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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 gallbladder diseases with Foundayo™ (orforglipron)?
In pooled data from ATTAIN-1 and ATTAIN-2, cholelithiasis was reported in 1% of orforglipron-treated and 0.7% of placebo-treated patients. Acute cholecystitis was reported in 0.4% of orforglipron-treated and 0.3% of placebo-treated patients.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
- What Are the Warnings and Precautions Related to Acute Gallbladder Disease in the US Prescribing Information?
- Were Acute Gallbladder Events Reported With Orforglipron in Phase 3 Studies for Weight Management?
- Enclosed Prescribing Information
- References
What Are the Warnings and Precautions Related to Acute Gallbladder Disease in the US Prescribing Information?
Treatment with orforglipron and glucagon-like peptide-1 (GLP-1) receptor agonists is associated with an increased occurrence of acute gallbladder disease.1
In a pool of 2 randomized, double-blind, placebo-controlled clinical trials of orforglipron for weight reduction (ATTAIN-1 and ATTAIN-2), cholelithiasis was reported in
- 1% of patients treated with orforglipron once daily, and
- 0.7% of placebo-treated patients.1
Acute cholecystitis was reported in
- 0.4% of patients treated with orforglipron once daily, and
- 0.3% of placebo-treated patients.1
Acute gallbladder events were associated with weight reduction. If cholecystitis is suspected, gallbladder diagnostic studies and appropriate clinical follow-up are indicated.1
Were Acute Gallbladder Events 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.1-3
Gallbladder-related treatment-emergent adverse events (TEAEs) in ATTAIN-1 and ATTAIN-2 in the different treatment groups are summarized in Table 1.
| Patients With Gallbladder-Related TEAEs, n (%) | OFG 5.5 mg | OFG 9 mg | OFG 17.2 mg | Placebo |
|---|---|---|---|---|
| ATTAIN-1 | N=723 | N=724 | N=728 | N=948 |
| Cholelithiasis | 6 (0.8) | 11 (1.5) | 11 (1.5) | 8 (0.8) |
| Acute cholecystitis | 1 (0.1) | 2 (0.3) | 4 (0.5) | 1 (0.1) |
| Chronic cholecystitis | 2 (0.3) | 3 (0.4) | 1 (0.1) | 1 (0.1) |
| Gallbladder disease (only severe or serious adverse events) | 3 (0.4) | 6 (0.8) | 6 (0.8) | 4 (0.4) |
| ATTAIN-2 | N=328 | N=331 | N=321 | N=628 |
| Cholelithiasis | 4 (1.2) | 7 (2.1) | 2 (0.6) | 2 (0.3) |
| Acute cholecystitis | 1 (0.3) | 1 (0.3) | 2 (0.6) | 2 (0.3) |
| Chronic cholecystitis | 0 | 0 | 1 (0.3) | 0 |
| Gallbladder disease (only severe or serious adverse events) | 1 (0.3) | 3 (0.9) | 3 (0.9) | 4 (0.6) |
Abbreviations: OFG = orforglipron; TEAE = treatment-emergent adverse event.
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.
Date of Last Review: April 07, 2026