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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.
Is Foundayo™ (orforglipron) associated with renal adverse events?
There have been reports of AKI, in some cases requiring hemodialysis, in people receiving products with GLP-1 RA activity or orforglipron. Monitor renal function in patients reporting adverse reactions to orforglipron that could lead to volume depletion.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
- Warnings and Precautions Related to Acute Kidney Injury Due to Volume Depletion
- Were Renal Adverse Events Reported With Orforglipron in Phase 3 Studies for Weight Management?
- Enclosed Prescribing Information
- References
Warnings and Precautions Related to Acute Kidney Injury Due to Volume Depletion
There have been reports of acute kidney injury, in some cases requiring hemodialysis, in patients treated with glucagon-like peptide-1 receptor agonists or orforglipron.1
The majority of the reported events occurred in participants 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 the pooled ATTAIN-1 and ATTAIN-2 trials, acute kidney injury was reported in
- 0.2% of orforglipron-treated participants, and
- 0.05% of placebo-treated participants.1
Were Renal Adverse 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
Serious or severe renal adverse events reported in ATTAIN-1 and ATTAIN-2 are presented in Table 1.
| OFG 5.5 mg | OFG 9 mg | OFG 17.2 mg | PBO | Total | |
|---|---|---|---|---|---|
| ATTAIN-1 | N=723 | N=725 | N=730 | N=949 | N=3127 |
| Participants with ≥1 serious or severe renal event, n (%)a | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (0.1) | 1 (<0.1) |
| ATTAIN-2 | N=329 | N=332 | N=322 | N=630 | N=1613 |
| Participants with ≥1 serious or severe renal event, n (%)a | 0 (0.0) | 4 (1.2) | 0 (0.0) | 1 (0.2) | 5 (0.3) |
Abbreviations: OFG = orforglipron; PBO = placebo.
a Events were classified as serious or severe adverse events.
In orforglipron-treated participants who reported serious or severe renal adverse events there were
- 3 reports of acute kidney injury in participants treated with orforglipron 9 mg, and
- 1 report of renal failure in a participant treated with orforglipron 9 mg.4
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.
- Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Date of Last Review: April 03, 2026