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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.
How do I treat patients who meet their weight reduction goals with Foundayo™ (orforglipron)?
Eli Lilly and Company cannot provide treatment recommendations beyond the approved prescribing information for patients who met their treatment goals. Information from the clinical trial protocols is provided in this response.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
- Are There Dosing Considerations for Orforglipron in Patients Who Have Met Their Weight Reduction Goals?
- What Information is Available From the Clinical Trials on Participants Who Met Goals?
- Enclosed Prescribing Information
- References
- Appendix
Are There Dosing Considerations for Orforglipron in Patients Who Have Met Their Weight Reduction Goals?
Orforglipron is indicated in combination with a reduced-calorie diet and increased physical activity to reduce excess body weight and maintain weight reduction long term in adults with
- obesity, or
- overweight in the presence of at least one weight-related comorbid condition.1
There are 6 available doses for orforglipron,
- 1 for initiation of treatment
- 1 for escalation, and
- 4 doses to individualize treatment based on clinical response and tolerability.1
The starting dosage is 0.8 mg orally once daily. After at least 30 days on the 0.8 mg dosage, increase the dosage to 2.5 mg once daily.1
After at least 30 days on the 2.5 mg dosage, increase the dosage to 5.5 mg once daily. If needed, the dosage may be increased through each dosage level (9 mg, 14.5 mg, or 17.2 mg) staying at least 30 days at each step, up to a maximum dose of 17.2 mg.1
This allows for 4 doses to meet individual patient needs based on treatment response and tolerability: 5.5 mg, 9 mg, 14.5 mg, or the maximum dose of 17.2 mg.1
Eli Lilly and Company cannot provide treatment recommendations beyond the approved dosing for patients who have met their treatment goals. The information below is based on the clinical trial protocols.
The health care practitioner may use the information provided, the patient’s prior medical history, and other individual factors in determining a maintenance dosage. The health care practitioner should consider potential risks and benefits of treatment options and monitor appropriately.
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What Information is Available From the Clinical Trials on Participants Who Met Goals?
The safety and efficacy of orforglipron 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.2,3
ATTAIN-1 and ATTAIN-2 had a treatment duration of 72 weeks and compared an investigational orforglipron capsule formulation with placebo.2,3
In both studies, all participants received lifestyle interventions, including guidance on healthy diet and physical activity counseling.2,3
Participants were maintained on the assigned dosage according to the randomization arm until the study endpoint.2,3
Participants reaching a body mass index (BMI) of ≤18.5 kg/m2 at any time during the treatment period, permanently discontinued the study intervention.2,3
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
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Proportion of Participants Achieving Weight Reduction Thresholds ≥5%, ≥10%, ≥15%, and ≥20%
For the treatment-regimen estimand, the percentage of participants meeting the weight loss thresholds of ≥5%, ≥10%, ≥15%, and ≥20% at week 72 can be found in Figure 1 and Figure 2.
For efficacy estimand results, please refer to the Appendix.
Figure 1 description: In ATTAIN-1, the percentage of participants with a ≥5% weight reduction at week 72 was between 60.6% and 71.8% with orforglipron 5.5, 9, and 17.2 mg, compared with 26.8% on placebo. The percentage of participants with a ≥10% weight reduction on orforglipron 5.5, 9, and 17.2 mg was between 33.3% and 54.6% compared with 12.9% on placebo. The percentage of participants with a ≥15% weight reduction on orforglipron 5.5, 9, and 17.2 mg was between 15.1% and 36.0% compared with 5.9% on placebo. The percentage of participants with a ≥20% weight reduction on orforglipron 5.5, 9, and 17.2 mg was between 6.4% and 18.4% compared with 2.8% on placebo.
Notes: Data are model-based estimates assessed using ANCOVA (treatment-regimen estimand).
Treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation of study intervention or initiation of prohibited weight management treatments.
Weight loss thresholds of ≥5%, ≥10%, and ≥15% at week 72 were key secondary endpoints for orforglipron 5.5, 9, and 17.2 mg. Weight reduction threshold of ≥20% was a key secondary endpoint for 9 and 17.2 mg only. The key secondary endpoint was tested under a multiplicity-control procedure. p<.001 for all comparisons with placebo.
Abbreviations: ANCOVA = analysis of covariance; OFG = orforglipron; PBO = placebo.
Figure 2 description: In ATTAIN-2, the percentage of participants with a ≥5% weight reduction at week 72 was between 47.7% and 67.2% with orforglipron 5.5, 9, and 17.2 mg compared with 26.6% on placebo. The percentage of participants with a ≥10% weight reduction on orforglipron 5.5, 9, and 17.2 mg was between 22.6% and 45.6% compared with 9.0% on placebo. The percentage of participants with a ≥15% weight reduction on orforglipron 5.5, 9, and 17.2 mg was between 6.8% and 26.0% compared with 3.0% on placebo. The percentage of participants with a ≥20% weight reduction on orforglipron 5.5, 9, and 17.2 mg was between 2.7% and 10.8% compared with 0.8% on placebo.
Notes: Data are model-based estimates assessed using ANCOVA (treatment-regimen estimand).
Treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation of study intervention or initiation of prohibited weight management treatments.
Weight loss thresholds of ≥5% and ≥10% on orforglipron 5.5 mg, and ≥5%, ≥10%, and ≥15% on 9 or 17.2 mg orforglipron were key secondary endpoints at week 72. The key secondary endpoints were tested under a multiplicity-control procedure. p<.001 for all comparisons with placebo.
Participants who achieve body weight reduction of ≥15% with orforglipron 5.5 mg and weight reductions of ≥20% with any orforglipron dose were not key secondary endpoints and not controlled for multiplicity.
Abbreviations: ANCOVA = analysis of covariance; OFG = orforglipron; PBO = placebo.
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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).
- 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
Appendix
Body Weight Reduction Thresholds in ATTAIN-1 (Efficacy Estimand)
Figure 3 description: In ATTAIN-1, the percentage of participants with a ≥5% weight reduction at week 72 was between 63.8% and 77.1% of participants using orforglipron 5.5, 9, and 17.2 mg compared with 22.1% on placebo. The percentage of participants with a ≥10% weight reduction on orforglipron 5.5, 9, and 17.2 mg was between 35.9% and 59.6% compared with 8.6% on placebo. The percentage of participants with a ≥15% weight reduction on orforglipron 5.5, 9, and 17.2 mg was between 16.5% and 39.6% compared with 3.6% on placebo. The percentage of participants with a ≥20% weight reduction on orforglipron 5.5, 9, and 17.2 mg was between 7.2% and 20.1% compared with 1.6% on placebo.
Notes: Data are model-based estimates assessed using MMRM (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.
Weight loss thresholds of ≥5%, ≥10%, and ≥15% at week 72 were key secondary endpoints for orforglipron 5.5, 9, and 17.2 mg. Weight reduction threshold of ≥20% was a key secondary endpoint for 9 and 17.2 mg only. The key secondary endpoint was tested under a multiplicity-control procedure. p<.001 for all comparisons with placebo.
Abbreviations: MMRM = mixed model for repeated measures; OFG = orforglipron; PBO = placebo.
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Body Weight Reduction Thresholds in ATTAIN-2 (Efficacy Estimand)
Figure 4 description: In ATTAIN-2, the percentage of participants with a ≥5% weight reduction at week 72 was between 49.8% and 72.8% of participants using orforglipron 5.5, 9, and 17.2 mg compared with 24.4% on placebo. The percentage of participants with a ≥10% weight reduction on orforglipron 5.5, 9, and 17.2 mg was between 23.9% and 50.1% compared with 7.0% on placebo. The percentage of participants with a ≥15% weight reduction on orforglipron 5.5, 9, and 17.2 mg was between 7.3% and 28.4% compared with 1.9% on placebo. The percentage of participants with a ≥20% weight reduction on orforglipron 5.5, 9, and 17.2 mg was between 3.9% and 12.0% compared with 0.2% on placebo.
Notes: Data are model-based estimates assessed using MMRM (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.
Weight loss thresholds of ≥5% and ≥10% on orforglipron 5.5 mg, and ≥5%, ≥10%, and ≥15% on 9 or 17.2 mg orforglipron were key secondary endpoints at week 72. The key secondary endpoints were tested under a multiplicity-control procedure. p<.001 for all comparisons with placebo.
Participants who achieved body weight reduction of ≥15% with orforglipron 5.5 mg and weight reductions of ≥20% with any orforglipron dose were not key secondary endpoints and not controlled for multiplicity.
Abbreviations: MMRM = mixed model for repeated measures; OFG = orforglipron; PBO = placebo.
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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.2,3
The treatment-regimen estimand represents the estimated average treatment effect regardless of treatment discontinuation of study intervention or initiation of prohibited weight management treatments.2,3
Date of Last Review: April 14, 2026