switching from daily GH treatment in this pivotal phase 3 REAL4 trial,” the authors write. “The safety profile of somapacitan was similar to the well-known safety profile of daily GH.”
SOURCE:
The study was funded by Novo Nordisk. The trial findings were presented at ENDO 2024, the annual meeting of the Endocrine Society, by first author Bradley Miller, MD, PhD, of the University of Minnesota in Minneapolis.
LIMITATIONS:
Blinding was not possible for the first part of this study, where participants were given either once weekly GH or daily GH treatment.
DISCLOSURES:
Miller disclosed consulting fees from Abbvie, Ascendis Pharma, BioMarin, Bristol Myers Squibb, EMD Serono, Endo Pharmaceuticals, Novo Nordisk, Orchard Therapeutics, Pfizer, Provention Bio, and Tolmar. He has received grant funding from Alexion, Abbvie, Aeterna Zentaris, Amgen, Amicus, Lumos Pharma, Lysogene, Novo Nordisk, OPKO Health Pfizer, Prevail Therapeutics, Sangamo Therapeutics. The other authors also disclosed several relationships with pharmaceutical companies.
