AMG 745 in Subjects With Age-associated Muscle Loss

NCT00975104 | Withdrawn Phase 2

• 1 other identifier: 20080733
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Age-associated Muscle Loss

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (4)

AMG 745 0.3 mg/kg

EXPERIMENTAL

0.3 mg/kg AMG 745

Drug: AMG 745 0.3 mg/kg

AMG 745 1.0 mg/kg

EXPERIMENTAL

1.0 mg/kg, AMG 745

Drug: AMG 745 1.0 mg/kg

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

AMG 745 3.0 mg/kg

EXPERIMENTAL

3.0 mg/kg, AMG 745

Drug: AMG 745 3.0 mg/kg

Interventions

AMG 745 0.3 mg/kg DRUG

AMG 745 0.3 mg/kg IV QW

AMG 745 0.3 mg/kg

AMG 745 1.0 mg/kg DRUG

AMG 745 1.0 mg/kg IV QW

AMG 745 1.0 mg/kg

AMG 745 3.0 mg/kg DRUG

AMG 745 3.0 mg/kg IV QW

AMG 745 3.0 mg/kg

Placebo DRUG

Placebo IV QW

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Frailty; Sedentary Behavior; Atrophy; Muscular Atrophy; Motor Activity

Interventions

AMG 745

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior; Pathological Conditions, Anatomical; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 10, 2009
• First Posted: September 11, 2009
• Study Start: April 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: August 1, 2011
• Last Updated: October 4, 2018

Record last verified: 2018-10