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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.
Why do the results in the Foundayo™ (orforglipron) US Prescribing Information differ from those in published manuscripts?
Re-analysis of data from registration clinical trials by the FDA may involve statistical approaches different from those used in peer-reviewed publications, resulting in numerical differences between published results and the US Prescribing Information.
See important safety information, including boxed warning, in the attached prescribing information.
Results in US Prescribing Information Versus Results in Published Manuscripts
Phase 3 registration clinical trials intended to support product approval and their statistical analysis methods are reviewed and aligned with the Food and Drug Administration (FDA).1-3
FDA-approved labeling reflects analyses reviewed and accepted by the FDA, which may include re-analysis of the data using different statistical approaches. These analyses often apply FDA-preferred methods, which may differ from the analytical approaches used in peer-reviewed publications and can result in numerical differences between published results and the US Prescribing Information.1-3
Enclosed Prescribing Information
FOUNDAYO™ (orforglipron) tablets, for oral use, Lilly
References
- US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Providing clinical evidence of effectiveness for human drug and biological products: FDA guidance for industry. May 1998. Accessed April 7, 2026. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/providing-clinical-evidence-effectiveness-human-drug-and-biological-products
- US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER). Missing data in clinical trials for drugs and biological products: FDA guidance for industry.
- ICH E9 statistical principles for clinical trials - scientific guideline. European Medicines Agency. Accessed April 7, 2026. https://www.ema.europa.eu/en/ich-e9-statistical-principles-clinical-trials-scientific-guideline
Date of Last Review: April 07, 2026