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Lilly Begins Cardiovascular Outcomes Study on Tirzepatide

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Eli Lilly & Company (LLY - Free Report) announced the initiation of a cardiovascular (CV) outcome study on its dual GIP and GLP-1 receptor agonist (GIP/GLP-1 RA) candidate, tirzepatide. The first patient dose has been delivered in the phase III study (SURPASS-CVOT) to evaluate if tirzepatide can reduce the risk of cardiovascular events in patients with type II diabetes and atherosclerotic cardiovascular disease 

The head-to-head study will evaluate non-inferiority and superiority of tirzepatide to Lilly’s blockbuster GLP-1 receptor agonist, Trulicity. Please note that Trulicity is already approved to reduce the risk of major adverse cardiovascular events (MACE) in type II diabetes patients.

The large phase III study will include 12,500 participants from 30 countries. It will measure time to first occurrence of MACE-3, the composite endpoint of CV death and myocardial infarction or stroke, which will be the study’s primary endpoint. Lilly expects the study to get completed in over four years.

Tirzepatide is being evaluated in phase III studies to reduce blood sugar levels and body weight in type II diabetes patients. The candidate has shown impressive blood sugar reductions and weight loss in type II diabetes patients. Tirzepatide is also in phase III studies for obesity and phase II in NASH.

Lilly’s shares have risen 13.5% this year so far against a decrease of 1.1% for the industry.

 

 

Lilly has a strong portfolio of medicines to treat diabetes that includes drugs like Tradjenta, Jardiance, Trulicity, Synjardy, Synjardy XR, Glyxambi (a fixed dose combination of Jardiance/metformin), Basalgar and Humalog U-200 KwikPen. Trulicity, its highest revenue generating product, recorded sales of $1.23 billion in the first quarter of 2020. Meanwhile, Trulicity as well as Jardiance are approved for the cardiovascular indications which have improved the drugs’ sales. Lilly is also developing an automated insulin delivery system (phase II) to automate insulin dosing in type I diabetes in order to make diabetes management easier.

However, the diabetes market is extremely crowded with players like Novartis (NVO - Free Report) , Sanofi (SNY - Free Report) , AstraZeneca (AZN - Free Report) and Merck.

Lilly currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

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