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Lilly's (LLY) Fifth Tirzepatide Study Meets All Key Endpoints
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Eli Lilly and Company (LLY - Free Report) announced that the phase III – SURPASS-4 – study evaluating its dual GIP and GLP-1 receptor agonist, tirzepatide, has met all of its primary and key secondary endpoints.
Top-line data from the above-mentioned study showed that treatment with tirzepatide led to superior A1C (a measure of blood glucose) and body weight reductions from baseline across all three doses (5 mg, 10 mg and 15 mg) compared with titrated insulin glargine in adults with type II diabetes who have increased cardiovascular risk.
The highest dose of tirzepatide led to an A1C reduction of 2.58% and weight loss of 11.7 kg compared with A1C reduction of 1.44% and weight gain of 1.9 kg for insulin glargine at 52 weeks of treatment.
Notably, the SURPASS-4 study is the fifth and final global registration study for tirzepatide in type II diabetes to have been successfully completed. With this, the SURPASS program has now met regulatory submission requirements for evaluating cardiovascular risk for diabetes medications.
Lilly plans to submit the registration package for tirzepatide to regulatory authorities by 2021-end.
Shares of the company have rallied 18.1% so far this year compared with the industry’s increase of 6.6%.
We remind investors that, in December 2020, Lilly announced encouraging top-line data from the SURPASS-1 phase III study on tirzepatide, which showed that the candidate was superior to placebo in reducing A1C levels and body weight from the study baseline.
The SURPASS program consists of eight clinical studies, including five global registration studies. Tirzepatide is also in phase III studies for obesity and phase II studies in NASH, a serious liver disorder.
We note that 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. However, the diabetes market remains extremely crowded with players like Novartis (NVO - Free Report) , Sanofi (SNY - Free Report) , AstraZeneca (AZN - Free Report) and Merck.
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 77 billion devices by 2025, creating a $1.3 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 4 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2022.
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Lilly's (LLY) Fifth Tirzepatide Study Meets All Key Endpoints
Eli Lilly and Company (LLY - Free Report) announced that the phase III – SURPASS-4 – study evaluating its dual GIP and GLP-1 receptor agonist, tirzepatide, has met all of its primary and key secondary endpoints.
Top-line data from the above-mentioned study showed that treatment with tirzepatide led to superior A1C (a measure of blood glucose) and body weight reductions from baseline across all three doses (5 mg, 10 mg and 15 mg) compared with titrated insulin glargine in adults with type II diabetes who have increased cardiovascular risk.
The highest dose of tirzepatide led to an A1C reduction of 2.58% and weight loss of 11.7 kg compared with A1C reduction of 1.44% and weight gain of 1.9 kg for insulin glargine at 52 weeks of treatment.
Notably, the SURPASS-4 study is the fifth and final global registration study for tirzepatide in type II diabetes to have been successfully completed. With this, the SURPASS program has now met regulatory submission requirements for evaluating cardiovascular risk for diabetes medications.
Lilly plans to submit the registration package for tirzepatide to regulatory authorities by 2021-end.
Shares of the company have rallied 18.1% so far this year compared with the industry’s increase of 6.6%.
We remind investors that, in December 2020, Lilly announced encouraging top-line data from the SURPASS-1 phase III study on tirzepatide, which showed that the candidate was superior to placebo in reducing A1C levels and body weight from the study baseline.
The SURPASS program consists of eight clinical studies, including five global registration studies. Tirzepatide is also in phase III studies for obesity and phase II studies in NASH, a serious liver disorder.
We note that 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. However, the diabetes market remains extremely crowded with players like Novartis (NVO - Free Report) , Sanofi (SNY - Free Report) , AstraZeneca (AZN - Free Report) and Merck.
Zacks Rank
Lilly currently carries a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
More Stock News: This Is Bigger than the iPhone!
It could become the mother of all technological revolutions. Apple sold a mere 1 billion iPhones in 10 years but a new breakthrough is expected to generate more than 77 billion devices by 2025, creating a $1.3 trillion market.
Zacks has just released a Special Report that spotlights this fast-emerging phenomenon and 4 tickers for taking advantage of it. If you don't buy now, you may kick yourself in 2022.
Click here for the 4 trades >>