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Onswik ™ (insulin efsitora alfa-gobe) injection
500 units/mL (U-500), 1,000 units/mL (U-1,000)
This information is provided in response to your request. Resources may contain information about doses, uses, formulations and populations different from product labeling. See Prescribing Information above, if applicable.
What fasting glucose targets were used in the ONSWIK™ (insulin efsitora alfa-gobe) phase 3 studies?
The prescribing information does not specify a fasting glucose target for efsitora. Dosage is individualized to metabolic needs, glucose monitoring results, and glycemic goals. The phase 3 studies used targets of 80 to 130 mg/dL or 80 to 120 mg/dL.
Content Overview
- Is a fasting glucose target specified for efsitora?
- What fasting glucose targets were used in the efsitora phase 3 studies?
- How were efsitora doses adjusted in the phase 3 studies?
- Enclosed Prescribing Information
- References
Is a fasting glucose target specified for efsitora?
No fasting glucose target is specified. The dosage of efsitora is individualized and adjusted based on metabolic needs, glucose monitoring results, and glycemic control goal, and is titrated as necessary based on the patient's fasting glycemic goal.1
Eli Lilly and Company cannot provide treatment recommendations for individual patients. The treating health care provider may use the information provided, the patient's prior medical history and concomitant medications, and other individual factors in developing a treatment plan. The treating health care provider should consider potential risks and benefits of treatment options and monitor appropriately.
What fasting glucose targets were used in the efsitora phase 3 studies?
All 4 phase 3 studies in adults with type 2 diabetes used a treat-to-target design. The fasting glucose targets and the frequency of dose adjustment are shown in Table 1.
Study |
Fasting Glucose Target |
Dose Adjustment Frequency |
|---|---|---|
QWINT-12 |
80-130 mg/dL (4.4-7.2 mmol/L) |
Every 4 weeks |
QWINT-23 |
80-120 mg/dL (4.4-6.7 mmol/L) |
Weekly to week 12, then at least every 4 weeks |
QWINT-34 |
80-120 mg/dL (4.4-6.7 mmol/L) |
Weekly to week 12, then at least monthly |
QWINT-45 |
80-120 mg/dL (4.4-6.7 mmol/L) |
Weekly to week 12, then every 4 weeks |
Notes: The targets shown are those used in the study protocols and do not constitute a treatment recommendation. QWINT-1 evaluated a fixed-dose regimen; the other 3 studies used flexible dosing.
How were efsitora doses adjusted in the phase 3 studies?
In all 4 studies, the decision to change the efsitora dose was based on the median of the 3 most recent fasting glucose values. Hypoglycemia was also taken into account in each study.2-5
In QWINT-1, efsitora was given as a fixed-dose regimen. Treatment started at 100 units once weekly and, where required to reach the fasting glucose target, was escalated after at least 4 weeks to the next fixed dose of 150, 250, or 400 units once weekly.2
In QWINT-2, QWINT-3, and QWINT-4, efsitora was given as a flexible-dose regimen with dose adjustments made at each assessment.3-5 For the flexible-dose regimen, dose adjustments of 20 to 40 units per week are described in the prescribing information.1
Enclosed Prescribing Information
ONSWIK™ (insulin efsitora alfa-gobe) injection, for subcutaneous use, Lilly
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
- Onswik [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
- Rosenstock J, Bailey T, Connery L, et al. Weekly fixed-dose insulin efsitora in type 2 diabetes without previous insulin therapy. N Engl J Med. 2025;393(4):325-335. https://doi.org/10.1056/NEJMoa2502796
- Wysham C, Bajaj HS, Del Prato S, et al; QWINT-2 Investigators. Insulin efsitora versus degludec in type 2 diabetes without previous insulin treatment. N Engl J Med. 2024;391:2201-2211. https://doi.org/10.1056/NEJMoa2403953
- Philis-Tsimikas A, Bergenstal RM, Bailey TS, et al. 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. Lancet. 2025;405(10497):2279-2289. https://doi.org/10.1016/S0140-6736(25)01044-X
- Blevins T, Dahl D, Pérez Manghi FC, et al. 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. Lancet. 2025;405(10497):2290-2301. https://doi.org/10.1016/S0140-6736(25)01069-4
Date of Last Review: October 09, 2026