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  1. Medical Information Right
  2. Obesity Right
  3. Foundayo (orforglipron) tablet Right
  4. What clinical trials established the efficacy and safety of Foundayo™ (orforglipron) for weight management?
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Foundayo ™ (orforglipron) tablet

0.8 mg / 2.5 mg / 5.5 mg / 9 mg / 14.5 mg / 17.2 mg

Full Prescribing Information

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 clinical trials established the efficacy and safety of Foundayo™ (orforglipron) for weight management?

The effectiveness of orforglipron in adults with obesity or overweight in the presence of at least 1 weight-related comorbid condition was established in 2 randomized, double-blind, placebo-controlled trials.

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US_cFAQ_OFG90014_USPI_STUDIES_SUPPORTING_WM_INDICATION_WMen-US

See important safety information, including boxed warning, in the attached prescribing information.

Orforglipron Clinical Trials in Adult Participants with Obesity or Overweight With At Least One Weight-Related Comorbid Condition

The effectiveness of orforglipron has been established 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 adults with overweight in the presence of at least one weight-related comorbid condition based on adequate and well-controlled trials of an investigational orforglipron formulation (ATTAIN-1 and ATTAIN-2).1

Orforglipron was studied in two randomized, double-blind, placebo-controlled trials (ATTAIN-1 and ATTAIN-2) in adults aged 18 years and older. In these trials, all patients received standard lifestyle intervention which included instruction on reduced-calorie diet and physical activity counseling (recommended minimum of 150 minutes/week) that began with the first dose of trial medication or placebo and continued throughout the trials.1

ATTAIN-1

ATTAIN-1 (NCT05869903) was a 72-week trial that enrolled 3127 adult patients with obesity (body mass index [BMI] ≥30 kg/m2 ), or with overweight (BMI 27 to <30 kg/m2 ) and at least one weight-related comorbid condition, such as dyslipidemia, hypertension, obstructive sleep apnea, or cardiovascular disease; patients with type 2 diabetes were excluded.1

In ATTAIN-1, patients were randomized in a 3:3:3:4 ratio to orforglipron 5.5 mg once daily, 9 mg once daily, 17.2 mg once daily, or placebo once daily.1

ATTAIN-2

ATTAIN-2 (NCT05872620) was a 72-week trial that enrolled 1613 adult patients with BMI ≥27 kg/m2 and type 2 diabetes.1

In ATTAIN-2, patients were randomized in a 1:1:1:2 ratio to orforglipron 5.5 mg once daily, 9 mg once daily, 17.2 mg once daily, or placebo once daily.1

Enclosed Prescribing Information

FOUNDAYO™ (orforglipron) tablets, for oral use, Lilly

References

1Foundayo [package insert]. Indianapolis, IN: Eli Lilly and Company; 2026.

Date of Last Review: June 24, 2026

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