NCT00975104WithdrawnPhase 2
A Randomized, Double-blind, Placebo-controlled Dose Ranging Study to Evaluate the Safety and Efficacy of AMG 745 in Age-associated Muscle Loss
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Withdrawn
- Sponsor
- Amgen
- Primary Endpoint
- To evaluate the effect of AMG 745 weekly IV doses of 0.3 mg/kg, 1.0 mg/kg, or 3.0 mg/kg, compared with weekly IV placebo on thigh muscle CSA in subjects ≥ 65 yrs old with limited exercise tolerance and functional limitations
Study Overview
Brief Summary
Randomized, Double-blind, Placebo-controlled Dose Ranging Study to Evaluate the Safety and Efficacy of AMG 745 in Age-associated Muscle Loss
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
AMG 745 0.3 mg/kg
Experimental
0.3 mg/kg AMG 745
Intervention: AMG 745 0.3 mg/kg (Drug)
AMG 745 1.0 mg/kg
Experimental
1.0 mg/kg, AMG 745
Intervention: AMG 745 1.0 mg/kg (Drug)
Placebo
Placebo Comparator
Placebo
Intervention: Placebo (Drug)
AMG 745 3.0 mg/kg
Experimental
3.0 mg/kg, AMG 745
Intervention: AMG 745 3.0 mg/kg (Drug)
Outcomes
Primary Outcomes
To evaluate the effect of AMG 745 weekly IV doses of 0.3 mg/kg, 1.0 mg/kg, or 3.0 mg/kg, compared with weekly IV placebo on thigh muscle CSA in subjects ≥ 65 yrs old with limited exercise tolerance and functional limitations
Time Frame: 12 Weeks
Secondary Outcomes
- To evaluate the effect of treatment with AMG 745 on muscle strength (hand grip strength) and function (gait speed, 10-step stair climb power, chair stand and 6 minute walk distance) and to evaluate the PK of AMG 745 following multiple IV administrations(12 Weeks)
Investigators
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