Sarcopenia
Conditions
Brief summary
This is a randomized, double-blind, placebo-controlled, multicenter phase 2 study of the safety and efficacy of 3-month subcutaneous (SC) REGN1033 (SAR391786) treatment in patients with sarcopenia.
Interventions
DRUGplacebo
Sponsors
Sanofi
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men and women aged 70 years and older (all women participating in the study must be postmenopausal) 2. Are capable, in the investigator's opinion, to complete the study per protocol and have no significant health issues or conditions 3. Ability to follow a walking program 4. Willing and able to comply with clinic visits and study-related procedures 5. Provide signed informed consent 6. Able to understand and complete study-related questionnaires
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 1 month prior to screening, or a planned surgical procedure requiring general anesthesia within the next 6 months 3. Participate in resistance training more than 3 times per week and 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. Respiratory disease that requires oxygen treatment 6. Cancer requiring treatment currently or in the past 3 years (except primary nonmelanoma skin cancer or in situ cervical cancer) 7. Neurological conditions that are causing impaired muscle function or mobility 8. Certain cardiovascular conditions 9. Uncontrolled diabetes The information listed above is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial and not all inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent change in total lean body mass | day 1 to day 85 | The primary endpoint in the study is the percent change in total lean body mass measured by DEXA (dual energy X-ray absorptiometry) from baseline (day 1) to week 12 (day 85). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in appendicular lean mass | day 1 to day 141 | Changes from baseline (day 1) in appendicular lean mass by DEXA |
| Change in maximal leg press strength (1-RM) | day 1 to day 141 | Change from baseline in maximal leg press strength (1-repetition max) |
| Change in maximal chest press strength (1-RM) | day 1 to day 141 | Change from baseline in maximal chest press strength (1-repetition max) |
| Change in 4M gait speed | day 1 to day 141 | Change from baseline in 4-meter (4M) gait speed |
| TEAEs | day 1 to day 141 | TEAEs (Treatment emergent adverse events) from baseline (day 1) to the end of the study (day 141). |
| Change in distance walked in the 6MWT | day 1 to day 141 | Change from baseline in distance walked in the 6MWT (6-Minute Walk Test) |
| Change in regional and total fat mass by DEXA | day 1 to day 141 | Change from baseline in regional and total fat mass by DEXA |
| Change in hand grip strength by handheld dynamometer | day 1 to day 141 | Change from baseline in hand grip strength by handheld dynamometer |
| Change in unloaded and loaded stair climb power | day 1 to day 141 | Change from baseline in unloaded and loaded stair climb power |
| Change in SPPB subscores | day 1 to day 141 | Change from baseline in SPPB (Short Physical Performance Battery) subscores |
Countries
France, Netherlands, Spain, United States
Outcome results
None listed