AMG 745 in Subjects With Age-associated Muscle Loss

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

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

Conditions
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Age-associated Muscle Loss

Intervention / Treatment
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* Drug: AMG 745 0.3 mg/kg
* Drug: AMG 745 1.0 mg/kg
* Drug: AMG 745 3.0 mg/kg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMG 745 0.3 mg/kg<br>0.3 mg/kg AMG 745 | Drug: AMG 745 0.3 mg/kg<br>* AMG 745 0.3 mg/kg IV QW<br>|
| Experimental: AMG 745 1.0 mg/kg<br>1.0 mg/kg, AMG 745 | Drug: AMG 745 1.0 mg/kg<br>* AMG 745 1.0 mg/kg IV QW<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo IV QW<br>|
| Experimental: AMG 745 3.0 mg/kg<br>3.0 mg/kg, AMG 745 | Drug: AMG 745 3.0 mg/kg<br>* AMG 745 3.0 mg/kg IV QW<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aging, Frailty, Sedentary, Immobilization, Atrophy, Muscle Wasting, Physical Activity