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GAUSS-III - A Double-blind, Randomized, Multicenter Study to Evaluate the Safety and Efficacy of Evolocumab, Compared With Ezetimibe, in Hypercholesterolemic Subjects Unable to Tolerate an Effective Dose of a HMG-CoA Reductase Inhibitor Due to Muscle Related Side Effects
Enrollment: 519
Study Start Date: December 2013
Estimated Study Completion Date: November 2017
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. https://clinicaltrials.gov/ct2/show/NCT01984424?term=repatha&phase=2&ran...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Repatha (Evolocumab) (AMG 145)CardiovascularAtherosclerosisPCSK9 inhibitorPCSK9

Mechanism of action: Repatha (Evolocumab) (AMG 145) is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C from the blood causing bad cholesterol to increase. AMG 145, developed by Amgen scientists, binds to PCSK9 circulating in the blood and prevents PCSK9 from binding to LDL receptors in the liver. Without PCSK9 bound to them, the LDL receptors can take up and remove LDL-C from the blood, recycle and remain available for binding additional LDL-C.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2015-12-01 - 2016-02-29

Results:

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Amgen Announces Positive Top-Line Results From Phase 3 GAUSS-3 Trial Of Repatha® (Evolocumab) In Statin-Intolerant Patients With High Cholesterol
Study Meets Co-Primary Endpoints of LDL Cholesterol Reduction
THOUSAND OAKS, Calif., Feb. 4, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Phase 3 GAUSS-3 (Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects-3) trial evaluating Repatha® (evolocumab) in patients with high cholesterol who cannot tolerate statins met its co-primary endpoints: mean percent reductions from baseline in low-density lipoprotein cholesterol (LDL-C) at weeks 22 and 24, and the percent reduction from baseline in LDL-C at week 24. The mean percent reductions in LDL-C, or "bad" cholesterol, compared to ezetimibe, were consistent with results observed in the 12-week Phase 2 GAUSS-1 and Phase 3 GAUSS-2 trials.

"The positive results from the GAUSS-3 study contribute to the growing body of evidence supporting Repatha as an innovative treatment option for patients who have not been able to adequately lower their LDL cholesterol through diet and statins alone," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Many patients with high LDL cholesterol are unable to tolerate effective doses of statins, and the findings from the rigorously-designed GAUSS-3 study confirm the results in the previous GAUSS studies. We look forward to exploring these data further."

GAUSS-3 is a three-part trial that is evaluating the safety, tolerability and efficacy of Repatha, an injectable proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in patients with high cholesterol who could not tolerate statins due to muscle-related side effects (MRSE). The active-controlled part of the trial evaluated the effect of 24 weeks of treatment with Repatha compared to ezetimibe on percent change from baseline in LDL-C.

In the GAUSS-3 trial there were no new safety findings. The most common adverse events that occurred in greater than 5 percent of patients in the Repatha group were myalgia, nasopharyngitis, muscle spasms, arthralgia, pain in extremity, fatigue, headache and back pain.

The full data results from the Phase 3 GAUSS-3 trial will be submitted to a future medical conference and for publication.
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Source: press release, 2/04/16. http://wwwext.amgen.com/media/news-releases/2016/02/amgen-announces-posi...

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