Trial · NCT02333331

Dose Range Finding Study of Bimagrumab in Sarcopenia

NCT02333331, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2019-08-06

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Dose Range Finding Study of Bimagrumab in Sarcopenia. Trials, record NCT02333331. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02333331

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Dose Range Finding Study of Bimagrumab in Sarcopenia
NCT number: NCT02333331
Status: Completed
Phases: Phase 2
Enrollment: 217 participants, actual
Lead sponsor: Novartis Pharmaceuticals
Conditions: Sarcopenia
Interventions: bimagrumab, placebo
First posted: 2015-01-07
Last updated: 2021-01-05
Results first posted: 2019-08-06

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25	Baseline, week 25	Change from Baseline in total Short Physical Performance Battery (SPPB) Score to week 25; SPPB is a series of six activities involving three domains of physical function - balance, usual walking speed and rising from a chair , is commonly used globally to assess and quantify (score 0-12) lower extremity function and has been shown to predict future adverse health events. A decline of one or more points in the SPPB total score is predictive of a decrease in lower extremity function and future adverse clinical outcomes in older adults, including falls, hospitalizations, institutionalization, incident disability and death
Secondary	Change From Baseline at Week 25 in the 6 Minute Walk Test (6MWT) Distance	Baseline, week 25	Change from Baseline at Week 25 in the 6 minute walk test (6MWT) distance to measure improvement in physical function
Secondary	Change From Baseline to Week 25 in Usual Gait Speed (GS) Over 4 Meters	baseline, week 25	Change from Baseline to Week 25 in usual Gait speed (GS) over 4 meters Gait speed in this study was assessed as part of the SPPB, over a 4 meter distance of a 6 meter course. This test assessed a person's usual walking speed, which was defined as the speed a person normally walks from one place to another without urgency (e.g., walking down a hallway).
Secondary	Percentage Change From Baseline to Week 25 on Appendicular Skeletal Muscle Index (ASMI) Measured by Dual Energy X-ray Absorptiometry (DXA)	baseline, week 25	Change from Baseline to Week 25 on appendicular skeletal muscle index (ASMI) measured by Dual Energy X-ray Absorptiometry (DXA) Appendicular skeletal muscle index (ASMI) is a core requirement for determining the presence of sarcopenia and is calculated as the sum of the appendicular lean mass (kg) of the two upper and two lower limbs quantified by DXA, divided by height (m\^2). Therefore, an increase in ASMI indicates an increase in the quantity of an individual's lean mass.
Secondary	Percentage Change From Baseline to Week 25 on Total Lean Body Mass Measured by Dual Energy X-ray Absorptiometry (DXA)	baseline, week 25	Change from Baseline to Week 25 on Total lean body mass and appendicular skeletal muscle index (ASMI) measured by Dual Energy X-ray Absorptiometry (DXA) total lean body mass (LBM) is measured by dual energy x-ray absorptiometry (DXA).Percent Change = \[(LBM at Visit - LBM at Baseline) / LBM at Baseline\] \* 100.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25	Baseline, week 25	Full Analysis Set (FAS) -comprised all patients to whom study treatment had been assigned. Following the intent to treat principle, patients were analyzed according to treatment assigned at randomization.	Score on a scale	MEAN
SECONDARY	Change From Baseline at Week 25 in the 6 Minute Walk Test (6MWT) Distance	Baseline, week 25	Full Analysis Set (FAS) -comprised all patients to whom study treatment had been assigned. Following the intent to treat principle, patients were analyzed according to treatment assigned at randomization.	meters	MEAN
SECONDARY	Change From Baseline to Week 25 in Usual Gait Speed (GS) Over 4 Meters	baseline, week 25	Full Analysis Set (FAS) -comprised all patients to whom study treatment had been assigned. Following the intent to treat principle, patients were analyzed according to treatment assigned at randomization.	m/sec	MEAN
SECONDARY	Percentage Change From Baseline to Week 25 on Appendicular Skeletal Muscle Index (ASMI) Measured by Dual Energy X-ray Absorptiometry (DXA)	baseline, week 25	Full Analysis Set (FAS) -comprised all patients to whom study treatment had been assigned. Following the intent to treat principle, patients were analyzed according to treatment assigned at randomization.	Percent Change	MEAN
SECONDARY	Percentage Change From Baseline to Week 25 on Total Lean Body Mass Measured by Dual Energy X-ray Absorptiometry (DXA)	baseline, week 25	Full Analysis Set (FAS) -comprised all patients to whom study treatment had been assigned. Following the intent to treat principle, patients were analyzed according to treatment assigned at randomization.	Percent Change	MEAN

Source ClinicalTrials.gov

Results by group40

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25	BYM338 70 mg	Baseline	7.1	Standard Deviation 2.12	Score on a scale
Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25	BYM338 210 mg	Baseline	7.3	Standard Deviation 2.11	Score on a scale
Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25	BYM338 700 mg	Baseline	7.2	Standard Deviation 1.63	Score on a scale
Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25	Placebo	Baseline	7.3	Standard Deviation 1.67	Score on a scale
Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25	BYM338 70 mg	Week 25	8.5	Standard Deviation 2.48	Score on a scale
Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25	BYM338 210 mg	Week 25	8.7	Standard Deviation 1.64	Score on a scale
Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25	BYM338 700 mg	Week 25	8.7	Standard Deviation 2.12	Score on a scale
Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25	Placebo	Week 25	8.4	Standard Deviation 2.25	Score on a scale
Change From Baseline at Week 25 in the 6 Minute Walk Test (6MWT) Distance	BYM338 70 mg	Baseline	293.30	Standard Deviation 91.842	meters
Change From Baseline at Week 25 in the 6 Minute Walk Test (6MWT) Distance	BYM338 210 mg	Baseline	291.81	Standard Deviation 82.527	meters

1 to 10 of 40Source ClinicalTrials.gov

See all 40 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	BYM338 70 mg	19
Overall Study	STARTED	BYM338 210 mg	18
Overall Study	STARTED	BYM338 700 mg	113
Overall Study	STARTED	Placebo	67
Overall Study	COMPLETED	BYM338 70 mg	17
Overall Study	COMPLETED	BYM338 210 mg	12
Overall Study	COMPLETED	BYM338 700 mg	95
Overall Study	COMPLETED	Placebo	64
Overall Study	NOT COMPLETED	BYM338 70 mg	2
Overall Study	NOT COMPLETED	BYM338 210 mg	6

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events436

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anaemia	Blood and lymphatic system disorders	BYM338 70 mg	0	19
other	Anaemia	Blood and lymphatic system disorders	BYM338 210 mg	1	18
other	Anaemia	Blood and lymphatic system disorders	BYM338 700 mg	3	113
other	Anaemia	Blood and lymphatic system disorders	Placebo	0	67
other	Bradycardia	Cardiac disorders	BYM338 70 mg	2	19
other	Bradycardia	Cardiac disorders	BYM338 210 mg	0	18
other	Bradycardia	Cardiac disorders	BYM338 700 mg	3	113
other	Bradycardia	Cardiac disorders	Placebo	0	67
other	Palpitations	Cardiac disorders	BYM338 70 mg	0	19
other	Palpitations	Cardiac disorders	BYM338 210 mg	1	18

1 to 10 of 436Source ClinicalTrials.gov

See all 436 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	BYM338 70 mg	0	19
Total, all-cause mortality	BYM338 210 mg	0	18
Total, all-cause mortality	BYM338 700 mg	2	113
Total, all-cause mortality	Placebo	0	67
Total, other adverse events	BYM338 70 mg	12	19
Total, other adverse events	BYM338 210 mg	13	18
Total, other adverse events	BYM338 700 mg	94	113
Total, other adverse events	Placebo	41	67
Total, serious adverse events	BYM338 70 mg	0	19
Total, serious adverse events	BYM338 210 mg	3	18

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33074327	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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