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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.
Can Foundayo™ (orforglipron) be used in people with renal impairment?
The intrinsic factor of renal impairment (eGFR 27.8 to 156 mL/min/1.73 m2) does not have a clinically relevant effect on the PK of orforglipron, therefore, no dosage adjustment of orforglipron is recommended for patients with renal impairment.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
- Are Dose Adjustments of Orforglipron Needed in Patients With Renal Impairment?
- Does Impaired Renal Function Impact the Pharmacokinetics of Orforglipron?
- Are There Any Efficacy and Safety Data Available for Orforglipron Based on Different Baseline Kidney Function Levels?
- Can Orforglipron be Used in People Undergoing Dialysis?
- Enclosed Prescribing Information
- References
Are Dose Adjustments of Orforglipron Needed in Patients With Renal Impairment?
No dosage modification of orforglipron is recommended for patients with renal impairment.1
Does Impaired Renal Function Impact the Pharmacokinetics of Orforglipron?
Renal impairment does not impact the pharmacokinetics (PK) of orforglipron. The PK of orforglipron after a single oral 0.8 mg dose were evaluated in participants with severe renal impairment and end-stage renal disease (ESRD) compared with participants who had normal renal function.1
Data from clinical studies have also shown that renal impairment in participants with overweight or obesity does not impact the PK of orforglipron.1
Are There Any Efficacy and Safety Data Available for Orforglipron Based on Different Baseline Kidney Function Levels?
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 ATTAIN-1 and ATTAIN-2, participants were excluded if they had an estimated glomerular filtration rate (eGFR) <15 mL/min/1.73 m², calculated by Chronic Kidney Disease-Epidemiology cystatin-C equation as determined by central laboratory at screening.2,3
Additionally, in ATTAIN-2, participants were also excluded if they had an eGFR that would contraindicate the use of the participant's concurrent oral antihyperglycemic medication per the label in their respective country.3
Please refer to Table 1 for information on baseline eGFR and eGFR categories of participants in ATTAIN-1 and ATTAIN-2.
| Parametera | OFG 5.5 mg | OFG 9 mg | OFG 17.2 mg | PBO | Total |
|---|---|---|---|---|---|
| ATTAIN-1 | N=723 | N=725 | N=730 | N=949b | N=3127 |
| Baseline eGFR, mL/min/1.73 m² | 93.1 (18.7) | 92.5 (18.7) | 92.8 (18.4) | 92.4 (18.5) | 92.7 (18.6) |
| eGFR category, mL/min/1.73 m² | |||||
| <30 | 0 (0) | 0 (0) | 0 (0) | 2.0 (0.2) | 2 (0.1) |
| ≥30 to <45 | 5 (0.7) | 8 (1.1) | 3 (0.4) | 2 (0.2) | 18 (0.6) |
| ≥45 to <60 | 24 (3.3) | 25 (3.4) | 29 (4.0) | 43 (4.5) | 121 (3.9) |
| ≥60 to <90 | 270 (37.3) | 278 (38.3) | 401 (54.9) | 357 (37.7) | 1202 (38.5) |
| ≥90 | 424 (58.6) | 414 (57.1) | 401 (54.9) | 544 (57.4) | 1783 (57.0) |
| ATTAIN-2 | N=329 | N=332 | N=322 | N=630 | N=1613 |
| Baseline eGFR, mL/min/1.73 m² | 82.3 (20.9) | 83.9 (21.0) | 82.2 (22.5) | 82.7 (21.5) | 82.8 (21.5) |
| eGFR category, mL/min/1.73 m² | |||||
| <30 | 1 (0.3) | 0 (0) | 4 (1.2) | 4 (0.6) | 9 (0.6) |
| ≥30 to <45 | 13 (4.0) | 12 (3.6) | 9 (2.8) | 21 (3.3) | 55 (3.4) |
| ≥45 to <60 | 34 (10.3) | 29 (8.7) | 38 (11.8) | 75 (11.9) | 176 (10.9) |
| ≥60 to <90 | 159 (48.3) | 150 (45.2) | 141 (43.8) | 267 (42.4) | 717 (44.5) |
| ≥90 | 122 (37.1) | 141 (42.5) | 130 (40.4) | 263 (41.7) | 656 (40.7) |
Abbreviations: eGFR = estimated glomerular filtration rate; OFG = orforglipron; PBO = placebo.
a Data are presented as mean (SD) and n (%).
b N=948 for the placebo dose group in ATTAIN-1 for eGFR category as data was missing for 1 participant.
Eli Lilly and Company (Lilly) has not conducted subgroup analyses of orforglipron efficacy and safety in participants with different degrees of renal impairment.
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. 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
Can Orforglipron be Used in People Undergoing Dialysis?
There is no information available regarding the efficacy and safety of orforglipron in adults undergoing dialysis as this has not been studied by Lilly.
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 06, 2026