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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 effect did Foundayo™ (orforglipron) have on waist circumference in phase 3 studies for weight management?
In ATTAIN-1 and ATTAIN-2, for the treatment-regimen estimand, change from baseline in waist circumference ranged from -7.1 cm to -10.0 cm and -5.4 cm to -8.3 cm across orforglipron doses, respectively, and -3.1 cm and -2.8 cm 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 Waist Circumference?
What Were the Changes in Waist Circumference in ATTAIN-1 in Adults With Obesity or Overweight With Weight-Related Comorbidities Except Type 2 Diabetes?
What Were the Changes in Waist Circumference in ATTAIN-2 in Adults With Obesity or Overweight With Type 2 Diabetes?
Efficacy Endpoints Related to Waist Circumference in ATTAIN-1 (Efficacy Estimand)
Efficacy Endpoints Related to Waist Circumference in ATTAIN-2 (Efficacy Estimand)
Enclosed Prescribing Information
Which Weight Management Studies Evaluated the Effect of Orforglipron on Waist Circumference?
The effects of orforglipron on waist circumference in adults with obesity or overweight were evaluated in 2 randomized, double-blind, placebo-controlled trials, including
- ATTAIN-1 in adults with obesity or overweight with at least one weight-related comorbidity excluding type 2 diabetes (T2D), and
- ATTAIN-2 in adults with obesity or overweight with T2D.1,2
ATTAIN-1 and ATTAIN-2 had a treatment duration of 72 weeks and compared an investigational orforglipron capsule formulation at doses of 6 mg, 12 mg, and 36 mg 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). 1-4
In both studies, all participants received lifestyle interventions, including guidance on diet and physical activity.1,2
What Were the Changes in Waist Circumference in ATTAIN-1 in Adults With Obesity or Overweight With Weight-Related Comorbidities Except Type 2 Diabetes?
In ATTAIN-1, change from baseline in waist circumference at week 72 was a multiplicity-adjusted key secondary endpoint.1
In ATTAIN-1, for the treatment-regimen estimand, participants treated with orforglipron had significant reductions in waist circumference compared with placebo (p<.001 for all orforglipron doses vs placebo; Table 1).1
For efficacy results based on the efficacy estimand, please refer to the Appendix.
Table 1. Change From Baseline in Waist Circumference at Week 72 in ATTAIN-1 (Treatment-Regimen Estimand)1,3,5
| Parametera | OFG 5.5 mg (N=723) |
OFG 9 mg (N=725) |
OFG 17.2 mg (N=730) |
PBO (N=949) |
|---|---|---|---|---|
| Waist circumference, cm | ||||
| Baseline, mean | 112.2 | 112.0 | 112.4 | 112.8 |
| CFB | -7.1 | -8.2 | -10.0 | -3.1 |
| Difference vs PBO (95% CI) | -4.0 (-4.9 to -3.1)* | -5.1 (-6.1 to -4.2)* | -6.9 (-7.9 to -6.0)* | NA |
Abbreviations: ANCOVA = analysis of covariance; CFB = change from baseline; NA = not applicable; OFG = orforglipron; PBO = placebo.
Notes: Treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation of study intervention or initiation of prohibited weight management treatments. Confidence intervals were not adjusted for multiplicity and should not be used for hypothesis testing.
* p<.001 vs placebo.
a Data are model-based estimates (95% CI) from ANCOVA (treatment-regimen estimand).
What Were the Changes in Waist Circumference in ATTAIN-2 in Adults With Obesity or Overweight With Type 2 Diabetes?
In ATTAIN-2, change from baseline in waist circumference at week 72 was a multiplicity-adjusted key secondary endpoint for orforglipron 17.2 mg.2
At week 72, for the treatment-regimen estimand, participants treated with orforglipron 17.2 mg had significant reductions in waist circumference compared with placebo (p<.0001 for orforglipron 17.2 mg vs placebo; Table 2).2
Results for the orforglipron 5.5 mg and 9 mg dose groups are presented in Table 2.
For efficacy results based on the efficacy estimand, please refer to the Appendix.
Table 2. Change From Baseline in Waist Circumference at Week 72 in ATTAIN-2 (Treatment-Regimen Estimand)2,3
| Parametera | OFG 5.5 mg (N=329) |
OFG 9 mg (N=332) |
OFG 17.2 mg (N=322) |
PBO (N=630) |
|---|---|---|---|---|
| Waist circumference, cm | ||||
| Baseline, mean | 116.8 | 116.2 | 114.7 | 115.0 |
| CFBb | -5.4 | -6.3 | -8.3 | -2.8 |
| Difference vs PBO (95% CI) | -2.6 (-3.6 to -1.5) | -3.5 (-4.5 to -2.5) | -5.5 (-6.5 to -4.5)* | NA |
Abbreviations: ANCOVA = analysis of covariance; CFB = change from baseline; NA = not applicable; OFG = orforglipron; PBO = placebo.
Notes: Treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation of study intervention or initiation of prohibited weight management treatments. The 6 mg and 12 mg doses were additional secondary endpoints not controlled for multiplicity; the 36 mg dose was a multiplicity-adjusted key secondary endpoint. Confidence intervals were not adjusted for multiplicity and should not be used for hypothesis testing.
* p<.0001 vs placebo.
a Data are model-based estimates (95% CI) from ANCOVA (treatment-regimen estimand).
b Change from baseline to week 72 in waist circumference for orforglipron 5.5 mg and 9 mg vs placebo was not a key secondary endpoint in ATTAIN-2 and thus not controlled for type 1 error. P values were not included.
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).
- Wharton S, Aronne LJ, Stefanski A, et al. 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(10519):2927-2944. https://doi.org/10.1016/S0140-6736(25)02165-8
- Foundayo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
- Ma X, Li YG, Raha S, et al. Pharmacokinetic bioequivalence of orforglipron tablets and capsules in healthy participants with obesity or overweight. Diabetes Obes Metab. Published online April 17, 2026. https://doi.org/10.1111/dom.70783
- Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Appendix
Efficacy Endpoints Related to Waist Circumference in ATTAIN-1 (Efficacy Estimand)
Table 3. Change From Baseline in Waist Circumference at Week 72 in ATTAIN-1 (Efficacy Estimand)1,3,5
| Parametera | OFG 5.5 mg (N=723) |
OFG 9 mg (N=725) |
OFG 17.2 mg (N=730) |
PBO (N=949) |
|---|---|---|---|---|
| Waist Circumference, cm | ||||
| Baseline, mean | 112.2 | 112.0 | 112.4 | 112.8 |
| CFB | -7.5 | -9.0 | -11.1 | -2.1 |
| Difference vs PBO (95% CI) | -5.5 (-6.2 to -4.7)* | -6.9 (-7.7 to -6.1)* | -9.0 (-9.8 to -8.2)* | NA |
Abbreviations: CFB = change from baseline; MMRM = mixed model for repeated measures; NA = not applicable; OFG = orforglipron; PBO = placebo.
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. Confidence intervals were not adjusted for multiplicity and should not be used for hypothesis testing.
a Data are model-based estimates (95% CI) from MMRM (efficacy estimand).
Efficacy Endpoints Related to Waist Circumference in ATTAIN-2 (Efficacy Estimand)
Table 4. Change From Baseline in Waist Circumference at Week 72 in ATTAIN-2 (Efficacy Estimand)2,3
| Parametera | OFG 5.5 mg (N=329) |
OFG 9 mg (N=332) |
OFG 17.2 mg (N=322) |
PBO (N=630) |
|---|---|---|---|---|
| Waist Circumference, cm | ||||
| Baseline, mean | 116.8 | 116.2 | 114.7 | 115.0 |
| CFBb | -5.6 | -7.2 | -9.2 | -2.7 |
| Difference vs PBO (95% CI) | -3.0 (-3.9, -2.1) | -4.5 (-5.4, -3.5) | -6.5 (-7.5, -5.5)* | NA |
Abbreviations: CFB = change from baseline; MMRM = mixed model for repeated measures; NA = not applicable; OFG = orforglipron; PBO = placebo.
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. Confidence intervals were not adjusted for multiplicity and should not be used for hypothesis testing.
* p<.001 vs placebo.
a Data are model-based estimates (95% CI) from MMRM (efficacy estimand).
b Change from baseline to week 72 in waist circumference for orforglipron 5.5 mg and 9 mg vs placebo was not a key secondary endpoint in ATTAIN-2 and thus not controlled for type 1 error. P values were not included.
Definition 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
⇑ Back to Content OverviewDate of Last Review: May 27, 2026