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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 patients with gallbladder disease or prior gallbladder removal?
Lilly cannot provide treatment recommendations on the use of orforglipron in people with a history of gallbladder disease or removal. These patients were not excluded from orforglipron trials, but no subgroup analysis was completed in this population.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
- Can People With Gallbladder Disease or Prior Gallbladder Removal Take Orforglipron?
- Are There Clinical Considerations for the Use of Orforglipron in Patients With Gallbladder Disease or Prior Gallbladder Removal?
- Enclosed Prescribing Information
- References
Can People With Gallbladder Disease or Prior Gallbladder Removal Take Orforglipron?
The use of orforglipron in people with gallbladder disease or prior gallbladder removal is not listed as a contraindication in the US prescribing information.1
Participants with gallbladder disease or prior gallbladder removal were not explicitly excluded from the orforglipron weight management studies, ATTAIN-1 and ATTAIN-2. However, no subgroup analyses have been conducted in this patient population.2,3
Are There Clinical Considerations for the Use of Orforglipron in Patients With Gallbladder Disease or Prior Gallbladder Removal?
Treatment with orforglipron and other glucagon-like peptide-1 (GLP-1) receptor agonists is associated with an increased occurrence of acute gallbladder disease.1
In a pool of 2 orforglipron clinical trials for weight reduction (ATTAIN-1 and ATTAIN-2),
- cholelithiasis was reported in 1% of orforglipron-treated patients and 0.7% of placebo-treated patients, and
- acute cholecystitis was reported in 0.4% of patients treated with orforglipron and 0.3% of placebo-treated patients.1
Acute gallbladder events were associated with weight reduction. If cholecystitis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated.1
Eli Lilly and Company cannot provide treatment recommendations for the use of orforglipron in people with a history of gallbladder disease or prior gallbladder removal. In formulating an assessment and approach, the health care practitioner may consider
- the information provided
- the patient’s prior medical history and concomitant medications, and
- other individual factors.
The health care professional should consider the potential risks and benefits of orforglipron use in these patients.
Enclosed Prescribing Information
FOUNDAYO™ (orforglipron) tablets, for oral use, Lilly
References
- 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.
Date of Last Review: March 10, 2026