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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.
How does the consumption of food affect availability of Foundayo™ (orforglipron) in the body?
Take orforglipron tablet orally once daily, with or without food. No clinically relevant food effect on orforglipron exposure was observed.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
What Is the Effect of Food on Orforglipron Bioavailability?
Orforglipron can be taken orally once daily, with or without food.1
No clinically relevant food effect on orforglipron exposure was observed.1
Studies on the effect of food on orforglipron bioavailability have been conducted with the investigational capsule formulation that was studied in clinical trials and the tablet formulation currently available in the United States.1,2
In a study evaluating multiple doses of an investigational orforglipron 37.5 mg tablet, the area under the curve (AUC[0-24h]) decreased by 19%, and maximum concentration (Cmax) decreased by 26% with food compared to fasted state. The time to maximum concentration (tmax) and half-life (t1/2) were unchanged.1 Detailed results from this study have not been published.
Two other studies were conducted with the investigational orforglipron capsule formulation at a single dose of 3 mg and multiple doses of 16 mg.2 Published results from these studies are summarized below.
Phase 1 Study Design Overview
The two phase 1 studies, Study A and Study B, were both randomized, crossover studies conducted in healthy adults (Orforglipron Phase 1 Study A Design and Orforglipron Phase 1 Study B Design).2
Figure 1 description: Study A was a single low dose (orforglipron capsule 3 mg), 2-treatment arm, 2-period study. In each treatment period, participants were assigned to one of two treatment sequences (S1 or S2) in either the fasted or fed treatment arms.
Abbreviation: OFG = orforglipron; S1 = sequence 1; S2 = sequence 2.
Notes: There was a washout period of ≥5 days between each dose. In each period, participants remained in the clinical research unit at least until completion of assessments on day 4 and returned for an outpatient visit on day 5.
Figure 2 description: Study B began with a single daily dose of orforglipron 2 mg capsule that was escalated weekly to 4 mg, 8, mg, and 16 mg capsule on day 22. On day 21, participants were randomized to either fed or fasted treatment arms.
Abbreviations: OFG = orforglipron; PK = pharmacokinetics.
In Study A, a total of 12 participants received a single dose of oral orforglipron 3 mg capsule (treatment period 1) followed by another single dose of orforglipron 3 mg capsule after a washout period of at least 5 days (treatment period 2). In each treatment period, participants were assigned to either fasted or fed treatment arms. In both studies, orforglipron was taken with approximately 240 mL of water.2,4
In Study B, a total of 34 participants received a single daily dose of orforglipron capsule, escalating the dose weekly to 2 mg, 4 mg, 8 mg, and to 16 mg on day 22. There were no food or water restrictions during this escalation period.2
On day 21, Study B participants were randomized to either fasted or fed treatment.2
For both studies, fasted treatment was defined as receiving the orforglipron dose following an overnight fast of at least 10 hours and no food was allowed for at least 4 hours postdose.2
In Study A, fed (eg, food effect) treatment was defined as receiving the orforglipron dose following a standardized high-calorie meal consumed after an overnight fast of at least 10 hours. This meal consisted of about 500 kcal with approximately
- 30% fat
- 50% carbohydrates, and
- 20% protein.2
In Study B, fed treatment was defined as receiving a predose meal on days 1 to 6, with a standardized high-fat, high-calorie meal predose on day 7. This meal consisted of 800 to 1000 kcal with approximately
- 50% fat
- 25%-30% carbohydrates, and
- 15%-19% protein.2
Blood samples for PK measurements were collected at specified intervals pre- and postdose to assess
- AUC
- Cmax,
- tmax, and
- t1/2 associated with terminal rate constant.2
For Study A, AUC0-∞ was evaluated after a single dose of orforglipron 3 mg capsule. For Study B, steady-state AUC0-24 was evaluated after multiple doses of orforglipron 16 mg.2
Results
In these phase 1 studies, the overall mean exposure to orforglipron (AUC and Cmax) was 18%-24% lower when administered with food. The effect on tmax and half-life was comparable between fed and fasted states. See Study A: Profile in Participants Taking Orforglipron 3 mg Capsule Daily and Study B: Profile in Participants Taking Orforglipron 16 mg Capsule Daily for the concentration-time curve for Study A and Study B, respectively.2
Figure 3 description: In Study A, maximum plasma orforglipron concentration and area under the concentration–time curve were numerically lower through 24 hours postdose when orforglipron was administered in a fed versus fasted state. Time to maximum plasma concentration and half-life were similar between fed and fasted states.
Abbreviation: OFG = orforglipron.
Notes: Data in graph are arithmetic mean (+1 SD).
Figure 4 description: In Study B, maximum plasma orforglipron concentration and area under the concentration–time curve were numerically lower through 24 hours postdose when orforglipron was administered in a fed versus fasted state. Time to maximum plasma concentration and half-life were similar between fed and fasted states.
Abbreviation: OFG = orforglipron.
Notes: Data in graph are arithmetic mean (+1 SD).
Considering the exposure-response relationship of orforglipron, the noted PK differences attributable to the prandial state are not expected to lead to clinically meaningful differences in orforglipron's safety and efficacy.2
Safety
In both studies, the majority of treatment-emergent adverse events (TEAEs) were related to gastrointestinal events and were mild to moderate in severity. No serious adverse events or deaths were reported in either study.2
In Study A, all TEAEs occurred under the fasted condition. Of the 12 participants who received at least one dose of orforglipron 3 mg capsule, 2 (16.7%) reported at least 1 TEAE. Reported adverse events of special interest (AESI) included
- nausea (n=2), and
- vomiting (n=1).2
In Study B, under the fasted condition, 18 of 28 participants (64.3%) reported at least 1 TEAE. Reported AESI under the fasted condition were
- nausea (n=4)
- vomiting (n=2), and
- diarrhea (n=2).2
Under the fed condition, 12 of 27 participants (44.4%) reported at least 1 TEAE. Reported AESI under the fed condition were
- nausea (n=5)
- vomiting (n=2), and
- diarrhea (n=2).2
There were no reported cases of acute pancreatitis in either study.2
Food and Water Restrictions in Orforglipron Phase 2 and Phase 3 Studies
In the phase 2 and completed phase 3 studies, ATTAIN-1 and ATTAIN-2, that evaluated the efficacy and safety of orforglipron in adult participants with obesity or overweight, there were no food or water restrictions.5-7
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Foundayo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
2Ma X, Liu R, Pratt EJ, et al. Effect of food consumption on the pharmacokinetics, safety, and tolerability of once-daily orally administered orforglipron (LY3502970), a non-peptide GLP-1 receptor agonist. Diabetes Ther. 2024;15:819-832. https://doi.org/10.1007/s13300-024-01554-1
3Ma X, Liu R, Pratt E, et al. Effect of food on the pharmacokinetics, safety and tolerability of orforglipron (LY3502970) an oral, non-peptide GLP-1 receptor agonist. Poster presented at: 83rd Annual Scientific Sessions of the American Diabetes Association (ADA); June 23-26, 2023; San Diego, CA.
4Data on file, Eli Lilly and Company and/or one of its subsidiaries.
5Wharton 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
6Wharton 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
7Horn 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 19, 2026