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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 pancreatitis with Foundayo™ (orforglipron)?
In clinical studies, 6 events of acute pancreatitis were confirmed by adjudication in 6 orforglipron-treated participants (0.14 patients per 100 years of exposure) versus 2 events in 1 placebo-treated participant (0.04 patients per 100 years of exposure).
See important safety information, including boxed warning, in the attached prescribing information.
Warnings and Precautions Related to Pancreatitis
Acute pancreatitis has been reported in patients treated with orforglipron. Fatal and non-fatal hemorrhagic or necrotizing pancreatitis has been observed in patients treated with glucagon-like peptide-1 (GLP-1) receptor agonists.1
After initiation of orforglipron, observe patients carefully for signs and symptoms of acute pancreatitis, which may include persistent or severe abdominal pain (sometimes radiating to the back) and which may or may not be accompanied by nausea or vomiting.1
If pancreatitis is suspected, discontinue orforglipron and initiate appropriate management.1
Pancreatitis Reported in Orforglipron Phase 3 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
In pooled data from ATTAIN-1 and ATTAIN-2, 6 events of acute pancreatitis were confirmed by adjudication in 6 orforglipron-treated participants (0.14 patients per 100 years of exposure) compared with 2 events in 1 placebo-treated participant (0.04 patients per 100 years of exposure).1
Adverse events of adjudication-confirmed pancreatitis reported in each study are presented in Adverse Events of Adjudication-Confirmed Pancreatitis in ATTAIN-1 and ATTAIN-2.
Adverse Eventa |
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 |
Adjudication-confirmed pancreatitis |
1 (0.1) |
2 (0.3) |
2 (0.3) |
0 |
5 (0.2) |
ATTAIN-2 |
N=328 |
N=331 |
N=321 |
N=628 |
N=1608 |
Adjudication-confirmed pancreatitis |
0 |
1 (0.3) |
0 |
2 (0.3) |
3 (0.2) |
Abbreviations: OFG = orforglipron; PBO = placebo.
Notes: In participants with an adverse event of adjudication-confirmed pancreatitis in ATTAIN‑1 and ATTAIN‑2, all reported adjudicated adverse events were acute pancreatitis, except for one participant treated with placebo who reported an adjudicated event of chronic pancreatitis.
aData are number of patients (%).
In ATTAIN-1, all 5 cases of adjudication-confirmed pancreatitis were considered mild and no complications were reported.2
Diagnosis of Acute Pancreatitis in Orforglipron Phase 3 Weight Management Studies
The diagnosis of acute pancreatitis requires 2 of the following 3 features:
- abdominal pain, characteristic of acute pancreatitis, that is, epigastric pain radiating to the back, often associated with nausea and vomiting
- serum amylase (total, pancreatic, or both) and/or lipase ≥3x the upper limit of normal (ULN)
- characteristic findings of acute pancreatitis on computed tomography (CT) scan or magnetic resonance imaging (MRI).2,4-6
If acute pancreatitis was suspected during ATTAIN-1 and ATTAIN-2, the investigators should have
- obtained appropriate laboratory tests, including pancreatic amylase and lipase
- performed imaging studies, such as abdominal CT scan with or without contrast, abdominal MRI, or abdominal ultrasound (only if CT and MRI cannot be performed), and
- evaluated for possible causes of acute pancreatitis (alcohol use, gallstone or gallbladder disease, hypertriglyceridemia, and concomitant medications).2,4
Pancreatitis From Postmarketing Data
Acute pancreatitis, including hemorrhagic and necrotizing pancreatitis sometimes resulting in death have been reported during post-approval use of GLP-1 receptor agonists.1
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
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.
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
4Data on file, Eli Lilly and Company and/or one of its subsidiaries.
5Banks PA, Freeman ML; Practice Parameters Committee of the American College of Gastroenterology. Practice guidelines in acute pancreatitis. Am J Gastroenterol. 2006;101(10):2379-2400. https://doi.org/10.1111/j.1572-0241.2006.00856.x
6Koizumi M, Takada T, Kawarada Y, et al. JPN Guidelines for the management of acute pancreatitis: diagnostic criteria for acute pancreatitis. J Hepatobiliary Pancreat Surg. 2006;13(1):25-32. https://doi.org/10.1007/s00534-005-1048-2
Date of Last Review: April 01, 2026