Recent Updates
Recently added Catalysts

ALN-PCS02

Phase 1

Elevated LDL-Cholesterol (LDL-C) | Small molecule | Cardiovascular |Alnylam Pharmaceuticals, Inc.|Last Updated: Oct 12, 2012

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedPLACEBO_CONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

ALN-PCS02 · 1 trial · 1 indication

Phase 1 1
NCT01437059Trial to Evaluate Safety and Tolerability of ALN-PCS02 in Subjects With Elevated LDL-Cholesterol (LDL-C)Elevated LDL-Cholesterol (LDL-C)
COMPLETED32 Analytics
PHASE1COMPLETED
Trial to Evaluate Safety and Tolerability of ALN-PCS02 in Subjects With Elevated LDL-Cholesterol (LDL-C)
Elevated LDL-Cholesterol (LDL-C)Unlock trial analytics

Study Endpoints

Primary Endpoints

The proportion of subjects experiencing adverse events (AEs), serious adverse events (SAEs) and study drug discontinuation.
Up to 28 days

Secondary Endpoints

Pharmacokinetics (PK) of ALN-PCS02 (Cmax, tmax, t1/2, AUC0-last, CL).
Up to 180 days
Effect of ALN-PCS02 on Circulating PCSK9 Levels (Determination of % Lowering of PCSK9 to pretreatment/Baseline PCSK9 Level).
Up to 28 days
Effect of ALN-PCS02 on Circulating LDL-c Levels (Determination of % Lowering of LDL-c to pretreatment/Baseline LDL-c Level).
Up to 28 days
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ALN-PCS02ACTIVE_COMPARATOR -
Sterile Normal Saline (0.9% NaCl)PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
ALN-PCS02DRUGDose levels between 15 and 400 μg/kg by intravenous (IV) infusion
Sterile Normal Saline (0.9% NaCl)DRUGCalculated volume to match active comparator
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Elevated LDL-C of \>3.0 mmol/L and \<5.7 mmol/L * Fasting triglyceride concentration ≤2.8 mmol/L * Body weight \>60.0 kg; body mass index (BMI) between 19.00 kg/m2 and \<35.00 kg/m2 * Adequate blood counts, liver and renal function * May not received any lipid lowering drug/ag...

Countries:United Kingdom
Unlock Eligibility Criteria

Frequently asked questions about ALN-PCS02

What is ALN-PCS02 used for?

ALN-PCS02 is an investigational drug being studied for the treatment of elevated LDL-Cholesterol (LDL-C). It is being developed as a potential therapy for patients with high levels of LDL cholesterol, a condition associated with increased cardiovascular risk.

Who makes ALN-PCS02?

ALN-PCS02 is being developed by Alnylam Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALNY. The company is conducting clinical research to evaluate the safety and tolerability of this investigational drug.

What phase is ALN-PCS02 in?

ALN-PCS02 is in Phase 1 clinical development. It is an investigational drug that has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug remains under clinical investigation for its potential use in treating elevated LDL cholesterol.

What clinical trials is ALN-PCS02 in?

ALN-PCS02 has one completed clinical trial, registered as NCT01437059. This Phase 1 study evaluated the safety and tolerability of ALN-PCS02 in subjects with elevated LDL-Cholesterol. The trial was conducted in the United Kingdom and enrolled 32 participants.

Is ALN-PCS02 the same as any other drug?

ALN-PCS02 is the primary name for this investigational drug. No alternative names have been reported for this asset. It is being studied under this name in clinical trials for elevated LDL-Cholesterol.