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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 does Foundayo™ (orforglipron) have on body composition?
Orforglipron reduces body weight, with greater fat mass loss than lean mass loss.
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 Composition?
- Enclosed Prescribing Information
- References
- Appendix
- Definition of Estimands
Which Weight Management Studies Evaluated the Effect of Orforglipron on Body Composition?
The effect of orforglipron on body composition was evaluated in ATTAIN-1, a randomized, double-blind, placebo-controlled trial in adults with obesity or overweight with at least one weight-related comorbidity. Participants with type 2 diabetes (T2D) were excluded.1
ATTAIN-1 had a treatment duration of 72 weeks and compared an investigational orforglipron capsule formulation with placebo.1
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.1,2
In ATTAIN-1, a subgroup analysis of 171 participants was completed to assess change in body composition from baseline to week 72 using dual-energy X-ray absorptiometry (DXA).1
Orforglipron reduces body weight, with greater fat mass loss than lean mass loss.2
As presented in Figure 1, at week 72 among participants who underwent DXA, the mean percent change in body composition for the treatment regimen estimand was
- -12.6% to -28.2% in visceral fat mass,-9.4% to -20.0% in total fat mass and -3.2% to -6.6% in lean mass across orforglipron doses studied, and
- 7.4% in visceral fat mass, -1.7% in total fat mass and 0.3% in lean mass in the placebo group.1
For the pooled orforglipron doses, 73.1% of the total body weight reduction was due to loss of fat mass and 26.9% was due to a loss in lean mass.1
Figure 1. Body Composition Changes in ATTAIN-1 DXA Subgroup Analysis (Treatment-Regimen Estimand)1,2
Figure 1 description: For the treatment-regimen estimand at week 72, mean percent change from baseline in visceral fat mass was -12.6% to -28.2% across orforglipron dose groups (5.5 mg, 9 mg, and 17.2 mg) versus 7.4% with placebo. Mean percent change in total fat mass was -9.4% to -20.0% across orforglipron dose groups versus -1.7% with placebo. Mean percent change in total lean mass was -3.2% to -6.6% across orforglipron dose groups versus 0.3% with placebo.
Notes: Data are presented as MBE with 95% CI for change in body composition from baseline to week 72 with the different OFG groups and PBO.
Treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation of study intervention or initiation of prohibited weight management treatments.
Abbreviations: DXA = dual-energy X-ray absorptiometry; MBE = model-based estimate; OFG = orforglipron; PBO = placebo.
See the Appendix for information on mean percent change in visceral fat mass, total fat mass, and total lean mass for the efficacy estimand.
Enclosed Prescribing Information
FOUNDAYO™ (orforglipron) tablets, for oral use, Lilly
References
The published reference below is 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
- Foundayo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
Appendix
Changes in Body Composition From DXA Subgroup ATTAIN-1 (Efficacy Estimand)
Figure 2. Body Composition Changes in ATTAIN-1 DXA Subgroup Analysis (Efficacy Estimand)1,2
Figure 2 description: For the efficacy estimand at week 72, mean percent change from baseline in visceral fat mass was -16.0% to -34.3% across orforglipron dose groups (5.5 mg, 9 mg, and 17.2 mg) versus 7.3% with placebo. Mean percent change in total fat mass was -11.1% to -25.7% across orforglipron dose groups versus −1.2% with placebo. Mean percent change in total lean mass was -4.1% to -8.2% across orforglipron dose groups versus 0.8% with placebo.
Notes: Data are presented as MBE with 95% CI for change in body composition from baseline to Week 72 between the OFG groups and PBO.
Abbreviations: DXA = dual-energy x-ray absorptiometry; MBE = model-based estimate; OFG = orforglipron; PBO = placebo.
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
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
Date of Last Review: April 02, 2026