AMG 745 in Subjects With Age-associated Muscle Loss

Phase 2

Withdrawn

• Conditions: Age-associated Muscle Loss
• Interventions: Drug: AMG 745 1.0 mg/kg; Drug: Placebo; Drug: AMG 745 3.0 mg/kg; Drug: AMG 745 0.3 mg/kg

• Registration Number: NCT00975104
• Lead Sponsor: Amgen

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-10
• Study First Submitted QC: 2009-09-10
• Study First Posted: 2009-09-11
• Study Start: 2010-04
• Primary Completion: 2011-05
• Study Completion: 2011-08
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-03
• Last Update Posted: 2018-10-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMG 745 1.0 mg/kg	AMG 745 1.0 mg/kg	1.0 mg/kg, AMG 745
Placebo	Placebo	Placebo
AMG 745 3.0 mg/kg	AMG 745 3.0 mg/kg	3.0 mg/kg, AMG 745
AMG 745 0.3 mg/kg	AMG 745 0.3 mg/kg	0.3 mg/kg AMG 745

Primary Outcome Measures

Name	Time	Method
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	12 Weeks

Secondary Outcome Measures

Name	Time	Method
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