insulin efsitora alfa (LY3209590) / Eli Lilly - LARVOL DELTA

Low immunogenicity of insulin efsitora alfa in participants with type 1 and type 2 diabetes mellitus. (PubMed, Diabetes Obes Metab) - "Efsitora caused an immunogenic response in up to 3.0% of participants with T1DM and T2DM. Descriptive analysis indicates that the immunogenicity of efsitora did not noticeably impact its pharmacokinetics, efficacy or safety. The molecular design of efsitora may contribute to its low immunogenicity."

Journal • Diabetes • Immunology • Metabolic Disorders • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

An Adjusted Indirect Comparison of Once-Weekly Insulin Efsitora Alfa vs. Insulin Icodec for Adults With Type 2 Diabetes Mellitus Previously Treated With Basal Insulin (ISPOR-EU 2025) - "Efsitora showed comparable results to icodec for all efficacy, composite and key safety endpoints in individuals with T2DM previously treated with basal insulin."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

An Adjusted Indirect Comparison of Once-Weekly Insulin Efsitora Alfa vs. Insulin Icodec for Adults With Type 2 Diabetes Mellitus Previously Treated With Basal-Bolus Insulin (ISPOR-EU 2025) - "Efsitora showed comparable results to icodec for key efficacy and safety endpoints in adults with T2DM previously treated with basal-bolus insulin."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Once-Weekly Insulin Efsitora Alfa Versus Once Daily Insulin in Patients With Type 2 Diabetes: A Systematic Review and Meta-Analysis. (PubMed, Endocrinol Diabetes Metab) - "Once-weekly efsitora provides comparable glycaemic control and improved time-in-range compared to daily insulin, although with a higher rate of TEAEs."

Clinical • Journal • Retrospective data • Review • Diabetes • Hypoglycemia • Immunology • Metabolic Disorders • Type 2 Diabetes Mellitus

Breaking the Daily Routine With Insulin Efsitora Alfa, a Once-Weekly Basal Insulin. (PubMed, Clin Diabetes) - No abstract available

Journal

Is once-weekly insulin a viable alternative for type 2 diabetes? A meta-analysis of randomized controlled trials. (PubMed, Diabetol Int) - "Once-weekly novel insulin preparations such as Icodec and basal insulin Fc (BIF)/insulin Efsitora Alfa have raised hope among clinicians and patients when they were developed and evaluated in a series of clinical trials...No significant differences were observed between once-weekly and once-daily insulin for other safety outcomes. Once-weekly insulin regimen was superior in reducing HbA1c level while maintaining a similar safety profile to the once-daily insulin regimen, thus suggesting that such regimen may potentially be an alternative to the currently established once-daily basal insulin regimen."

Journal • Retrospective data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Once-weekly insulin efsitora alfa showed consistent time in range and rates of hypoglycaemia throughout the week relative to day of administration in insulin naive adults with type 2 diabetes (EASD 2025) - P3 | "Clinical Trial Registration Number: NCT05362058 Background and aims: Insulin efsitora alfa (efsitora) is a once-weekly basal insulin in development for the treatment of diabetes. Use of once weekly efsitora provides steady glycaemic control throughout the week with a consistently low risk of hypoglycaemia, as assessed by blinded CGM in insulin naïve adults with T2D."

Clinical • Late-breaking abstract • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Weekly insulin efsitora alfa vs daily insulin glargine in adults with type 2 diabetes treated with basal and bolus insulin: QWINT-4 (EASD 2025) - P3 | "In adults with T2D treated with basal and bolus insulin, efsitora demonstrated noninferior HbA1c reductions and similar rates of hypoglycaemia vs glargine."

Clinical • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Insulin efsitora alfa (efsitora) demonstrates better overall health state vs daily degludec in insulin naive adults with type 2 diabetes in QWINT-2 (EASD 2025) - P3 | "Weekly efsitora treatment resulted in a better overall health state, easier management, and reduced treatment burden vs daily degludec in insulin-naïve adults with T2D, with a greater simplicity perception by the participants. These findings may reduce insulin initiation inertia and delays in T2D management."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Insulin efsitora alfa (efsitora) demonstrates better overall health state vs daily degludec in basal switch adults with type 2 diabetes in QWINT-3 (EASD 2025) - P3 | "Treatment with weekly efsitora resulted in greater tx satisfaction, better overall health state, and reduced tx burden vs degludec in adults with T2D currently treated with basal insulin. Greater satisfaction and perceived improved overall health state may improve adherence and clinical outcomes."

Clinical • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Fixed-dose titration of insulin efsitora alfa demonstrates greater patient preference vs daily glargine in insulin naive adults with type 2 diabetes in QWINT-1 (EASD 2025) - P3 | "In insulin naïve adults with T2D, efsitora improved health outcomes across a variety of domains and reduced treatment burden. More participants receiving efsitora vs glargine indicated that they were "very likely" to use their study treatment."

Clinical • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Innovative fixed-dose titration of weekly insulin efsitora alfa using a single-dose pen vs daily glargine to facilitate insulin therapy in type 2 diabetes: the QWINT-1 phase 3 trial (EASD 2025) - P3 | "In insulin-naïve adults with T2D, fixed-dose titration of QW efsitora had similar mean HbA1c reductions to 7%, with lower rates of clinically meaningful hypoglycemia, compared to QD glargine. This simple fixed-dose regimen for QW efsitora could facilitate insulin treatment and reduce injection burden compared to traditional titration of QD insulins."

P3 data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Characteristics and glycaemic outcomes of insulin naive adults with type 2 diabetes treated with an innovative fixed-dose regimen of weekly insulin efsitora in QWINT-1 (EASD 2025) - P3 | "Supported by Eli Lilly and Company Clinical Trial Registration Number: NCT05662332 Background and aims: QWINT-1 evaluated innovative fixed-dose titration of weekly insulin efsitora alfa (efsitora) vs daily glargine U100 over 52 wks in 795 insulin naïve adults with type 2 diabetes (T2D)... In QWINT-1, trends in certain characteristics were as expected: those requiring higher doses had greater baseline BMI and glycemic measures. HbA1c reductions were similar across efsitora doses compared to glargine at wk 52. Fixed-dose titration, including escalation to higher doses, did not increase the clinically significant hypoglycemia rate."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Weekly insulin efsitora alfa in adults with type 2 diabetes treated with basal insulin (QWINT-3) (EASD 2025) - P3 | "Clinical Trial Registration Number: NCT05275400 Background and aims: Basal insulin plays a key role in T2D treatment, but there is a substantial burden with daily injections. In adults with T2D treated with basal insulin, efsitora demonstrated noninferiority to degludec in HbA1c reduction at 26 weeks, which was maintained to 78 weeks of treatment. Both efistora and degludec-treated participants achieved increased TIR by 2 hours with similarly low rates of hypoglycaemia."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Novel Once-Weekly Basal Insulin Efsitora Alfa Versus Once-Daily Insulin Degludec in Adults With Diabetes Mellitus: A Systematic Review and Meta-Analysis (ENDO 2025) - "This meta-analysis demonstrates that once-weekly insulin efsitora is noninferior to once-daily insulin degludec in achieving glycemic control in adults with diabetes. Both treatments resulted in comparable reductions in HbA1c and showed no significant differences in the rates of moderate or severe hypoglycemia. These findings indicate that insulin efsitora may serve as a viable alternative to daily basal insulin regimens, potentially enhancing patient adherence through a once-weekly dosing schedule."

Retrospective data • Review • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Once-weekly basal insulin therapy in type 1 diabetes: A paradigm shift or a work in progress? (PubMed, Am J Health Syst Pharm) - "Once-weekly basal insulin represents a potential paradigm shift in T1DM management, offering convenience but presenting challenges related to hypoglycemia risk, patient acceptance, and regulatory hurdles. Further research is needed to refine titration protocols, identify optimal patient populations, and address safety concerns before these therapies can become standard of care."

Journal • Diabetes • Hypoglycemia • Metabolic Disorders • Type 1 Diabetes Mellitus • IR

Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 2 diabetes currently treated with basal insulin (QWINT-3): a phase 3, randomised, non-inferiority trial. (PubMed, Lancet) - P3 | "Efsitora is a well tolerated and efficacious once-weekly alternative to daily basal insulin, with a reduced injection frequency, for the treatment of adults with type 2 diabetes."

Head-to-Head • Journal • P3 data • Cardiovascular • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Once-weekly insulin efsitora alfa versus once-daily insulin glargine U100 in adults with type 2 diabetes treated with basal and prandial insulin (QWINT-4): a phase 3, randomised, non-inferiority trial. (PubMed, Lancet) - P3 | "Efsitora showed non-inferior HbA1c reductions and similar rates of combined clinically significant or severe hypoglycaemia versus glargine U100 in participants with type 2 diabetes treated with basal and prandial insulin. These findings show that efsitora is a well tolerated and efficacious once-weekly alternative to daily basal insulin, with a reduced injection frequency, for the treatment of adults with type 2 diabetes."

Head-to-Head • Journal • P3 data • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 2 Diabetes Mellitus

Treatment Experience of People with Type 2 Diabetes Using Once-Weekly Efsitora in QWINT Phase 3 Trials—A Qualitative Study (ADA 2025) - "PwT2D were interviewed about their experience and willingness to take an innovative weekly basal insulin to better understand the potential of once-weekly insulin efsitora alfa in addressing the burdens associated with insulin treatment. Primary objective was to explore PwT2D experiences with once-weekly efsitora... Once-weekly basal insulin may reduce the complexity of insulin therapy by being easy to use, convenient, and flexible. The majority of PwT2D, especially those who are IE with a daily insulin, were "definitely willing" to continue with weekly basal insulin which may result in improved experiences with insulin therapy and outcomes for PwT2D."

Late-breaking abstract • P3 data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Symposium - Advancing and Facilitating Basal Insulin Therapy in Type 2 Diabetes—Breaking News on the QWINT 1, 3, and 4 Trials with Once-Weekly Insulin Efsitora Alfa! (ADA 2025) - No abstract available

Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Fixed-Dose Titration of Insulin Efsitora Alfa Demonstrates Greater Patient Preference vs. Daily Glargine in Insulin-Naïve Adults with T2D in QWINT-1 (ADA 2025) - "In insulin naïve adults with T2D, efsitora improved health outcomes across a variety of domains and reduced treatment burden. More participants receiving efsitora vs glargine indicated that they were "very likely" to use their study treatment."

Clinical • Metabolic Disorders • Type 2 Diabetes Mellitus

Insulin Efsitora Alfa (Efsitora) Demonstrates Better Overall Health State vs. Daily Degludec in Insulin-Naive Adults with T2D in QWINT-2 (ADA 2025) - "Weekly efsitora treatment resulted in a better overall health state, easier management, and reduced treatment burden vs daily degludec in insulin-naïve adults with T2D, with a greater simplicity perception by the participants. These findings may reduce insulin initiation inertia and delays in T2D management."

Clinical • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Insulin Efsitora Alfa (Efsitora) Demonstrates Better Overall Health State vs. Daily Degludec in Basal-Switch Adults with T2D in QWINT-3 (ADA 2025) - "Treatment with weekly efsitora resulted in greater tx satisfaction, better overall health state, and reduced tx burden vs degludec in adults with T2D currently treated with basal insulin. Greater satisfaction and perceived improved overall health state may improve adherence and clinical outcomes."

Clinical • Metabolic Disorders • Type 2 Diabetes Mellitus

Insulin Efsitora Alfa vs. Insulin Degludec in Adults with Insulin-Naïve T2D (QWINT-2)—A Japan Subgroup Analysis (ADA 2025) - P3 | "Once-weekly efsitora was comparable to once-daily degludec in reducing HbA1c in insulin-naïve Japan participants with T2D. Efficacy and safety were consistent with the overall study population."

Clinical • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Steady-State Pharmacokinetics and Glucodynamics of Once-Weekly Insulin Efsitora Alfa (Efsitora) in Individuals with Type 2 Diabetes (T2D) (ADA 2025) - "After a lead-in period with once-daily degludec for dose-finding, eligible participants received a one-time starting dose of 12 U/kg efsitora and weekly doses of 4 U/kg for 9 weeks. Efsitora demonstrated a flat and prolonged PK profile providing a constant level of insulin and as a result a stable glucose lowering response across the weekly dosing interval."

Clinical • PK/PD data • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus