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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BYM338 70 mg | Experimental | BYM338 70 mg intravenous infusion |
|
| BYM338 210 mg | Experimental | BYM338 210 mg intravenous infusion |
|
| BYM338 700 mg | Experimental | BYM338 700 mg intravenous infusion |
|
| Placebo | Placebo Comparator | Placebo intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bimagrumab | Drug | Bimagrumab will be administered as an intravenous infusion starting on Day 1 until week 21. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, week 25 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline, week 25 |
| Change From Baseline to Week 25 in Usual Gait Speed (GS) Over 4 Meters |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Little Rock | Arkansas | 72205 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33074327 | Derived | 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. |
| Label | URL |
|---|---|
| A Plain Language Trial Summary is available on novartisclinicatrials.com | View source |
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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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A total of 220 patients were randomized to receive six doses of either BYM338 70 mg, BYM338 210 mg, BYM338 700 mg or the placebo. However, only 217 patients were enrolled and dosed with BYM338 or placebo due to the withdrawal of three patients who did not meet the inclusion/exclusion criteria prior to receiving the first dose.
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| ID | Title | Description |
|---|---|---|
| FG000 | BYM338 70 mg | BYM338 70 mg intravenous infusion |
| FG001 | BYM338 210 mg | BYM338 210 mg intravenous infusion |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 16, 2018 | Jun 13, 2019 |
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|
| placebo | Other | Placebo will be administered as an intravenous infusion starting on Day 1 until week 21. |
|
|
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). |
| 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. | 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. | baseline, week 25 |
| Cypress |
| California |
| 90630 |
| United States |
| Novartis Investigative Site | La Jolla | California | 92093-9405 | United States |
| Novartis Investigative Site | Farmington | Connecticut | 06030-5215 | United States |
| Novartis Investigative Site | Gainesville | Florida | 32611 | United States |
| Novartis Investigative Site | Miami | Florida | 33143 | United States |
| Novartis Investigative Site | Miami Lakes | Florida | 33014 | United States |
| Novartis Investigative Site | Orlando | Florida | 32804 | United States |
| Novartis Investigative Site | Gainesville | Georgia | 30501 | United States |
| Novartis Investigative Site | Boston | Massachusetts | 02115 | United States |
| Novartis Investigative Site | Rochester | Minnesota | 55905 | United States |
| Novartis Investigative Site | High Point | North Carolina | 27262 | United States |
| Novartis Investigative Site | Columbus | Ohio | 43210 | United States |
| Novartis Investigative Site | Spartanburg | South Carolina | 29303 | United States |
| Novartis Investigative Site | Mesquite | Texas | 75150 | United States |
| Novartis Investigative Site | San Antonio | Texas | 78229 | United States |
| Novartis Investigative Site | Madison | Wisconsin | 53706 | United States |
| Novartis Investigative Site | Adelaide | South Australia | 5000 | Australia |
| Novartis Investigative Site | St Albans | Victoria | 3021 | Australia |
| Novartis Investigative Site | Brussels | 1090 | Belgium |
| Novartis Investigative Site | Leuven | 3000 | Belgium |
| Novartis Investigative Site | Brno | 62500 | Czechia |
| Novartis Investigative Site | Opava | 74601 | Czechia |
| Novartis Investigative Site | Prague | 12000 | Czechia |
| Novartis Investigative Site | Copenhagen | 2100 | Denmark |
| Novartis Investigative Site | Copenhagen NV | 2400 | Denmark |
| Novartis Investigative Site | Montpellier | 34295 | France |
| Novartis Investigative Site | Paris | 75013 | France |
| Novartis Investigative Site | Pessac | 33604 | France |
| Novartis Investigative Site | Toulouse | 31052 | France |
| Novartis Investigative Site | Berlin | 10117 | Germany |
| Novartis Investigative Site | Würzburg | 97074 | Germany |
| Novartis Investigative Site | Ōbu | Aichi-ken | 474-8511 | Japan |
| Novartis Investigative Site | Toyohashi | Aichi-ken | 440-8510 | Japan |
| Novartis Investigative Site | Mizunami | Gifu | 509 6134 | Japan |
| Novartis Investigative Site | Nara | Nara | 630-8581 | Japan |
| Novartis Investigative Site | Kawachi-Nagano | Osaka | 586-8521 | Japan |
| Novartis Investigative Site | Kitaadachigun Inamachi | Saitama | 362-0806 | Japan |
| Novartis Investigative Site | Kitamoto | Saitama | 364-8501 | Japan |
| Novartis Investigative Site | Yoshinogawa | Tokushima | 776-8585 | Japan |
| Novartis Investigative Site | Itabashi Ku | Tokyo | 173 0015 | Japan |
| Novartis Investigative Site | Kiyose | Tokyo | 204-0021 | Japan |
| Novartis Investigative Site | Koto-ku | Tokyo | 136-0075 | Japan |
| Novartis Investigative Site | Musashimurayama | Tokyo | 208-0011 | Japan |
| Novartis Investigative Site | Moscow | 101990 | Russia |
| Novartis Investigative Site | Moscow | 117997 | Russia |
| Novartis Investigative Site | Saint Petersburg | 190068 | Russia |
| Novartis Investigative Site | Yaroslavl | 150003 | Russia |
| Novartis Investigative Site | Bundang Gu | Gyeonggi-do | 13620 | South Korea |
| Novartis Investigative Site | Suwon | Gyeonggi-do | 16499 | South Korea |
| Novartis Investigative Site | Seoul | Korea | 02447 | South Korea |
| Novartis Investigative Site | Albacete | Castille-La Mancha | 02006 | Spain |
| Novartis Investigative Site | Getafe | Madrid | 28905 | Spain |
| Novartis Investigative Site | Barcelona | 08024 | Spain |
| Novartis Investigative Site | Madrid | 28034 | Spain |
| Novartis Investigative Site | Basel | CH | 4002 | Switzerland |
| Novartis Investigative Site | Geneva | 1211 | Switzerland |
| Novartis Investigative Site | Taipei | 11217 | Taiwan |
| FG002 |
| BYM338 700 mg |
BYM338 700 mg intravenous infusion |
| FG003 | Placebo | Placebo intravenous infusion |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | BYM338 70 mg | BYM338 70 mg intravenous infusion |
| BG001 | BYM338 210 mg | BYM338 210 mg intravenous infusion |
| BG002 | BYM338 700 mg | BYM338 700 mg intravenous infusion |
| BG003 | Placebo | Placebo intravenous infusion |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | Posted | Mean | Standard Deviation | Score on a scale | Baseline, week 25 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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 | 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. | Posted | Mean | Standard Deviation | meters | Baseline, week 25 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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). | 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. | Posted | Mean | Standard Deviation | m/sec | baseline, week 25 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Percent Change | baseline, week 25 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Percent Change | baseline, week 25 |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BYM338 70 mg | BYM338 70 mg intravenous infusion | 0 | 19 | 0 | 19 | 12 | 19 |
| EG001 | BYM338 210 mg | BYM338 210 mg intravenous infusion | 0 | 18 | 3 | 18 | 13 | 18 |
| EG002 | BYM338 700 mg | BYM338 700 mg intravenous infusion | 2 | 113 | 14 | 113 | 94 | 113 |
| EG003 | Placebo | Placebo intravenous infusion | 0 | 67 | 5 | 67 | 41 | 67 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Atrial flutter | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cardio-respiratory arrest | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pulseless electrical activity | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Colitis ulcerative | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Anaphylactic reaction | Immune system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Erysipelas | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Aortic injury | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Hepatic enzyme increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Metastases to lung | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
| |
| Renal neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (21.0) | Systematic Assessment |
| |
| Aphasia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Ischaemic stroke | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Subarachnoid haemorrhage | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Respiratory arrest | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Androgen deficiency | Endocrine disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Trichiasis | Eye disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dental necrosis | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Infusion site swelling | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Oedema | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Peripheral swelling | General disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Fungal skin infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Vaginal infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (21.0) | Systematic Assessment |
| |
| Arthropod bite | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA (21.0) | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Lipase increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA (21.0) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Muscle contractions involuntary | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Device dislocation | Product Issues | MedDRA (21.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Lower urinary tract symptoms | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Nocturia | Renal and urinary disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Actinic keratosis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Eczema asteatotic | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Skin fissures | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA (21.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (21.0) | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 8627788300 | novartis.email@novartis.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Oct 4, 2017 | Jun 13, 2019 | Prot_001.pdf |
| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D009133 | Muscular Atrophy |
| ID | Term |
|---|---|
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000596367 | bimagrumab |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
| Week 25 |
|
|
| Mean Difference (Final Values) |
| 0.26 |
| 2-Sided |
| 95 |
| -0.83 |
| 1.35 |
| Superiority |
| Mixed Models Analysis | 0.134 | Mean Difference (Final Values) | 0.31 | 2-Sided | 95 | -0.24 | 0.87 | Superiority |
| Units |
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| Counts |
|---|
| Participants |
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| Placebo |
Placebo intravenous infusion |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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| Title | Measurements |
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