Study of Safety, Tolerability, and Pharmacokinetics of REGN2477 Alone and in Combination With REGN1033 in Healthy Postmenopausal Women and Healthy Adult Men

NCT02943239 | Completed Phase 1

• 2 other identifiers: R2477-1033-HV-16212016-002979-95
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Incidence and severity of treatment-emergent adverse events (TEAEs)

  Up to 40 weeks

Secondary Outcomes (10)

• Percent change in thigh muscle volume as measured by MRI

  Up to 28 weeks

• Change in thigh muscle volume as measured by MRI

  Up to 28 weeks

• Percent change in total and regional body composition as measured by Dual X-ray absorptiometry (DXA)

  Up to 28 weeks

• Change in total body composition as measured by DXA

  Up to 28 weeks

• Change in regional body composition as measured by DXA

  Up to 28 weeks

Study Arms (7)

Panel A

EXPERIMENTAL

REGN1033 + REGN2477 (Regimen 1) or placebo

Drug: REGN1033; Drug: REGN2477; Other: Placebo

Panel B

EXPERIMENTAL

Panel B - REGN1033 + REGN2477 (Regimen 2) or Placebo

Drug: REGN1033; Drug: REGN2477; Other: Placebo

Panel C

EXPERIMENTAL

Panel C - Patients will receive either REGN1033 + REGN2477 (Regimen 3) or Placebo

Drug: REGN1033; Drug: REGN2477; Other: Placebo

Panel D

EXPERIMENTAL

Panel D - Patients will receive either REGN1033 + REGN2477 (Regimen 4), REGN1033, REGN2477 (high dose) or Placebo

Drug: REGN1033; Drug: REGN2477; Other: Placebo

Panel E

EXPERIMENTAL

REGN2477 (Regimen 5) or placebo

Drug: REGN2477; Other: Placebo

Panel F

EXPERIMENTAL

REGN2477 + REGN1033 (Regimen 6) or placebo

Drug: REGN1033; Drug: REGN2477; Other: Placebo

Panel G

EXPERIMENTAL

REGN2477 (Regimen 7) or placebo

Drug: REGN2477; Other: Placebo

Interventions

REGN1033 DRUG

REGN1033

Panel A; Panel B; Panel C; Panel D; Panel F

REGN2477 DRUG

REGN2477

Panel A; Panel B; Panel C; Panel D; Panel E; Panel F; Panel G

Placebo OTHER

Placebo

Panel A; Panel B; Panel C; Panel D; Panel E; Panel F; Panel G

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal women age 45 to 70 years and age 35 to 60 years inclusive for men not intending to father children
• BMI between 18 to 32 kg/m2, inclusive
• Willing and able to maintain current diet, supplements and physical activity level throughout the study
• Provides signed informed consent

You may not qualify if:

• Significant illness or history of significant illness
• Contraindication to MRI
• History of human immunodeficiency virus (HIV); hepatitis B or hepatitis C virus (HCV)
• History of immobilization, major surgical procedure, fracture, or major trauma within 9 months prior to screening
• History of significant gynecological disorders or malignancies; history of breast malignancies (uterine fibroids or dysfunctional uterine bleeding is acceptable)
• Inconsistent vigorous physical activity (on fewer than 5 days per week), such as intermittent weight lifting
• History of hypersensitivity reactions to tetracycline antibiotics (includes doxycycline), vaccines, or biologics
• Use of agents that alter muscle mass that have not been at a stable dose for 3 months prior to screening (includes protein supplements), or use of any weight altering or anabolic steroid drugs (includes drugs for obesity, diuretics, testosterone)
• Participants treated with a biologic therapy or biologic immunotherapy in the previous 12 weeks prior to screening and during the study

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (2)

Unknown Facility

Auckland, New Zealand

Location

Unknown Facility

Christchurch, New Zealand

Location

Related Publications (1)

• Gonzalez Trotter D, Donahue S, Wynne C, Ali S, Parasoglou P, Boyapati A, Mohammadi K, Musser BJ, Meier P, Mastaitis J, Sleeman MW, Glass DJ, Gasparino E, Trejos J, Davis JD, Hirshberg B, Pordy R, Yancopoulos GD, Herman GA. GDF8 and activin A are the key negative regulators of muscle mass in postmenopausal females: a randomized phase I trial. Nat Commun. 2025 May 13;16(1):4376. doi: 10.1038/s41467-025-59380-3.

  PMID: 40360471 DERIVED

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: October 24, 2016
• Study Start: December 8, 2016
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

NZ (2)