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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 glycated hemoglobin (HbA1c) in phase 3 studies for weight management?
In ATTAIN-2, in adults with obesity or overweight with type 2 diabetes, orforglipron significantly reduced HbA1c by 1.2% to 1.7% vs 0.5% with placebo (treatment-regimen estimand). Results from ATTAIN-1 in participants without T2D are also presented.
See important safety information, including boxed warning, in the attached prescribing information.
Which Weight Management Studies Evaluated the Effect of Orforglipron on HbA1c?
The effect of orforglipron on glycated hemoglobin (HbA1c) was evaluated in ATTAIN-2, a phase 3 study that enrolled adult participants with obesity or overweight and type 2 diabetes (T2D).1
Results on HbA1c are also available from ATTAIN-1, a phase 3 study in adults with obesity or overweight with weight-related comorbidities such as dyslipidemia, hypertension, obstructive sleep apnea, or cardiovascular disease (without T2D).2
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
What Were the Changes in Glycated Hemoglobin in ATTAIN-2 in Adults With Obesity or Overweight With Type 2 Diabetes?
In ATTAIN-2, key secondary endpoints related to changes in HbA1c at week 72 and adjusted for multiplicity included
- mean change from baseline in HbA1c, and
- the proportion of participants with HbA1c thresholds <7% and ≤6.5%.2
At baseline, participants had a mean
- HbA1c of 8.05%, and
- duration of T2D of 8.5 years.2
Additionally, 89.2% of participants were taking at least 1 oral antihyperglycemic medication.2
At week 72, for the treatment-regimen estimand, mean change from baseline in HbA1c were
- -1.22% with orforglipron 5.5 mg
- -1.50% with orforglipron 9 mg
- -1.66% with orforglipron 17.2 mg, and
- -0.47% with placebo (p<.001 for all doses vs placebo; Efficacy Endpoints Related to HbA1c in ATTAIN-2 (Treatment-Regimen Estimand)).2,3
As presented in Efficacy Endpoints Related to HbA1c in ATTAIN-2 (Treatment-Regimen Estimand), at week 72, for the treatment-regimen estimand, 64.6% to 75.9% of participants treated with orforglipron had an HbA1c threshold <7.0% compared with 30.5% for participants treated with placebo (p<.001 for all orforglipron doses vs placebo).2
Additionally, as presented in Efficacy Endpoints Related to HbA1c in ATTAIN-2 (Treatment-Regimen Estimand), for the treatment-regimen estimand, between 52.5% and 66.6% of participants treated with orforglipron had an HbA1c threshold ≤6.5% compared with 15.4% for participants treated with placebo (p<.001 for all orforglipron doses vs placebo).2
Parametera |
OFG 5.5 mg |
OFG 9 mg |
OFG 17.2 mg |
PBO |
HbA1c, % |
||||
Baseline |
8.03 |
8.08 |
8.05 |
8.03 |
Change in HbA1c from baseline |
-1.22 |
-1.50 |
-1.66 |
-0.47 |
ETD vs PBO (95% CI) |
-0.76 (-0.93, -0.58)* |
1.03 (-1.19, -0.87)* |
-1.20 (-1.35, -1.04)* |
NA |
Proportion of participants with HbA1c threshold at week 72, % |
||||
<7% |
64.6* |
75.9* |
75.5* |
30.5 |
≤6.5% |
52.5* |
57.6* |
66.6* |
15.4 |
<5.7%b |
6.6 |
15.7 |
23.7 |
1.6 |
Abbreviations: ANCOVA = analysis of covariance; ETD = estimated treatment difference; HbA1c = glycated hemoglobin; 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 PBO, 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 HbA1c threshold <5.7% for all orforglipron doses vs placebo was not a key secondary endpoint in ATTAIN-2 and thus not adjusted for multiplicity.
Mean change in HbA1c over time for the efficacy estimand is presented in HbA1c Changes Over Time in ATTAIN-2 (Efficacy Estimand).2
Figure 1 description: In ATTAIN-2, change from baseline in HbA1c at week 72 was -1.29%, -1.60%, and -1.79% with orforglipron 5.5 mg, 9 mg, and 17.2 mg, respectively, and -0.14% with placebo.
Abbreviations: ETD = estimated treatment difference; HbA1c = glycated hemoglobin; 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).
***p<.0001 (two-sided) for superiority vs placebo, adjusted for multiplicity at week 72.
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 HbA1c in ATTAIN-2 (Efficacy Estimand) for efficacy results related to HbA1c based on the efficacy estimand in ATTAIN-2.
What Were the Changes in HbA1c in ATTAIN-1 in Adults With Obesity or Overweight Without Type 2 Diabetes?
In ATTAIN-1, in adults with obesity or overweight without T2D, change from baseline in HbA1c was not a primary or key secondary endpoint; therefore, results for these parameters were not controlled for type 1 error.1
At baseline, participants had a mean HbA1c of 5.6% and 1127 (36.0%) of participants had prediabetes.1
As presented in Change in HbA1c at 72 Weeks in ATTAIN-1 (Treatment-Regimen Estimand), for the treatment-regimen estimand, change in HbA1c from baseline to week 72 in ATTAIN-1 was
Parametera |
OFG 5.5 mg |
OFG 9 mg |
OFG 17.2 mg |
PBO |
HbA1c, % |
||||
Baseline |
5.6 |
5.6 |
5.6 |
5.6 |
CFB |
-0.27 |
-0.27 |
-0.33 |
-0.05 |
ETD vs PBO (95% CI) |
-0.22 (-0.27, -0.18) |
-0.21 (-0.25, -0.17) |
-0.28 (-0.32, -0.23) |
NA |
Abbreviations: ANCOVA = analysis of covariance; CFB = change from baseline; ETD = estimated treatment difference; HbA1c = glycated hemoglobin; MBE = model-based estimate; 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.
aData for baseline HbA1c are mean values. Data are MBE from ANCOVA for CFB. All data is from baseline to week 72.
Additional information on change in HbA1c from baseline to week 72 for the efficacy estimand in ATTAIN-1 can be found in Change in HbA1c at 72 Weeks in ATTAIN-1 (Efficacy Estimand).
Participants with baseline prediabetes were scheduled to continue receiving their assigned study treatment for an additional 2 year extension study.1
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 HbA1c in ATTAIN-2 (Efficacy Estimand)
Parametera |
OFG 5.5 mg |
OFG 9 mg |
OFG 17.2 mg |
PBO |
HbA1c, % |
||||
Baseline |
8.03 |
8.08 |
8.05 |
8.03 |
Change in HbA1c from baseline |
-1.29 |
-1.60 |
-1.79 |
-0.14 |
ETD vs PBO (95% CI) |
-1.16 (-1.34, -0.98)* |
1.46 (-1.62, -1.30)* |
-1.65 (-1.82, -1.49)* |
NA |
Proportion of participants with HbA1c threshold at week 72, % |
||||
<7% |
70.0* |
78.0* |
85.1* |
23.0 |
≤6.5% |
56.2* |
67.5* |
75.0* |
10.6 |
<5.7%b |
7.8 |
17.9 |
28.1 |
0.7 |
Abbreviations: ETD = estimated treatment difference; HbA1c = glycated hemoglobin; MBE = model-based estimates; 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.
*p<.001 (two-sided) for superiority vs PBO, 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 placebo 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 HbA1c threshold <5.7% for all orforglipron doses vs placebo was not a key secondary endpoint in ATTAIN-2 and thus not adjusted for multiplicity.
Efficacy Endpoint Related to HbA1c in ATTAIN-1 (Efficacy Estimand)
Parametera |
OFG 5.5 mg |
OFG 9 mg |
OFG 17.2 mg |
PBO |
HbA1c, % |
||||
Baseline |
5.6 |
5.6 |
5.6 |
5.6 |
Change in HbA1c from baseline |
-0.31 |
-0.31 |
-0.38 |
-0.03 |
ETD vs. PBO (95% CI) |
-0.28 (-0.31, -0.25) |
-0.29 (-0.31, -0.26) |
-0.35 (-0.38, -0.32) |
NA |
Abbreviations: CFB = change from baseline; HbA1c = glycated hemoglobin; MBE = model-based estimate; MMRM = mixed model 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.
aData for baseline HbA1c are mean values. Data are MBE from MMRM for CFB. All data is from baseline to week 72.
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