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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 efficacy of Foundayo™ (orforglipron) in reducing body weight based on baseline body mass index?
A reduction in body weight was observed with orforglipron regardless of baseline BMI.
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?
- Did Baseline BMI Affect the Efficacy of Orforglipron in Reducing Body Weight in ATTAIN-1?
- Did Baseline BMI Affect the Efficacy of Orforglipron in Reducing Body Weight in ATTAIN-2?
- Enclosed Prescribing Information
- References
- Appendix
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 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 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
In both ATTAIN-1 and ATTAIN-2, patients taking orforglipron demonstrated significantly greater reductions in body weight than those taking placebo.1,2
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Did Baseline BMI Affect the Efficacy of Orforglipron in Reducing Body Weight in ATTAIN-1?
Baseline BMI Distribution in ATTAIN-1
Participants included in ATTAIN-1 were required to have a body mass index (BMI) of
- ≥30.0 kg/m², or
- ≥27.0 kg/m² and presence of at least one weight-related comorbidity (treated or untreated, including hypertension, dyslipidemia, cardiovascular disease, or obstructive sleep apnea).1
At randomization, participants had a mean
- body weight of 103.2 kg, and
- BMI of 37.0 kg/m².1
A total of 46.0% of the participants had a BMI <35 kg/m².1
The proportions of participants in different BMI categories at baseline in ATTAIN-1 are given in Table 1.
| OFG 5.5 mg (N=723) | OFG 9 mg (N=725) | OFG 17.2 mg (N=730) | Placebo (N=949) | Total (N=3127) | |
|---|---|---|---|---|---|
| BMI category,a kg/m², n (%) | |||||
| <30 | 62 (8.6) | 72 (9.9) | 68 (9.3) | 86 (9.1) | 288 (9.2) |
| 30 to <35 | 263 (36.4) | 272 (37.5) | 285 (39.0) | 331 (34.9) | 1151 (36.8) |
| 35 to <40 | 202 (27.9) | 198 (27.3) | 183 (25.1) | 266 (28.0) | 849 (27.2) |
| ≥40 | 196 (27.1) | 183 (25.2) | 194 (26.6) | 266 (28.0) | 839 (26.8) |
| Mean BMI (±SD) | 37.0±6.5 | 36.7±6.5 | 36.9±6.7 | 37.1±6.3 | 37.0±6.5 |
Abbreviations: BMI = body mass index; OFG = orforglipron.
aBody mass index is the weight in kilograms divided by the square of the height in meters.
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Effect of Baseline BMI on Treatment Efficacy
Subgroup analyses were conducted to evaluate the effect of baseline BMI on percent change in body weight from baseline to week 72. Using the treatment regimen estimand, weight change results were consistent across all 4 baseline BMI subgroups (<30 kg/m², 30 to <35 kg/m², 35 to <40 kg/m², and ≥40 kg/m²) and with the primary results of the study, ie, greater percent weight reduction with all orforglipron doses relative to placebo (Figure 1).4
At the significance level of 0.1, the treatment-by- baseline BMI subgroup interaction was not statistically significant (Figure 1). Because the interaction effects were evaluated without adjustment for multiplicity, the results should be interpreted with caution given the large number of prespecified interactions tested.4
Figure 1 description: Forest plot showing percent change in body weight from baseline to week 72 across 4 baseline BMI subgroups (<30 kg/m², 30 to <35 kg/m², 35 to <40 kg/m², and ≥40 kg/m²) in ATTAIN-1. Each subgroup displays results for placebo and 3 orforglipron doses (5.5 mg, 9 mg, and 17.2 mg). All orforglipron doses demonstrated greater percent weight reduction compared with placebo across all BMI subgroups. Treatment-by-subgroup interaction p value is .417, indicating no statistically significant effect of baseline BMI subgroup on treatment effect.
Abbreviations: ANCOVA = analysis of covariance; BMI = body mass index; MBE = model-based estimate; OFG = orforglipron.
Note: Results analyzed using ANCOVA with primary multiple imputation method. Randomized participants-treatment regimen estimand data points set. Interaction effects were evaluated without adjustment for multiplicity; hence, results should be interpreted with caution.
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Percentage of Participants Achieving Different BMI Thresholds Based on Baseline BMI
An exploratory endpoint of the ATTAIN-1 study was the percentage of participants in the different treatment groups who, at week 72, had achieved BMI thresholds of
- <25 kg/m²
- <27 kg/m², and
- <30 kg/m².1
The results, stratified based on baseline BMI (<35 kg/m² or ≥35 kg/m²), are provided in Figure 2 (treatment regimen estimand) and the Appendix (efficacy estimand).
Figure 2 description: Bar graphs showing the percentages of participants who achieved BMI thresholds of <25 kg/m², <27 kg/m², and <30 kg/m² at week 72 in ATTAIN-1. Panel A shows the results for all participants, panel B for the subgroup with baseline BMI <35 kg/m², and panel C for the subgroup with baseline BMI ≥35 kg/m².
(A) All participants, (B) Participants with baseline BMI <35 kg/m², (C) Participants with baseline BMI ≥35 kg/m². Assessed using treatment regimen estimand.
Abbreviations: BMI = body mass index; OFG = orforglipron; PBO = placebo.
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Did Baseline BMI Affect the Efficacy of Orforglipron in Reducing Body Weight in ATTAIN-2?
Baseline BMI Distribution in ATTAIN-2
Participants included in ATTAIN-2 were required to have a BMI of ≥27 kg/m² at baseline, with preexisting T2D (glycated hemoglobin [HbA1C] of 7%-10% [53-86 mmol/mol]).2
At baseline, participants had a mean
- body weight of 101.4 kg, and
- BMI of 35.6 kg/m².2
The proportions of participants in different BMI categories at baseline in ATTAIN-2 are given in Table 2.
| OFG 5.5 mg (N=329) | OFG 9 mg (N=332) | OFG 17.2 mg (N=322) | Placebo (N=630) | Total (N=1613) | ||
|---|---|---|---|---|---|---|
| BMI category,ᵃ kg/m², n (%) | ||||||
| <30 | 67 (20·4) | 52 (15·7) | 83 (25·8) | 124 (19·7) | 326 (20·2) | |
| ≥30 to <35 | 108 (32·8) | 111 (33·4) | 97 (30·1) | 222 (35·2) | 538 (33·4) | |
| ≥35 to <40 | 85 (25·8) | 90 (27·1) | 83 (25·8) | 151 (24·0) | 409 (25·4) | |
| ≥40 | 69 (21·0) | 79 (23·8) | 59 (18·3) | 133 (21·1) | 340 (21·1) | |
| Mean BMI (±SD) | 35·9 (7·0) | 36·1 (6·3) | 35·1 (6·5) | 35·5 (6·5) | 35·6 (6·6) |
Abbreviations: BMI = body mass index; OFG = orforglipron.
ᵃBody mass index is the weight in kilograms divided by the square of the height in meters.
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Effect of Baseline BMI on Treatment Efficacy
Subgroup analyses were conducted to evaluate the effect of baseline BMI on percent change in body weight from baseline to week 72. Using the treatment regimen estimand, weight change results were consistent across all 4 baseline BMI subgroups (<30 kg/m², 30 to <35 kg/m², 35 to <40 kg/m², and ≥40 kg/m²) and with the primary results of the study, ie, greater percent weight reduction with all orforglipron doses relative to placebo (Figure 3).4
At the significance level of 0.1, the treatment-by- baseline BMI subgroup interaction was not statistically significant (Figure 3). Because the interaction effects were evaluated without adjustment for multiplicity, the results should be interpreted with caution given the large number of prespecified interactions tested.4
Figure 3 description: Forest plot showing percent change in body weight from baseline to week 72 across 4 baseline BMI subgroups (<30 kg/m², 30 to <35 kg/m², 35 to <40 kg/m², and ≥40 kg/m²) in ATTAIN-2. Each subgroup displays results for placebo and 3 orforglipron doses (5.5 mg, 9 mg, and 17.2 mg). All orforglipron doses demonstrated greater percent weight reduction compared with placebo across all BMI subgroups. Treatment-by-subgroup interaction p value is .924, indicating no statistically significant effect of baseline BMI subgroup on treatment effect.
Abbreviations: ANCOVA = analysis of covariance; BMI = body mass index; MBE = model-based estimate; OFG = orforglipron.
Note: Results analyzed using ANCOVA with primary multiple imputation method. Randomized participants-treatment regimen estimand data points set. Interaction effects were evaluated without adjustment for multiplicity; hence, results should be interpreted with caution.
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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; 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
- 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(10522):2927-2944. https://doi.org/10.1016/S0140-6736(25)02165-8.
- Foundayo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
- Data on file, Eli Lilly and Company and/or one of its subsidiaries.
Appendix
Efficacy Endpoint Related to Participants Achieving BMI Thresholds in ATTAIN-1 (Efficacy Estimand)
Figure 4 description: Bar graphs showing the percentages of participants who achieved BMI thresholds of <25 kg/m², <27 kg/m², and <30 kg/m² at week 72 in ATTAIN-1. Panel A shows the results for all participants, panel B for the subgroup with baseline BMI <35 kg/m², and panel C for the subgroup with baseline BMI ≥35 kg/m².
(A) All participants, (B) Participants with baseline BMI <35 kg/m², (C) Participants with baseline BMI ≥35 kg/m². Assessed using efficacy estimand.
Abbreviations: BMI = body mass index; EE = efficacy estimand.
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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: March 05, 2026