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Clinical Trials/NCT00975104
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

Amgen0 sitesStarted: April 2010Last updated:
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Withdrawn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

Sponsor
Amgen
Sponsor Class
Industry

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