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

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ClinicalTrials.gov Identifier: NCT02943239
Recruitment Status : Active, not recruiting
First Posted : October 24, 2016
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

October 19, 2016
October 24, 2016
July 2, 2018
December 7, 2016
March 28, 2019   (Final data collection date for primary outcome measure)
Incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: Up to 40 weeks ]
Incidence and severity of treatment-emergent adverse events (TEAEs) [ Time Frame: From baseline to week 16 ]
Incidence and severity of treatment-emergent adverse events (TEAEs)
Complete list of historical versions of study NCT02943239 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Percent change in thigh muscle volume as measured by MRI [ Time Frame: From baseline to week 8 ]
    Percent change in thigh muscle volume as measured by MRI
  • Change in thigh muscle volume as measured by MRI [ Time Frame: From baseline to week 8 ]
    Change in thigh muscle volume as measured by MRI
  • Percent change in total and regional body composition as measured by DXA [ Time Frame: From baseline to week 8 ]
    Percent change in total and regional body composition as measured by DXA
  • Change in total body composition as measured by DXA [ Time Frame: From baseline to week 8 ]
    Change in total body composition as measured by DXA
  • Change in regional body composition as measured by DXA [ Time Frame: From baseline to week 8 ]
    Change in regional body composition as measured by DXA
  • Pharmacokinetic profile of REGN2477 assessed via measurement of concentrations of REGN2477 in serum over time [ Time Frame: From baseline to week 16 ]
    Pharmacokinetic profile of REGN2477
  • Pharmacokinetic profile of REGN1033 assessed via measurement of concentrations of REGN1033 in serum overtime [ Time Frame: From baseline to week 16 ]
    Pharmacokinetic profile of REGN1033
  • Change in total Activin A levels in blood [ Time Frame: From baseline to week 16 ]
    Change in total Activin A levels in blood
  • Change in total GDF8 levels in blood [ Time Frame: From baseline to week 16 ]
    Change in total GDF8 levels in blood
  • Presence or absence of antibodies against REGN2477 and REGN1033 [ Time Frame: From baseline to week 16 ]
    Presence or absence of antibodies against REGN2477 and REGN1033
Not Provided
Not Provided
 
Study of Safety, Tolerability, and Pharmacokinetics of REGN2477 Alone and in Combination With REGN1033 in Healthy Postmenopausal Women
A Randomized, Double-Blind, Placebo-Controlled, Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacodynamic Effects of REGN2477 Alone and in Combination With REGN1033 in Healthy Postmenopausal Women

The primary objective is to assess the safety and tolerability of REGN2477 alone and combined with REGN1033 in health postmenopausal women.

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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Healthy Volunteers
  • Drug: REGN1033
    REGN1033
  • Drug: REGN2477
    REGN2477
  • Other: Placebo
    Placebo
  • Experimental: Panel A
    REGN1033 + REGN2477 (Regimen 1) or placebo
    Interventions:
    • Drug: REGN1033
    • Drug: REGN2477
    • Other: Placebo
  • Experimental: Panel B
    Panel B - REGN1033 + REGN2477 (Regimen 2) or Placebo
    Interventions:
    • Drug: REGN1033
    • Drug: REGN2477
    • Other: Placebo
  • Experimental: Panel C
    Panel C - Patients will receive either REGN1033 + REGN2477 (Regimen 3) or Placebo
    Interventions:
    • Drug: REGN1033
    • Drug: REGN2477
    • Other: Placebo
  • Experimental: Panel D
    Panel D - Patients will receive either REGN1033 + REGN2477 (Regimen 4), REGN1033, REGN2477 (high dose) or Placebo
    Interventions:
    • Drug: REGN1033
    • Drug: REGN2477
    • Other: Placebo
  • Experimental: Panel E
    REGN2477 (Regimen 5) or placebo
    Interventions:
    • Drug: REGN2477
    • Other: Placebo
  • Experimental: Panel F
    REGN2477 + REGN1033 (Regimen 6) or placebo
    Interventions:
    • Drug: REGN1033
    • Drug: REGN2477
    • Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
48
Same as current
March 28, 2019
March 28, 2019   (Final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Postmenopausal women age 45 to 70 years
  • 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

Key Exclusion Criteria:

  • 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)
  • Patients treated with a biologic therapy or biologic immunotherapy in the previous 12 weeks prior to screening and during the study

Note: Other protocol Inclusion/Exclusion criteria may apply.

Sexes Eligible for Study: Female
45 Years to 70 Years   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
New Zealand
 
 
NCT02943239
R2477-1033-HV-1621
2016-002979-95 ( EudraCT Number )
No
Not Provided
Not Provided
Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
Not Provided
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
Regeneron Pharmaceuticals
June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP