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OpenTrials
Completed

NCT Number: NCT02943239

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

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

Completed

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Key information

Conditions

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Auckland, New Zealand

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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

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)
  • Participants 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 apply.

Treatment and study plan

REGN1033

Drug

REGN1033

REGN2477

Drug

REGN2477

Placebo

Other

Placebo

Primary outcomes

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

    Time frame: Up to 40 weeks

Secondary outcomes

  1. Percent change in thigh muscle volume as measured by MRI

    Time frame: Up to 28 weeks

  2. Change in thigh muscle volume as measured by MRI

    Time frame: Up to 28 weeks

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

    Time frame: Up to 28 weeks

  4. Change in total body composition as measured by DXA

    Time frame: Up to 28 weeks

  5. Change in regional body composition as measured by DXA

    Time frame: Up to 28 weeks

  6. Pharmacokinetic profile of REGN2477 assessed via measurement of concentrations of REGN2477 in serum over time

    Time frame: Up to 40 weeks

  7. Pharmacokinetic profile of REGN1033 assessed via measurement of concentrations of REGN1033 in serum overtime

    Time frame: Up to 40 weeks

  8. Change in total Activin A levels in blood

    Time frame: Up to 40 weeks

  9. Change in total GDF8 levels in blood

    Time frame: Up to 32 weeks

  10. Presence or absence of antibodies against REGN2477 and REGN1033

    Time frame: Up to 40 weeks

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

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 and Healthy Adult Men

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Oct 24, 2016
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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