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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 body weight in phase 3 studies for weight management?
In 2 phase 3 studies in adults with obesity or overweight with and without type 2 diabetes, treatment with orforglipron significantly reduced body weight at week 72 compared 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 Body Weight?
The effects of orforglipron on body weight in adults with obesity or overweight were evaluated in 2 randomized, double-blind, placebo-controlled trials, including
ATTAIN-1 and ATTAIN-2 had a primary 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
What Were the Changes in Body Weight in ATTAIN-1 in Adults With Obesity or Overweight With Weight-Related Comorbidities?
In ATTAIN-1, for all orforglipron doses the primary and key secondary endpoints related to body weight at week 72 and adjusted for multiplicity included
- percent change from baseline in body weight, and
- the proportion of participants with weight reduction thresholds ≥5%, ≥10%, ≥15%.1
The proportion of participants with weight reduction thresholds ≥20% was also a key secondary endpoint for orforglipron 9 mg and 17.2 mg.1,3
In ATTAIN-1, treatment with orforglipron met the primary endpoint of superior body weight reduction compared with placebo.1
At baseline, participants had a mean
- body weight of 103.2 kg, and
- body mass index (BMI) of 37.0 kg/m2.1
As presented in Efficacy Endpoints Related to Body Weight in ATTAIN-1 (Treatment-Regimen Estimand), at week 72, for the treatment-regimen estimand, mean percent change from baseline in body weight was
As presented in Efficacy Endpoints Related to Body Weight in ATTAIN-1 (Treatment-Regimen Estimand), for the treatment-regimen estimand at week 72, when compared with placebo, significantly more participants treated with orforglipron had body weight reductions of ≥5%, ≥10%, and ≥15% (p<.001 for all orforglipron doses vs placebo).1
At week 72, for the treatment-regimen estimand, 9.0% and 18.4% of orforglipron 9 mg and 17.2 mg participants had body weight reductions of ≥20%, respectively (p<.001 for orforglipron 9 mg and 17.2 mg vs placebo).1,3
Parametera |
OFG 5.5 mg |
OFG 9 mg |
OFG 17.2 mg |
PBO |
Primary endpoint |
||||
Body weight |
||||
Baseline, kg |
103.2 |
102.2 |
103.1 |
103.9 |
Change in body weight from baseline to week 72, % |
-7.5 |
-8.4 |
-11.2 |
-2.1 |
ETD vs. PBO (95% CI), % |
-5.5 (-6.5, -4.5)* |
-6.3 (-7.3, -5.4)* |
-9.1 (-10.1, -8.1)* |
NA |
Key secondary endpoints |
||||
Proportion of participants with weight reduction threshold at week 72, % |
||||
≥5% |
60.6* |
63.5* |
71.8* |
26.8 |
≥10% |
33.3* |
40.0* |
54.6* |
12.9 |
≥15% |
15.1* |
20.3* |
36.0* |
5.9 |
Abbreviations: ANCOVA = analysis of covariance; NA = not applicable; MBE = model-based estimates; 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.
*p<.001 (two-sided) for superiority vs placebo, adjusted for multiplicity at week 72.
aData are presented as MBE for changes from baseline to week 72, along with ETD (95% CI) between the OFG groups and PBO based on ANCOVA analysis. 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 MBE from logistic regression. Percentages were calculated by combining the percentages of participants who met the target in imputed data sets with the use of Rubin’s rules.
Change in body weight over time in ATTAIN-1 is presented in Change From Baseline in Body Weight Over Time in ATTAIN-1 (Efficacy Estimand) for the efficacy estimand. Changes in body weight were observed with orforglipron at week 4, the first post‑baseline time point assessed. At this time point, participants were receiving orforglipron 0.8 mg (starting dose).1,3
Figure 1 description: In ATTAIN-1, change from baseline in body weight at week 72 was -7.8%, -9.3%, and -12.4% with orforglipron 5.5 mg, 9 mg, and 17.2 mg, respectively, and -0.9% with placebo.
Abbreviations: ETD = estimated treatment difference; MMRM = mixed model for repeated measures; OFG = orforglipron; PBO = placebo.
Notes: Data are presented as model-based estimates (95% CI), along with ETD (95% CI) between orforglipron groups and placebo based on MMRM analysis (efficacy estimand).
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.
See Efficacy Endpoints Related to Body Weight in ATTAIN-1 (Efficacy Estimand) for efficacy results related to body weight based on the efficacy estimand in ATTAIN-1.
What Were the Changes in Body Weight in ATTAIN-2 in Adults With Obesity or Overweight With Type 2 Diabetes
In ATTAIN-2, the primary and key secondary endpoints related to body weight at week 72 and adjusted for multiplicity included the
In ATTAIN-2, treatment with orforglipron met the primary endpoint of superior body weight reduction compared with placebo.2
At baseline, participants had a mean
- body weight of 101.4 kg, and
- BMI of 35.6 kg/m2.1
As presented in Efficacy Endpoints Related to Body Weight in ATTAIN-2 (Treatment-regimen Estimand), at week 72, for the treatment-regimen estimand, mean percent change from baseline in body weight was
For the treatment-regimen estimand, significantly more participants receiving orforglipron 5.5 mg had body weight reduction ≥5% and ≥10% at week 72 compared with placebo (p<.001). Similarly, significantly more participants receiving orforglipron 9 mg or 17.2 mg had reductions ≥10% and ≥15%, respectively, versus placebo (p<.001 for both), as shown in Efficacy Endpoints Related to Body Weight in ATTAIN-2 (Treatment-regimen Estimand).2,3
Although not a key secondary endpoint, for the treatment-regimen estimand, 10.8% of participants receiving orforglipron 17.2 mg had body weight reductions of ≥20% at week 72.2,3
Parametera |
OFG 5.5 mg |
OFG 9 mg |
OFG 17.2 mg |
PBO |
Primary endpoint |
||||
Body weight |
||||
Baseline, kg |
102.3 |
102.7 |
99.8 |
101.2 |
Change in body weight from baseline, % |
-5.1 |
-7.0 |
-9.6 |
-2.5 |
ETD vs PBO (95% CI) |
-2.7 (-3.7, -1.6)* |
-4.5 (-5·5, -3·6)* |
-7.1 (-8.2, -6.1)* |
NA |
Key secondary endpoints |
||||
Proportion of participants with weight reduction threshold at week 72, % |
||||
≥5% |
47.7* |
54.6* |
67.2* |
26.6 |
≥10% |
22.6* |
31.2* |
45.6* |
9.0 |
≥15%b |
6.8 |
14.4* |
26.0* |
3.0 |
Abbreviations: ANCOVA = analysis of covariance; ETD = estimated treatment difference; MBE = model-based estimates; 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.
*p<.001 (two-sided) for superiority vs placebo, adjusted for multiplicity at week 72.
aData are presented as MBE for changes from baseline to week 72, along with ETD (95% CI) between the OFG groups and PBO based on ANCOVA analysis. 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 MBE from logistic regression. Percentages were calculated by combining the percentages of participants who met the target in imputed data sets with the use of Rubin’s rules.
bPercentage of participants with weight reduction threshold ≥15% for OFG 6 mg vs PBO was not a key secondary endpoint in ATTAIN-2 and thus not adjusted for multiplicity.
Percent change in body weight over time for the efficacy estimand is presented in Weight Changes Over Time in ATTAIN-2 (Efficacy Estimand). Changes in body weight were observed with orforglipron at week 4, the first post‑baseline time point assessed. At this time point, participants were receiving orforglipron 0.8 mg (starting dose).2,3
Figure 2 description: In ATTAIN-2, change from baseline in body weight at week 72 was -5.5%, -7.8%, and -10.5% with orforglipron 5.5 mg, 9 mg, and 17.2 mg, respectively, and -2.2% with placebo.
Notes: Data are presented as model-based estimates (95% CI), along with ETD (95% CI) between orforglipron groups and placebo based on MMRM analysis (efficacy estimand).
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.
Abbreviations: ETD = estimated treatment difference; MMRM = mixed model for repeated measures; OFG = orforglipron; PBO = placebo.
See Efficacy Endpoints Related to Body Weight in ATTAIN-2 (Efficacy Estimand) for efficacy results related to body weight based on the efficacy estimand in ATTAIN-2.
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 Body Weight in ATTAIN-1 (Efficacy Estimand)
Parametera |
OFG 5.5 mg |
OFG 9 mg |
OFG 17.2 mg |
PBO |
Primary endpoint |
||||
Body Weight, kg |
||||
Baseline |
103.2 |
102.2 |
103.1 |
103.9 |
Change in body weight from baseline to week 72, % |
-7.8 |
-9.3 |
-12.4 |
-0.9 |
ETD vs. PBO, % |
-6.9 (-7.7, -6.2)* |
-8.4 (-9.3, -7.6)* |
-11.5 (-12.3, -10.6)* |
NA |
Key secondary endpoints |
||||
Proportion of participants with weight reduction threshold at week 72, % |
||||
≥5% |
63.8* |
69.3* |
77.1* |
22.1 |
≥10% |
35.9* |
45.1* |
59.6* |
8.6 |
≥15% |
16.5* |
24.0* |
39.6* |
3.6 |
Abbreviations: ETD = estimated treatment difference; MBE = model-based estimates; MMRM = mixed model for repeated measures; NA = not applicable OFG = orforglipron; PBO = placebo.
Notes: 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.
*p<.001 (two-sided) for superiority vs placebo, adjusted for multiplicity at week 72.
aData are presented as MBE for changes from baseline to week 72, along with ETD (95% CI) between the OFG groups and PBO based on MMRM analysis. 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 MBE from logistic regression. Percentages were calculated by combining the percentages of participants who met the target in imputed data sets with the use of Rubin’s rules.
Efficacy Endpoints Related to Body Weight in ATTAIN-2 (Efficacy Estimand)
Parametera |
OFG 5.5 mg |
OFG 9 mg |
OFG 17.2 mg |
PBO |
Primary endpoint |
||||
Body weight, kg |
||||
Baseline |
102.3 |
102.7 |
99.8 |
101.2 |
Change in body weight from baseline, % |
-5.5 |
-7.8 |
-10.5 |
-2.2 |
ETD vs PBO (95% CI) |
-3.3 (-4.1, -2.5)* |
-5.6 (-6.5, -4.7)* |
-8.3 (-9.3, -7.3)* |
NA |
Key secondary endpoint |
||||
Proportion of participants with weight reduction threshold at week 72, % |
||||
≥5% |
49.8* |
60.2* |
72.8* |
24.4 |
≥10% |
23.9* |
35.5* |
50.1* |
7.0 |
≥15%b |
7.3 |
17.7* |
28.4* |
1.9 |
Abbreviations: ETD = estimated treatment difference; MBE = model-based estimates; MMRM= mixed model for repeated measures; NA = not applicable; OFG = orforglipron; PBO = placebo.
Notes: 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.
*p<.001 (two-sided) for superiority vs placebo, adjusted for multiplicity at week 72.
aData are presented as MBE for changes from baseline to week 72, along with ETD (95% CI) between the OFG groups and PBO based on MMRM analysis. 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 MBE from logistic regression. Percentages were calculated by combining the percentages of participants who met the target in imputed data sets with the use of Rubin’s rules.
bPercentage of participants with weight reduction threshold ≥15% for OFG 6 mg vs PBO was not a key secondary endpoint in ATTAIN-2 and thus not adjusted for multiplicity.
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
Date of Last Review: April 01, 2026