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Lilly's (LLY) Tirzepatide Meets Endpoints in Late-Stage Study
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Eli Lilly & Company (LLY - Free Report) announced encouraging top-line data from the phase III study — SURPASS-1 — evaluating its dual GIP and GLP-1 receptor agonist (GIP/GLP-1 RA) candidate, tirzepatide, in patients with type II diabetes. Data from the study showed that the candidate is superior to placebo in reducing A1C (blood sugar) levels and body weight from the study baseline.
Shares of Lilly closed 5.8% higher on Dec 9 following the news. The company’s shares have gained 20.2% so far this year compared with the industry’s 4% increase.
The SURPASS-1 study evaluated three doses — 5 mg, 10 mg or 15 mg — of tirzepatide monotherapy for 40 weeks in type II diabetes patients who have not been treated with injectable therapy or received oral antidiabetic medicines within three months.
Data from the study showed that treatment with tirzepatide achieved statistically significant reduction in A1C levels and body weight in higher percentage of patients across all doses compared to placebo. Moreover, reduction of A1C level below 7% was achieved in statistically significant higher percentage of participants versus placebo for all dose groups. Please note that A1C level of 7% is the target level recommended by the American Diabetes Association's for people with diabetes. Additionally, the highest dose achieved A1C levels below 5.7%, normal A1C levels seen in people without diabetes, in 51.7% of patients compared to 0.9% for placebo. The highest dose also reduced body weight by 9.5kg or 11% and A1C levels by 2.07%.
Detailed data from the study will be presented at the American Diabetes Association's 81st Scientific Sessions and will be published in a peer-reviewed publication in 2021.
The SURPASS-1 study is part of SURPASS phase 3 global clinical development program for tirzepatide as a potential treatment for type II diabetes. The SURPASS program consists of eight clinical studies including five global registration studies. Further data from this program is anticipated in 2021. Tirzepatide is also in phase III studies for obesity and phase II in NASH.
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 is extremely crowded with players like Novartis (NVO - Free Report) , Sanofi (SNY - Free Report) , AstraZeneca (AZN - Free Report) and Merck.
In a separate press release, Lilly announced additional data from a pre-planned primary outcome analysis from the phase III monarchE study evaluating its cancer drug, Verzenio. Data showed that the drug in combination with standard adjuvant endocrine therapy (ET) decreased the risk of breast cancer recurrence by 28.7% compared to adjuvant ET alone in high-risk early breast cancer patients with hormone receptor-positive (HR+) or human epidermal growth factor receptor 2-negative (HER2-) mutation.
Experts extracted 7 stocks from the list of 220 Zacks Rank #1 Strong Buys that has beaten the market more than 2X over with a stunning average gain of +24.4% per year.
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Lilly's (LLY) Tirzepatide Meets Endpoints in Late-Stage Study
Eli Lilly & Company (LLY - Free Report) announced encouraging top-line data from the phase III study — SURPASS-1 — evaluating its dual GIP and GLP-1 receptor agonist (GIP/GLP-1 RA) candidate, tirzepatide, in patients with type II diabetes. Data from the study showed that the candidate is superior to placebo in reducing A1C (blood sugar) levels and body weight from the study baseline.
Shares of Lilly closed 5.8% higher on Dec 9 following the news. The company’s shares have gained 20.2% so far this year compared with the industry’s 4% increase.
The SURPASS-1 study evaluated three doses — 5 mg, 10 mg or 15 mg — of tirzepatide monotherapy for 40 weeks in type II diabetes patients who have not been treated with injectable therapy or received oral antidiabetic medicines within three months.
Data from the study showed that treatment with tirzepatide achieved statistically significant reduction in A1C levels and body weight in higher percentage of patients across all doses compared to placebo. Moreover, reduction of A1C level below 7% was achieved in statistically significant higher percentage of participants versus placebo for all dose groups. Please note that A1C level of 7% is the target level recommended by the American Diabetes Association's for people with diabetes. Additionally, the highest dose achieved A1C levels below 5.7%, normal A1C levels seen in people without diabetes, in 51.7% of patients compared to 0.9% for placebo. The highest dose also reduced body weight by 9.5kg or 11% and A1C levels by 2.07%.
Detailed data from the study will be presented at the American Diabetes Association's 81st Scientific Sessions and will be published in a peer-reviewed publication in 2021.
The SURPASS-1 study is part of SURPASS phase 3 global clinical development program for tirzepatide as a potential treatment for type II diabetes. The SURPASS program consists of eight clinical studies including five global registration studies. Further data from this program is anticipated in 2021. Tirzepatide is also in phase III studies for obesity and phase II in NASH.
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 is extremely crowded with players like Novartis (NVO - Free Report) , Sanofi (SNY - Free Report) , AstraZeneca (AZN - Free Report) and Merck.
In a separate press release, Lilly announced additional data from a pre-planned primary outcome analysis from the phase III monarchE study evaluating its cancer drug, Verzenio. Data showed that the drug in combination with standard adjuvant endocrine therapy (ET) decreased the risk of breast cancer recurrence by 28.7% compared to adjuvant ET alone in high-risk early breast cancer patients with hormone receptor-positive (HR+) or human epidermal growth factor receptor 2-negative (HER2-) mutation.
Eli Lilly and Company Price
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Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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