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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 is the incidence of hypersensitivity reactions with Foundayo™ (orforglipron)?

In ATTAIN-1 and -2, 1 (<1%) orforglipron-treated participant reported a severe or serious hypersensitivity reaction. Orforglipron is contraindicated in people with known serious hypersensitivity to orforglipron or any of the excipients in orforglipron.

US_cFAQ_OFG509B_HYPERSENSITIVITY_REACTIONS

See important safety information, including boxed warning, in the attached prescribing information.

Prescribing Information Related to Hypersensitivity

Orforglipron is contraindicated in patients with known serious hypersensitivity to orforglipron or any of the excipients in orforglipron.¹

Serious hypersensitivity reactions, including anaphylaxis and angioedema, have been reported with glucagon-like peptide-1 (GLP-1) receptor agonists.¹

If hypersensitivity reactions occur, advise the patient to promptly seek medical attention and discontinue use of orforglipron.¹

Use caution in a patient with a history of anaphylaxis or angioedema with another GLP-1 receptor agonist because it is unknown whether such patients will be predisposed to these reactions with orforglipron.¹

Were Hypersensitivity Events Reported in Orforglipron Phase 3 Weight Management Studies?

ATTAIN-1 and -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 for 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.^1-4

In the ATTAIN-1 and -2 clinical studies, which enrolled more than 4000 participants across 13 counties, there was 1 orforglipron-treated participant who reported a hypersensitivity reaction.^2,3

Severe or serious adverse events of hypersensitivity reported in ATTAIN-1 and -2 are presented in Table 1.

Table 1. Severe or Serious Adverse Events of Hypersensitivity in ATTAIN-1 and ATTAIN-2^2-4

Adverse event^a	OFG 5.5 mg	OFG 9 mg	OFG 17.2 mg	PBO	Total
ATTAIN-1	N=723	N=724	N=728	N=948	N=3123
Hypersensitivity	0 (0)	0 (0)	0 (0)	1 (1)	1 (<0.1)
ATTAIN-2	N=328	N=331	N=321	N=628	N=1608
Hypersensitivity	1 (0.3)	0 (0)	0 (0)	0 (0)	1 (0·1)

Abbreviations: OFG = orforglipron; PBO = placebo.
^a Data are shown as n (%).

How to Manage Hypersensitivity Reactions in Patients Taking Orforglipron?

If hypersensitivity reactions occur, advise the patient to promptly seek medical attention and discontinue use of orforglipron.¹

The ATTAIN-1 and -2 protocols did not provide specific guidance about the management of hypersensitivity reactions. During the trials, investigators used local guidelines to manage systemic hypersensitivity reactions or participants were permanently discontinued from study intervention.^2,5

Eli Lilly and Company cannot provide treatment recommendations on how to manage hypersensitivity reactions in patients using orforglipron. In formulating an assessment and approach, the health care practitioner may consider

the patient’s prior medical history and concomitant medications, and
other individual factors.

The health care practitioner should consider potential risks and benefits of treatment options and monitor appropriately.

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.
Ma X, Li YG, Raha S, Sperry DC, Coutant DE, Bhattachar S. Pharmacokinetic bioequivalence of orforglipron tablets and capsules in healthy participants with obesity or overweight. Diabetes Obes Metab. 2026;28(7):5803-5809. https://doi.org/10.1111/dom.70783
Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Date of Last Review: August 25, 2026

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Foundayo ™ (orforglipron) tablet

0.8 mg / 2.5 mg / 5.5 mg / 9 mg / 14.5 mg / 17.2 mg

What is the incidence of hypersensitivity reactions with Foundayo™ (orforglipron)?

In ATTAIN-1 and -2, 1 (<1%) orforglipron-treated participant reported a severe or serious hypersensitivity reaction. Orforglipron is contraindicated in people with known serious hypersensitivity to orforglipron or any of the excipients in orforglipron.

Foundayo ^™ (orforglipron) tablet