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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.
What happens when patients discontinue Foundayo™ (orforglipron)?
Eli Lilly and Company did not evaluate efficacy outcomes following discontinuation of orforglipron treatment. The safety follow-up period in phase 3 studies was not designed to characterize the effects of discontinuing orforglipron treatment on safety.
See important safety information, including boxed warning, in the attached prescribing information.
Orforglipron efficacy and safety after discontinuation
Eli Lilly and Company does not have data on the impact of orforglipron treatment discontinuation on efficacy outcomes such as weight regain or glycemic control, as these have not been systematically evaluated.1-7
In the phase 3 studies, adverse events, laboratory parameters, and vital signs continued to be collected during a protocol-defined off-drug follow-up period after the last dose, and these data are included in the safety information in the Prescribing Information. The follow-up period was not designed to characterize the effects of discontinuing orforglipron treatment.1-8
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).
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
Rosenstock J, Hsia S, Nevarez Ruiz L, et al; ACHIEVE-1 Trial Investigators. Orforglipron, an oral small-molecule GLP-1 receptor agonist, in early type 2 diabetes. N Engl J Med. 2025;393(11):1065-1076. https://doi.org/10.1056/NEJMoa2505669
Welch M, Forst T, Jia W, et al; ACHIEVE-2 Trial Investigators. Orforglipron compared with dapagliflozin in adults with type 2 diabetes and inadequate glycaemic control with metformin (ACHIEVE-2): a multicentre, randomised, non-inferiority, open-label, phase 3 trial. Lancet. 2026;408(10550):125-140. https://doi.org/10.1016/S0140-6736(26)00800-7
Rosenstock J, Yabe D, Cox D, et al; ACHIEVE-3 Investigators. Efficacy and safety of once-daily oral orforglipron compared with oral semaglutide in adults with type 2 diabetes (ACHIEVE-3): a multinational, multicentre, non-inferiority, open-label, randomised, phase 3 trial. Lancet. 2026;407(10534):1147-1160. https://doi.org/10.1016/S0140-6736(26)00202-3
A study of daily oral orforglipron (LY3502970) compared with insulin glargine in participants with type 2 diabetes and obesity or overweight at increased cardiovascular risk (ACHIEVE-4). ClinicalTrials.gov identifier: NCT05803421. Updated April 17, 2026. Accessed July 22, 2026. https://clinicaltrials.gov/study/NCT05803421
Giorgino F, D’Souza S, Ludwig L, et al. Orforglipron added to titrated insulin glargine in type 2 diabetes: the ACHIEVE-5 randomized clinical trial. JAMA. 2026;336(5):389-399. https://doi.org/10.1001/jama.2026.9512
Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: August 21, 2026