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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 cancer or a history of cancer?
Orforglipron is contraindicated in patients with a personal or family history of MTC or in patients with MEN2. Patients with a history of active, untreated, or clinically significant malignancy in remission for <5 years were excluded from the studies.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
Warnings and Precautions Related to The Risk of Thyroid C-Cell Tumors
In products with glucagon-like peptide-1 (GLP-1) receptor agonist activity that are pharmacologically active in rats and mice, rodent thyroid C-cell tumors (adenomas and carcinomas) have been observed at clinically relevant exposures and are considered GLP-1 receptor-dependent effects in rodents. Orforglipron is not pharmacologically active in rats or mice and did not produce tumors in rodents. While orforglipron is pharmacologically active at the human GLP-1 receptor, the human relevance of GLP-1 receptor-dependent thyroid C-cell tumors observed in rodents has not been determined.1
Cases of medullary thyroid cancer (MTC) in patients treated with liraglutide, another GLP-1 receptor agonist, have been reported in the postmarketing period; the data in these reports are insufficient to establish or exclude a causal relationship between MTC and GLP-1 receptor agonist use in humans.1
Orforglipron is contraindicated in patients with a personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2 (MEN2). Counsel patients regarding the potential risk for MTC with the use of orforglipron and inform them of symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, or persistent hoarseness).1
Routine monitoring of serum calcitonin or using thyroid ultrasound is of uncertain value for early detection of MTC in patients treated with orforglipron. Such monitoring may increase the risk of unnecessary procedures, due to the low test specificity for serum calcitonin and a high background incidence of thyroid disease. Significantly elevated serum calcitonin values may indicate MTC and patients with MTC usually have calcitonin values >50 ng/L. If serum calcitonin is measured and found to be elevated, the patient should be further evaluated. Patients with thyroid nodules noted on physical examination or neck imaging should also be further evaluated.1
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Has Orforglipron Been Studied in People With Cancer or a History of Cancer?
Eli Lilly and Company cannot provide a recommendation on whether to use orforglipron in a patient with cancer or a history of cancer. These patients were excluded from the phase 3 clinical trial program, and as a result, subgroup analysis evaluating the safety and efficacy of orforglipron in this population was not performed.2,3
The health care practitioner may use the information provided, the patient’s prior medical history and concomitant medications, and other individual factors in developing a treatment plan. The health care practitioner should consider potential risks and benefits of treatment options and monitor appropriately.
Study Exclusion Criteria Related to Cancer
ATTAIN-1 and ATTAIN-2 were randomized, double-blind, placebo-controlled trials evaluating the efficacy and safety of orforglipron in adults with obesity or overweight. ATTAIN-1 enrolled participants without type 2 diabetes (T2D) and ATTAIN-2 enrolled participants with T2D.2,3
In these studies, participants were excluded if they had
- a family (first-degree relative) or personal history of MTC or MEN2 syndrome
- a history of an active or untreated malignancy, or
- been in remission from a clinically significant malignancy for less than 5 years (with the exception of basal or squamous cell skin cancer, in situ carcinomas of the cervix or in situ or grade 1 (for example, Gleason 6 or lower) prostate cancer).2,3
Participants in remission from malignancy for more than 5 years may have been enrolled in the clinical trials, but no subgroup analyses were conducted in these populations.
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What Was the Incidence of Cancer in the Orforglipron Weight Management Studies?
ATTAIN-1 and ATTAIN-2 were randomized, double-blind, placebo-controlled trials evaluating the efficacy and safety of orforglipron in adults with obesity or overweight. ATTAIN-1 enrolled participants without type 2 diabetes (T2D) and ATTAIN-2 enrolled participants with T2D.2,3
These studies compared an investigational orforglipron capsule formulation with placebo during 72 weeks, plus a 2-week off-drug follow-up.2,3
This response presents safety data from the investigational orforglipron capsule formulation (1 mg, 3 mg, 6 mg, 12 mg, 24 mg, and 36 mg) shown as equivalent doses of once daily orforglipron tablets (0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, and 17.2 mg) approved in the United States.1-3
The percentages of participants with malignancies were similar across the orforglipron and placebo groups. Data on the incidence of cancer across ATTAIN-1 and ATTAIN-2 are summarized in Adverse Events of Cancer in ATTAIN-1 and ATTAIN-2.4
Study |
OFG 5.5 mg |
OFG 9 mg |
OFG 17.2 mg |
Placebo |
Total |
ATTAIN-1 |
N=723 |
N=724 |
N=728 |
N=948 |
N=3123 |
6 (0.8) |
8 (1.1) |
6 (0.8) |
10 (1.1) |
30 (1.0) |
|
ATTAIN-2 |
N=328 |
N=331 |
N=321 |
N=628 |
N=1608 |
4 (1.2) |
3 (0.9) |
8 (2.5) |
11 (1.8) |
26 (1.6) |
Abbreviations: N = number of participants; OFG = orforglipron.
Note: Data are shown as number of participants (%).
No cases of MTC have been reported in the ATTAIN-1 and ATTAIN-2 studies with orforglipron treatment.2,3
No information about cancer other than thyroid c-cell tumors is included in the current US Foundayo™ (orforglipron) prescribing information.1 At the time of review, to the extent there was data available on cancer from the orforglipron clinical trials experience, it did not meet FDA's criteria for clinical significance, causality to the drug, or relevance to patient safety and treatment decisions.
Patient safety is Eli Lilly and Company’s top priority and we actively engage in evaluating, monitoring, and reporting safety information for all our medicines. If new information indicates a new safety concern or signal for the product or the class, including postmarketing experience, the prescribing information will be properly updated in alignment with regulatory authorities.
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What Relevant Information Is Available From Nonclinical Studies?
Orforglipron is not pharmacologically active in rats or mice.
- In a 2-year rat carcinogenicity study, orforglipron was non-carcinogenic at oral daily doses of 5, 30, and 200 mg/kg/day resulting in exposures approximately 3, 9, and 26 times the clinical exposure at the maximum recommended human dose (MRHD), respectively, based on area under the curve (AUC).
- In a 26-week study in Tg.RasH2 transgenic mice, orforglipron was non-carcinogenic at oral daily doses of 5, 30, and 200 mg/kg/day.1
For other GLP-1 receptor agonists that are pharmacologically active in rats, thyroid C-cell hyperplasia, and thyroid C-cell adenoma and carcinoma have been observed at clinically relevant exposures and are considered an on-target class effect. Orforglipron would be expected to have the same on-target class effect if it was pharmacologically active in rats. The human relevance of these findings is unknown.1
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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.
2Horn 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
3Wharton 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
4Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: April 01, 2026