SarcopeniaPhase 2NCT02333331

Dose Range Finding Study of Bimagrumab in Sarcopenia

A Phase 2 study testing bimagrumab in people with Sarcopenia, run by Novartis Pharmaceuticals at 58 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 70 years and older
Conditions the study is for: Sarcopenia
What is being tested?: bimagrumab
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 217 participants
Where: 58 sitesin 13 countries
Study dates: 9 Dec 2014to 28 Jun 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 70 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Low muscle mass as confirmed by DXA;
Low gait speed <0.8 m/s
SPPB score less than or equal to 9;
Weigh at least 35 kg;
Adequate dietary intake;

Who cannot join

A lower limb fracture in the past 6 months or any impairment or disease severely affecting gait (e.g. stroke with hemiparesis, myasthenia gravis, Parkinson's disease, peripheral polyneuropathy, intermittent claudication in advanced peripheral vascular disease, spinal stenosis, or severe osteoarthritis of the knee or hip with ineffective pain management);
Requires regular assistance from another person for general activities of daily living (e.g. bathing, dressing, toileting).
Intraocular surgery and laser procedures for refractive correction within 6 months prior to screening;
Any underlying muscle disease including active myopathy or muscular dytrophy;
Confirmed diagnosis of heart failure classified as New York Heart Association Class III or IV (e.g. dilated cardiomyopathy);
Type I diabetes or uncontrolled Type 2 diabetes;

Show all 13Show fewer

Chronic kidney disease [estimated glomerular filtration rate (GFR) < 30 mL/min];
History of confirmed chronic obstructive pulmonary disease with a severity grade > 2 on the Medical Research Council Dyspnea Scale;
Confirmed rheumatoid arthritis or other systemic autoimmune disease requiring immunosuppressive therapy or corticosteroids >10 mg/d prednisone equivalent;
Known history or presence of severe active acute or chronic liver disease (e.g., cirrhosis);
Myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention (e.g. angioplasty or stent placement), or deep vein thrombosis/pulmonary embolism within 12 weeks of screening;
Active cancer (i.e., under current treatment), or cancer requiring treatment in the last 5 years excluding non-melanoma skin cancers or cancers with excellent prognosis (e.g., early stage prostate or breast cancer, carcinoma in situ of the uterine cervix);
Any chronic active infection (e.g., HIV, Hepatitis B or C, tuberculosis, etc).

Trial locations and contacts

58 sites in 13 countries.

Country

City, postcode or hospital

58 sites in 13 countries

United States17 sites

Novartis Investigative Site
Boston, Massachusetts, 02115
Novartis Investigative Site
Columbus, Ohio, 43210
Novartis Investigative Site
Cypress, California, 90630
Novartis Investigative Site
Farmington, Connecticut, 06030-5215
Novartis Investigative Site
Gainesville, Florida, 32611
Novartis Investigative Site
Gainesville, Georgia, 30501
Novartis Investigative Site
High Point, North Carolina, 27262
Novartis Investigative Site
La Jolla, California, 92093-9405
Novartis Investigative Site
Little Rock, Arkansas, 72205
Novartis Investigative Site
Madison, Wisconsin, 53706
Novartis Investigative Site
Mesquite, Texas, 75150
Novartis Investigative Site
Miami, Florida, 33143
Novartis Investigative Site
Miami Lakes, Florida, 33014
Novartis Investigative Site
Orlando, Florida, 32804
Novartis Investigative Site
Rochester, Minnesota, 55905
Novartis Investigative Site
San Antonio, Texas, 78229
Novartis Investigative Site
Spartanburg, South Carolina, 29303

Other trials in United States

Japan12 sites

Novartis Investigative Site
Itabashi Ku, Tokyo, 173 0015
Novartis Investigative Site
Kawachi-Nagano, Osaka, 586-8521
Novartis Investigative Site
Kitaadachigun Inamachi, Saitama, 362-0806
Novartis Investigative Site
Kitamoto, Saitama, 364-8501
Novartis Investigative Site
Kiyose, Tokyo, 204-0021
Novartis Investigative Site
Koto-ku, Tokyo, 136-0075
Novartis Investigative Site
Mizunami, Gifu, 509 6134
Novartis Investigative Site
Musashimurayama, Tokyo, 208-0011
Novartis Investigative Site
Nara, Nara, 630-8581
Novartis Investigative Site
Ōbu, Aichi-ken, 474-8511
Novartis Investigative Site
Toyohashi, Aichi-ken, 440-8510
Novartis Investigative Site
Yoshinogawa, Tokushima, 776-8585

Other trials in Japan

France4 sites

Novartis Investigative Site
Montpellier, 34295
Novartis Investigative Site
Paris, 75013
Novartis Investigative Site
Pessac, 33604
Novartis Investigative Site
Toulouse, 31052

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Russia4 sites

Novartis Investigative Site
Moscow, 101990
Novartis Investigative Site
Moscow, 117997
Novartis Investigative Site
Saint Petersburg, 190068
Novartis Investigative Site
Yaroslavl, 150003

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Spain4 sites

Novartis Investigative Site
Albacete, Castille-La Mancha, 02006
Novartis Investigative Site
Barcelona, 08024
Novartis Investigative Site
Getafe, Madrid, 28905
Novartis Investigative Site
Madrid, 28034

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Czechia3 sites

Novartis Investigative Site
Brno, 62500
Novartis Investigative Site
Opava, 74601
Novartis Investigative Site
Prague, 12000

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South Korea3 sites

Novartis Investigative Site
Bundang Gu, Gyeonggi-do, 13620
Novartis Investigative Site
Seoul, Korea, 02447
Novartis Investigative Site
Suwon, Gyeonggi-do, 16499

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Australia2 sites

Novartis Investigative Site
Adelaide, South Australia, 5000
Novartis Investigative Site
St Albans, Victoria, 3021

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Belgium2 sites

Novartis Investigative Site
Brussels, 1090
Novartis Investigative Site
Leuven, 3000

Other trials in Belgium

Denmark2 sites

Novartis Investigative Site
Copenhagen, 2100
Novartis Investigative Site
Copenhagen NV, 2400

Other trials in Denmark

Germany2 sites

Novartis Investigative Site
Berlin, 10117
Novartis Investigative Site
Würzburg, 97074

Other trials in Germany

Switzerland2 sites

Novartis Investigative Site
Basel, CH, 4002
Novartis Investigative Site
Geneva, 1211

Other trials in Switzerland

Taiwan1 site

Novartis Investigative Site
Taipei, 11217

Other trials in Taiwan

About this study

Official title: 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)

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.

Conditions: Sarcopenia
Being tested: bimagrumab, placebo
Keywords: Sarcopenia, muscle wasting, elderly, strength, physical function, muscle, gait speed
Medical subject headings: Sarcopenia, Muscular Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

bimagrumabDrug
Also called BYM338
Bimagrumab will be administered as an intravenous infusion starting on Day 1 until week 21.
placeboOther
Also called 5% dextrose
Placebo will be administered as an intravenous infusion starting on Day 1 until week 21.

Study groups in NCT02333331
Study group	Role	What they receive
BYM338 70 mg	Experimental	BYM338 70 mg intravenous infusion Receives: Drug: bimagrumab
BYM338 210 mg	Experimental	BYM338 210 mg intravenous infusion Receives: Drug: bimagrumab
BYM338 700 mg	Experimental	BYM338 700 mg intravenous infusion Receives: Drug: bimagrumab
Placebo	Placebo comparator	Placebo intravenous infusion Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to 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
Measured: Baseline, week 25

Secondary outcomes (4)

Change From Baseline at Week 25 in the 6 Minute Walk Test (6MWT) Distance
Change from Baseline at Week 25 in the 6 minute walk test (6MWT) distance to measure improvement in physical function
Measured: Baseline, week 25
Change From Baseline to Week 25 in Usual Gait Speed (GS) Over 4 Meters
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).
Measured: baseline, week 25
Percentage Change From Baseline to Week 25 on Appendicular Skeletal Muscle Index (ASMI) Measured by Dual Energy X-ray Absorptiometry (DXA)
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.
Measured: baseline, week 25
Percentage Change From Baseline to Week 25 on Total Lean Body Mass Measured by Dual Energy X-ray Absorptiometry (DXA)
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.
Measured: baseline, week 25

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Dec 201428 Jun 2018

First posted7 Jan 2015 (estimated)
Study start9 Dec 2014
Primary completion26 Jun 2018
Study completion28 Jun 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SarcopeniaStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 217 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02333331
Sponsor's protocol ID: CBYM338E2202
Status last verified: Jul 2019
First submitted: 10 Dec 2014
Last updated: 5 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

Rooks D, Swan T, Goswami B, Filosa LA, Bunte O, Panchaud N, Coleman LA, Miller RR, Garcia Garayoa E, Praestgaard J, Perry RG, Recknor C, Fogarty CM, Arai H, Chen LK, Hashimoto J, Chung YS, Vissing J, Laurent D, Petricoul O, Hemsley S, Lach-Trifilieff E, Papanicolaou DA, Roubenoff R. Bimagrumab vs Optimized Standard of Care for Treatment of Sarcopenia in Community-Dwelling Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2020836. doi: 10.1001/jamanetworkopen.2020.20836.
PubMed 33074327

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT02333331
Acronym / sponsor ID: CBYM338E2202
Conditions: Sarcopenia
Keywords: Sarcopenia, muscle wasting, elderly, strength, physical function, muscle, gait speed
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 217 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 9 Dec 2014 (actual)
Primary completion: 26 Jun 2018 (actual)
Study completion: 28 Jun 2018 (actual)
First posted: 7 Jan 2015 (estimated)
Results: Posted 6 Aug 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
BYM338 70 mg	Experimental	Drug: bimagrumabBYM338 70 mg intravenous infusion
BYM338 210 mg	Experimental	Drug: bimagrumabBYM338 210 mg intravenous infusion
BYM338 700 mg	Experimental	Drug: bimagrumabBYM338 700 mg intravenous infusion
Placebo	Placebo comparator	Other: placeboPlacebo intravenous infusion

Who may qualify

Ages: 70 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (5 listed)

Low muscle mass as confirmed by DXA;
Low gait speed <0.8 m/s
SPPB score less than or equal to 9;
Weigh at least 35 kg;
Adequate dietary intake;

Key exclusion criteria (13 listed)

A lower limb fracture in the past 6 months or any impairment or disease severely affecting gait (e.g. stroke with hemiparesis, myasthenia gravis, Parkinson's disease, peripheral polyneuropathy, intermittent claudication in advanced peripheral vascular disease, spinal stenosis, or severe osteoarthritis of the knee or hip with ineffective pain management);
Requires regular assistance from another person for general activities of daily living (e.g. bathing, dressing, toileting).
Intraocular surgery and laser procedures for refractive correction within 6 months prior to screening;
Any underlying muscle disease including active myopathy or muscular dytrophy;
Confirmed diagnosis of heart failure classified as New York Heart Association Class III or IV (e.g. dilated cardiomyopathy);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
bimagrumabAlso: BYM338Bimagrumab will be administered as an intravenous infusion starting on Day 1 until week 21.	Drug	BYM338 210 mg, BYM338 70 mg, BYM338 700 mg
placeboAlso: 5% dextrosePlacebo will be administered as an intravenous infusion starting on Day 1 until week 21.	Other	Placebo

Primary outcome

Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25
Time frame: 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

4 secondary outcomes

Change From Baseline at Week 25 in the 6 Minute Walk Test (6MWT) Distance
Time frame: Baseline, week 25
Change From Baseline to Week 25 in Usual Gait Speed (GS) Over 4 Meters
Time frame: baseline, week 25
Percentage Change From Baseline to Week 25 on Appendicular Skeletal Muscle Index (ASMI) Measured by Dual Energy X-ray Absorptiometry (DXA)
Time frame: baseline, week 25
Percentage Change From Baseline to Week 25 on Total Lean Body Mass Measured by Dual Energy X-ray Absorptiometry (DXA)
Time frame: baseline, week 25

Results and safety

Results posted to the registry on 6 Aug 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BYM338 70 mg	19	17
BYM338 210 mg	18	12
BYM338 700 mg	113	95
Placebo	67	64

Primary outcome: Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25

Time frame: Baseline, week 25. Mean (Standard Deviation). Unit: Score on a scale

Measure	BYM338 70 mg n = 19	BYM338 210 mg n = 18	BYM338 700 mg n = 113	Placebo n = 67
Baseline	7.1 (2.12)	7.3 (2.11)	7.2 (1.63)	7.3 (1.67)
Week 25	8.5 (2.48)	8.7 (1.64)	8.7 (2.12)	8.4 (2.25)

BYM338 70 mg vs Placebo: Mean Difference (Final Values): 0.28 (95% CI -0.64 to 1.21), p = 0.274, Mixed Models Analysis
BYM338 210 mg vs Placebo: Mean Difference (Final Values): 0.26 (95% CI -0.83 to 1.35), p = 0.320, Mixed Models Analysis
BYM338 700 mg vs Placebo: Mean Difference (Final Values): 0.31 (95% CI -0.24 to 0.87), p = 0.134, Mixed Models Analysis

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events and serious adverse events were collected for the maximum actual duration of treatment exposure and follow up for a participant per the protocol for approximately 25 weeks.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BYM338 70 mg	0 of 19 (0%)	12 of 19 (63.2%)	0 of 19
BYM338 210 mg	3 of 18 (16.7%)	13 of 18 (72.2%)	0 of 18
BYM338 700 mg	14 of 113 (12.4%)	94 of 113 (83.2%)	2 of 113
Placebo	5 of 67 (7.5%)	41 of 67 (61.2%)	0 of 67

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33074327Rooks D, Swan T, Goswami B, Filosa LA, Bunte O, Panchaud N, Coleman LA, Miller RR, Garcia Garayoa E, Praestgaard J, Perry RG, Recknor C, Fogarty CM, Arai H, Chen LK, Hashimoto J, Chung YS, Vissing J, Laurent D, Petricoul O, Hemsley S, Lach-Trifilieff E, Papanicolaou DA, Roubenoff R. Bimagrumab vs Optimized Standard of Care for Treatment of Sarcopenia in Community-Dwelling Older Adults: A Randomized Clinical Trial. JAMA Netw Open. 2020 Oct 1;3(10):e2020836. doi: 10.1001/jamanetworkopen.2020.20836.
A Plain Language Trial Summary is available on novartisclinicatrials.comLink provided by the sponsor.
Individual participant dataSharing planned: Undecided. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

58 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing bimagrumab in people with Sarcopenia, run by Novartis Pharmaceuticals at 58 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 58 sites in United States, Japan, France, Russia, Spain and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Total Short Physical Performance Battery (SPPB) Score to Week 25 (time frame: Baseline, week 25). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02333331, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.