You are now leaving the Lilly Medical website
The link you clicked on will take you to a site maintained by a third party, which is solely responsible for its content. Lilly USA, LLC does not control, influence, or endorse this site, and the opinions, claims, or comments expressed on this site should not be attributed to Lilly USA, LLC. Lilly USA, LLC is not responsible for the privacy policy of any third-party websites. We encourage you to read the privacy policy of every website you visit.
Click "Continue" to proceed or "Return" to return to Lilly Medical
If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)
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.
Can ONSWIK™ (insulin efsitora alfa-gobe) be used in patients with hepatic impairment?
Additional dose adjustment of efsitora should not be necessary in patients with hepatic impairment. As with all insulins, glucose monitoring should be intensified and the dosage adjusted on an individual basis.
Content Overview
- Are dose adjustments of efsitora needed in patients with hepatic impairment?
- Does impaired hepatic function impact the pharmacokinetics of efsitora?
- Were patients with hepatic impairment or liver disease included in the efsitora phase 3 trials?
- References
Are dose adjustments of efsitora needed in patients with hepatic impairment?
Additional dose adjustment should not be necessary for patients with hepatic impairment. However, as with all insulin products, glucose monitoring should be intensified and the efsitora dosage adjusted on an individual basis in patients with hepatic impairment. Patients with hepatic impairment may be at higher risk of hypoglycemia.1
Does impaired hepatic function impact the pharmacokinetics of efsitora?
No difference in the pharmacokinetics of efsitora was identified comparing healthy subjects and subjects with hepatic impairment. No clinically significant differences in the pharmacokinetics of efsitora were observed based on alanine aminotransferase (5 to 398 U/L) and aspartate aminotransferase (5 to 325 U/L). The effect of severe hepatic impairment on the pharmacokinetics of efsitora is unknown.1
Were patients with hepatic impairment or liver disease included in the efsitora phase 3 studies?
The QWINT (Once Weekly [QW] Insulin Therapy) clinical program assessed the efficacy and safety of efsitora as treatment for adults with type 2 diabetes mellitus in 4 phase 3 trials (QWINT-1 to QWINT-4).2-5
There were no dose adjustments based on hepatic function in these trials.2-5
The exclusion criteria for these trials related to hepatic function included
- acute or chronic hepatitis, cirrhosis, or obvious clinical signs or symptoms of any other liver disease, except nonalcoholic fatty liver disease (NAFLD)
- total bilirubin >2× upper limit of normal (ULN), except for participants with Gilbert’s syndrome
- alanine aminotransferase or serum glutamic pyruvic transaminase >3× ULN
- aspartate aminotransferase or serum glutamic oxaloacetic transaminase >3× ULN, or
- alkaline phosphatase >2.5× ULN.2-5
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; QWINT-1 Trial Investigators. 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(23):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: August 20, 2026