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. 2019 Nov 2;105(6):e2121–e2133. doi: 10.1210/clinem/dgz149

Table 2.

Summary of Growth Responses in LAGH Clinical Trials in Children with GHD

Drug Dose (LAGH vs Daily rhGH) Phase of Study Annual Height Velocity on LAGH (cm/y) Annual Height Velocity on daily rhGH (cm/y)
Declage (Eutropin Plus, LB03002) 0.5 mg/kg/wk vs 0.21 mg/kg/wk Phase 3: 12-mo study + 12-mo uncontrolled extension (117) Year 1: 11.63 ± 2.60 Year 1: 11.97 ± 3.09
Year 2: 8.33 ± 1.92
Year 2 (switched to LB3002): 7.28 ± 2.34
Jintrolong 0.2 mg/kg/wk vs 0.25 mg/kg/wk Phase 3: 25-wk study (42) 13.41 ± 3.72 12.55 ± 2.99
TransCon GH (ACP-001) 0.24 mg/kg/wk vs 0.24 mg/kg/wk Phase 3: 52-wk study (118) 11.2 ± 0.23 10.3 ± 0.30
Somapacitan (NNC0195-0092) 0.04 mg/kg/wk vs 0.08 mg/kg/wk vs 0.16 mg/kg/wk vs 0.24 mg/kg/wk of rhGH Phase 2: 6-mo study (57) 0.04 mg/kg/wk: 8.0 ± 2.0 11.4 ± 3.3
0.08 mg/kg/wk: 10.9 ± 1.9
0.16 mg/kg/wk: 12.9 ± 3.5
GX-H9 0.8 mg/kg/wk vs 1.2 mg/kg/wk vs 2.4 mg/kg/wk vs 0.21 mg/kg/wk of rhGH Phase 2: 6-mo results (119) 0.8 mg/kg/wk: 11.50 11.24
1.2 mg/kg/wk: 11.54
2.4 mg/kg/wk: 11.86
Somatrogon (MOD-4023) 0.25 mg/kg/wk vs 0.48 mg/kg/wk vs 0.66 mg/kg/wk vs 0.24 mg/kg/wk of rhGH Phase 2: 12-mo study (71) 0.25 mg/kg/wk: 10.4 ± 2.6 12.5 ± 2.1
Phase 3 study in children using weekly dosing of 0.66 mg/kg/wk (73) 0.48 mg/kg/wk: 11.0 ± 2.3
0.66 mg/kg/wk: 11.9 ± 3.5
Somavaratan (VRS-317) XTEN sequence: naturally occurring hydrophilic amino acids Phase 3 trial discontinued (79) 9.44 10.70

Abbreviations: GHD, GH deficiency; LAGH, long-acting GH; rhGH, recombinant human GH.