AMG 745 in Subjects With Age-associated Muscle Loss

October 3, 2018 updated by: Amgen

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

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

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo IV QW
Experimental: AMG 745 0.3 mg/kg
0.3 mg/kg AMG 745
Drug: AMG 745 0.3 mg/kg
AMG 745 0.3 mg/kg IV QW
Experimental: AMG 745 1.0 mg/kg
1.0 mg/kg, AMG 745
Drug: AMG 745 1.0 mg/kg
AMG 745 1.0 mg/kg IV QW
Experimental: AMG 745 3.0 mg/kg
3.0 mg/kg, AMG 745
Drug: AMG 745 3.0 mg/kg
AMG 745 3.0 mg/kg IV QW

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 12 Weeks
12 Weeks

Secondary Outcome Measures

Outcome 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
Time Frame: 12 Weeks
12 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Anticipated)

May 1, 2011

Study Completion (Anticipated)

August 1, 2011

Study Registration Dates

First Submitted

September 10, 2009

First Submitted That Met QC Criteria

September 10, 2009

First Posted (Estimate)

September 11, 2009

Study Record Updates

Last Update Posted (Actual)

October 4, 2018

Last Update Submitted That Met QC Criteria

October 3, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20080733

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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