Eligibility

Ages Eligible for Study

65 years and up

Genders Eligible for Study

Both

Keywords

Sponsors

Industry

Novartis Pharmaceuticals

Inclusion Criteria

1. Men or women aged 65 or older with difficulty standing up from a chair or walking for
longer than 10 minutes on a flat surface or climbing a flight of stairs.

2. Written informed consent must be obtained before any laboratory or physical
assessment is performed to establish eligibility. Answering initial questions for
qualification, whether in person or over the phone does not require written consent.

3. At the onsite screening, candidates should have gait speed measured over 4 meters of
20mmHg

- diastolic blood pressure, 50-90 mm Hg and a reduction of >10mmHg

- pulse rate, 50 - 100 bpm

6. Patients must weigh at least 35 kg to participate in the study, and must have a body
mass index (BMI) within the range of 18 - 32 kg/m2, inclusive. (See Appendix 4) of
this protocol for BMI ranges.

7. Be able to communicate well with the investigator, to understand and comply with the
requirements of the study.

Exclusion Criteria

1. Use of other investigational drugs at the time of enrollment, or within 30 days or 5
halflives of enrollment, whichever is longer; or longer if required by local
regulations, and for any other limitation of participation in an investigational
trial based on local regulations.

2. History of hypersensitivity to antibodies.

3. A history of clinically significant ECG abnormalities, which, in the opinion of the
investigator, may indicate active cardiac disease.

4. History of malignancy of any organ system (other than localized nonmelanomatous cell
carcinoma of the skin), treated or untreated, within the past 5 years, regardless of
whether there is evidence of local recurrence or metastases.

5. Diseases other than cancer known to cause cachexia or muscle atrophy, including but
not limited to congestive heart failure of any stage, COPD, chronic kidney disease
(estimated GFR < 30 mL/min using the MDRD equation), rheumatoid arthritis, primary
myopathy, stroke, HIV infection, tuberculosis or other chronic infection,
uncontrolled diabetes mellitus.

6. Diseases known to cause malabsorption of protein or energy, including inflammatory
bowel disease, celiac disease, short bowel syndrome, pancreatic insufficiency, etc.

7. Liver disease or liver injury as indicated by abnormal liver function tests such as
SGOT (AST), SGPT (ALT), γ-GT, alkaline phosphatase, or serum bilirubin (except
Gilbert's

Disease). The Investigator should be guided by the following criteria:

- Any single transaminase listed above may not exceed 3x upper limit of normal (ULN).

- If the total bilirubin concentration is increased above 1.5 x ULN, total bilirubin
should be differentiated into the direct and indirect reacting bilirubin. In any
case, serum bilirubin should not exceed the value of 1.6 mg/dL (27 μmol/L). 8. Use of
any prescription drugs known to affect muscle mass, including androgen supplements,
anti-androgens (such as LHRH agonists), anti-estrogens (tamoxifen, etc.) recombinant
human growth hormone (rhGH), insulin, oral beta agonists, megestrol acetate,
dronabinol, etc. 9. Donation or loss of 400 mL or more of blood within eight (8)
weeks prior to initial dosing, or longer if required by local regulation. 10. Plasma
donation (> 250 mL) within 14 days prior to first dosing. 11. Hemoglobin
concentration below 11.0 g/dL at screening. 12. Significant illness within two (2)
weeks prior to initial dosing. 13. Patients with known claustrophobia, presence of
pacemaker and/or ferromagnetic material in their body that would prohibit
administration of MRI assessments. 14. Patient smokes more than one cigarette, pipe
or cigar a month

Detailed Description

The purpose of this Proof of Concept study is to determine the effects of BYM338 on skeletal muscle volume, mass, and strength and patient function (gait speed) in non-demented elderly adults with sarcopenia and mobility limitations. In addition, this study will generate data on the safety, tolerability, and pharmacokinetics of BYM338 in older adults and its response on additional physical function measures in this population. Furthermore, the extended study duration will provide information on the stability of BYM-induced changes in skeletal muscle and patient function in this subgroup of the older population.