Latest news with #efsitora
Medscape
14 hours ago
- Health
- Medscape
Once-Weekly Efsitora Noninferior to Daily Insulin in T2D
CHICAGO — The investigational once-weekly basal insulin analog efsitora alfa lowered A1c as effectively as daily basal insulins in people with type 2 diabetes (T2D) who require insulin, showed three trials from the QWINT global phase 3 clinical trial program. However, two of the trials showed increased mild hypoglycemia in patients treated with efsitora, which some experts say is a concern. The QWINT-1 trial compared the efficacy and safety of a fixed-dose regimen of efsitora with once-daily glargine for 52 weeks in insulin-naive people with T2D; QWINT-3 compared efsitora with daily degludec for 78 weeks in adults already taking basal insulin; and QWINT-4 compared efsitora with daily glargine for 26 weeks in adults with T2D taking both basal and pre-meal bolus insulin. Results from the three trials were presented on June 22 during a single symposium here at the American Diabetes Association (ADA) 85th Scientific Sessions and simultaneously published in the New England Journal of Medicine (QWINT-1) and The Lancet (QWINT-3 and QWINT-4). QWINT-1: Fixed-Dose Efsitora QWINT-1 was an open-label trial of 795 adults with T2D who had not previously taken insulin. Participants were randomized to weekly efsitora delivered by a single-use auto-injector or daily injected insulin glargine. Efsitora was titrated to four fixed doses at 4-week intervals, as needed for blood glucose control. At week 52, efsitora had reduced A1c from 8.20% at baseline to 7.05% (–1.19 percentage points), compared with 8.28% to 7.08% with glargine (–1.16 percentage points), confirming noninferiority. "The novel fixed-dose regimen used in QWINT-1 for once-weekly efsitora, with titration options of only four different doses, can facilitate and substantially simplify initiating and escalating insulin therapy, potentially changing the insulin management paradigm in type 2 diabetes," lead investigator Julio Rosenstock, MD, senior scientific advisor for Velocity Clinical Research and clinical professor of medicine at the University of Texas Southwestern Medical Center, Dallas, said during a press briefing held at the meeting. In addition, the rate of combined clinically significant hypoglycemia (< 54 mg/dL) or severe hypoglycemia (requiring assistance for treatment) was significantly lower with efsitora than glargine (0.50 vs 0.88 events per participant-year of exposure with glargine [estimated rate ratio, 0.57]). In an editorial accompanying QWINT-1, NEJM Deputy Editor Julie R. Ingelfinger, MD, and Clifford J. Rosen, MD, director of clinical and translational research and a senior scientist at Maine Medical Center's Research Institute, Scarborough, write: "The present trial of efsitora potentially offers a ready-made and possibly straightforward algorithm for dose escalation. If packaged at a widely affordable price, efsitora would most likely simplify glycemic control for many persons with type 2 diabetes." However, limitations of QWINT-1 include the open-label design and lack of use of continuous glucose monitoring (CGM), Ingelfinger and Rosen note. QWINT-3 and QWINT-4 In both QWINT-3 and QWINT-4, efsitora was administered using traditional insulin dosing with adjustments based on each patient's glucose level. In QWINT-3, 986 adults with T2D who had already been treated with basal insulin and other noninsulin glucose-lowering medications, were randomized 2:1 to weekly efsitora or daily degludec. At week 26, A1c decreased by 0.81 percentage points with efsitora versus 0.72 with degludec, also meeting the noninferiority margin. Combined level 2 and 3 hypoglycemia from baseline to week 78 was similar in the efsitora and degludec groups, at 0.84 versus 0.74 events per patient-year, respectively. However, level 1 (mild) hypoglycemia was significantly more common with efsitora (8.34 vs 6.05; P = .0005). Nine deaths occurred during the trial but none were related to study treatment. In QWINT-4, 730 participants with T2D who had been treated with both basal and prandial insulin and up to three noninsulin glucose-lowering agents were randomized to efsitora or glargine U100, both with premeal insulin lispro. Mean baseline A1c was 8.18%. At 26 weeks, mean A1c was 7.17% in the efsitora group and 7.18% in the glargine group, meeting noninferiority criteria. As in QWINT-3, rates of moderate/severe hypoglycemia in QWINT-4 did not differ between the efsitora and glargine groups (6.6 vs 5.9 events per patient-year; P = .44), but mild hypoglycemia was more common with efsitora (25.3 vs 19.0; P < .0004). Other adverse event rates were similar. Is Hypoglycemia a Problem With Weekly Insulin? These three new studies round out the QWINT program, as results from QWINT-5, in type 1 diabetes (T1D), and from QWINT-2, in insulin-naive adults with T2D, were presented at the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting. Hypoglycemia emerged as a significant issue with efsitora compared with insulin degludec in adults with T1D in the QWINT-5 trial. Another once-weekly insulin analog, Novo-Nordisk's insulin Icodec, has been approved under the brand name Awiqli in the European Union, Canada, Australia, Japan, and Switzerland for T1D and T2D, and in China for T2D. However, the US Food and Drug Administration requested more data to address the concern about hypoglycemia in T1D. "The risk of hypoglycemia remains a crucial factor when evaluating the safety of novel insulin preparations with a long half-life, such as efsitora, which has a half-life of 17 days," wrote Edith WK Chow, MD, and Elaine Chow, MD, PhD, both of The Chinese University of Hong Kong, in an editorial accompanying QWINT-3 and QWINT-4. "In both trials, the efsitora group had higher rates of overall level 1 hypoglycemia. When stratified by study timeline, higher rates of hypoglycemia were observed within the first 12 weeks of the study in both trials," they point out. In addition, they note that because CGM use was only intermittent and masked for participants, "the actual rate of hypoglycemic events might be underestimated, especially in the presence of hypoglycemia unawareness, which has been reported to be as high as 40% of people with type 2 diabetes using continuous glucose monitoring. Even asymptomatic episodes might be associated with increased cardiovascular risk." Asked about this at the press briefing, Rosenstock said that the increased mild hypoglycemia was "just little numerical imbalances. And the most important thing is that the number of events per patient per year are very low. It's less than one event per patient per year. I think that is something that we can take." Asked to comment on all three new QWINT studies, independent industry consultant Charles Alexander, MD, told Medscape Medical News : "Whether once-weekly insulin will be an advantage compared to once-daily insulin will depend upon factors like cost, convenience, and individual preference." Ingelfinger and Rosen agree with Alexander that the use of efsitora may depend on coverage, cost, and availability. "Long-term, formal government approval for efsitora is awaited, and uptake by patients is not yet known," they write. "The advent of newer or more effective noninsulin hypoglycemic drugs such as the GLP-1 receptor agonists, which simultaneously also produce weight loss, might ultimately be a more appealing option than efsitora and allow greater patient adherence than weekly insulin in some patients with type 2 diabetes." Despite these unknowns and caveats, the development of even longer-acting insulins now offers promising options for better glucose control in this disease," Ingelfinger and Rosen conclude. Rosenstock has reported receiving research grant support from, serving on advisory boards for, and/or receiving consulting fees honoraria from Applied Therapeutics, AstraZeneca, Biomea Fusion, Boehringer Ingelheim, Corcept, Eli Lilly, Hanmi, Merck, Novartis, Novo Nordisk, Oramed, Pfizer, Regeneron, Regor Therapeutics, Roche, Sanofi, Structure Therapeutics, and Terns Pharmaceuticals. Ingelfinger is a licensee of St. Martin's Press. Edith WK Chow has reported receiving travel sponsorship from Boehringer Ingelheim. Elaine Chow has reported receiving speaker honoraria from AstraZeneca, Boehringer Ingelheim, and Sinocare and institutional research grant support from Hua Medicine, Merck KGaA, and Medtronic Diabetes. All proceeds were donated to The Chinese University of Hong Kong for research purposes. Rosen and Alexander had no disclosures.
Malaysian Reserve
18 hours ago
- Health
- Malaysian Reserve
Lilly's once-weekly insulin efsitora alfa demonstrated A1C reduction and a safety profile consistent with daily insulin in multiple Phase 3 trials
Results from the fixed-dose QWINT-1 study, along with the QWINT-3 and QWINT-4 studies, reinforce efsitora's potential to simplify insulin management with weekly dosing Lilly plans to submit efsitora for the treatment of adults with type 2 diabetes to global regulatory agencies by the end of this year INDIANAPOLIS, June 22, 2025 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) today announced detailed results from QWINT-1, QWINT-3, and QWINT-4 Phase 3 clinical trials evaluating the safety and efficacy of investigational once-weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes who used insulin for the first time, previously used daily basal insulin, and previously used daily basal insulin and mealtime insulin, respectively. In each trial, once-weekly efsitora met the primary endpoint of non-inferior A1C reduction compared to daily basal insulin. The complete results from these studies were presented at the American Diabetes Association (ADA) 85th Scientific Sessions 2025. Simultaneously, results from QWINT-1, a first-of-its-kind fixed-dose study, were published in The New England Journal of Medicine, while results from QWINT-3 and QWINT-4 were published in The Lancet. In QWINT-1, efsitora reduced A1C by 1.31% compared to 1.27% for insulin glargine at week 52 for the efficacy estimand.1,2 In the trial, efsitora was titrated to four fixed doses at four-week intervals, as needed for blood glucose control.3 In QWINT-3, efsitora reduced A1C by 0.86% compared to 0.75% for insulin degludec at week 26 for the efficacy estimand.4 In QWINT-4, efsitora reduced A1C by 1.07% compared to 1.07% for insulin glargine at week 26 for the efficacy estimand.5 In these two trials, efsitora was administered using traditional insulin dosing with adjustments based on each patient's glucose level. 'The novel fixed-dose regimen used in QWINT-1 for once-weekly efsitora, which consisted of only four single-dose titration options, has the potential to facilitate and simplify insulin therapy, reducing the hesitation often associated with starting insulin to treat type 2 diabetes,' said Dr. Julio Rosenstock, senior scientific advisor for Velocity Clinical Research at Medical City Dallas, clinical professor of medicine, University of Texas Southwestern Medical Center, and lead trial investigator for QWINT-1. 'A simpler, once-weekly regimen with efsitora may help people with type 2 diabetes initiate and manage insulin therapy with the goal of improving blood sugar levels. Across all QWINT trials, the results showed that once-weekly efsitora controlled glucose as effectively as the most popular once-daily basal insulins.' QWINT-1 Primary Endpoint Efficacy Estimand Treatment-RegimenEstimand6 Primary Endpoint – A1C Reduction (Resulting A1C) at Week 52 Efsitora -1.31 % (6.92 %) -1.19 % (7.05 %) Glargine -1.27 % (6.96 %) -1.16 % (7.08 %) QWINT-3 Primary and Key Secondary Endpoints Efficacy Estimand Treatment-RegimenEstimand Primary Endpoint – A1C Reduction (Resulting A1C) at Week 26 Efsitora -0.86 % (6.93 %) -0.81 % (6.99 %) Degludec -0.75 % (7.03 %) -0.72 % (7.08 %) Key Secondary Endpoint – Rates of Clinically Significant or Severe Nocturnal Hypoglycemic Events Per Patient-Year of Exposure up to Week 787,8 Efsitora 0.11 Degludec 0.10 Key Secondary Endpoint – Percent Time in Range (70-180 mg/dL) During the FourWeeks Prior to Week 26 Efsitora 62.8 % 61.4 % Degludec 61.3 % 61.0 % QWINT-4 Primary and Key Secondary Endpoints Efficacy Estimand Treatment-Regimen Estimand Primary Endpoint – A1C Reduction (Resulting A1C) at Week 26 Efsitora -1.07 % (7.12 %) -1.01 % (7.17 %) Glargine -1.07 % (7.11 %) -1.00 % (7.18 %) Key Secondary Endpoint – Participants Achieving A1C <7% at Week 26 Without Nocturnal Hypoglycemia Efsitora 39.5 % 38.6 % Glargine 36.6 % 35.9 % Key Secondary Endpoint – Rates of Clinically Significant or Severe NocturnalHypoglycemic Events Per Patient-Year of Exposure up to Week 26 Efsitora 0.67 Glargine 1.00 'Building on Lilly's legacy of innovation in insulin therapy, once-weekly efsitora may offer a significant advancement for people with type 2 diabetes who need insulin by eliminating over 300 injections per year,' said Jeff Emmick, M.D., Ph.D., senior vice president of product development at Lilly. 'These results reinforce the potential for once-weekly efsitora to help reduce the overall burden of insulin therapy through a simplified treatment approach. We look forward to working with regulatory agencies to bring this innovation to patients around the world.' Across the three trials, efsitora demonstrated an overall safety profile similar to two of the most commonly used daily basal insulin therapies for the treatment of type 2 diabetes. In QWINT-1, efsitora resulted in approximately 40% fewer hypoglycemic events compared to insulin glargine, with estimated combined rates of severe or clinically significant hypoglycemic events per patient-year of exposure of 0.50 with efsitora vs. 0.88 with insulin glargine at 52 weeks. In QWINT-3, these rates were 0.84 with efsitora vs. 0.74 with insulin degludec at 78 weeks. In QWINT-4, estimated combined rates of severe or clinically significant hypoglycemic events per patient-year of exposure were 6.6 with efsitora vs. 5.9 with insulin glargine at 26 weeks. Lilly plans to submit efsitora for the treatment of adults with type 2 diabetes to global regulatory agencies by the end of this year. About the QWINT clinical trial programThe QWINT Phase 3 global clinical development program for insulin efsitora alfa (efsitora) in diabetes began in 2022 and has enrolled more than 3,000 people living with type 2 diabetes across four global registration studies. QWINT-1 (NCT05662332) was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin using a fixed dose escalation to daily insulin glargine for 52 weeks in insulin-naïve adults with type 2 diabetes. The trial randomized 795 participants across the U.S., Argentina and Mexico to receive efsitora once weekly or insulin glargine once daily, administered subcutaneously. Participants treated with efsitora received a starting dose of 100 units of insulin, followed by escalation to fixed dosages of 150 units, 250 units and 400 units every four weeks, as needed, until achieving a target fasting blood glucose of 80-130 mg/dL. Participants with fasting blood glucose greater than 130 mg/dL on or after 16 weeks were transferred to flexible dosing. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 52 with efsitora compared to daily use of insulin glargine. QWINT-3 (NCT05275400) was a multicenter, randomized, parallel-design, open-label trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin to insulin degludec for 78 weeks after a three-week lead-in followed by a five-week safety follow up period, in adults with type 2 diabetes who are currently treated with basal insulin. The trial randomized 986 participants across the U.S., Argentina, Hungary, Japan, Korea, Poland, Puerto Rico, Slovakia, Spain and Taiwan to receive efsitora once weekly or insulin degludec once daily, administered subcutaneously. The primary objective of the study was to demonstrate non-inferiority in reducing A1C at week 26 with efsitora compared to insulin degludec. QWINT-4 (NCT05462756) was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a weekly basal insulin to insulin glargine for 26 weeks in adults with type 2 diabetes who have previously been treated with basal insulin and at least two injections per day of mealtime insulin. The trial randomized 730 participants across the U.S., Argentina, Germany, India, Italy, Mexico, Puerto Rico and Spain to receive efsitora once weekly or insulin glargine once daily, both of which were administered subcutaneously along with insulin lispro. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 26 with efsitora compared to insulin glargine. About insulin efsitora alfaInsulin efsitora alfa (efsitora) is a once-weekly basal insulin, a fusion protein that combines a novel single-chain variant of insulin with a human IgG2 Fc domain. It is specifically designed for once-weekly subcutaneous administration, and with its low peak-to-trough ratio, it has the potential to provide more stable glucose levels (less glucose variability) throughout the week. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit and or follow us on Facebook, Instagram, and LinkedIn. P-LLY The efficacy estimand represents the treatment effect on all participants who adhered to the study drug without initiating rescue therapy for persistent severe hyperglycemia. From a baseline of 8.20% for efsitora and 8.28% for insulin glargine. Participants treated with efsitora received a starting dose of 100 units of insulin, followed by escalation to fixed dosages of 150 units, 250 units and 400 units every four weeks, as needed, until achieving a target fasting blood glucose of 80-130 mg/dL. Participants with fasting blood glucose greater than 130 mg/dL on or after 16 weeks were transferred to flexible dosing. From a baseline of 7.80% for both efsitora and insulin degludec. From a baseline of 8.18% for both efsitora and insulin glargine. The treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation or introduction of rescue therapy for persistent severe hyperglycemia. Blood glucose <54 mg/dL. Nocturnal hypoglycemia was defined as any event that occurred at night between midnight and 6 a.m. Cautionary Statement Regarding Forward-Looking StatementsThis press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about insulin efsitora alfa as a potential treatment for people with type 2 diabetes and the timeline for future readouts, presentations, and other milestones relating to insulin efsitora alfa and its clinical trials and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that future study results will be consistent with study results to date, that insulin efsitora alfa will prove to be a safe and effective treatment for type 2 diabetes, that insulin efsitora alfa will receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. Trademarks and Trade NamesAll trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Refer to: Niki Biro; niki_biro@ 317-358-9074 (Media) Michael Czapar; czapar_michael_c@ 317-617-0983 (Investors)
Yahoo
18 hours ago
- Health
- Yahoo
Lilly's once-weekly insulin efsitora alfa demonstrated A1C reduction and a safety profile consistent with daily insulin in multiple Phase 3 trials
Results from the fixed-dose QWINT-1 study, along with the QWINT-3 and QWINT-4 studies, reinforce efsitora's potential to simplify insulin management with weekly dosing Lilly plans to submit efsitora for the treatment of adults with type 2 diabetes to global regulatory agencies by the end of this year INDIANAPOLIS, June 22, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced detailed results from QWINT-1, QWINT-3, and QWINT-4 Phase 3 clinical trials evaluating the safety and efficacy of investigational once-weekly insulin efsitora alfa (efsitora) in adults with type 2 diabetes who used insulin for the first time, previously used daily basal insulin, and previously used daily basal insulin and mealtime insulin, respectively. In each trial, once-weekly efsitora met the primary endpoint of non-inferior A1C reduction compared to daily basal insulin. The complete results from these studies were presented at the American Diabetes Association (ADA) 85th Scientific Sessions 2025. Simultaneously, results from QWINT-1, a first-of-its-kind fixed-dose study, were published in The New England Journal of Medicine, while results from QWINT-3 and QWINT-4 were published in The Lancet. In QWINT-1, efsitora reduced A1C by 1.31% compared to 1.27% for insulin glargine at week 52 for the efficacy estimand.1,2 In the trial, efsitora was titrated to four fixed doses at four-week intervals, as needed for blood glucose control.3 In QWINT-3, efsitora reduced A1C by 0.86% compared to 0.75% for insulin degludec at week 26 for the efficacy estimand.4 In QWINT-4, efsitora reduced A1C by 1.07% compared to 1.07% for insulin glargine at week 26 for the efficacy estimand.5 In these two trials, efsitora was administered using traditional insulin dosing with adjustments based on each patient's glucose level. "The novel fixed-dose regimen used in QWINT-1 for once-weekly efsitora, which consisted of only four single-dose titration options, has the potential to facilitate and simplify insulin therapy, reducing the hesitation often associated with starting insulin to treat type 2 diabetes," said Dr. Julio Rosenstock, senior scientific advisor for Velocity Clinical Research at Medical City Dallas, clinical professor of medicine, University of Texas Southwestern Medical Center, and lead trial investigator for QWINT-1. "A simpler, once-weekly regimen with efsitora may help people with type 2 diabetes initiate and manage insulin therapy with the goal of improving blood sugar levels. Across all QWINT trials, the results showed that once-weekly efsitora controlled glucose as effectively as the most popular once-daily basal insulins." QWINT-1 Primary EndpointEfficacy Estimand Treatment-RegimenEstimand6 Primary Endpoint – A1C Reduction (Resulting A1C) at Week 52 Efsitora -1.31 % (6.92 %) -1.19 % (7.05 %) Glargine -1.27 % (6.96 %) -1.16 % (7.08 %)QWINT-3 Primary and Key Secondary EndpointsEfficacy Estimand Treatment-RegimenEstimand Primary Endpoint – A1C Reduction (Resulting A1C) at Week 26 Efsitora -0.86 % (6.93 %) -0.81 % (6.99 %) Degludec -0.75 % (7.03 %) -0.72 % (7.08 %) Key Secondary Endpoint – Rates of Clinically Significant or Severe Nocturnal Hypoglycemic Events Per Patient-Year of Exposure up to Week 787,8 Efsitora 0.11 Degludec 0.10 Key Secondary Endpoint – Percent Time in Range (70-180 mg/dL) During the FourWeeks Prior to Week 26 Efsitora 62.8 % 61.4 % Degludec 61.3 % 61.0 %QWINT-4 Primary and Key Secondary EndpointsEfficacy Estimand Treatment-Regimen Estimand Primary Endpoint – A1C Reduction (Resulting A1C) at Week 26 Efsitora -1.07 % (7.12 %) -1.01 % (7.17 %) Glargine -1.07 % (7.11 %) -1.00 % (7.18 %) Key Secondary Endpoint – Participants Achieving A1C <7% at Week 26 Without Nocturnal Hypoglycemia Efsitora 39.5 % 38.6 % Glargine 36.6 % 35.9 % Key Secondary Endpoint – Rates of Clinically Significant or Severe NocturnalHypoglycemic Events Per Patient-Year of Exposure up to Week 26 Efsitora 0.67 Glargine 1.00 "Building on Lilly's legacy of innovation in insulin therapy, once-weekly efsitora may offer a significant advancement for people with type 2 diabetes who need insulin by eliminating over 300 injections per year," said Jeff Emmick, M.D., Ph.D., senior vice president of product development at Lilly. "These results reinforce the potential for once-weekly efsitora to help reduce the overall burden of insulin therapy through a simplified treatment approach. We look forward to working with regulatory agencies to bring this innovation to patients around the world." Across the three trials, efsitora demonstrated an overall safety profile similar to two of the most commonly used daily basal insulin therapies for the treatment of type 2 diabetes. In QWINT-1, efsitora resulted in approximately 40% fewer hypoglycemic events compared to insulin glargine, with estimated combined rates of severe or clinically significant hypoglycemic events per patient-year of exposure of 0.50 with efsitora vs. 0.88 with insulin glargine at 52 weeks. In QWINT-3, these rates were 0.84 with efsitora vs. 0.74 with insulin degludec at 78 weeks. In QWINT-4, estimated combined rates of severe or clinically significant hypoglycemic events per patient-year of exposure were 6.6 with efsitora vs. 5.9 with insulin glargine at 26 weeks. Lilly plans to submit efsitora for the treatment of adults with type 2 diabetes to global regulatory agencies by the end of this year. About the QWINT clinical trial programThe QWINT Phase 3 global clinical development program for insulin efsitora alfa (efsitora) in diabetes began in 2022 and has enrolled more than 3,000 people living with type 2 diabetes across four global registration studies. QWINT-1 (NCT05662332) was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin using a fixed dose escalation to daily insulin glargine for 52 weeks in insulin-naïve adults with type 2 diabetes. The trial randomized 795 participants across the U.S., Argentina and Mexico to receive efsitora once weekly or insulin glargine once daily, administered subcutaneously. Participants treated with efsitora received a starting dose of 100 units of insulin, followed by escalation to fixed dosages of 150 units, 250 units and 400 units every four weeks, as needed, until achieving a target fasting blood glucose of 80-130 mg/dL. Participants with fasting blood glucose greater than 130 mg/dL on or after 16 weeks were transferred to flexible dosing. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 52 with efsitora compared to daily use of insulin glargine. QWINT-3 (NCT05275400) was a multicenter, randomized, parallel-design, open-label trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin to insulin degludec for 78 weeks after a three-week lead-in followed by a five-week safety follow up period, in adults with type 2 diabetes who are currently treated with basal insulin. The trial randomized 986 participants across the U.S., Argentina, Hungary, Japan, Korea, Poland, Puerto Rico, Slovakia, Spain and Taiwan to receive efsitora once weekly or insulin degludec once daily, administered subcutaneously. The primary objective of the study was to demonstrate non-inferiority in reducing A1C at week 26 with efsitora compared to insulin degludec. QWINT-4 (NCT05462756) was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a weekly basal insulin to insulin glargine for 26 weeks in adults with type 2 diabetes who have previously been treated with basal insulin and at least two injections per day of mealtime insulin. The trial randomized 730 participants across the U.S., Argentina, Germany, India, Italy, Mexico, Puerto Rico and Spain to receive efsitora once weekly or insulin glargine once daily, both of which were administered subcutaneously along with insulin lispro. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 26 with efsitora compared to insulin glargine. About insulin efsitora alfaInsulin efsitora alfa (efsitora) is a once-weekly basal insulin, a fusion protein that combines a novel single-chain variant of insulin with a human IgG2 Fc domain. It is specifically designed for once-weekly subcutaneous administration, and with its low peak-to-trough ratio, it has the potential to provide more stable glucose levels (less glucose variability) throughout the week. About Lilly Lilly is a medicine company turning science into healing to make life better for people around the world. We've been pioneering life-changing discoveries for nearly 150 years, and today our medicines help tens of millions of people across the globe. Harnessing the power of biotechnology, chemistry and genetic medicine, our scientists are urgently advancing new discoveries to solve some of the world's most significant health challenges: redefining diabetes care; treating obesity and curtailing its most devastating long-term effects; advancing the fight against Alzheimer's disease; providing solutions to some of the most debilitating immune system disorders; and transforming the most difficult-to-treat cancers into manageable diseases. With each step toward a healthier world, we're motivated by one thing: making life better for millions more people. That includes delivering innovative clinical trials that reflect the diversity of our world and working to ensure our medicines are accessible and affordable. To learn more, visit and or follow us on Facebook, Instagram, and LinkedIn. P-LLY The efficacy estimand represents the treatment effect on all participants who adhered to the study drug without initiating rescue therapy for persistent severe hyperglycemia. From a baseline of 8.20% for efsitora and 8.28% for insulin glargine. Participants treated with efsitora received a starting dose of 100 units of insulin, followed by escalation to fixed dosages of 150 units, 250 units and 400 units every four weeks, as needed, until achieving a target fasting blood glucose of 80-130 mg/dL. Participants with fasting blood glucose greater than 130 mg/dL on or after 16 weeks were transferred to flexible dosing. From a baseline of 7.80% for both efsitora and insulin degludec. From a baseline of 8.18% for both efsitora and insulin glargine. The treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation or introduction of rescue therapy for persistent severe hyperglycemia. Blood glucose <54 mg/dL. Nocturnal hypoglycemia was defined as any event that occurred at night between midnight and 6 a.m. Cautionary Statement Regarding Forward-Looking StatementsThis press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995) about insulin efsitora alfa as a potential treatment for people with type 2 diabetes and the timeline for future readouts, presentations, and other milestones relating to insulin efsitora alfa and its clinical trials and reflects Lilly's current beliefs and expectations. However, as with any pharmaceutical product, there are substantial risks and uncertainties in the process of drug research, development, and commercialization. Among other things, there is no guarantee that future study results will be consistent with study results to date, that insulin efsitora alfa will prove to be a safe and effective treatment for type 2 diabetes, that insulin efsitora alfa will receive regulatory approval, or that Lilly will execute its strategy as expected. For further discussion of these and other risks and uncertainties that could cause actual results to differ from Lilly's expectations, see Lilly's Form 10-K and Form 10-Q filings with the United States Securities and Exchange Commission. Except as required by law, Lilly undertakes no duty to update forward-looking statements to reflect events after the date of this release. Trademarks and Trade NamesAll trademarks or trade names referred to in this press release are the property of the company, or, to the extent trademarks or trade names belonging to other companies are referenced in this press release, the property of their respective owners. Solely for convenience, the trademarks and trade names in this press release are referred to without the ® and ™ symbols, but such references should not be construed as any indicator that the company or, to the extent applicable, their respective owners will not assert, to the fullest extent under applicable law, the company's or their rights thereto. We do not intend the use or display of other companies' trademarks and trade names to imply a relationship with, or endorsement or sponsorship of us by, any other companies. Refer to: Niki Biro; niki_biro@ 317-358-9074 (Media)Michael Czapar; czapar_michael_c@ 317-617-0983 (Investors) View original content to download multimedia: SOURCE Eli Lilly and Company Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
