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Foundayo ™ (orforglipron) tablet
0.8 mg / 2.5 mg / 5.5 mg / 9 mg / 14.5 mg / 17.2 mg
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 Foundayo™ (orforglipron) be used in people with hepatic impairment?
Orforglipron is not recommended for use in people with severe hepatic impairment. No dosage modification of orforglipron is recommended in people with mild or moderate hepatic impairment. Lilly cannot provide recommendations beyond the approved US label.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
- Are Dose Adjustments of Orforglipron Needed in Patients With Hepatic Impairment?
- Does Impaired Hepatic Function Impact the Pharmacokinetics of Orforglipron?
- Were People With Hepatic Impairment or Liver Disease Included in the Orforglipron Weight Management Studies?
- Treatment Recommendations
- Enclosed Prescribing Information
- References
Are Dose Adjustments of Orforglipron Needed in Patients With Hepatic Impairment?
Orforglipron is not recommended for use in patients with severe hepatic impairment.1
No dosage adjustment of orforglipron is recommended in patients with mild or moderate hepatic impairment.1
Does Impaired Hepatic Function Impact the Pharmacokinetics of Orforglipron?
Orforglipron is metabolized primarily via hepatic cytochrome P450 3A4 (CYP3A4) to several oxidative metabolites.1
The pharmacokinetics of orforglipron after a single oral 1 mg (capsule) dose was evaluated in participants with mild, moderate, and severe hepatic impairment (Child-Pugh Class A, B, and C, respectively) and in participants with normal hepatic function.1
Orforglipron exposure was similar in participants with mild hepatic impairment and normal hepatic function.1
Orforglipron area under the curve from time zero to infinity (AUC[0-∞]) increased by 1.7-fold and 4.6-fold in participants with moderate and severe hepatic impairment, respectively, compared to participants with normal hepatic function.1
Maximum plasma concentration (Cmax) in participants with moderate and severe hepatic impairment was similar to Cmax in participants with normal hepatic function.1
Were People With Hepatic Impairment or Liver Disease Included in the Orforglipron Weight Management Studies?
In ATTAIN-1, ATTAIN-2, and phase 2 orforglipron studies, participants were excluded if they had
- acute or chronic hepatitis, including a history of autoimmune hepatitis or signs and symptoms of any other liver disease other than metabolic dysfunction-associated steatotic liver disease (MASLD)
- an alanine aminotransferase (ALT) or aspartate aminotransferase (AST) level ≥3.0x upper limit of normal (ULN)
- an alkaline phosphatase level ≥1.5x ULN
- a total bilirubin level ≥1.5x ULN, except for cases of known Gilbert’s Syndrome
- hepatitis B infection, or
- a positive hepatitis C antibody and positive hepatitis C virus RNA.2-5
Hepatitis B infection was defined as positive hepatitis B core antibody and positive for hepatitis B virus DNA or positive hepatitis B surface antigen.2-5
Participants with MASLD were eligible to participate in this trial if their ALT level was <3.0x ULN.2-5
Participants with unknown or undiagnosed cirrhosis, not meeting the criteria listed above, were not specifically excluded from the trials. However, no subgroup analyses have been conducted to identify if these participants were enrolled in orforglipron clinical trials or their outcomes.
There are no dedicated studies of orforglipron currently ongoing in adults with
- MASLD, or
- metabolic dysfunction–associated steatohepatitis (MASH).
Treatment Recommendations
Eli Lilly and Company cannot provide a recommendation on whether to use orforglipron in a patient with hepatic impairment and/or liver disease beyond the approved orforglipron US Prescribing Information.
The health care practitioner should consider potential risks and benefits of treatment options and monitor appropriately.
Enclosed Prescribing Information
FOUNDAYO™ (orforglipron) tablets, for oral use, Lilly
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
- Foundayo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
- Wharton S, Aronne LJ, Stefanski A, et al; ATTAIN-1 Trial Investigators. Orforglipron, an oral small-molecule GLP-1 receptor agonist for obesity treatment. N Engl J Med. 2025;393(18):1796-1806. https://doi.org/10.1056/NEJMoa2511774
- Horn DB, Ryan DH, Giljanovic Kis S, et al; ATTAIN-2 Trial Investigators. Orforglipron, an oral small-molecule GLP-1 receptor agonist, for the treatment of obesity in people with type 2 diabetes (ATTAIN-2): a phase 3, double-blind, randomised, multicentre, placebo-controlled trial. Lancet. 2025;406(10522):2927-2944. https://doi.org/10.1016/S0140-6736(25)02165-8.
- Wharton S, Blevins T, Connery L, et al; GZGI Investigators. Daily oral GLP-1 receptor agonist orforglipron for adults with obesity. N Engl J Med. 2023;389(10):877-888. https://doi.org/10.1056/NEJMoa2302392
- Frias JP, Hsia S, Eyde S, et al. Efficacy and safety of oral orforglipron in patients with type 2 diabetes: a multicentre, randomised, dose-response, phase 2 study. Lancet. 2023;402(10400):472-483. https://doi.org/10.1016/S0140-6736(23)01302-8
Date of Last Review: April 06, 2026