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March 19, 2020updated 12 Jul 2022 11:57am

Novartis’ trials of cholesterol-lowering therapy meet primary endpoints

Novartis’ Phase III clinical trials for inclisiran, an investigational first-in-class siRNA cholesterol-lowering therapy, have met their primary endpoints of durable and potent LDL-C reductions versus placebo.

Novartis’ Phase III clinical trials for inclisiran, an investigational first-in-class siRNA cholesterol-lowering therapy, have met their primary endpoints of durable and potent LDL-C reductions versus placebo.

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
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Inclisiran is a potential small interfering RNA (siRNA) investigational agent used to treat hyperlipidemia in adults.

ORION-9, the first pivotal Phase III, placebo-controlled, double-blind, randomised study evaluated the efficacy, safety and tolerability of 300mg inclisiran sodium in 482 patients with clinical or genetic evidence of heterozygous familial hypercholesterolemia (HeFH).

The study administrated the drug in two starter doses and then every six months.

In ORION-10, 300mg of inclisiran sodium was administered in an initial dose, again at three months, and then every six months in 1,561 participants with ASCVD and elevated LDL-C.

The Phase III, placebo-controlled, double-blind, randomised ORION-11 study also evaluated the efficacy, safety, and tolerability of 300mg inclisiran sodium in 1,617 patients. The international study was conducted at 70 sites in seven countries.

In all three studies, the drug was found to be well-tolerated with a safety profile similar to placebo.

ORION-11 principal investigator Kausik Ray said: “Inclisiran and its twice-yearly dosing schedule in three large trials consistently delivered potent and sustained cholesterol-lowering and was generally well tolerated.

“These data provide support for this groundbreaking approach to reducing LDL-C in patients who are not achieving LDL-C treatment goals with the current standard of care.”

The most common adverse reactions reported during the trials were diabetes mellitus, hypertension, nasopharyngitis, arthralgia, back pain, dypspnea, bronchitis and upper respiratory tract infection.

Adverse events at the injection site were noted to be more frequent with inclisiran than placebo and were generally mild. None were severe or persistent.

Hyperlipidemia refers to the high level of lipids, such as Low Density Lipoprotein Cholesterol (LDL-C). Elevated LDL-C levels can lead to ASCVD, which may cause cardiovascular event such as a heart attack or stroke.

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Direct-to-Patient Trials: How IRT Plays an Important Role in Bellerophon's Direct-to-Patient Trials

As the industry strengthens its focus on patient centricity, Direct-to-Patient clinical trials have emerged as a popular trial design that have the potential to increase patient recruitment and retention. IRT plays a crucial role in the success of a Direct-to-Patient trial. Because drug supplies are being managed and shipped from distribution facilities directly to patients’ homes, a sponsor must have a high-quality system in place to accurately track the chain of custody, ensure patient-blinding and handle other logistical challenges. What You Will Learn Benefits and challenges associated with the Direct-to-Patient model Bellerophon's top considerations when implementing this trial design How IRT can equip study teams to successfully track chain of custody, ensure patient blinding, and handle logistical challenges
by Suvoda
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