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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 concomitantly with statins?
Do not exceed simvastatin 20 mg once daily when concomitantly used with orforglipron. There were no clinically relevant changes when orforglipron was used with rosuvastatin or atorvastatin.
See important safety information, including boxed warning, in the attached prescribing information.
What Does the Prescribing Information Say About Use of Orforglipron with Statins?
Orforglipron was studied with commonly used medications, including statins.1
Use of orforglipron with simvastatin increased exposure of the active metabolite simvastatin acid 2-fold, whether orforglipron was co-administered or dosing was staggered by 2 hours. A two-fold increase in simvastatin acid exposure at the highest simvastatin dose could be clinically meaningful.2
The mechanism explaining why concomitant use of orforglipron increases simvastatin acid exposure is unknown.
Do not exceed simvastatin 20 mg once daily when concomitantly used with orforglipron.2
No clinically relevant changes were observed for orforglipron when used with rosuvastatin or atorvastatin.2
How Many Patients in the Weight Management Trials Received Orforglipron With Concomitant Use of Statins?
The efficacy and safety of orforglipron have been evaluated in 2 randomized, double-blind, placebo-controlled trials, including
The numbers of participants who received statins concomitantly with orforglipron or placebo at any time post-baseline in the pooled safety population of ATTAIN-1 and ATTAIN-2 trials are provided in Summary of Concomitant Statins Received Post-Baseline in the Pooled Safety Populations of ATTAIN-1 and ATTAIN-2.
Statins (HMG-CoA Reductase Inhibitors), n (%) |
Pooled Orforgliprona |
Placebo |
Subjects with ≥1 concomitant statins |
1040 (33.0) |
597 (37.9) |
Atorvastatin |
438 (13.9) |
248 (15.7) |
Rosuvastatin |
399 (12.6) |
247 (15.7) |
Simvastatin |
193 (6.1) |
99 (6.3) |
Pitavastatin |
37 (1.2) |
18 (1.1) |
Pravastatin |
26 (0.8) |
8 (0.5) |
Lovastatin |
3 (0.1) |
3 (0.2) |
Abbreviations: HMG-CoA = β-hydroxy β-methylglutaryl coenzyme A; N = number of subjects in safety population; n = number of subjects who received medication.
Note: Data include participants who received at least one dose of study drug (safety population) and received concomitant statins at any time post-baseline, including medications started at or before first dose and continuing into post-baseline. Subjects may be counted in more than one row.
aThe pooled orforglipron group includes participants treated with an investigational orforglipron formulation (6 mg, 12 mg, and 36 mg), referred to here as orforglipron and shown as equivalent once‑daily doses of the approved orforglipron tablet formulation (5.5 mg, 9 mg, and 17.2 mg).
Use of Statins in People With Obesity or Overweight With a Comorbidity in the United States
According to IQVIA Total Rx data, between January 2023 and March 2026, among US adults with obesity or overweight and a comorbidity including T2D, approximately
- 1% were taking simvastatin doses >20 mg, and
- 4% were taking simvastatin at any dose.1
Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2Foundayo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
3Wharton 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
4Horn 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 03, 2026