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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 pregnant or nursing women for weight management?
Orforglipron should not be used for weight management during pregnancy. Advise women of childbearing potential to use effective contraception. When pregnancy is recognized, discontinue orforglipron. Orforglipron is not recommended for nursing women.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
- Can Orforglipron be Used During Pregnancy?
- Can Orforglipron be Used During Breastfeeding?
- Are There Additional Clinical Considerations for Males and Females of Reproductive Potential?
- Enclosed Prescribing Information
- References
Can Orforglipron be Used During Pregnancy?
Weight loss offers no benefit to a pregnant patient and may cause fetal harm. When a pregnancy is recognized, advise the pregnant patient of the risk to a fetus and discontinue orforglipron.1
There are no adequate and well-controlled studies of orforglipron during pregnancy. Based on animal reproduction studies, there may be risks to the fetus from exposure to orforglipron during pregnancy.1
Advise women of childbearing potential to use effective contraception during treatment with orforglipron.1
Imbalances in malformations have been reported in rats and rabbits at low multiples of clinical exposure with GLP-1 receptor agonists active in those species. Orforglipron is not pharmacologically active in rats and rabbits.1
In animal reproduction studies, oral administration of orforglipron to pregnant monkeys, during organogenesis at doses lower than the maximum recommended human dose (MRHD) did not result in embryofetal effects. Higher dose levels and exposures could not be evaluated in monkeys due to dose-limiting effects on body weight.1
In a rabbit dose-range finding study, oral administration of orforglipron to pregnant rabbits during organogenesis at exposures 14 times the clinical exposure at the MRHD resulted in external malformations and decreases in fetal and placental weights in the absence of maternal toxicity. In the definitive rabbit study, oral administration of orforglipron to pregnant rabbits during organogenesis at exposures up to 6 times the clinical exposure at the MRHD did not result in embryofetal effects.1
In a tissue distribution study, [¹⁴C]orforglipron-derived radioactivity was not distributed to fetal tissues in pregnant rats.1
What Data Are Available About Pregnancy From the Orforglipron Weight Management Studies?
In ATTAIN-1 and ATTAIN-2,
- female participants could not be pregnant, intend to be pregnant, breastfeed, or intend to breastfeed
- women of childbearing potential were required to agree to use 2 forms of effective contraception, with at least one being highly effective (<1% failure rate), during the study and for at least 30 days after the last dose of the study intervention
- contraceptive use by participants had to be consistent with local regulations regarding the methods of contraception.2,3
No male contraception was required except in compliance with specific local government study requirements.2,3
In ATTAIN-1 and ATTAIN-2, pregnancies were reported by 14 female participants treated with orforglipron and 4 receiving placebo.4
The number of pregnancies reported by female partners of male participants was 3 for orforglipron-treated patients and 1 for placebo.4
How Long Before a Planned Pregnancy Should Orforglipron be Discontinued?
When pregnancy is recognized, discontinue orforglipron.1
There are no data on when orforglipron use should be discontinued prior to a planned pregnancy.
Can Orforglipron be Used During Breastfeeding?
Orforglipron is not recommended for nursing women. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for orforglipron and any potential adverse effects on the breastfed child from orforglipron or from the underlying maternal condition.1
No cases of orforglipron use during breastfeeding have been reported in any of the clinical trials.4
There are no data on the presence of orforglipron or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. Orforglipron was present in the milk of lactating rats in in vivo testing. When a drug is present in animal milk, it is likely that the drug will be present in human milk.1
In a tissue distribution study, [¹⁴C]orforglipron-derived radioactivity was excreted into rat breast milk, with concentrations in milk 3-fold higher than in plasma.1
Are There Additional Clinical Considerations for Males and Females of Reproductive Potential?
Does Orforglipron Affect Fertility?
Eli Lilly and Company did not conduct studies to evaluate the effect of orforglipron on male or female fertility.
There were no effects on male and female fertility in rats orally administered orforglipron up to 200 mg/kg/day (19 times and 36 times the clinical exposure at the MRHD, respectively, based on area under the curve [AUC]).1
Orforglipron has not been specifically studied in women who are planning to become pregnant via natural conception or in vitro fertilization (IVF). Therefore, no additional information is available in this patient population beyond the approved prescribing information.
Does Orforglipron Affect Oral Contraceptives?
Orforglipron delays gastric emptying and has the potential to affect the rate of absorption of other concomitantly administered oral drugs.1
The effect of orforglipron on the absorption of oral contraceptives has not been evaluated in a clinical trial. Because delayed gastric emptying may affect the absorption of oral medications, advise patients using oral hormonal contraceptives to switch to a non-oral contraceptive method, or add a barrier method of contraception for 30 days after initiation with orforglipron and for 30 days after each dose escalation.1
Pregnancy Exposure Registry
There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to orforglipron during pregnancy. Pregnant patients exposed to orforglipron and healthcare providers are encouraged to contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).1
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.
- Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: April 01, 2026