CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 217 enrolled
Drug / intervention
bimagrumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02333331
NCT02333331Phase 2Completed

A 28 Week, Randomized, Double-blind, Placebo-controlled, Two-part, Multi-center, Parallel Group Dose Range Finding Study to Assess the Effect of Monthly Doses of Bimagrumab 70, 210, and 700 mg on Skeletal Muscle Strength and Function in Older Adults With Sarcopenia (InvestiGAIT)

Novartis Pharmaceuticals·interventional·Posted Jan 7, 2015·Updated Jan 5, 2021

In Brief

A Phase 2 clinical trial evaluating bimagrumab and placebo for Sarcopenia. Completed, enrolled 217 participants across 58 sites in 13 countries.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSarcopenia
CountriesAustralia, Belgium, Czechia, Denmark, France, Germany, Japan, Russia, South Korea, Spain, Switzerland, Taiwan, United States
Collaborators--

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJan 7, 2015
Enrollment StartDec 9, 2014
Primary CompletionJun 26, 2018
Study CompletionJun 28, 2018
TodayJul 2, 2026
Enrollment to primary: 3.5 yearsPosted 11.5 years ago

Interventions

bimagrumabdrug

Bimagrumab will be administered as an intravenous infusion starting on Day 1 until week 21.

placeboother

Placebo will be administered as an intravenous infusion starting on Day 1 until week 21.