Search Foundayo (type in keywords)

Search Medical Information

If you wish to report an adverse event or product complaint, please call 1-800-LILLYRX (1-800-545-5979)

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 gastrointestinal disease?

Orforglipron is not recommended in patients with severe gastroparesis. Lilly cannot advise on its use in people with other gastrointestinal conditions. The use of orforglipron has been associated with gastrointestinal adverse reactions, sometimes severe.

US_cFAQ_OFG305B_USE_IN_PEOPLE_WITH_GI_DISEASE_WM

en-US

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

Orforglipron Use in People With Gastrointestinal Disease

Orforglipron is not recommended in patients with severe gastroparesis.1

In the orforglipron weight management clinical study program, participants were excluded if they

had a known clinically significant gastric emptying abnormality such as gastric outlet obstruction, or
were chronically taking drugs that directly affect gastrointestinal (GI) motility.2,3

Participants with no known, clinically significant gastric abnormality were not specifically excluded from the orforglipron weight management clinical studies.2,3 However, no efficacy and safety data of orforglipron are available in these participants.

Eli Lilly and Company cannot provide treatment recommendations on the use of orforglipron in people who have comorbid GI diseases or GI-related medical conditions (other than gastroparesis). This includes people with

inflammatory bowel disease (IBD)
gastroesophageal reflux disease (GERD)
ostomy surgery
etc.

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

Clinical Considerations for the Use of Orforglipron in People With Comorbid Gastrointestinal Disease

Orforglipron delays gastric emptying. The delay is largest after the first dose and diminishes over time.1

The use of orforglipron has been associated with GI adverse reactions, sometimes severe. Severe GI adverse reactions have also been reported postmarketing with glucagon-like peptide-1 (GLP-1) receptor agonists.1

In a pool of 2 randomized, placebo-controlled studies in adults with obesity or overweight, without or with type 2 diabetes (ATTAIN-1 and ATTAIN-2, respectively), GI adverse reactions occurred more frequently among patients treated with once daily orforglipron than placebo, specifically in

60% of participants treated with orforglipron 5.5 mg
68% of participants treated with orforglipron 9 mg
69% of participants treated with orforglipron 17.2 mg, and
37% of participants receiving placebo.1

More patients treated with once daily orforglipron 5.5 mg (3%), 9 mg (6%), and 17.2 mg (6%) discontinued treatment due to GI adverse reactions than patients receiving placebo (0.7%).1

Of the orforglipron-treated patients who reported GI adverse reactions, 60%, 36%, and 4% reported mild or moderate or severe adverse reactions, respectively.1

The incidence of nausea, vomiting, and diarrhea was higher during the orforglipron dosage escalation period and decreased over time.1

Common adverse reactions in the pooled placebo-controlled trials occurring in ≥5% of patients treated with orforglipron are described in Adverse Reactions Reported in ≥5% of Orforglipron-Treated Participants in Pool of Placebo-Controlled Trials ATTAIN-1 and ATTAIN-2.

Adverse Reactions Reported in ≥5% of Orforglipron-Treated Participants in Pool of Placebo-Controlled Trials ATTAIN-1 and ATTAIN-21
Adverse Reaction, %	Orforglipron 5.5 mg (N=1051)	Orforglipron 9 mg (N=1055)	Orforglipron 17.2 mg (N=1049)	Placebo (N=1576)
Nausea	26	34	35	10
Constipation	20	27	24	9
Diarrhea	21	23	25	11
Vomiting	13	21	24	4
Dyspepsia	12	16	13	4
Abdominal paina	13	14	14	7
Headache	8	9	9	7
Abdominal distension	7	9	8	3
Fatiguea	6	7	9	4
Eructation	6	8	8	1
Gastroesophageal reflux disease	6	6	7	2
Flatulence	5	6	6	2
Hair lossa	4	4	5	2

aIncludes other related terms.

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).

1Foundayo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.

2Wharton 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

3Horn 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: April 01, 2026

Are you satisfied with this content?

Foundayo ™ (orforglipron) tablet