AMG 745 in Subjects With Age-associated Muscle Loss

Age-associated Muscle Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00975104
• Other study ID #: 20080733
• Status: Withdrawn
• Phase: Phase 2
• Start date: April 2010
• Est. completion date: August 2011

Study information

• Verified date: October 2018
• Source: Amgen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-associated Muscle Loss

Intervention

Drug:
• AMG 745 0.3 mg/kg
AMG 745 0.3 mg/kg IV QW
• AMG 745 1.0 mg/kg
AMG 745 1.0 mg/kg IV QW
• AMG 745 3.0 mg/kg
AMG 745 3.0 mg/kg IV QW
• Placebo
Placebo IV QW

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Amgen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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

External Links

•   AmgenTrials clinical trials website