AMG 745 in Subjects With Age-associated Muscle Loss

Amgen

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Age-associated Muscle Loss

Interventions

AMG 745 0.3 mg/kgDRUG

AMG 745 0.3 mg/kg IV QW

AMG 745 1.0 mg/kgDRUG

AMG 745 1.0 mg/kg IV QW

AMG 745 3.0 mg/kgDRUG

AMG 745 3.0 mg/kg IV QW

Placebo

Eligibility

Sex: ALLMin age: 65 Years

Medical Language ↔ Plain English

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

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

Time frame: 12 Weeks

Data from ClinicalTrials.gov

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