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

Insulin Efsitora Alfa (Efsitora) Demonstrates Better Overall Health State vs. Daily Degludec in Insulin-Naive Adults with T2D in QWINT-2 (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Clinical • 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) - "Available on Friday, June 13, 2025 at 08:00am CDT."

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) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Clinical • 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) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Clinical • 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) - "Available on Friday, June 13, 2025 at 08:00am CDT."

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

Bioequivalence of Insulin Efsitora Alfa (Efsitora) U-500 and U-1000 Formulations (ADA 2025) - "Available on Friday, June 13, 2025 at 08:00am CDT."

Metabolic Disorders

Once-weekly Basal Insulin Fc versus daily insulin degludec for glycemic control in diabetes: a systematic review, meta-analysis, and meta-regression. (PubMed, J Diabetes Metab Disord) - "However, increased hypoglycemia risks in certain subgroups and higher adverse event rates warrant further evaluation. The online version contains supplementary material available at 10.1007/s40200-025-01602-y."

Journal • Retrospective data • Review • Diabetes • Hypoglycemia • Metabolic Disorders • Pain • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

EFSITORA VS. DEGLUDEC IN PATIENTS WITH TYPE 1 DIABETES (QWINT-5) (ATTD 2025) - "Background and Aims: The study aimed to evaluate the efficacy and safety of a novel once-weekly basal insulin efsitora alfa (efsitora) compared to daily insulin degludec in patients with type 1 diabetes (T1D). Once-weekly efsitora showed similar HbA1c reduction compared to degludec. The imbalance in hypoglycaemia for efsitora versus degludec suggests the need for further evaluation of efsitora dose initiation and optimization of basal-bolus insulin in T1D."

Clinical • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus

EFSITORA VS. DEGLUDEC IN INSULIN-NAÏVE ADULTS WITH TYPE 2 DIABETES (QWINT-2) (ATTD 2025) - "Background and Aims Insulin efsitora alfa (efsitora) is a novel basal insulin designed for once-weekly administration. Efsitora offers less frequent dosing and overall low rates of combined L2/L3 hypoglycaemia, with a comparable safety profile. These findings support the potential of efsitora as an effective treatment option for T2D."

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

EVOLUTION OF A NOVEL CLINICAL DECISION SUPPORT (CDS) ALGORITHM WITH INSULIN EFSITORA ALFA IN ADULTS WITH TYPE 2 DIABETES (T2D) (ATTD 2025) - "Switch and naïve participants improved by 16.2% (p=0.003) and 25.7% (p=<0.001) to 47.3% and 61.7% in time spent between 3.9-10.0 mmol/L (70-180 mg/dL), respectively, from baseline to endpoint. Conclusions The novel CDS algorithm-maintained investigator trust and glycaemic efficacy with improved hypoglycaemia after algorithm refinement."

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

Pharmacokinetic and Pharmacodynamic Properties of Once-Weekly Insulin Efsitora Alfa in Japanese Patients with Type 2 Diabetes. (PubMed, Diabetes Ther) - P1 | "Efsitora was well tolerated, and the pharmacokinetic and pharmacodynamic profiles were consistent with findings in prior global studies, supporting the participation of Japanese patients in phase 3 studies."

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

Optimal use of once-weekly basal insulin efsitora alfa in type 1 and type 2 diabetes: A systematic review and meta-analysis. (PubMed, Endocr Pract) - "Once-weekly basal insulin efsitora alfa is well tolerated with glycaemic efficacy similar to once-daily degludec."

Journal • Retrospective data • Review • Diabetes • Hypoglycemia • Immunology • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus • Type 2 Diabetes Mellitus

Efficacy and safety of once-weekly insulin versus once-daily insulin in patients with type 1 and type 2 diabetes mellitus: an updated meta-analysis of randomized controlled trials. (PubMed, Front Endocrinol (Lausanne)) - "This meta-analysis was performed to obtain a comprehensive overview of the differences between once-weekly basal insulin (including icodec and basal insulin Fc) and once-daily basal insulin (including glargine and degludec) in patients with type 1 and type 2 diabetes mellitus. Once-weekly basal insulin is safe and effective in modestly reducing HbA1c with similar level 2 or 3 hypoglycemic events compared to once-daily insulin, although the risk of level 1 hypoglycemia and weight gain was slightly increased. https://www.crd.york.ac.uk/PROSPERO, Identifier CRD42024496812."

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

A Study to Evaluate Pharmacokinetics of LY3209590 in Pediatric Participants With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1 | N=22 | Recruiting | Sponsor: Eli Lilly and Company | Trial primary completion date: Nov 2025 ➔ Nov 2026

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

Insulin Efsitora Alpha An Investigational OnceWeekly Basal Insulin for the Treatment of Type 1 or Type 2 Diabetes (ASHP 2024) - No abstract available

Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

A Study to Evaluate Pharmacokinetics of LY3209590 in Pediatric Participants With Type 2 Diabetes Mellitus (clinicaltrials.gov) - P1 | N=22 | Recruiting | Sponsor: Eli Lilly and Company | Not yet recruiting ➔ Recruiting

Enrollment open • Diabetes • Metabolic Disorders • Pediatrics • Type 2 Diabetes Mellitus

Efficacy and Safety of Basal Insulin Fc versus Degludec Insulin: A Meta-Analysis of Randomized Controlled Trials. (PubMed, Am J Ther) - No abstract available

Clinical • Journal • Retrospective data

Evaluation of the pharmacokinetic profile of insulin efsitora alfa (efsitora) administered subcutaneously at different injection sites (EASD 2024) - "Efsitora can be injected SC into the abdomen, upper arm, or thigh, without a change in exposure."

PK/PD data • Diabetes • Metabolic Disorders • IR

Effects of insulin Efsitora alfa on frequency and severity of hypoglycaemia under conditions of increased hypo risk compared to glargine in type 2 diabetes (EASD 2024) - "Once weekly efsitora did not increase the incidence, duration, or severity of hypo compared to once daily glargine during periods of provocation in patients with T2D."

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

Efficacy and safety of insulin efsitora alfa as a weekly basal insulin compared with insulin degludec in participants with type 1 diabetes treated with multiple daily injection therapy (QWINT-5) (EASD 2024) - "There is no abstract associated with this presentation."

Clinical • Diabetes • Metabolic Disorders • Type 1 Diabetes Mellitus

S18. A paradigm change for basal insulin replacement? Results from the QWINT programme of insulin efsitora alfa (EASD 2024) - No abstract available

Metabolic Disorders

Once-weekly insulin efsitora alfa versus once-daily insulin degludec in adults with type 1 diabetes (QWINT-5): a phase 3 randomised non-inferiority trial. (PubMed, Lancet) - P3 | "In adults with type 1 diabetes, once-weekly efsitora showed non-inferior HbA1c reduction compared with daily insulin degludec. Higher rates of combined level 2 or level 3 hypoglycaemia and greater incidence of severe hypoglycaemia in participants treated with efsitora compared with participants treated with degludec might suggest the need for additional evaluation of efsitora dose initiation and optimisation in people with type 1 diabetes."

Head-to-Head • Journal • P3 data • Diabetes • Metabolic Disorders • Severe Hypoglycemia • Type 1 Diabetes Mellitus

Insulin Efsitora versus Degludec in Type 2 Diabetes without Previous Insulin Treatment. (PubMed, N Engl J Med) - P3 | "In adults with type 2 diabetes who had not previously received insulin, once-weekly efsitora was noninferior to once-daily degludec in reducing glycated hemoglobin levels. (Funded by Eli Lilly; QWINT-2 ClinicalTrials.gov number, NCT05362058.)."

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

A Multiple Dose Study of LY3209590 in Participants With Type 2 Diabetes (clinicaltrials.gov) - P1 | N=56 | Completed | Sponsor: Eli Lilly and Company | Active, not recruiting ➔ Completed

Trial completion • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus