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MPSK3169A

Phase 2

Coronary Heart Disease | 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 Enrollment248

FDA Designations

No designations recorded

Clinical trial landscape

MPSK3169A · 1 trial · 1 indication

Phase 2 1
NCT01609140A Phase II Study of the Safety and Efficacy of MPSK3169A in Patients With Coronary Heart Disease or High Risk of Coronary Heart DiseaseCoronary Heart Disease
COMPLETED248 Analytics
PHASE2COMPLETED
A Phase II Study of the Safety and Efficacy of MPSK3169A in Patients With Coronary Heart Disease or High Risk of Coronary Heart Disease
Coronary Heart DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Absolute change from baseline in LDL-c concentration
at Day 169

Secondary Endpoints

Absolute change from baseline in LDL-c concentration for each arm at the nadir for that arm
over the 24 week treatment period
Average value over time of the change in LDL-c (absolute and percent change) for each arm, up to Day 169, weighted by the number of weeks between consecutive LDL-c measurements
up to Day 169
Percent change from baseline in LDL-c concentration at Day 169 and at the nadir for each arm
at Day 169 and over the 24 week treatment period
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -
BEXPERIMENTAL -
CEXPERIMENTAL -
DEXPERIMENTAL -
EEXPERIMENTAL -
FPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
MPSK3169ADRUGDose regimen A, repeating subcutaneous injections every 4 weeks
PlaceboDRUGRepeating subcutaneous injections of placebo every 4 weeks
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites73

Inclusion Criteria: * Use of a standard-of-care statin at a stable dose, or intolerance of statins, without use of other lipid modifying therapies * Fasting LDL cholesterol 90-250 mg/dL on the statin regimen above And at least one of the following: * Coronary heart disease (CHD) with a history of...

Countries:United StatesCanadaCzechiaGermanyHungaryNew ZealandNorwaySlovakiaSouth Africa
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Frequently asked questions about MPSK3169A

What is MPSK3169A used for?

MPSK3169A is an investigational small molecule being studied for the treatment of Coronary Heart Disease. It is being developed by Roche Holding AG (RHHBY) and is currently in Phase 2 clinical development. The drug has been evaluated in a completed Phase 2 trial involving patients with coronary heart disease or at high risk of the condition.

Who makes MPSK3169A?

MPSK3169A is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this investigational small molecule for the treatment of Coronary Heart Disease. The drug is currently in Phase 2 development.

What phase is MPSK3169A in?

MPSK3169A is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by regulatory authorities. A Phase 2 trial has been completed, evaluating the safety and efficacy of MPSK3169A in patients with Coronary Heart Disease or at high risk of the condition.

What clinical trials is MPSK3169A in?

MPSK3169A has one completed clinical trial, NCT01609140, a Phase 2 study of its safety and efficacy in patients with Coronary Heart Disease or at high risk of the condition. The trial enrolled 248 participants across multiple countries, including the United States, Canada, Germany, and others.

Is MPSK3169A FDA approved?

MPSK3169A is not FDA approved. It is an investigational drug currently in Phase 2 clinical development for Coronary Heart Disease. A Phase 2 trial has been completed, but the drug has not yet received regulatory approval for any indication.

How does MPSK3169A work?

MPSK3169A is a small molecule being developed by Roche Holding AG for the treatment of Coronary Heart Disease. The specific molecular target of MPSK3169A has not been disclosed in available information. It is currently in Phase 2 clinical development, with one completed trial evaluating its safety and efficacy.