AMG 745 in Subjects With Age-associated Muscle Loss

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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00975104

Enrollment

Registered

2009-09-11

Start date

2010-04-30

Completion date

2011-08-31

Last updated

2018-10-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-associated Muscle Loss

Keywords

Aging, Frailty, Sedentary, Immobilization, Atrophy, Muscle Wasting, Physical Activity

Brief summary

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

Interventions

DRUGAMG 745 0.3 mg/kg

AMG 745 0.3 mg/kg IV QW

DRUGAMG 745 1.0 mg/kg

AMG 745 1.0 mg/kg IV QW

DRUGAMG 745 3.0 mg/kg

AMG 745 3.0 mg/kg IV QW

DRUGPlacebo

Placebo IV QW

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026