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BYM338 active drug

Phase 2

Cachexia | Small molecule | Oncology |Novartis AG|Last Updated: Mar 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment57

FDA Designations

No designations recorded

Clinical trial landscape

BYM338 active drug · 1 trial · 1 indication

Phase 2 1
NCT01433263Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the PancreasCachexia
COMPLETED57 Analytics
PHASE2COMPLETED
Clinical Study of BYM338 for the Treatment of Unintentional Weight Loss in Patients With Cancer of the Lung or the Pancreas
Cachexia
NCT0143326357
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Study Endpoints

Primary Endpoints

Percentage Change From Baseline of Thigh Muscle Volume (TMV) by MRI Scan at Week 8
Baseline, week 8

Thigh Muscle Volume (TMV) change was evaluated by a responder analysis. Patients whose loss of muscle TMV by MRI was no more than or equal to 2% at Week 8 was considered responders.

Secondary Endpoints

Percentage Change in Body Weight From Baseline at Week 7 and Week 9
Baseline, Week 7 and Week 9
Maximum Observed Serum Concentration (Cmax)
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8
Time to Reach the Maximum Concentration After Drug Administration (Tmax)
0, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96 hours post-dose on Day 1 and Week 8
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
30mg/kg BYM338EXPERIMENTAL -
Placebo / late 30mg/kg BYM338PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
BYM338 active drugDRUG -
PlaceboDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

Key Inclusion criteria: 1. Patients must sign an informed consent before assessment 2. Patients with pathologically and/or clinically confirmed diagnosis of stage IV non-small (squamous or non-squamous) cell lung cancer (NSCLC) or stage III/IV adenocarcinoma of the pancreas. 3. Patients with stage ...

Countries:United StatesLithuaniaRomaniaSwitzerlandUnited Kingdom
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Frequently asked questions about BYM338 active drug

What is BYM338 used for?

BYM338 is an investigational small molecule being studied for the treatment of cachexia, specifically unintentional weight loss in patients with cancer of the lung or the pancreas. It is being developed by Novartis AG and is currently in Phase 2 clinical development.

What does BYM338 target?

The specific molecular target of BYM338 is not disclosed in the available information. The drug is being studied for its potential to treat cachexia, a condition of severe weight loss and muscle wasting, in cancer patients.

Who makes BYM338?

BYM338 is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol NVS. The drug is currently in Phase 2 clinical trials for the treatment of cachexia in cancer patients.

What phase is BYM338 in?

BYM338 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed to evaluate its safety and efficacy in treating cachexia.

What clinical trials is BYM338 in?

BYM338 has one completed Phase 2 clinical trial, identified as NCT01433263. This study evaluated the drug for the treatment of unintentional weight loss in patients with cancer of the lung or the pancreas. The trial enrolled 57 participants and was conducted in the United States, Lithuania, Romania, Switzerland, and the United Kingdom.

Is BYM338 the same as bimagrumab?

BYM338 is also known as bimagrumab. It is an investigational drug being developed by Novartis AG for the treatment of cachexia in cancer patients. The drug is currently in Phase 2 clinical development.