Dose Range Finding Study of Bimagrumab in Sarcopenia

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02333331
Phase
PHASE2
Status
Completed

Conditions

  • Sarcopenia

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • bimagrumab — DRUG
    Bimagrumab will be administered as an intravenous infusion starting on Day 1 until week 21.
  • placebo — OTHER
    Placebo will be administered as an intravenous infusion starting on Day 1 until week 21.

Study Details

The purpose of this study was to determine the efficacy of repeat dosing with multiple dose levels of bimagrumab on patient physical function, skeletal muscle mass and strength in older adults with sarcopenia. In addition, this study generated data on the safety, tolerability, and pharmacokinetics of bimagrumab in older adults with sarcopenia.

Key Dates

Start date
Dec 9, 2014
Status verified
Jul 2019
Primary completion
Jun 26, 2018
Completion
Jun 28, 2018

Study Design

Enrollment
217 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: BYM338 70 mg
    BYM338 70 mg intravenous infusion
  • Experimental: BYM338 210 mg
    BYM338 210 mg intravenous infusion
  • Experimental: BYM338 700 mg
    BYM338 700 mg intravenous infusion
  • Placebo Comparator: Placebo
    Placebo intravenous infusion

Primary Outcome Measure

Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25 [ Time Frame: Baseline, week 25 ]

Locations (17)

FacilityCityStateZIPSite coordinators
Novartis Investigative SiteLittle RockArkansas72205-
Novartis Investigative SiteCypressCalifornia90630-
Novartis Investigative SiteLa JollaCalifornia92093-9405-
Novartis Investigative SiteFarmingtonConnecticut06030-5215-
Novartis Investigative SiteGainesvilleFlorida32611-
Novartis Investigative SiteMiamiFlorida33143-
Novartis Investigative SiteMiami LakesFlorida33014-
Novartis Investigative SiteOrlandoFlorida32804-
Novartis Investigative SiteGainesvilleGeorgia30501-
Novartis Investigative SiteBostonMassachusetts02115-
Novartis Investigative SiteRochesterMinnesota55905-
Novartis Investigative SiteHigh PointNorth Carolina27262-
Novartis Investigative SiteColumbusOhio43210-
Novartis Investigative SiteSpartanburgSouth Carolina29303-
Novartis Investigative SiteMesquiteTexas75150-
Novartis Investigative SiteSan AntonioTexas78229-
Novartis Investigative SiteMadisonWisconsin53706-

Find similar trials in Little Rock, AR

By research site
Novartis Investigative Site· Little Rock, ARNovartis Investigative Site· Cypress, CANovartis Investigative Site· La Jolla, CANovartis Investigative Site· Farmington, CTNovartis Investigative Site· Gainesville, FLNovartis Investigative Site· Miami, FL

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