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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.
Is data available on participants with overweight or obesity who did not respond to Foundayo™ (orforglipron)?
No information is available regarding nonresponders to orforglipron treatment during the ATTAIN clinical trial program. No subgroup analyses were conducted.
See important safety information, including boxed warning, in the attached prescribing information.
Content Overview
Nonresponders in the Orforglipron Clinical Trial Program
No dose adjustment is needed based on age, sex, race/ethnicity, body weight, renal function, or mild or moderate hepatic impairment.1 The intrinsic factors of age (18 to 92 years), sex, race (White, Asian, Black or African American, American Indian, Multiracial, or Hawaiian Pacific Islander), ethnicity (Hispanic, Non-Hispanic), body weight (56.4 to 227 kg), and renal impairment (eGFR 27.8 to 156 mL/min/1.73 m2) do not have a clinically relevant effect on the pharmacokinetics of orforglipron.2
There is no information available on ATTAIN-1 and ATTAIN-2 clinical study participants who did not respond to orforglipron. Due to the small number of nonresponders in the studies, it would be difficult to assess reasoning for nonresponse.
The Food and Drug Administration (FDA) considers a drug effective for weight loss if there is a statistically significant reduction in baseline body weight of ≥5% after 12 months of treatment.3
Studies on Effects of Orforglipron in Adults With Obesity or Overweight: ATTAIN-1 and ATTAIN-2
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 and ATTAIN-2 had a treatment duration of 72 weeks and compared an investigational orforglipron capsule formulation with placebo.4,5
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.2,4,5
In both studies, all participants received lifestyle interventions, including guidance on diet and physical activity.4,5
Back to => Content Overview
Nonresponders in ATTAIN-1 in Adults With Obesity or Overweight With Weight-Related Comorbidities Excluding Type 2 Diabetes
In ATTAIN-1, the percentage of patients achieving ≥5% weight reduction at week 72 was
Waterfall plots from ATTAIN-1 show that the body weight reduction was observed in
- 87.7% of participants taking orforglipron 5.5 mg
- 88% of participants taking orforglipron 9 mg
- 90.2% of participants taking orforglipron 17.2 mg, and
- 55.8% of participants taking placebo (Waterfall Plots of Percent Change in Body Weight at Week 72 in ATTAIN-1).2,4
Figure 1 description: Body weight reduction was observed in 87.7%, 88%, and 90.2% of subjects administered orforglipron at doses of 5.5 mg, 9 mg, and 17.2 mg, respectively, compared with 55.8% of subjects receiving placebo.
Abbreviations: OFG = orforglipron; PBO = placebo.
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Nonresponders in ATTAIN-2 in Adults With Obesity or Overweight With Type 2 Diabetes
In ATTAIN-2, the percentage of patients achieving ≥5% weight reduction at week 72 were
Waterfall plots from ATTAIN-2 show that the body weight reduction was observed in
- 81.8% of participants taking orforglipron 5.5 mg
- 88.6% of participants taking orforglipron 9 mg
- 89.6% of participants taking orforglipron 17.2 mg, and
- 66.9% of participants taking placebo (Waterfall Plots of Percent Change in Body Weight at Week 72 in ATTAIN-2).2,5
Figure 2 description: Body weight reduction was observed in 81.8%, 88.6%, and 89.6% of subjects administered orforglipron at doses of 5.5 mg, 9 mg, and 17.2 mg, respectively, compared with 66.9% of subjects receiving placebo.
Abbreviation: OFG = orforglipron.
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Enclosed Prescribing Information
References
The published references below are available by contacting 1-800-LillyRx (1-800-545-5979).
1Data on file, Eli Lilly and Company and/or one of its subsidiaries.
2Foundayo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.
3Obesity and Overweight: Developing Drugs and Biological Products for Weight Reduction Guidance for Industry. Regulations.gov document identifier: FDA-2007-D-0435-0020. Accessed January 26, 2026. https://www.regulations.gov/document/FDA-2007-D-0435-0020
4Wharton 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
5Horn 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
Date of Last Review: November 28, 2025