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Clinical trials for Bimagrumab

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    6 result(s) found for: Bimagrumab. Displaying page 1 of 1.
    EudraCT Number: 2016-004124-26 Sponsor Protocol Number: CBYM338X2211 Start Date*: 2017-09-16
    Sponsor Name:Novartis Pharma AG
    Full Title: A randomized, subject- and investigator-blinded, placebo-controlled study to assess the safety, pharmacokinetics and efficacy of intravenous bimagrumab in overweight and obese patients with type 2 ...
    Medical condition: Diabetes Mellitus, Type 2
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2014-003482-25 Sponsor Protocol Number: CBYM338E2202 Start Date*: 2015-01-30
    Sponsor Name:Novartis Farmacéutica, S.A.
    Full Title: A 28 week, randomized, double-blind, placebo-controlled, multi-center, parallel group dose range finding study to assess the effect of monthly doses of bimagrumab 70, 210, and 700 mg on skeletal mu...
    Medical condition: sarcopenia
    Disease: Version SOC Term Classification Code Term Level
    17.1 10028395 - Musculoskeletal and connective tissue disorders 10063024 Sarcopenia PT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DK (Completed) BE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2015-000471-27 Sponsor Protocol Number: CBYM338E2202E1 Start Date*: 2015-10-15
    Sponsor Name:Novartis Farmacéutica, S.A.
    Full Title: A 28 week randomized withdrawal extension of a doubleblind, placebo-controlled, parallel group study to assess durability of effect on skeletal muscle strength and function upon withdrawal of bimag...
    Medical condition: Sarcopenia
    Disease: Version SOC Term Classification Code Term Level
    18.0 10028395 - Musculoskeletal and connective tissue disorders 10063024 Sarcopenia PT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: ES (Completed) BE (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2013-003439-31 Sponsor Protocol Number: CBYM338D2201 Start Date*: 2014-06-17
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A 24-week Double-blind Treatment and 24-week Follow-up, Randomized, Multicenter, Placebo-controlled, Phase IIa/IIb Study to Evaluate Safety and Efficacy of i.v. Bimagrumab on Total Lean Body Mass a...
    Medical condition: Patients with muscle wasting (atrophy) after hip fracture surgery and subsequent postsurgical rehabilitation
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004859 10028371 Muscular wasting and disuse atrophy, not elsewhere classified LLT
    20.0 10022117 - Injury, poisoning and procedural complications 10020100 Hip fracture PT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: BE (Completed) GB (Completed) DE (Completed) HU (Completed) CZ (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2015-001411-12 Sponsor Protocol Number: CBYM338B2203E1 Start Date*: 2015-11-04
    Sponsor Name:Novartis Pharma Services AG
    Full Title: Extension of the CBYM338B2203 phase IIb/III study to evaluate the long-term efficacy, safety and tolerability of intravenous BYM338 in patients with sporadic inclusion body myositis
    Medical condition: Sporadic Inclusion Body Myositis
    Disease: Version SOC Term Classification Code Term Level
    18.0 10028395 - Musculoskeletal and connective tissue disorders 10066407 Inclusion body myositis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) NL (Completed) DK (Completed) GB (Completed) BE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2013-000705-23 Sponsor Protocol Number: CBYM338B2203 Start Date*: 2014-02-09
    Sponsor Name:Novartis Farma SpA
    Full Title: A randomized, double-blind, placebo-controlled, multicenter, parallel group, dose-finding, pivotal, phase IIb/III study to evaluate the efficacy, safety and tolerability of intravenous BYM338 at 52...
    Medical condition: Sporadic Inclusion Body Myositis
    Disease: Version SOC Term Classification Code Term Level
    14.1 10028395 - Musculoskeletal and connective tissue disorders 10066407 Inclusion body myositis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) NL (Completed) DE (Completed) BE (Completed) GB (Completed) DK (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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