AMG 745 in Subjects With Age-associated Muscle Loss

Amgen

Status and phase: Withdrawn; Phase 2

Conditions: Age-associated Muscle Loss

Treatments: Drug: Placebo; Drug: AMG 745 0.3 mg/kg; Drug: AMG 745 3.0 mg/kg; Drug: AMG 745 1.0 mg/kg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00975104

20080733

Details and patient eligibility

About

Randomized, Double-blind, Placebo-controlled Dose Ranging Study to Evaluate the Safety and Efficacy of AMG 745 in Age-associated Muscle Loss

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Limited exercise tolerance and Rapid Assessment of Physical Activity (RAPA) score ≤ 3
• Hand grip (dominant hand): men ≤ 30.3 kg, women ≤ 19.3 kg
• Walk speed ≤ 0.8 m/s (based on a 4 meter walk)

Exclusion criteria

• Subject weight > 137 kg (300 lbs), or Body Mass Index (BMI) > 32 kg/m2
• Primary muscle disease or myopathy
• Recent immobilization, or major trauma to the legs within 6 months
• Knee or hip replacement within 12 months or lower extremity amputation
• Significant laboratory abnormalities
• Significant comorbidities or medical history
• Weight loss (intentional or unintentional) of > 5 kg in 12 weeks
• Unable to complete an MRI scan

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 4 patient groups, including a placebo group

AMG 745 0.3 mg/kg

Experimental group

Description:

0.3 mg/kg AMG 745

Treatment:

Drug: AMG 745 0.3 mg/kg

AMG 745 1.0 mg/kg

Experimental group

Description:

1.0 mg/kg, AMG 745

Treatment:

Drug: AMG 745 1.0 mg/kg

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

AMG 745 3.0 mg/kg

Experimental group

Description:

3.0 mg/kg, AMG 745

Treatment:

Drug: AMG 745 3.0 mg/kg