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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 effect of Foundayo™ (orforglipron) on lipids in adults with obesity or overweight?
At week 72, for the treatment-regimen estimand, the mean change of orforglipron pooled doses from baseline in non-HDL cholesterol was -6.7% and -6.2% in ATTAIN-1 and ATTAIN-2, respectively, compared with -1.9% and -2.5% with placebo.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
Which Weight Management Studies Evaluated the Effect of Orforglipron on Lipids?
Which Weight Management Studies Evaluated the Effect of Orforglipron on Lipids?
The effects of orforglipron on lipids in adults with obesity or overweight were evaluated in 2 randomized, double-blind, placebo-controlled trials, including
ATTAIN-1 and ATTAIN-2 had a treatment duration of 72 weeks and compared an investigational orforglipron capsule formulation with placebo.1,2
This response presents efficacy 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 both studies, all participants received lifestyle interventions, including guidance on diet and physical activity.1,2
What Were The Changes in Lipids in ATTAIN-1 in Adults With Obesity or Overweight With Weight-Related Comorbidities Excluding Type 2 Diabetes?
In ATTAIN-1, key secondary endpoints related to lipids and adjusted for multiplicity included the percent change from baseline to week 72 in non-high-density lipoprotein (non-HDL) cholesterol and triglycerides for the pooled orforglipron doses.1
Additional endpoints not controlled for multiplicity included the percent change in
- total cholesterol
- low-density lipoprotein (LDL) cholesterol
- high-density lipoprotein (HDL) cholesterol, and
- very low density lipoprotein (VLDL) cholesterol.1
At week 72, for the treatment-regimen estimand, pooled orforglipron doses led to a
- -6.7% change in non-HDL cholesterol compared with -1.9% with placebo (p<.001), and
- -14.8% change in triglycerides compared with -3.8% with placebo (p<.001, Efficacy Endpoints Related to Lipids in ATTAIN-1 (Treatment-Regimen Estimand)).1
Refer to Additional Secondary Efficacy Endpoints Related to Lipids in ATTAIN-1 (Treatment-Regimen Estimand) for changes in other lipids based on the treatment-regimen estimand in ATTAIN-1.
For efficacy results based on the efficacy estimand, please refer to the Appendix.
Parametera |
OFG 5.5 mg (N=723) |
OFG 9 mg (N=725) |
OFG 17.2 mg (N=730) |
Pooled OFG (N=2178) |
Placebo (N=949) |
Non-HDL cholesterol, mg/dLb |
|||||
Baseline |
146.4 |
144.6 |
147.5 |
146.4 |
147.0 |
CFB, % |
-5.4 |
-7.0 |
-7.7 |
-6.7* |
-1.9 |
Difference vs placebo (95% CI) |
-3.6 (-5.8, -1.3) |
-5.2 (-7.3, -3.0) |
-5.9 (-8.2, -3.6) |
-4.9 (-6.7, -3.1)* |
NA |
Triglycerides, mg/dLb |
|||||
Baseline |
135.4 |
133.5 |
142.8 |
138.8 |
142.4 |
CFB, % |
-10.4 |
-13.5 |
-20.2 |
-14.8* |
-3.8 |
Difference vs placebo (95% CI) |
-6.9 (-10.8, -2.9) |
-10.1 (-13.8, -6.3) |
-17.1 (-20.7, -13.3) |
-11.5 (-14.5, -8.3)* |
NA |
Abbreviations: ANCOVA = analysis of covariance; CFB = change from baseline; HDL = high-density lipoprotein; NA = not applicable; OFG = orforglipron.
*p<.001 vs placebo, adjusted for multiplicity at week 72.
Notes: Treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation of study intervention or initiation of prohibited weight management treatments.
aData are model-based estimates assessed with the use of ANCOVA (treatment-regimen estimand). Lipid measures were log-transformed before fitting the ANCOVA, and results were then back-transformed with the delta method from the model-based estimate and standard errors on the natural log scale.
bChange from baseline to week 72 in non-HDL cholesterol, and triglyceride for orforglipron individual doses of 5.5 mg, 9 mg, or 17.2 mg vs placebo were not key secondary endpoints in ATTAIN-1 and thus not controlled for multiplicity. P values were not included.
Figure 1 description: In ATTAIN-1, mean percent change from baseline to week 72 in total cholesterol was between -3.4 and -4.4% with orforglipron 5.5, 9, and 17.2 mg compared to -2.0% with placebo. The mean percent change in HDL was between 2.2 and 4.4% with orforglipron 5.5, 9, and 17.2 mg compared to -0.9% with placebo. Orforglipron 5.5, 9, and 17.2 mg led to a -3.9 to -4.9% change in LDL compared with a change of -1.3% with placebo. The mean percent change in VLDL was between -10.2 and -19.7% with orforglipron 5.5, 9, and 17.2 mg compared to -3.5% with placebo.
Notes: Data are model-based estimates assessed with the use of ANCOVA (treatment-regimen estimand). Lipid measures were log-transformed before fitting the ANCOVA model, and results were then back-transformed with the delta method from the model-based estimate and standard errors on the natural log scale.
Treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation of study intervention or initiation of prohibited weight management treatments.
Change from baseline to week 72 in total cholesterol, LDL cholesterol, HDL cholesterol, and VLDL cholesterol for orforglipron vs placebo were not key secondary endpoints in ATTAIN-1 and thus not controlled for multiplicity. P values were not included.
Abbreviations: ANCOVA = analysis of covariance; HDL = high-density lipoprotein; LDL = low-density lipoprotein; OFG = orforglipron; PBO = placebo; VLDL = very-low-density lipoprotein.
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What Were The Changes in Lipids in ATTAIN-2 in Adults With Obesity or Overweight With Type 2 Diabetes?
In ATTAIN-2, key secondary endpoints related to lipids and adjusted for multiplicity included the mean change from baseline to week 72 in non-HDL cholesterol and triglycerides for the pooled orforglipron doses.2
Additional secondary endpoints not controlled for multiplicity included the percent change in
- total cholesterol
- LDL cholesterol
- HDL cholesterol, and
- VLDL cholesterol.2
At week 72, for the treatment-regimen estimand, pooled orforglipron doses led to a
- -6.2% change in non-HDL cholesterol compared to -2.5% with placebo (p<.05), and
- -16.0% change in triglycerides compared to -4.2% with placebo (p<.001, Efficacy Endpoints Related to Lipids in ATTAIN-2 (Treatment-Regimen Estimand)).2
Refer to Efficacy Endpoints Related to Lipids in ATTAIN-2 (Treatment-Regimen Estimand) for changes in other lipids based on the treatment-regimen estimand in ATTAIN-2.
For efficacy results based on the efficacy estimand, please refer to the Appendix.
Parametera |
OFG 5.5 mg |
OFG 9 mg |
OFG 17.2 mg |
Pooled OFG |
Placebo |
Non-HDL cholesterol, mg/dLb |
|||||
Baseline |
120.7 |
121.4 |
121.2 |
121.1 |
122.3 |
CFB, % |
-4.4 |
-4.4 |
-9.8 |
-6.2 |
-2.5 |
Difference vs placebo (95% CI) |
-1.9 (-5.9, 2.2) |
-1.9 (-5.6, 2.0) |
-7.4 (-11.0, -3.7) |
-3.8 (-6.6, -0.8)** |
NA |
Triglycerides, mg/dLb |
|||||
Baseline |
157.4 |
164.4 |
157.2 |
159.6 |
162.8 |
CFB, % |
-13.5 |
-14.7 |
-19.6 |
-16.0 |
-4.2 |
Difference vs placebo (95% CI) |
-9.7 (-14.7, -4.4) |
-10.9 (-15.5, -6.0) |
-16.1 (-20.5, -11.4) |
-12.2 (-15.9, -8.4)* |
NA |
Abbreviations: ANCOVA = analysis of covariance; CFB = change from baseline; HDL = high-density lipoprotein; NA = not applicable; OFG = orforglipron.
*p<.001; **p<.05 vs placebo, adjusted for multiplicity at week 72.
Notes: Treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation of study intervention or initiation of prohibited weight management treatments.
aData are presented as model-based estimates for changes from baseline to week 72, along with ETD (95% CI) between the OFG groups and placebo based on ANCOVA analysis (treatment-regimen estimand). The CIs have not been adjusted for multiplicity and should not be used for hypothesis testing. For the percentage of participants with efficacy thresholds at week 72, data are presented as model-based estimate from logistic regression.
bChange from baseline to week 72 in non-HDL cholesterol, and triglyceride for orforglipron individual doses of 5.5 mg, 9 mg, or 17.2 mg vs placebo were not key secondary endpoints in ATTAIN-2 and thus not controlled for multiplicity. P values were not included.
Figure 2 description: In ATTAIN-2, mean percent change from baseline to week 72 in triglycerides was -16.0% with orforglipron pooled doses compared to -4.2% with placebo (p<.001). The mean percent change from baseline to week 72 in non-HDL cholesterol was -6.2% with orforglipron pooled doses compared to -2.5% with placebo (p<.05). Orforglipron pooled doses led to a 6.4% change in HDL cholesterol in comparison with 1.0% with placebo. The mean percent change in LDL cholesterol was -1.6% with orforglipron pooled doses in comparison with -2.7% with placebo. Orforglipron pooled doses led to a -14.3% change in VLDL cholesterol in comparison with -4.5% with placebo. The mean percent change from baseline to week 72 in total cholesterol was -2.5% with orforglipron pooled doses compared to -1.8% with placebo.
Notes: Data are model-based estimates assessed with the use of ANCOVA (treatment-regimen estimand). Lipid measures were log-transformed before fitting the ANCOVA model, and results were then back-transformed with the delta method from the model-based estimate and standard errors on the natural log scale.
Treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation of study intervention or initiation of prohibited weight management treatments.
Change from baseline to week 72 in total cholesterol, LDL cholesterol, HDL cholesterol, and VLDL cholesterol for orforglipron vs placebo were not key secondary endpoints in ATTAIN-2 and thus not controlled for multiplicity. P values were not included.
Abbreviations: ANCOVA = analysis of covariance; HDL-C = high-density lipoprotein cholesterol; LDL-C = low-density lipoprotein cholesterol; OFG = orforglipron; PBO = placebo; VLDL-C = very-low-density lipoprotein cholesterol.
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Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Wharton 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
2Horn 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
3Foundayo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
4Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Appendix
Efficacy Endpoints Related to Lipids in ATTAIN-1 (Efficacy Estimand)
Parametera |
OFG 5.5 mg (N=723) |
OFG 9 mg (N=725) |
OFG 17.2 mg (N=730) |
Pooled OFG (N=2178) |
Placebo (N=949) |
Non-HDL cholesterol, mg/dLb |
|||||
Baseline |
146.4 |
144.6 |
147.5 |
146.4 |
147.0 |
CFB |
-5.9 |
-8.3 |
-8.5 |
-7.6 |
-1.4 |
Difference vs placebo (95% CI) |
-4.5 (-6.6, -2.4) |
-7.0 (-9.1, -4.9) |
-7.2 (-9.2, -5.2) |
-6.3 (-7.8, -4.6)* |
NA |
Triglycerides, mg/dLb |
|||||
Baseline |
135.4 |
133.5 |
142.8 |
138.8 |
142.4 |
CFB |
-12.1 |
-15.2 |
-21.6 |
-16.4 |
-4.8 |
Difference vs placebo (95% CI) |
-7.7 (-11.2, -4.0) |
-10.9 (-14.4, -7.2) |
-17.6 (-20.7, -14.5) |
-12.2 (-14.8, -9.5)* |
NA |
Abbreviations: CFB = change from baseline; HDL = high-density lipoprotein; MMRM = mixed model for repeated measures; NA = not applicable; OFG = orforglipron.
*p<.001 vs placebo, adjusted for multiplicity at week 72.
Notes: Efficacy estimand represents treatment effect as if all randomized participants remained on study intervention (with possible dose interruptions and modifications) for 72 weeks without initiating prohibited weight management treatments.
aData are model-based estimates assessed with the use of MMRM (efficacy estimand). Lipid measures were log-transformed before fitting the analysis-of-covariance model, and results were then back-transformed with the delta method from the model-based estimate and standard errors on the natural log scale.
bChange from baseline to week 72 in non-HDL cholesterol, and triglyceride for orforglipron individual doses of 5.5 mg, 9 mg, or 17.2 mg vs placebo were not key secondary endpoints in ATTAIN-1 and thus not controlled for multiplicity. P values were not included.
Figure 3 description: In ATTAIN-1, mean percent change from baseline to week 72 in total cholesterol was between -3.5 and -5.0% with orforglipron 5.5, 9, and 17.2 mg compared to -1.1% with placebo. The mean percent change in HDL was between 2.3 and 5.2% with orforglipron 5.5, 9, and 17.2 mg compared to 0.1% with placebo. Orforglipron 5.5, 9, and 17.2 mg led to a -4.6 to -5.3% change in LDL compared with a change of -0.5% placebo. The mean percent change in VLDL was between -12.6 and -21.7% with orforglipron 5.5, 9, and 17.2 mg compared to -4.4% with placebo.
Notes: Data are model-based estimates assessed with the use of MMRM (efficacy estimand). Lipid measures were log-transformed before fitting the analysis-of-covariance model, and results were then back-transformed with the delta method from the model-based estimate and standard errors on the natural log scale.
Efficacy estimand represents treatment effect as if all randomized participants remained on study intervention (with possible dose interruptions and modifications) for 72 weeks without initiating prohibited weight management treatments.
Change from baseline to week 72 in total cholesterol, LDL cholesterol, HDL cholesterol, and VLDL cholesterol for orforglipron vs placebo were not key secondary endpoints in ATTAIN-1 and thus not controlled for multiplicity. P values were not included.
Abbreviations: HDL = high-density lipoprotein; LDL = low density lipoprotein; MMRM = mixed model for repeated measures; OFG = orforglipron; PBO = placebo; VLDL = very low density lipoprotein.
Back to => Content Overview
Efficacy Endpoints Related to Lipids in ATTAIN-2 (Efficacy Estimand)
Parametera |
OFG 5.5 mg (N=723) |
OFG 9 mg (N=725) |
OFG 17.2 mg (N=730) |
Pooled OFG (N=2178) |
Placebo (N=949) |
Non-HDL cholesterol, mg/dLb |
|||||
Baseline |
120.7 |
121.4 |
121.2 |
121.1 |
122.3 |
CFB, % |
-4.6 |
-6.2 |
-8.4 |
-6.4 |
-3.0 |
Difference vs placebo (95% CI) |
-1.7 (-5.7, 2.4) |
-3.3 (-7.0, 0.5) |
-5.7 (-9.3, -1.8) |
-3.6 (-6.4, -0.6)** |
NA |
Triglycerides, mg/dLb |
|||||
Baseline |
157.4 |
164.4 |
157.2 |
159.6 |
162.8 |
CFB, % |
-15.3 |
-16.0 |
-21.3 |
-17.6 |
-4.7 |
Difference vs placebo (95% CI) |
-11.2 (-16.1, -6.0) |
-11.9 (-16.8, -6.7) |
-17.4 (-22.0, -12.6) |
-13.5 (-17.2, -9.7)* |
NA |
Abbreviations: CFB = change from baseline; HDL = high-density lipoprotein; MMRM = mixed model for repeated measures; NA = not applicable; OFG = orforglipron.
*p<.001; **p<.05 vs placebo, adjusted for multiplicity at week 72.
Notes: Efficacy estimand represents treatment effect as if all randomized participants remained on study intervention (with possible dose interruptions and modifications) for 72 weeks without initiating prohibited weight management treatments.
aData are model-based estimates assessed with the use of MMRM (efficacy estimand). Lipid measures were log-transformed before fitting the analysis-of-covariance model, and results were then back-transformed with the delta method from the model-based estimate and standard errors on the natural log scale.
bChange from baseline to week 72 in non-HDL cholesterol, and triglyceride for orforglipron individual doses of 5.5 mg, 9 mg, or 17.2 mg vs placebo were not key secondary endpoints in ATTAIN-2 and thus not controlled for multiplicity. P values were not included.
Figure 4 description: In ATTAIN-2, mean percent change from baseline to week 72 in triglycerides was -17.6% with orforglipron pooled doses compared to -4.7% with placebo (p<.001). The mean percent change from baseline to week 72 in non-HDL cholesterol was -6.4% with orforglipron pooled doses compared to -3.0% with placebo (p<.05). Orforglipron pooled doses led to a 6.2% change in HDL cholesterol in comparison with 2.0% with placebo. The mean percent change in LDL cholesterol was -2.6% with orforglipron pooled doses in comparison with -1.6% with placebo. Orforglipron pooled doses led to a -16.7% change in VLDL cholesterol in comparison with -5.6% with placebo. The mean percent change from baseline to week 72 in total cholesterol was -2.9% with orforglipron pooled doses compared to -1.9% with placebo.
Notes: Data are model-based estimates assessed with the use of MMRM (efficacy estimand). Lipid measures were log-transformed before fitting the analysis-of-covariance model, and results were then back-transformed with the delta method from the model-based estimate and standard errors on the natural log scale.
Efficacy estimand represents treatment effect as if all randomized participants remained on study intervention (with possible dose interruptions and modifications) for 72 weeks without initiating prohibited weight management treatments.
Change from baseline to week 72 in total cholesterol, LDL cholesterol, HDL cholesterol, and VLDL cholesterol for orforglipron vs placebo were not key secondary endpoints in ATTAIN-2 and thus not controlled for multiplicity. P values were not included.
Abbreviations: HDL = high-density lipoprotein; LDL = low density lipoprotein; MMRM = mixed model for repeated measures; OFG = orforglipron; PBO = placebo; VLDL = very low density lipoprotein.
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Definitions of Estimands
The efficacy estimand represents treatment effect as if all randomized participants remained on study intervention (with possible dose interruptions and modifications) for 72 weeks without initiating prohibited weight management treatments.1,2
The treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation of study intervention or initiation of prohibited weight management treatments.1,2
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Date of Last Review: November 05, 2025