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Completed Phase 2 Interventional

A Multi-center Study to Assess the Effects of BYM338 on Skeletal Muscle in Sarcopenic Adults

ClinicalTrials.gov ID: NCT01601600

Public ClinicalTrials.gov record NCT01601600. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 12:55 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Randomized, Double-blind, Placebo-controlled Multi-center Study to Assess the Effects of BYM338 on Skeletal Muscle in Sarcopenic Adults With Mobility Limitations

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT01601600
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Novartis Pharmaceuticals
Industry
Enrollment
40 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
65 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Dec 31, 2011
Primary completion
Nov 30, 2013
Completion
Nov 30, 2013
Last update posted
Dec 16, 2020

2012 – 2013

United States locations

U.S. sites
5
U.S. states
3
U.S. cities
4
Facility City State ZIP Site status
Novartis Investigative Site Hot Springs Arkansas 71913
Novartis Investigative Site Little Rock Arkansas 72201
Novartis Investigative Site Miami Florida 33143
Novartis Investigative Site Miami Florida 33169
Novartis Investigative Site Brighton Massachusetts 02135

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01601600, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Dec 16, 2020 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT01601600 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →