Study of the Safety and Efficacy of REGN1033 (SAR391786) in Patients With Sarcopenia

Sarcopenia Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Multi-center Study of the Safety and Efficacy of 3-month Subcutaneous REGN1033 Treatment in Patients With Sarcopenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01963598
• Other study ID #: R1033-SRC-1239
• Status: Completed
• Phase: Phase 2
• First received: October 11, 2013
• Last updated: March 31, 2015
• Start date: November 2013
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Regeneron Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationFrance: Ministry of HealthNetherlands: Medicines Evaluation Board (MEB)Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: February 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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/ exclusion criteria are listed.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sarcopenia

Intervention

Drug:
• REGN1033 (SAR391786)

• placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Regeneron Pharmaceuticals	Sanofi

Countries where clinical trial is conducted

United States,  France,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change in total lean body mass	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).	day 1 to day 85	No
Secondary	TEAEs	TEAEs (Treatment emergent adverse events) from baseline (day 1) to the end of the study (day 141).	day 1 to day 141	Yes
Secondary	Change in appendicular lean mass	Changes from baseline (day 1) in appendicular lean mass by DEXA	day 1 to day 141	No
Secondary	Change in maximal leg press strength (1-RM)	Change from baseline in maximal leg press strength (1-repetition max)	day 1 to day 141	No
Secondary	Change in maximal chest press strength (1-RM)	Change from baseline in maximal chest press strength (1-repetition max)	day 1 to day 141	No
Secondary	Change in 4M gait speed	Change from baseline in 4-meter (4M) gait speed	day 1 to day 141	No
Secondary	Change in SPPB subscores	Change from baseline in SPPB (Short Physical Performance Battery) subscores	day 1 to day 141	No
Secondary	Change in distance walked in the 6MWT	Change from baseline in distance walked in the 6MWT (6-Minute Walk Test)	day 1 to day 141	No
Secondary	Change in regional and total fat mass by DEXA	Change from baseline in regional and total fat mass by DEXA	day 1 to day 141	No
Secondary	Change in hand grip strength by handheld dynamometer	Change from baseline in hand grip strength by handheld dynamometer	day 1 to day 141	No
Secondary	Change in unloaded and loaded stair climb power	Change from baseline in unloaded and loaded stair climb power	day 1 to day 141	No