Dose Range Finding Study of Bimagrumab in Sarcopenia

Novartis

Status and phase: Completed; Phase 2

Conditions: Sarcopenia

Treatments: Drug: bimagrumab; Other: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02333331

CBYM338E2202

Details and patient eligibility

About

The purpose of this study was to determine the efficacy of repeat dosing with multiple dose levels of bimagrumab on patient physical function, skeletal muscle mass and strength in older adults with sarcopenia. In addition, this study generated data on the safety, tolerability, and pharmacokinetics of bimagrumab in older adults with sarcopenia.

Enrollment: 217 patients

Sex: All

Ages: 70+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Low muscle mass as confirmed by DXA;
• Low gait speed <0.8 m/s
• SPPB score less than or equal to 9;
• Weigh at least 35 kg;
• Adequate dietary intake;

Exclusion criteria

• A lower limb fracture in the past 6 months or any impairment or disease severely affecting gait (e.g. stroke with hemiparesis, myasthenia gravis, Parkinson's disease, peripheral polyneuropathy, intermittent claudication in advanced peripheral vascular disease, spinal stenosis, or severe osteoarthritis of the knee or hip with ineffective pain management);
• Requires regular assistance from another person for general activities of daily living (e.g. bathing, dressing, toileting).
• Intraocular surgery and laser procedures for refractive correction within 6 months prior to screening;
• Any underlying muscle disease including active myopathy or muscular dytrophy;
• Confirmed diagnosis of heart failure classified as New York Heart Association Class III or IV (e.g. dilated cardiomyopathy);
• Type I diabetes or uncontrolled Type 2 diabetes;
• Chronic kidney disease [estimated glomerular filtration rate (GFR) < 30 mL/min];
• History of confirmed chronic obstructive pulmonary disease with a severity grade > 2 on the Medical Research Council Dyspnea Scale;
• Confirmed rheumatoid arthritis or other systemic autoimmune disease requiring immunosuppressive therapy or corticosteroids >10 mg/d prednisone equivalent;
• Known history or presence of severe active acute or chronic liver disease (e.g., cirrhosis);
• Myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (e.g. angioplasty or stent placement), or deep vein thrombosis/pulmonary embolism within 12 weeks of screening;
• Active cancer (i.e., under current treatment), or cancer requiring treatment in the last 5 years excluding non-melanoma skin cancers or cancers with excellent prognosis (e.g., early stage prostate or breast cancer, carcinoma in situ of the uterine cervix);
• Any chronic active infection (e.g., HIV, Hepatitis B or C, tuberculosis, etc).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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217 participants in 4 patient groups, including a placebo group

BYM338 70 mg

Experimental group

Description:

BYM338 70 mg intravenous infusion

Treatment:

Drug: bimagrumab

BYM338 210 mg

Experimental group

Description:

BYM338 210 mg intravenous infusion

Treatment:

Drug: bimagrumab

BYM338 700 mg

Experimental group

Description:

BYM338 700 mg intravenous infusion

Treatment:

Drug: bimagrumab

Placebo

Placebo Comparator group

Description:

Placebo intravenous infusion

Treatment:

Other: placebo