A STUDY OF THE SAFETY AND EFFICACY OF REGN1033

• Conditions: Sarcopenia; MedDRA version: 14.1Level: PTClassification code 10063024Term: SarcopeniaSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2013-003134-33-ES
• Lead Sponsor: Regeneron Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-27
• Last Update Posted: 9 March 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

1. Men and women aged 70 years and older
2. Are capable, in the investigator's opinion, to complete the study per protocol and have no significant health issues or conditions (including but not limited to severe arthritis of the major lower extremity joints and symptom-limited ambulation) that would impact the capability to get an accurate measurement of study endpoints
3. Appendicular lean mass relative to height squared: ?7.23 kg/m² (men); ?5.67 kg/m² (women)
4. 4M gait speed <1.0 m/s
5. BMI between 18.5 kg/m² and 37 kg/m², inclusive
6. Ability to follow the First Step to Active Health program
7. Willing and able to comply with clinic visits and study-related procedures
8. Provide signed informed consent
9. Able to understand and complete study-related questionnaires
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 240

Exclusion Criteria

1. Hospitalization or immobilization with a duration of >48 hours within the month prior to screening
2. Surgical procedure requiring general anesthesia within 2 months prior to screening, or a planned surgical procedure requiring general anesthesia within the next 6 months
3. Participate in resistance training more than 2 times per week or regular exercise consisting of an average of 30 minutes per day or more of at least moderate physical activity
4. Chronic medications introduced within 2 weeks prior to screening
5. Weight loss of >10% body weight within 6 months prior to screening
6. Respiratory disease (eg, severe chronic obstructive pulmonary disease) that requires oxygen treatment
7. Cancer requiring treatment currently or in the past 3 years (except primary nonmelanoma skin cancer or in situ cervical cancer)
8. Neurological conditions that are causing impaired muscle function or mobility (may include stroke with residual paresis, paralysis, neuropathy, Parkinson disease, or multiple sclerosis)
9. Mini Mental State Exam score of <24
10. Active Major Depressive Disorder per Diagnostic and Statistical Manual-V criteria within 3 months prior to screening
11. Cardiovascular conditions such as New York Heart Association class III or IV heart failure, cardiomyopathy, intermittent claudication, myocardial infarction, or acute coronary syndrome within 6 months prior to screening; symptomatic ventricular cardiac arrhythmia (note: sinus dysrhythmia, asymptomatic block or well controlled atrial fibrillation with normal resting ventricular rate are not exclusion criteria)
12. Abnormal echocardiogram findings at screening that are clinically significant, which may include but are not limited to:
- Cardiomyopathy
- Left ventricular ejection fraction <50%
- Moderate or severe diastolic dysfunction, grade II/III
- Aortic stenosis
- Valvular disease with hemodynamic significance
- Left ventricular wall thickness ?1.4 cm (men) and ?1.3 cm (women)
13. Uncontrolled diabetes defined as hemoglobin A1C (HbA1C) >10% at screening
14. Diastolic blood pressure >100 mm Hg or systolic blood pressure >180 mm Hg (average of 2 readings)
15. Alanine aminotransferase (ALT) >3x the upper limit of normal (1 retest allowed)
16. Reduced renal function defined as estimated glomerular filtration rate <30 mL/min/1.73 m² (1 retest allowed)
17. Creatine phosphokinase >5 x the upper limit of normal (1 repeat lab is allowed)
18. Use of any prescription or over-the-counter agents known to influence muscle mass or performance within 1 year prior to screening. These may include but are not limited to
anabolic steroids, insulin-like growth factor-1 (IGF-1), growth hormone (GH), replacement androgen therapy, and anti-androgen therapy.
19. Participation in any clinical trial of small molecule drugs within 30 days prior to screening or biologics within 3 months prior to screening
20. Participation within 6 months prior to screening in clinical trials of interventions that are intended to influence muscle mass or performance
21. History of human immunodeficiency virus infection
22. Positive test for hepatitis B surface antigen and/or hepatitis C antibody at the screening visit
23. Pregnant or breastfeeding women
24. Sexually active men* or women of childbearing potential** who are unwilling to practice adequate contraception during the study (adequate contraceptive measures include stable use of oral contraceptives or other prescription pharmaceutical contraceptives for 2 or more

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified