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MLDL1278A

Phase 2

Atherosclerosis | Small molecule | Cardiovascular |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment147

FDA Designations

No designations recorded

Clinical trial landscape

MLDL1278A · 1 trial · 1 indication

Phase 2 1
NCT01258907A Study to Evaluate the Safety, Tolerability, and Activity of Intravenous MLDL1278A in Patients on Standard-of-Care Therapy for Stable Atherosclerotic Cardiovascular Disease (GLACIER)Atherosclerosis
COMPLETED147 Analytics
PHASE2COMPLETED
A Study to Evaluate the Safety, Tolerability, and Activity of Intravenous MLDL1278A in Patients on Standard-of-Care Therapy for Stable Atherosclerotic Cardiovascular Disease (GLACIER)
AtherosclerosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in TBR as measured by FDG-PET/CT
Baseline to Week 12

Secondary Endpoints

Incidence and severity of adverse events and clinical laboratory abnormalities as a measure of safety and tolerability of MLDL1278A
Throughout study or until early discontinuation
Effects of MLDL1278A on inflammatory and metabolic biomarkers
Throughout study or until early discontinuation
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -
BEXPERIMENTAL -
CPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
MLDL1278ADRUGSingle intravenous dose
placeboDRUGRepeating intravenous dose
statin, stable doseDRUGRepeating oral dose
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Eligibility Criteria

Age Range35 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites24

Inclusion Criteria: * Evidence of qualifying vessel (carotid or aortic) plaque inflammation * Documented atherosclerotic vascular disease clinically stable for at least 3 months prior to screening or type 2 diabetes mellitus with elevated cardiovascular risk * Use of a stable dose of statin therapy...

Countries:United StatesCanada
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Frequently asked questions about MLDL1278A

What is MLDL1278A used for?

MLDL1278A is an investigational small molecule being studied for the treatment of atherosclerosis, a condition characterized by the buildup of plaque in the arteries. It is administered intravenously and is being evaluated in patients with stable atherosclerotic cardiovascular disease who are already receiving standard-of-care therapy.

Who is developing MLDL1278A?

MLDL1278A is being developed by Roche Holding AG, which trades under the ticker RHHBY. The drug is currently in Phase 2 clinical development for atherosclerosis, a cardiovascular condition.

What phase is MLDL1278A in?

MLDL1278A is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities and is still being studied for safety and efficacy in clinical trials.

What clinical trials is MLDL1278A in?

MLDL1278A has been studied in one completed Phase 2 clinical trial with the identifier NCT01258907. This trial, known as GLACIER, evaluated the safety, tolerability, and activity of intravenous MLDL1278A in patients with stable atherosclerotic cardiovascular disease. The trial enrolled 147 participants in the United States and Canada.

Is MLDL1278A the same as GLACIER?

MLDL1278A is the drug being studied in the GLACIER clinical trial, which has the identifier NCT01258907. GLACIER is the name of the trial, not an alternative name for the drug itself. The trial evaluated the safety, tolerability, and activity of MLDL1278A in patients with atherosclerosis.