Eli Lilly, maker of the weight-loss drug Zepbound (tirzepatide), has revealed new clinical trial findings showing that women with obesity or overweight achieved significant weight loss with Foundayo (orforglipron) across all stages of menopause.
The studies also showed meaningful reductions in waist circumference among women taking Foundayo, suggesting a decrease in abdominal fat and cardiometabolic risk.
Foundayo (orforglipron) is an FDA-approved once-daily oral GLP-1 receptor agonist for adults with obesity, or overweight adults with weight-related health conditions, to support long-term weight management, alongside a reduced-calorie diet and increased physical activity. Unlike injectable GLP-1 therapies, Foundayo is the only oral GLP-1 that can be taken at any time of day without restrictions on food or water intake.
Originally discovered by Chugai Pharmaceutical and licensed by Lilly in 2018, orforglipron is also being investigated for several other conditions, including type 2 diabetes, obstructive sleep apnea, osteoarthritis knee pain, hypertension, peripheral artery disease, and stress urinary incontinence.
The latest findings come from post-hoc analyses involving more than 1,500 women enrolled in the ATTAIN-1 and ATTAIN-2 clinical trials. The data were presented at the 86th Scientific Sessions of the American Diabetes Association (ADA).
Researchers highlighted that menopause is a major contributor to weight gain, yet its impact on obesity treatment outcomes has rarely been studied. Hormonal changes during menopause can increase fat accumulation, particularly around the abdomen, while also making weight loss more difficult to achieve and maintain.
Across both studies, women taking Foundayo experienced significant weight reduction over 72 weeks, regardless of menopausal stage.
In the ATTAIN-1 trial, women who were pre‑, peri‑ and post‑menopausal lost up to 28.0 lbs (12.8%), 30.4 lbs (14.4%) and 28.2 lbs (14.1%) respectively on the highest dose of Foundayo (17.2 mg).
In ATTAIN-2, which included women with type 2 diabetes, pre-menopausal women lost up to 23.4 lbs (11.3%), while peri-menopausal women reported weight loss of 18.5 lbs (8.9%) and post-menopausal women lost up to 27.8 lbs (13.6%).
At the highest dose (17.2 mg), up to 51.5% of women in ATTAIN-1 and 44.2% in ATTAIN-2 achieved at least 15% weight loss. Participants also recorded notable reductions in waist circumference, with decreases of up to 4.9 inches (12.5 cm) in ATTAIN-1 and 4.3 inches (11 cm) in ATTAIN-2 after 72 weeks.
Rachel Batterham, Lilly senior vice president of medical innovation and external engagement, said, “Menopause can be an incredibly frustrating time for many women, partly because weight gain often feels beyond their control, and the biology of menopause can undermine even the most determined efforts to manage weight.”
“These findings show that Foundayo was associated with meaningful weight loss in women at every stage of menopause. For women who have seen their weight become harder to manage precisely when their health is more at risk, this is what progress could look like,” she added.
Eli Lilly warned that Foundayo should not be used alongside other GLP-1 receptor agonist medicines. The company also noted that the medicine’s safety and effectiveness in children have not yet been established.
