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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 gastrointestinal adverse events with Foundayo™ (orforglipron)?
In ATTAIN-1 and 2, gastrointestinal adverse reactions occurred in 60%, 68%, and 69% of patients receiving orforglipron 5.5, 9, and 17.2 mg compared with 37% with placebo. The incidence was higher during the dose escalation period and decreased over time.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
- Prescribing Information Related to Gastrointestinal Adverse Reactions
- Were Gastrointestinal Adverse Reactions Reported With Orforglipron in Phase 3 Studies for Weight Management?
- Postmarketing Experience
- References
Prescribing Information Related to Gastrointestinal Adverse Reactions
From pooled ATTAIN-1 and ATTAIN-2 data, gastrointestinal adverse reactions occurred more frequently among patients treated with once daily orforglipron than placebo, occurring in
- 60% of participants receiving orforglipron 5.5 mg
- 68% of participants receiving orforglipron 9 mg
- 69% of participants receiving orforglipron 17.2 mg, and
- 37% of participants receiving placebo.1
Of the orforglipron-treated patients who reported gastrointestinal adverse reactions, 60%, 36%, and 4% reported mild or moderate or severe adverse reactions, respectively. The incidence of nausea, vomiting, and diarrhea was higher during the orforglipron dosage escalation period and decreased over time.1
Use of orforglipron has been associated with gastrointestinal adverse reactions, sometimes severe.1
In clinical trials, severe gastrointestinal adverse reactions were reported more frequently among patients treated with orforglipron (approximately 3%) than patients who received placebo (1%).1
Severe gastrointestinal adverse reactions have also been reported postmarketing with glucagon-like peptide-1(GLP-1) receptor agonists. Orforglipron is not recommended in patients with severe gastroparesis.1
Please refer to the prescribing information for the recommended starting dose and escalation for orforglipron to reduce the risk of gastrointestinal adverse reactions.
There have been reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with GLP-1 receptor agonists or orforglipron. The majority of the reported events occurred in patients who experienced gastrointestinal adverse reactions leading to dehydration such as nausea, vomiting, or diarrhea.1
Monitor renal function in patients reporting adverse reactions to orforglipron that could lead to volume depletion, especially during dosage initiation and escalation of orforglipron.1
In pooled data from ATTAIN-1 and ATTAIN-2 studies, acute kidney injury was reported in 0.2% of orforglipron-treated patients compared to 0.05% of placebo-treated patients.1
Were Gastrointestinal Adverse Reactions Reported With Orforglipron in Phase 3 Studies for Weight Management?
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.1,4
Table 1 shows common adverse reactions associated with the use of once daily orforglipron in the pool of two placebo-controlled trials for weight management (ATTAIN-1 and ATTAIN-2). These adverse reactions occurred more commonly with once daily orforglipron than with placebo and occurred in at least 5% of patients treated with orforglipron.1
A low starting dose (0.8 mg) and a slow dose titration (fixed 4-week intervals) were employed in these studies to optimize gastrointestinal tolerability.1,4
Table 1: Adverse Reactions Reported in ≥5% of Orforglipron-Treated Adult Patients With Obesity or Overweight (With or Without Type 2 Diabetes)1
| Adverse Reaction | Placebo (N=1576) % | OFG 5.5 mg (N=1051) % | OFG 9 mg (N=1055) % | OFG 17.2 mg (N=1049) % |
|---|---|---|---|---|
| Nausea | 10 | 26 | 34 | 35 |
| Constipation | 9 | 20 | 27 | 24 |
| Diarrhea | 11 | 21 | 23 | 25 |
| Vomiting | 4 | 13 | 21 | 24 |
| Dyspepsia | 4 | 12 | 16 | 13 |
| Abdominal paina | 7 | 13 | 14 | 14 |
| Headache | 7 | 7 | 9 | 9 |
| Abdominal distension | 3 | 7 | 9 | 8 |
| Fatiguea | 4 | 6 | 7 | 9 |
| Eructation | 1 | 6 | 8 | 8 |
| Gastroesophageal reflux disease | 2 | 6 | 6 | 7 |
| Flatulence | 2 | 5 | 6 | 6 |
| Hair lossa | 2 | 4 | 4 | 5 |
Abbreviations: OFG = orforglipron.
a Includes other related terms.
Across both trials, 8% of patients treated with orforglipron (5.5 mg, 6%; 9 mg, 9%; and 17.2 mg, 10%) once daily permanently discontinued treatment as a result of adverse reactions compared to 3% of patients receiving placebo.1
The majority of patients (5%) who discontinued orforglipron due to adverse reactions did so due to gastrointestinal adverse reactions.1
Postmarketing Experience
The following adverse reactions have been reported during post-approval use of GLP-1 receptor agonists. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.1
Gastrointestinal Disorders: acute pancreatitis, hemorrhagic and necrotizing pancreatitis sometimes resulting in death; ileus, intestinal obstruction, severe constipation including fecal impaction.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.
- Ma X, Li YG, Raha S, et al. Pharmacokinetic bioequivalence of orforglipron tablets and capsules in healthy participants with obesity or overweight. Diabetes Obes Metab. Published online April 17, 2026. https://doi.org/10.1111/dom.70783
Date of Last Review: April 01, 2026