The primary objective is to assess the safety and tolerability of REGN2477 alone and combined with REGN1033. The secondary objectives are to: * Assess the effect of REGN2477 alone, REGN1033 alone, and REGN2477 + REGN1033 in combination on thigh muscle volume * Assess the effects of REGN2477 alone, REGN1033 alone, and REGN2477 + REGN1033 in combination on total and regional body composition * Evaluate the Pharmacokinetic (PK) profile of REGN2477 and REGN1033 * Assess immunogenicity of REGN2477 or REGN1033 * Assess REGN2477 or REGN1033 target engagement
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Enrollment
82
REGN1033
REGN2477
Placebo
Unnamed facility
Auckland, New Zealand
Unnamed facility
Christchurch, New Zealand
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: Up to 40 weeks
Percent change in thigh muscle volume as measured by MRI
Time frame: Up to 28 weeks
Change in thigh muscle volume as measured by MRI
Time frame: Up to 28 weeks
Percent change in total and regional body composition as measured by Dual X-ray absorptiometry (DXA)
Time frame: Up to 28 weeks
Change in total body composition as measured by DXA
Time frame: Up to 28 weeks
Change in regional body composition as measured by DXA
Time frame: Up to 28 weeks
Pharmacokinetic profile of REGN2477 assessed via measurement of concentrations of REGN2477 in serum over time
Time frame: Up to 40 weeks
Pharmacokinetic profile of REGN1033 assessed via measurement of concentrations of REGN1033 in serum overtime
Time frame: Up to 40 weeks
Change in total Activin A levels in blood
Time frame: Up to 40 weeks
Change in total GDF8 levels in blood
Time frame: Up to 32 weeks
Presence or absence of antibodies against REGN2477 and REGN1033
Time frame: Up to 40 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.