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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 was the incidence of hypoglycemia with Foundayo™ (orforglipron)?
In ATTAIN-1 (no type 2 diabetes [T2D]), hypoglycemia was not systematically captured, occurring in 0.6% of orforglipron patients vs none on placebo. In ATTAIN-2 (patients with T2D), hypoglycemia occurred in 2% of orforglipron vs 0.2% of placebo patients.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
Warnings and Precautions Related to the Risk of Hypoglycemia With Concomitant Use of Insulin Secretagogues or Insulin
Orforglipron lowers blood glucose and can cause hypoglycemia.1
Concomitant use with insulin or an insulin secretagogue may increase the risk of hypoglycemia, including severe hypoglycemia.1
Hypoglycemia has also been associated with orforglipron and GLP-1 receptor agonists in adults without type 2 diabetes.1
Inform patients of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. In patients with diabetes, monitor blood glucose prior to starting orforglipron and during orforglipron treatment. The risk of hypoglycemia may be lowered by a reduction in the dose of insulin or sulfonylurea (or other concomitantly administered
insulin secretagogue).1
Were Hypoglycemia Events 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
Hypoglycemia Events in Patients With Obesity or Overweight With Type 2 Diabetes
ATTAIN-2 enrolled adult participants with obesity or overweight with T2D.3
In ATTAIN-2, glucometers were provided to all participants to self-monitor blood glucose and participants were encouraged to record values.3
In ATTAIN-2, hypoglycemia (plasma glucose <54 mg/dL) was reported in 2% of patients treated with orforglipron versus 0.2% of patients receiving placebo.1
Hypoglycemia Incidence in ATTAIN-2 presents the incidence of hypoglycemia per treatment arm in ATTAIN-2.
One patient treated with orforglipron 5.5 mg once-daily and no patients receiving placebo reported severe hypoglycemia in ATTAIN-2. The participant with the severe hypoglycemia event unintentionally missed their morning meal after taking the study drug and metformin. Severe hypoglycemia was defined as a hypoglycemic event characterized by altered mental status and/or altered physical status that the participant was unable to resolve without assistance.1,3
In ATTAIN-2, 7% of patients treated with orforglipron once daily in combination with sulfonylurea reported hypoglycemia compared with 0.5% of patients not taking a sulfonylurea (Hypoglycemia Incidence in ATTAIN-2).1
Type of Event | OFG 5.5 mg N=328 | OFG 9 mg N=331 | OFG 17.2 mg N=321 | OFG pooled doses N=980 | Placebo N= 628 |
Hypoglycemiaa | 5 (1.5) | 7 (2.1) | 8 (2.5) | 20 (2.0) | 1 (0.2) |
Severe hypoglycemiab | 1 (0.3) | 0 | 0 | 1 (0.1) | 0 |
Hypoglycemic events in participants using sulfonylureas at baselineac | 4 (5.6) | 5 (6.1) | 7 (8.2) | 16 (6.7) | 1 (0.7) |
Hypoglycemic events in participants not using sulfonylureas at baselinead | 1 (0.4) | 2 (0.8) | 1 (0.4) | 4 (0.5) | 1 (0.2) |
Abbreviations: N = number of participants; OFG = orforglipron.
Notes: Data are shown as number of participants (%).
aHypoglycemia was defined as a blood glucose of <54 mg/dL (3.0 mmol/L). Events occurring within a 1-hour period were considered as one event. The event with the highest severity was selected for analysis.
bSevere hypoglycemia was defined as a hypoglycemic event characterized by altered mental status and/or altered physical status that the participant was unable to resolve without assistance. Events occurring within a 1-hour period were considered as one event. The event with the highest severity was selected for analysis.
cThe number of participants in the orforglipron 5.5 mg, 9 mg, and 17.2 mg groups that were using sulfonylureas at baseline were 72, 82, and 85, respectively. In the placebo group, 149 participants were using sulfonylureas at baseline.
dThe number of participants in the orforglipron 5.5 mg, 9 mg, and 17.2 mg groups that were not using sulfonylureas at baseline were 256, 249, and 236, respectively. In the placebo group, 478 participants were not using sulfonylureas at baseline.
Hypoglycemia Events in Patients With Obesity or Overweight Without Type 2 Diabetes
ATTAIN-1 enrolled adult participants with obesity or overweight, excluding those with T2D.2
ATTAIN-1 did not include the routine provision of glucometers to systematically capture and report hypoglycemia. In ATTAIN-1, blood glucose levels were determined based on scheduled laboratory values.4
In ATTAIN-1, there was no systematic capturing of hypoglycemia, but glucose <54 mg/dL was reported in 0.6% of orforglipron-treated patients and no placebo-treated patients. No patients in ATTAIN-1 reported severe hypoglycemia.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.
Date of Last Review: April 03, 2026