Sarcopenia MedDRA version: 14.1 Level: PT Classification code 10063024 Term: Sarcopenia System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Product Name: REGN1033
Product Code: REGN1033
Pharmaceutical Form: Lyophilisate for solution for injection
INN or Proposed INN: Not available
Current Sponsor code: REGN1033
Concentration unit: mg/ml m
Sponsors
Regeneron Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range 240
Exclusion criteria
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 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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the effect of multiple doses of REGN1033 administered SC for 12 weeks on total lean body mass measured by DEXA in patients with sarcopenia.;Secondary Objective: - To assess the safety and tolerability of REGN1033 administered SC for 12 weeks in patients with sarcopenia - To assess the effects of REGN1033 administered SC for 12 weeks on measures of strength and function;Primary end point(s): The primary endpoint in the study is the percent change in total lean body mass.;Timepoint(s) of evaluation of this end point: Week 12. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are: TEAEs from baseline to the end of the study Changes from baseline in: - Appendicular lean mass by DEXA - Maximal leg press strength (1-RM) - Maximal chest press strength (1-RM) - 4M gait speed - SPPB and SPPB subscores - Distance walked in the 6MWT - Regional and total fat mass by DEXA - Hand grip strength by handheld dynamometer;Timepoint(s) of evaluation of this end point: The secondary endpoints will be evaluated from the timepoint of baseline estimation to the end of the study. | — |
Countries
France, Germany, Netherlands, Spain, United States
Contacts
Public ContactClin Dev & Regulatory Affairs
Regeneron Pharmaceuticals, Inc.
Outcome results
None listed