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A Multi-center Study to Assess the Effects of BYM338 on Skeletal Muscle in Sarcopenic Adults
NCT01601600 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this Proof of Concept study is to determine the effects of BYM338 on skeletal muscle volume, mass, and strength and patient function (gait speed) in non-demented elderly adults with sarcopenia and mobility limitations. In addition, this study will generate data on the safety, tolerability, and pharmacokinetics of BYM338 in older adults and its response on additional physical function measures in this population. Furthermore, the extended study duration will provide information on the stability of BYM-induced changes in skeletal muscle and patient function in this subgroup of the older population.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG BYM338
Study Locations (5)
Arkansas
- Novartis Investigative Site — Hot Springs
- Novartis Investigative Site — Little Rock
Florida
- Novartis Investigative Site — Miami
- Novartis Investigative Site — Miami
Massachusetts
- Novartis Investigative Site — Brighton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2012-01 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01601600
The ClinicalTrials.gov registry entry for NCT01601600 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 792 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Skeletal Muscle appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT01601600 reports 5 study locations spanning 3 distinct geographic areas — top geographies include Arkansas, Florida, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT01601600 about?
NCT01601600 is a clinical study titled "A Multi-center Study to Assess the Effects of BYM338 on Skeletal Muscle in Sarcopenic Adults". The purpose of this Proof of Concept study is to determine the effects of BYM338 on skeletal muscle volume, mass, and strength and patient function (gait speed) in non-demented elderly adults with sarcopenia and mobility limitations. In addition, this study will generate data on the safety, tolerabi...
What is the current status of trial NCT01601600?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2012-01. Estimated completion is 2013-12.
What conditions does trial NCT01601600 study?
This clinical trial studies the following conditions: Skeletal Muscle. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01601600?
The interventions under investigation include: Placebo (DRUG), BYM338 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01601600?
This trial is sponsored by Novartis Pharmaceuticals, which has 792 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT01601600 being conducted?
This trial has 5 study locations across Arkansas, Florida, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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