In a first-of-its-kind fixed dose study, once weekly insulin efsitora alfa leads to A1C reduction similar to daily insulin
Eli Lilly has announced positive topline results from two phase 3 clinical trials, QWINT-1 and QWINT-3, evaluating once weekly insulin efsitora alfa in adults with type 2 diabetes. The trials showed that efsitora was non-inferior to daily basal insulins in reducing A1C levels.
QWINT-1 studied insulin-naïve patients, using a novel fixed-dose regimen with four doses administered via a single-use autoinjector. QWINT-3 focused on patients switching from daily basal insulin. Both trials met their primary endpoints, demonstrating similar A1C reductions to daily insulins glargine and degludec, respectively.
Efsitora showed a comparable safety profile to daily basal insulins, with QWINT-1 reporting approximately 40% lower rates of severe or clinically significant hypoglycemic events compared to insulin glargine.
Eli Lilly ha annunciato risultati positivi preliminari da due studi clinici di fase 3, QWINT-1 e QWINT-3, che valutano l'insulina efsitora alfa da somministrare una volta a settimana in adulti con diabete di tipo 2. Gli studi hanno dimostrato che efsitora era non inferiore agli insulina basali giornalieri nella riduzione dei livelli di A1C.
QWINT-1 ha studiato pazienti naive all'insulina, utilizzando un nuovo regime a dose fissa con quattro dosi somministrate tramite un autoiniettore monouso. Il QWINT-3 si è concentrato su pazienti che cambiavano dal trattamento con insulina basale giornaliera. Entrambi gli studi hanno raggiunto i loro obiettivi primari, dimostrando riduzioni simili di A1C rispetto agli insuline giornalieri glargine e degludec, rispettivamente.
Efsitora ha mostrato un profilo di sicurezza comparabile a quello degli insuline basali giornalieri, con il QWINT-1 che riportava circa il 40% in meno di eventi ipoglicemici gravi o clinicamente significativi rispetto all'insulina glargine.
Eli Lilly ha anunciado resultados preliminares positivos de dos ensayos clínicos de fase 3, QWINT-1 y QWINT-3, evaluando la insulina efsitora alfa administrada una vez a la semana en adultos con diabetes tipo 2. Los ensayos mostraron que efsitora era no inferior a las insulinas basales diarias en la reducción de los niveles de A1C.
QWINT-1 estudió a pacientes naïve a insulina, utilizando un nuevo régimen de dosis fija con cuatro dosis administradas a través de un autoinyector de un solo uso. QWINT-3 se centró en pacientes que cambiaban de insulina basal diaria. Ambos ensayos cumplieron sus objetivos primarios, demostrando reducciones de A1C similares a las insulinas diarias glargina y degludec, respectivamente.
Efsitora mostró un perfil de seguridad comparable al de las insulinas basales diarias, con QWINT-1 reportando tasas de eventos hipoglucémicos severos o clínicamente significativos aproximadamente un 40% más bajas en comparación con la insulina glargina.
일라이 릴리는 2형 당뇨병 성인에서 주 1회 인슐린 에프시토라 알파를 평가하는 3상 임상시험 QWINT-1 및 QWINT-3의 긍정적인 주요 결과를 발표했습니다. 이 시험들은 에프시토라가 A1C 수치를 줄이는 데 있어 일일 기저 인슐린보다 비열등하다는 것을 보여주었습니다.
QWINT-1은 인슐린을 사용하지 않은 환자들을 연구했으며, 새로운 고정 용량 요법을 사용하여 단일 사용 자가 주입기를 통해 네 가지 용량을 투여했습니다. QWINT-3는 일일 기저 인슐린에서 전환하는 환자에 중점을 두었습니다. 두 시험 모두 주요 목표를 달성하였으며, 각각 glargine 및 degludec과 같은 일일 인슐린에 비슷한 A1C 감소를 보여주었습니다.
에프시토라는 일일 기저 인슐린과 비교 가능한 안전성 프로파일을 보여주었으며, QWINT-1에서는 인슐린 글라진과 비교하여 약 40% 낮은 심각하거나 임상적으로 중요한 저혈당 사건의 비율을 보고했습니다.
Eli Lilly a annoncé des résultats préliminaires positifs de deux essais cliniques de phase 3, QWINT-1 et QWINT-3, évaluant l'insuline efsitora alfa administrée une fois par semaine chez des adultes atteints de diabète de type 2. Les essais ont montré qu'efsitora était non inférieur aux insulines basales quotidiennes dans la réduction des niveaux de A1C.
QWINT-1 a étudié des patients naïfs d'insuline, en utilisant un nouveau schéma à dose fixe avec quatre doses administrées via un auto-injecteur à usage unique. QWINT-3 s'est concentré sur des patients changeant de l'insuline basale quotidienne. Les deux essais ont atteint leurs objectifs primaires, montrant des réductions similaires de l'A1C par rapport à l'insuline glargine et dégludec, respectivement.
Efsitora a présenté un profil de sécurité comparable à celui des insulines basales quotidiennes, avec QWINT-1 rapportant environ 40 % de taux d'événements hypoglycémiques graves ou cliniquement significatifs inférieurs à ceux de l'insuline glargine.
Eli Lilly hat positive vorläufige Ergebnisse aus zwei klinischen Studien der Phase 3, QWINT-1 und QWINT-3, veröffentlicht, die einmal wöchentliche Insulin efsitora alfa bei Erwachsenen mit Typ-2-Diabetes bewerten. Die Studien zeigten, dass efsitora nicht unterlegen zu täglichen Basalinsulinen in der Reduktion der A1C-Werte war.
QWINT-1 untersuchte insulin-naive Patienten und verwendete ein neues Festdosisregime mit vier Dosen, die über einen Einweg-Autoinjektor verabreicht wurden. QWINT-3 konzentrierte sich auf Patienten, die von täglichem Basalinsulin wechselten. Beide Studien erreichten ihre primären Endpunkte und zeigten ähnliche A1C-Reduktionen wie die täglichen Insuline Glargine und Degludec.
Efsitora zeigte ein vergleichbares Sicherheitsprofil zu den täglichen Basalinsulinen, wobei QWINT-1 etwa 40 % niedrigere Raten schwerer oder klinisch signifikanter Hypoglykämieereignisse im Vergleich zu Insulin Glargine berichtete.
- Efsitora showed non-inferior A1C reduction compared to daily basal insulins in both trials
- QWINT-1 trial used a novel fixed-dose regimen, potentially simplifying insulin therapy initiation
- In QWINT-1, efsitora showed approximately 40% lower rates of severe or clinically significant hypoglycemic events compared to insulin glargine
- QWINT-3 participants on efsitora spent more time in glucose range compared to baseline
- In QWINT-3, efsitora showed slightly higher rates of severe or clinically significant hypoglycemic events compared to insulin degludec (0.84 vs 0.74 events per patient-year)
Insights
The phase 3 QWINT-1 and QWINT-3 trials for Eli Lilly's once-weekly insulin efsitora alfa show promising results for type 2 diabetes management. In QWINT-1, efsitora demonstrated non-inferior A1C reduction compared to daily insulin glargine in insulin-naïve patients, with A1C reductions of
Eli Lilly's positive results for efsitora alfa could significantly impact the
Efsitora's potential to "transform diabetes care" is not hyperbole. The diabetes management market has long awaited innovations that reduce treatment burden. A once-weekly, fixed-dose insulin addresses key patient pain points: injection frequency and dosing complexity. This could lead to improved adherence, better outcomes and increased patient satisfaction. Market adoption might be swift, especially among newly diagnosed patients and those struggling with daily regimens. However, the success will depend on Lilly's ability to educate healthcare providers and overcome potential resistance to changing established treatment protocols. Long-term data on cardiovascular outcomes and cost-effectiveness studies will be important for widespread acceptance and favorable reimbursement decisions.
In the phase 3 study, QWINT-1, efsitora was administered via four fixed doses once weekly in a single-use autoinjector in people with type 2 diabetes using basal insulin for the first time
In a second phase 3 study, QWINT-3, efsitora also delivered non-inferior A1C reduction compared to daily insulin in people with type 2 diabetes switching from daily basal injections
"Once weekly insulins, like efsitora, have the potential to transform diabetes care as we know it," said Jeff Emmick, M.D., Ph.D., senior vice president, product development, Lilly. "Many patients are reluctant to start insulin because of the burden it places on them. With a simple fixed-dose regimen, once-weekly efsitora could make it easier for people with diabetes to start and manage insulin therapy, while reducing the impact it has on their day-to-day lives."
QWINT-1 evaluated the efficacy and safety of once weekly efsitora compared to once daily insulin glargine for 52 weeks. The trial randomized adults with type 2 diabetes who are insulin naïve to receive either efsitora once weekly in a single-use autoinjector or insulin glargine once daily. Efsitora was titrated across four fixed doses1 at four-week intervals, as needed for blood glucose control. The study's goal was to provide data supporting real-life applications of fixed dose regimens, which have the potential to make it easier for people living with diabetes to start and manage insulin therapy.
The trial met its primary endpoint of non-inferior A1C reduction with efsitora compared to insulin glargine at week 52. For the efficacy estimand2,3, efsitora reduced A1C by
QWINT-3 evaluated the efficacy and safety of once weekly efsitora compared to once daily insulin degludec for 78 weeks in adults with type 2 diabetes currently treated with basal insulin. Participants were randomized 2:1 to receive either efsitora once weekly or insulin degludec once daily.
The QWINT-3 trial met its primary endpoint of non-inferior A1C reduction with efsitora compared to insulin degludec at week 26. For the efficacy estimand7, efsitora reduced A1C by
Additionally, participants taking efsitora or insulin degludec spent approximately two hours more time in range (glucose 70-180 mg/dL) per day for weeks 22-26 compared to baseline. For the efficacy estimand11, participants taking efsitora spent
In both QWINT-1 and QWINT-3, the overall safety and tolerability profile of efsitora was similar to that of daily basal insulin therapies for the treatment of type 2 diabetes. In QWINT-1, estimated combined rates of severe or clinically significant (blood glucose <54 mg/dL) hypoglycemic events per patient-year of exposure from weeks 0-52 were 0.50 with efsitora vs. 0.88 with insulin glargine – approximately
Detailed results for QWINT-1 and QWINT-3 will be shared at an upcoming congress and published in a peer-reviewed journal. Additionally, detailed results for QWINT-2 and QWINT-5 will be presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2024.
About the QWINT clinical trial program
The QWINT phase 3 global clinical development program for insulin efsitora alfa (efsitora) in diabetes began in 2022 and has enrolled more than 4,000 people living with type 1 or type 2 diabetes across five 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 to insulin glargine for 52 weeks in insulin-naïve adults with type 2 diabetes. The trial randomized 796 participants across the
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 period, and 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
About insulin efsitora alfa
Insulin 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. Efsitora is in phase 3 development for adults with type 1 and 2 diabetes.
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 more than 51 million 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 Lilly.com and Lilly.com/news, or follow us on Facebook, Instagram and LinkedIn. P-LLY
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements (as that term is defined in the Private Securities Litigation Reform Act of 1995), including statements 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 planned or ongoing studies will be completed as planned, 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.
1 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 4 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.
2 The efficacy estimand represents the treatment effect had all participants adhered to the study drug without initiating rescue therapy for persistent severe hyperglycemia.
3
4 From a baseline A1C of
5 Treatment-regimen estimand represents the efficacy irrespective of adherence to the investigational medicine or introduction of rescue therapy for persistent severe hyperglycemia.
6
7
8 From a baseline A1C of
9
10 From a baseline A1C of
11
12 From a baseline time in range of
13
14 From a baseline time in range of
15 From a baseline tight time in range of
Refer to: | Niki Smithers; smithers_niki@lilly.com, 317-358-9074 (Media) |
Joe Fletcher; jfletcher@lilly.com, 317-296-2884 (Investors) |
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SOURCE Eli Lilly and Company
FAQ
What were the primary results of Eli Lilly's QWINT-1 and QWINT-3 trials for efsitora (LLY)?
How did efsitora (LLY) perform in terms of hypoglycemic events compared to daily insulins?
What unique feature did the QWINT-1 trial of efsitora (LLY) introduce in September 2024?
How did efsitora (LLY) affect time in glucose range for patients in the QWINT-3 trial?
