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Orforglipron-Diabetes
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.
Are there efficacy results for the Foundayo™ (orforglipron) 0.8 mg, 2.5 mg, and 14.5 mg doses for weight reduction?
No efficacy data are available for orforglipron 0.8 and 14.5 mg, as these doses were used only during dose initiation or 4-week escalation in both weight management and T2D studies. Changes in body weight from these studies are presented in this response.
See important safety information, including boxed warning, in the attached prescribing information.
What Is the Efficacy of Orforglipron for Weight Management at the 0.8 mg, 2.5 mg, and 14.5 mg Doses?
This response presents information from studies conducted with an 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
No efficacy data are available from the ATTAIN studies (weight management) for the orforglipron 0.8 mg, 2.5 mg, and 14.5 mg doses. These doses were
- part of the dose-escalation scheme, and
- used for no more than 4 weeks before dose escalation to the randomized doses (5.5 mg, 9 mg, or 17.2 mg).1,3,4
Similarly, no efficacy data are available from the ACHIEVE studies (type 2 diabetes [T2D]) for orforglipron 0.8 mg, 5.5 mg, and 14.5 mg, as these doses were also part of the dose-escalation scheme. Orforglipron 2.5 mg was one of the randomized doses studied in ACHIEVE-1, -2, and -5, along with 9 mg and 17.2 mg.1,5-7
Efficacy data on body weight are summarized below from the
- weight management studies ATTAIN-1 and ATTAIN-2 at orforglipron 5.5 mg, 9 mg, and 17.2 mg doses, and
- T2D studies ACHIEVE-1, -2, and -5 at orforglipron 2.5 mg, 9 mg, and 17.2 mg doses.1,3-7
What Is the Efficacy of Orforglipron on Body Weight From the ATTAIN-1 and ATTAIN-2 Studies?
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 T2D, and
- ATTAIN-2 in adults with obesity or overweight with T2D.3,4
ATTAIN-1 and ATTAIN-2 compared orforglipron with placebo and had a 72-week treatment period, including up to a 20-week dose escalation period and at least a 52-week maintenance period.3,4
Participants randomized to orforglipron initiated treatment at 0.8 mg once daily. The dose was then increased every 4 weeks until the randomly assigned dose (5.5 mg, 9 mg, or 17.2 mg) was reached.1,3,4
Table 1 presents the dose escalation schedule in ATTAIN-1 and ATTAIN-2.
| Treatment Group | Weeks 0-4 | Weeks 4-8 | Weeks 8-12 | Weeks 12-16 | Weeks 16-20 | Week 20 through End of Treatment |
|---|---|---|---|---|---|---|
| Orforglipron 5.5 mg | 0.8 mg | 2.5 mg | 5.5 mg | |||
| Orforglipron 9 mg | 0.8 mg | 2.5 mg | 5.5 mg | 9 mg | ||
| Orforglipron 17.2 mg | 0.8 mg | 2.5 mg | 5.5 mg | 9 mg | 14.5 mg | 17.2 mg |
Because the studies were designed to evaluate efficacy at the 5.5 mg, 9 mg, and 17.2 mg doses, no efficacy data are available for orforglipron at the 0.8 mg, 2.5 mg, and 14.5 mg doses for weight management in ATTAIN-1 and ATTAIN-2.1,3,4
Percent change in body weight over time with orforglipron 5.5 mg, 9 mg, and 17.2 mg from the ATTAIN-1 and ATTAIN-2 studies are presented in Figure 1 and Figure 2, respectively.
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).
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.
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.
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).
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.
What Is the Efficacy of Orforglipron on Body Weight From the ACHIEVE-1, -2 and -5 Studies?
The effects of orforglipron on body weight were also evaluated in the ACHIEVE studies in adults with T2D across different stages of the disease spectrum and treatment settings as presented in Table 2.5-9
| Studies | Studied OFG Doses | Comparator | Background Therapy | Treatment Duration |
|---|---|---|---|---|
| ACHIEVE-1 | 2.5 mg, 9 mg, 17.2 mg | Placebo | Diet and exercise alone | 40 weeks |
| ACHIEVE-2 | 2.5 mg, 9 mg, 17.2 mg | Dapagliflozin 10 mg | Metformin | 40 weeks |
| ACHIEVE-3 | 9 mg, 17.2 mg | Oral semaglutide 7 mg, 14 mg | Metformin | 52 weeks |
| ACHIEVE-4 | 17.2 mg or MTD | Insulin glargine | +/- metformin, SGLT-2i, and/or SU | Event driven |
| ACHIEVE-5 | 2.5 mg, 9 mg, 17.2 mg | Placebo | +/- metformin and/or SGLT-2i | 40 weeks |
Abbreviations: MTD = maximum tolerated dose; OFG = orforglipron; SGLT-2i = sodium-glucose cotransporter-2 inhibitor; SU = sulfonylurea.
In ACHIEVE-1, -2, and -5, participants randomized to orforglipron initiated treatment at 0.8 mg once daily. The dose was then increased every 4 weeks until the randomly assigned dose (2.5 mg, 9 mg, or 17.2 mg) was reached.1,5-7
Table 3 presents the dose escalation schedule in the ACHIEVE-1, -2, and -5 clinical studies.
| Treatment Group | Weeks 0-4 | Weeks 4-8 | Weeks 8-12 | Weeks 12-16 | Weeks 16-20 | Week 20 through End of Treatment |
|---|---|---|---|---|---|---|
| Orforglipron 5.5 mg | 0.8 mg | 2.5 mg | ||||
| Orforglipron 9 mg | 0.8 mg | 2.5 mg | 5.5 mg | 9 mg | ||
| Orforglipron 17.2 mg | 0.8 mg | 2.5 mg | 5.5 mg | 9 mg | 14.5 mg | 17.2 mg |
Because the studies were designed to evaluate efficacy at the 2.5 mg, 9 mg, and 17.2 mg doses, no efficacy data are available for orforglipron at the 0.8 mg, 5.5 mg, and 14.5 mg doses for T2D in ACHIEVE-1, -2, and -5.1,5-7
Percent change in body weight over time with orforglipron 2.5 mg, 9 mg, and 17.2 mg from the ACHIEVE-1, -2, and -5 studies are presented in Figure 3, Figure 4, and Figure 5, respectively.
Figure 3 description: In ACHIEVE-1, mean baseline body weight was 90.2 kg for the overall population. At week 40, percent change from baseline in body weight was -4.7%, -6.1%, and -7.9% with orforglipron 2.5 mg, 9 mg, and 17.2 mg, respectively, and by -1.6% with placebo. Changes in body weight were dose dependent and did not appear to have reached a plateau. Boxes indicate when the maintenance dose of orforglipron 2.5 mg, 9 mg, and 17.2 mg were achieved.
Notes: Data are LSM (95% CI) from MMRM analysis (efficacy estimand).
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; LSM = least squares mean; MMRM = mixed model repeated measures; OFG = orforglipron; PBO = placebo.
Figure 4 description: In ACHIEVE-2, mean baseline body weight was 89.9 kg for the overall population. At week 40, percent change from baseline in body weight was -3.5%, -6.3%, and -7.3% with orforglipron 2.5 mg, 9 mg, and 17.2 mg, respectively, and -3.0% with dapagliflozin 10 mg.
Notes: Data are observed percent change from baseline in bodyweight for the efficacy estimand; MBE at week 40 is actual value (change from baseline) for the efficacy estimand. Error bars denote SE.
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: BW = body weight; DAPA = dapagliflozin; MBE = model-based estimate; OFG = orforglipron.
Figure 5 description: In ACHIEVE-5, mean baseline body weight was 85.2 kg for the overall population. At week 40, percent change from baseline in body weight was -2.7%, -5.8%, and -6.1% with orforglipron 2.5 mg, 9 mg, and 17.2 mg, respectively, and +0.6% with placebo.
Notes: Time curve data are observed mean (SE). MBE (SE) and MBE of ETD vs placebo (95% CI) at week 40, based on MMRM analysis (efficacy estimand), are shown in the side panel of the graph.
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: BW = body weight; ETD = estimated treatment difference; MBE = model-based estimate; MMRM = mixed model repeated measures; OFG = orforglipron.
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).
- 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
- Foundayo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
- 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.
- Rosenstock J, Hsia S, Nevarez Ruiz L, et al. Orforglipron, an oral small-molecule GLP-1 receptor agonist, in early type 2 diabetes. N Engl J Med. 2025;392(25):1234-1245. https://doi.org/10.1056/NEJMoa2505669
- Welch M, Forst T, Jia W, et al. Orforglipron compared with dapagliflozin in adults with type 2 diabetes and inadequate glycaemic control with metformin (ACHIEVE-2): a multicentre, randomised, non-inferiority, open-label, phase 3 trial. Lancet. Published online June 8, 2026. https://doi.org/S0140-6736(26)00800-7
- Giorgino F, D’Souza S, Ludwig L, et al. Orforglipron added to titrated insulin glargine in type 2 diabetes: The ACHIEVE-5 randomized clinical trial. JAMA. Published online June 07, 2026. https://doi.org/10.1001/jama.2026.9512
- Rosenstock J, Yabe D, Cox D, et al. Efficacy and safety of once-daily oral orforglipron compared with oral semaglutide in adults with type 2 diabetes (ACHIEVE-3): a multinational, multicentre, non-inferiority, open-label, randomised, phase 3 trial. Lancet. 2026; 407: 1147-1160. https://doi.org/10.1016/S0140-6736(26)00202-3
- ACHIEVE-4, the longest Phase 3 study of Lilly's Foundayo (orforglipron) to date, reaffirmed its cardiovascular and overall safety profile as well as consistent improvements across key measures of cardiometabolic health. Press release. Eli Lilly and Company; April 16, 2026. Accessed April 16, 2026. https://investor.lilly.com/news-releases/news-release-details/achieve-4-longest-phase-3-study-lillys-foundayo-orforglipron
Date of Last Review: April 01, 2026