Foundayo Shows Consistent Weight Loss Across Menopause Stages in Phase 3 ATTAIN Studies

Post-hoc analyses from Eli Lilly’s Phase 3 ATTAIN program showed that women with obesity or overweight achieved clinically meaningful weight loss with the oral GLP-1 receptor agonist Foundayo (orforglipron) regardless of menopausal status.

The findings, presented at the American Diabetes Association (ADA) 2026 Scientific Sessions, included women with and without type 2 diabetes and demonstrated consistent efficacy across pre-, peri-, and post-menopausal groups.

Menopause is a major but often overlooked contributor to weight gain. Hormonal changes during this transition can promote abdominal fat accumulation, increase cardiometabolic risk, and make sustained weight loss more difficult, creating a significant unmet need for effective obesity treatments in this population.

Weight Loss Outcomes by Menopausal Status

In ATTAIN-1 (NCT05869903), which enrolled adults with obesity or overweight without diabetes, women receiving Foundayo 17.2 mg achieved weight reductions of 12.8% (pre-menopause), 14.4% (perimenopause), and 14.1% (post-menopause) over 72 weeks. Perimenopausal women experienced the greatest reduction, losing an average of 30.4 pounds (13.8 kg). More than half of participants in this group (51.5%) achieved at least 15% weight loss, while nearly 30% achieved reductions of 20% or greater.

In ATTAIN-2 (NCT05872620), which enrolled adults with obesity or overweight and type 2 diabetes, Foundayo maintained meaningful efficacy despite the additional metabolic burden associated with diabetes. Women lost up to 11.3%, 8.9%, and 13.6% of body weight across pre-, peri-, and post-menopausal groups, respectively. Notably, 44.2% of post-menopausal participants achieved at least 15% weight loss.

Waist Circumference and Cardiometabolic Risk

Across both studies, treatment produced reductions in waist circumference ranging from 3.3 to 4.9 inches (8.4–12.5 cm). These reductions are clinically relevant because excess abdominal fat is strongly associated with cardiometabolic risk, including cardiovascular disease, insulin resistance, and metabolic dysfunction.

Safety and Tolerability

The safety profile observed in these analyses was consistent with the established profile of Foundayo. Gastrointestinal adverse events, including nausea, diarrhea, and constipation, remained the most commonly reported treatment-related events and were generally consistent with the GLP-1 receptor agonist class.

Clinical and Regulatory Context

Foundayo is a once-daily, non-peptide oral GLP-1 receptor agonist approved for chronic weight management in adults with obesity and certain adults with overweight and weight-related comorbidities.

Unlike injectable GLP-1 therapies, Foundayo can be taken at any time of day without restrictions on food or water intake. Lilly licensed the molecule from Chugai Pharmaceutical in 2018.

Rachel Batterham, MBBS, PhD, FRCP, Lilly’s senior vice president of medical innovation and external engagement, noted that menopause often makes weight gain feel difficult to control because of underlying biological changes. She emphasized that the findings demonstrate meaningful weight loss with Foundayo throughout the menopausal transition, a period when women face increasing health risks associated with excess weight.

Broader Development Program

Beyond chronic weight management, Lilly continues to evaluate orforglipron across a range of obesity-related and cardiometabolic conditions, including type 2 diabetes, obstructive sleep apnea, hypertension, peripheral artery disease, osteoarthritis knee pain, and stress urinary incontinence. These ongoing studies support the company’s strategy to position orforglipron across multiple chronic disease indications where excess weight contributes to disease burden.

 Reference

Lilly’s Foundayo (orforglipron), the only oral GLP-1 taken without food or water restrictions, was associated with significant weight loss in women at every stage of menopause | Eli Lilly and Company