Age-associated Muscle LossPhase 2NCT00975104
AMG 745 in Subjects With Age-associated Muscle Loss
A Phase 2 study testing AMG 745 0.3 mg/kg, AMG 745 1.0 mg/kg and AMG 745 3.0 mg/kg in people with Age-associated Muscle Loss, run by Amgen.
Trial summary
Randomized, Double-blind, Placebo-controlled Dose Ranging Study to Evaluate the Safety and Efficacy of AMG 745 in Age-associated Muscle Loss Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Age-associated Muscle Loss
- What is being tested?
- AMG 745 0.3 mg/kg, AMG 745 1.0 mg/kg and AMG 745 3.0 mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2010to Aug 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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)
Who cannot join
- 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
About this study
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
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
- Being tested
- AMG 745 0.3 mg/kg, AMG 745 1.0 mg/kg, AMG 745 3.0 mg/kg, Placebo
- Keywords
- Aging, Frailty, Sedentary, Immobilization, Atrophy, Muscle Wasting, Physical Activity
- Medical subject headings
- Frailty, Sedentary Behavior, Atrophy, Muscular Atrophy, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboDrug
Placebo IV QW
| Study group | Role | What they receive |
|---|---|---|
| AMG 745 0.3 mg/kg | Experimental | 0.3 mg/kg AMG 745 Receives: Drug: AMG 745 0.3 mg/kg |
| AMG 745 1.0 mg/kg | Experimental | 1.0 mg/kg, AMG 745 Receives: Drug: AMG 745 1.0 mg/kg |
| Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| AMG 745 3.0 mg/kg | Experimental | 3.0 mg/kg, AMG 745 Receives: Drug: AMG 745 3.0 mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2009 (estimated)
- Study startApr 2010
- Primary completionMay 2011 (estimated)
- Study completionAug 2011 (estimated)
Why it stopped: Amgen has chosen at this time not to continue with AMG 745 study 20080733
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-associated Muscle LossStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00975104
- Sponsor's protocol ID
- 20080733
- Status last verified
- Oct 2018
- First submitted
- 10 Sep 2009
- Last updated
- 4 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00975104
- Acronym / sponsor ID
- 20080733
- Conditions
- Age-associated Muscle Loss
- Keywords
- Aging, Frailty, Sedentary, Immobilization, Atrophy, Muscle Wasting, Physical Activity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Amgen has chosen at this time not to continue with AMG 745 study 20080733
- Enrolment
- 0 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- May 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 11 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, Double-blind, Placebo-controlled Dose Ranging Study to Evaluate the Safety and Efficacy of AMG 745 in Age-associated Muscle Loss
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| AMG 745 0.3 mg/kg | Experimental | Drug: AMG 745 0.3 mg/kg0.3 mg/kg AMG 745 |
| AMG 745 1.0 mg/kg | Experimental | Drug: AMG 745 1.0 mg/kg1.0 mg/kg, AMG 745 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| AMG 745 3.0 mg/kg | Experimental | Drug: AMG 745 3.0 mg/kg3.0 mg/kg, AMG 745 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AMG 745 0.3 mg/kgAMG 745 0.3 mg/kg IV QW | Drug | AMG 745 0.3 mg/kg |
| AMG 745 1.0 mg/kgAMG 745 1.0 mg/kg IV QW | Drug | AMG 745 1.0 mg/kg |
| AMG 745 3.0 mg/kgAMG 745 3.0 mg/kg IV QW | Drug | AMG 745 3.0 mg/kg |
| PlaceboPlacebo IV QW | Drug | Placebo |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2018.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AMG 745 0.3 mg/kg, AMG 745 1.0 mg/kg and AMG 745 3.0 mg/kg in people with Age-associated Muscle Loss, run by Amgen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2018.