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

A Study to Evaluate Pharmacokinetics of LY3209590 in Pediatric Participants With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1 | N=15 | Completed | Sponsor: Eli Lilly and Company | Recruiting ➔ Completed | N=22 ➔ 15 | Trial completion date: Nov 2026 ➔ Jan 2026 | Trial primary completion date: Nov 2026 ➔ Jan 2026

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Diabetes • Metabolic Disorders • Pediatrics • Type 2 Diabetes Mellitus

Incidence of Medication Errors of Interest in the QWINT 1–4 Phase 3 Trial Program of Once-Weekly Basal Insulin Efsitora Alfa (Efsitora) (ADA 2026) - "Available on Friday, May 29, 2026 at 12:00am CDT."

P3 data • Metabolic Disorders

Hospitalizations and Outcomes in Adults with Type 2 Diabetes (T2D) Treated with Weekly Insulin Efsitora Alfa (Efsitora): Results from the QWINT Program (ADA 2026) - "Available on Friday, May 29, 2026 at 12:00am CDT."

Clinical • Diabetes • 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) (ATTD 2026) - "Following a dose-finding lead-in period with once-daily degludec, 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, prolonged PK profile, providing a consistent level of exposure at steady-state and stable glucose-lowering response across the week."

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

DURATION OF HYPOGLYCAEMIA WITH ONCE-WEEKLY INSULIN EFSITORA ALFA VERSUS ONCE-DAILY BASAL INSULINS IN ADULTS WITH TYPE 2 DIABETES: EXPLORATORY ANALYSIS OF QWINT 2-4 (ATTD 2026) - "Data from CGM sessions in three phase 3 T2D trials were included: QWINT-2 (insulin-naïve, insulin degludec comparator), QWINT-3 (prior basal insulin use, insulin degludec comparator), and QWINT-4 (prior basal/prandial insulin, insulin glargine comparator). Across all three studies, durations of overall hypoglycaemic events were similar between efsitora and once-daily basal insulin comparators. The duration of hypoglycaemic events, assessed by masked CGM, was similar with efsitora versus once-daily basal insulins in participants with T2D."

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

Characterisation of steady-state pharmacokinetics and glucodynamics of once-weekly insulin efsitora alfa in individuals with type 2 diabetes. (PubMed, Diabetes Obes Metab) - "Efsitora demonstrated a flat, prolonged PK profile, providing a consistent level of insulin exposure at steady-state and resulting in a stable glucose-lowering response across the weekly dosing interval."

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

Evaluation of Overall Health State, Treatment Burden, and Satisfaction with Insulin Efsitora Alfa (Efsitora) vs. Daily Comparator in Adults with Type 2 Diabetes in the QWINT Clinical Trial Program. (PubMed, Diabetes Ther) - P3 | "Participants in the QWINT-1 to -4 studies demonstrated a strong preference for efsitora, along with improved overall functioning, well-being, and treatment burden compared to daily basal insulins."

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

CGM-derived efficacy and overall safety of once-weekly insulin efsitora alfa (efsitora) relative to day of administration in adults with type 2 diabetes. (PubMed, Diabetes Obes Metab) - No abstract available

Journal • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

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