Bradley Miller, ESPE 2022: Once-weekly somapacitan versus daily GH in children with GH deficiency: The REAL 4 trial

The REAL 4 trial is a multicenter, randomized, controlled, double-blind phase 3 study (NCT03811535) to evaluate the efficacy, safety, and tolerability of once-weekly somapacitan vs once-daily growth hormone (GH). In this touchENDOCRINOLOGY interview, Prof. Bradley Miller (University of Minnesota, Minneapolis, MN, USA) discusses the aims, design and results of the REAL 4 trial. The next steps in the clinical development of somapacitan is also discussed. 

The abstract entitled: ‘Once-Weekly Somapacitan versus Daily GH in Children with GH Deficiency: The Randomized Phase 3 REAL 4 Trial’ was presented at the European Society for Paediatric Endocrinology, 15-17 Sept, 2022.

Questions:

1. What were the aims, design and inclusion criteria of the REAL 4 trial? (0:16)
2. How did somapacitan compare with GH in terms of efficacy, safety and treatment burden? (1:17)
3. What will be the next step in the clinical development of somapacitan? (2:45)

Disclosures: Bradley Miller is a consultant for Abbvie, Ascendis Pharma, BioMarin, Bristol Myers Squibb, EMD Serono, Endo Pharmaceuticals, Novo Nordisk, Orchard Therapeutics, Pfizer, Tolmar and Vertice and discloses grant/research support from Alexion, Abbvie, Aeterna Zentaris, Amgen, Amicus, Lumos Pharma, Lysogene, Novo Nordisk, OPKO Health Pfizer, Prevail Therapeutics and Sangamo Therapeutics.

Support: Interview supported by Touch Medical Media. Interview conducted by Shanice Allen.

Recorded as a highlight of ESPE 2022