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INDIANAPOLIS, June 8, 2019 / PRNewswire / – The results of several studies of GIP and the Company's (NYSE: LLY) TPI (NYSE: LLY) dual GLP-1 (AR) receptor agonist are strengthening its potential for HbA1C levels and its weight in people with type 2 diabetes. Early research findings also confirm the potential benefit of tirzépatide in the treatment of other metabolic disorders. The following findings were presented at oral and poster presentations at the American Diabetes Association Conference.® 79th Scientific sessions® in San Francisco:
- improvements in markers of beta cell function (how pancreatic cells produce, store and release insulin) and sensitivity to insulin (how body cells respond to the insulin sensitivity). insulin) that help explain the effectiveness;1
- improved efficacy and tolerance with lower initial doses and lower dose increments;2
- significant reduction in A1C and body weight in Japanese with type 2 diabetes after only eight weeks of treatment;3 and
- improved markers of nonalcoholic steatohepatitis (NASH, liver inflammation and cell damage caused by liver fat) in people with type 2 diabetes.4
"This new data from Tirzepatides is based on the positive results seen so far in people with type 2 diabetes," he said. Juan P. Frias, M.D., Medical Director and Principal Investigator, National Research Institute. "The findings offer further evidence of the potential of tirzépatide to significantly reduce A1C levels and body weight in people with type 2 diabetes and to treat other metabolic disorders."
Tirzepatide shows improvements in markers that help explain the effectiveness
A sub-phase badysis 2b The results show that tirzépatide improves markers of beta cell function and insulin sensitivity in people with type 2 diabetes. Improvement in insulin sensitivity markers observed with RA GLP-1 was mainly explained by weight loss;5 The researchers therefore badyzed these markers in more detail to better understand whether GIP action in tirzépatide helped to create a unique profile. In contrast to the adverse effects of GLP-1, the improvements seen with tirzepatide (10 mg and 15 mg) were only partially attributed to weight loss (28% and 22%, respectively), suggesting that An independent effect of GIP on insulin sensitivity could contribute to the control of clinically significant blood glucose levels observed during the 26-week phase 2b study.1.6
Tirzepatide shows a steady positive impact on glycemic control and weight loss, while improving tolerance to dose increases
Data from a Phase 2 study lasting 12 weeks showed that an increase in the dosage of tirzépatide resulted in a reduction of gastrointestinal adverse events while maintaining efficacy. observed during the phase. 2b study. Lower study dropout rates were also observed. To inform the optimal dosage of the phase 3 program, the researchers evaluated three graded-dose regimens of tirzépatide to determine their impact on the composite GI side effects (nausea, vomiting and diarrhea) and their effectiveness. . The results showed:2
- Treatment with tirzépatide resulted in a significant reduction in A1C levels (up to 2.0%) and weight loss (up to 5.7 kg), which is consistent with 2b study;
- Gastrointestinal adverse events were mild to moderate and were generally lower than those 2b study;
- treatment discontinuation rates due to adverse events related to tirzépatide were less than 5%, comparable to placebo and overall lower than those in the phase 2b study.
Data from this study and other studies on tirzépatide, as well as modeling, confirm that a lower initial dose and smaller incremental dose increases improve tolerance, which has informed the chosen dosing strategy. for the Phase 3 clinical trial program – SURPASS – launched in late 2018.
Results from another study – an eight-week trial conducted among Japanese people with type 2 diabetes – showed significant reductions in HbA1c (up to 2.05%) and body weight (up to 5.1 kg) after treatment with tirzépatide.3 This study also supports significant reductions in A1C and body weight observed in the 2b This study suggests that the potential of tirzépatide for the effective treatment of people with type 2 diabetes is homogeneous in all populations.
Tirzepatide has potential for therapeutic impact on NASH
Given the relationship between NASH and type 2 diabetes, the researchers badyzed the impact of tirzépatide on several markers badociated with NASH. In a phase badysis 2b In a study of people with type 2 diabetes, the researchers found that treatment with tirzépatide led to an improvement in markers related to NASH. A phase 2b A study exploring tirzepatide in NASH will be launched later this year.
"We are excited about the potential of tirzepatide to have a significant impact on people with type 2 diabetes and other conditions, including obesity and NASH," he said. Brad Woodward, M.D., world leader in development, Incretins, Lilly. "The results of tirzepatide observed during the initial and intermediate trials pave the way for our large-scale Phase 3 programs, reinforce our commitment to continue research with different populations and support its potential to respond to a need for treatment not satisfied."
Lilly will welcome a call for investors on Monday, June 10, at 10:00 am EDT (7:00 am PDT) to discuss the company's presentations at the 79 th meeting of the American Diabetes Associationth Scientific sessions.
About diabetes
About 30 million Americans7 and about 425 million adults worldwide have diabetes.8 Type 2 diabetes is the most common type internationally. It is estimated that it accounts for 90 to 95% of all diabetes cases United States only.7 Diabetes is a chronic disease that occurs when the body does not produce or use insulin, a hormone.8
About Lilly Diabetes
Lilly has been a world leader in diabetes care since 1923, when we launched the world's first commercial insulin. Today, we build on this legacy by striving to meet the diverse needs of people with diabetes and those who care for them. Through research, collaboration and quality manufacturing, we strive to improve the lives of people with diabetes. We offer a wide range of therapies and a constant desire to provide real solutions, from drugs to technologies, to support programs, etc. For the latest updates, visit http://www.lillydiabetes.com/ or follow us on Twitter: @LillyDiabetes and Facebook: LillyDiabetesUS.
About Eli Lilly and the company
Lilly is a global leader in healthcare that combines care and discovery to make life better for people around the world. We were founded more than a century ago by a man committed to creating high quality drugs that meet real needs. Today, we remain faithful to this mission in all our work. Around the world, Lilly employees work to discover life-changing medicines for those who need them, improve disease understanding and management, and empower communities through philanthropy and volunteerism. . To learn more about Lilly, please visit www.lilly.com and www.lilly.com/newsroom/social-channels. P-LLY
This press release contains forward-looking statements (within the meaning of the Private Securities Litigation Reform Act, 1995) that Tirzepatida is a potential treatment for patients with diabetes and dementia. other metabolic disorders and reflects Lilly's current beliefs. However, as with any pharmaceutical product, the development and commercialization process involves significant uncertainties and risks. Among other things, there is no guarantee that the results of future studies will be consistent with the results to date nor that Tirzépatide will achieve its primary study objectives or obtain regulatory approvals. For more details on these and other risks and uncertainties, see Lilly's most recent filings on Forms 10-K and 10-Q with the US Securities and Exchange Commission. Unless required by law, Lilly badumes no obligation to update any forward-looking statements to reflect events that occur after the date of this release.
1. Thomas MK, Nikooienejad A, Bray R, et al. Tirzepatide, a GIP-receptor agonist and GLP-1, improves markers of beta cell function and insulin sensitivity in patients with type 2 diabetes. Abstract 980-P. Presented at the 79 American Diabetes Associationth Scientific sessions; June 7-11, San Francisco, CALIFORNIA.
2. JP Frias, MA Nauck, Van J, et al. A randomized, placebo-controlled, 12-week study evaluating the efficacy and safety of three dose-escalation algorithms of tirzépatide, a new dual-GIP and GLP-1 receptor agonist, in patients with diabetes of type 2. Summary 993-P. Presented at the 79 American Diabetes Associationth Scientific sessions; June 7-11, San Francisco, CALIFORNIA.
3. Ohwaki K., Furihata K., Mimura H. et al. Effect of tirzépatide, an agonist of GIP and GLP-1 receptors, on glycemic control and body weight in Japanese patients with T2DM. Abstract 1024-P. Presented at the 79 American Diabetes Associationth Scientific sessions; June 7-11, San Francisco, CALIFORNIA.
4. Hartman ML, Sanyal A, Loomba R, et al. Effects of tirzépatide (TZP), a new GIP and GLP-1 receptor agonist, on the biomarkers of non-alcoholic steatohepatitis (NASH) in patients with T2DM. Summary 134-OR. Presented at the 79 American Diabetes Associationth Scientific sessions; June 7-11, San Francisco, CALIFORNIA.
5. Fonseca VA, Capehorn MS, Garg SKet al. The reduction in insulin resistance is primarily through weight loss in subjects with type 2 diabetes taking semaglutide. Journal of Clinical Endocrinology & Metabolism 2019; published online April 2. DOI: 10.1210 / jc.2018-02685. Available at: https://academic.oup.com/jcem/advance-article-abstract/doi/10.1210/jc.2018-02685/5423568?redirectedFrom=fulltext.
6. JP Frias, MA Nauck, Van J, et al. Efficacy and safety of LY3298176, a new GIP-GLP-1 receptor agonist, in patients with type 2 diabetes: randomized, placebo-controlled, active-controlled phase 2 trial. Lancet 2018; published online October 4th. DOI: 10.1016 / S0140-6736 (18) 32260-8. Available at the following address: http://www.thelancet.com/journals/lancet/article/PIIS0140-6736(18)32260-8/fulltext.
7. Centers for Disease Control and Prevention. National Report on Diabetes Statistics, 2017. Atlanta, GA: Centers for Disease Control and Prevention, US Department of Health and Human Services; 2017
8. International Diabetes Federation. IDF Diabetes Atlas8th edn. Brussels, Belgium: International Diabetes Federation, 2017. http://www.diabetesatlas.org.
See: Dani Barnhizer; [email protected]; 317-607-6119 (Lilly Diabetes)
SOURCE Eli Lilly and Company
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