FDA Approves Orforglipron (Foundayo) As First Daily GLP-1 Pill Without Food, Water Restrictions

The US Food and Drug Administration has approved Lilly’s orforglipron (Foundayo) for adults with obesity or overweight with weight-related medical problems. The once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist can be taken any time of the day without restrictions on food and water intake.

As described in an April 1, 2026, release from the Company, when used alongside a reduced-calorie diet and increased physical activity, orforglipron helps individuals lose excess body weight and keep the weight off. In the ATTAIN-1 clinical trial, adults taking orforglipron lost an average of 27 pounds on the highest dose.

"People living with obesity need treatment options that meet them where they are – and for many, a once-daily pill that can be taken with no food or water restrictions can offer them greater flexibility in how they approach their treatment," Deborah Horn, DO, director of the Center for Obesity Medicine at McGovern Medical School at UTHealth Houston, said in a statement. "With [orforglipron], we now have an oral option that delivered an average of 12.4% weight loss at the highest dose in clinical trials – addressing both the clinical realities of obesity and the practical challenges patients face every day."

Orforglipron is a once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist. In addition to chronic weight management, orforglipron is being studied as a potential treatment for type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease and stress urinary incontinence.

Its use in overweight and obesity was explored in the ATTAIN Phase 3 global clinical development program, which has enrolled > 4500 people with obesity or overweight across 2 global registration trials. ATTAIN-1 is a phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of orforglipron at various doses to placebo in adults with obesity, or overweight with ≥ 1 of the following comorbidities: hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease, who did not have diabetes.

The trial randomized 3127 participants across the US, Brazil, China, India, Japan, South Korea, Puerto Rico, Slovakia, Spain and Taiwan to receive various doses of orforglipron or placebo along with healthy diet and physical activity. The primary objective of the study was to demonstrate that orforglipron is superior to placebo in body weight reduction from baseline after 72 weeks.

ATTAIN-2 is a phase 3, 72-week, randomized, double-blind, placebo-controlled trial comparing the efficacy and safety of various doses of orforglipron with placebo in adults with obesity or overweight and type 2 diabetes. The trial randomized > 1600 participants across the US, Argentina, Australia, Brazil, China, Czechia, Germany, Greece, India, South Korea and Puerto Rico to receive various doses of orforglipron or placebo along with healthy diet and physical activity. The primary objective of the study was to demonstrate that orforglipron is superior to placebo in mean body weight change from baseline at 72 weeks.

In the ATTAIN-1 trial, individuals taking the highest dose of orforglipron and who stayed on treatment lost an average of 27.3 pounds (12.4%) compared to 2.2 pounds (0.9%) with placebo. Participants taking orforglipron, regardless of trial completion, lost an average of 25 pounds (11.1%), compared to 5.3 pounds (2.1%) with placebo.

Positive topline results from ATTAIN-2 were announced in August 2025 and showed all 3 doses of orforglipron met the trial’s primary and all key secondary endpoints, delivering significant weight loss, meaningful A1C reductions, and improvements in cardiometabolic risk factors at 72 weeks in adult patients with with obesity or overweight and type 2 diabetes.

In the ATTAIN program, orforglipron also led to reductions in many markers of cardiovascular risk, including waist circumference, non-HDL cholesterol, triglycerides and systolic blood pressure across all doses.

"There is no single path that works for everyone living with overweight or obesity," said Joe Nadglowski, president and CEO of the Obesity Action Coalition. "New treatment options expand choice and help more people find care that fits their lives, their goals and where they are in their journey – whether they're just starting to explore treatment or looking for a different long-term approach."

References

1. Lilly. FDA approves Lilly's Foundayo™ (orforglipron), the only GLP-1 pill for weight loss that can be taken any time of day without food or water restrictions/ April 1, 2026. Accessed April 1, 2026. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-foundayotm-orforglipron-only-glp-1-pill

2. Brooks A. Orforglipron Delivers Weight Loss, A1C Reductions in Phase 3 ATTAIN-2 Trial. August 26, 2025. Accessed April 1, 2026. https://www.hcplive.com/view/orforglipron-delivers-weight-loss-a1c-reductions-in-phase-3-attain-2-trial