New analyses from the ATTAIN-1 and ATTAIN-2 clinical trials show that women with obesity or overweight who took the highest dose of orforglipron (Foundayo) experienced significant weight loss at every stage of menopause. The data were presented at the American Diabetes Association (ADA) 86th Scientific Sessions in New Orleans, Louisiana.
About Orforglipron (Foundayo)
Medication class: Once-daily small molecule (non-peptide) oral glucagon-like peptide-1 receptor agonist
FDA approval: April 1, 2026; approved for adults with obesity, or some adults with overweight who also have weight-related medical problems to reduce excess body weight and maintain weight reduction long term, alongside a reduced-calorie diet and increased physical activity. Can be taken any time of the day without restrictions on food and water intake.
Clinical trials: ATTAIN-1 and ATTAIN-2
"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," Rachel Batterham, OBE, MBBS, PhD, FRCP, Lilly senior vice president of medical innovation and external engagement, said in a statement. "These findings show that [orforglipron] 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."
Orforglipron FDA Approval, ATTAIN Program
On April 1, 2026, the US Food and Drug Administration approved orforglipron 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 was approved for use any time of the day without restrictions on food and water intake.
The ATTAIN Phase 3 global clinical development program 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. 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.
In both trials, all participants in the orforglipron treatment arms started the study at a dose of Foundayo 0.8 mg once-daily and then increased the dose in a step-wise approach at 4-week intervals to their final randomized maintenance dose of 5.5 mg (via steps at 0.8 mg and 2.5 mg), 9 mg (via steps at 0.8 mg, 2.5 mg and 5.5 mg) or 17.2 mg (via steps at 0.8 mg, 2.5 mg, 5.5 mg, 9 mg and 14.5 mg).
New Menopause Analyses at ADA Scientific Sessions
In the post-hoc analysis of the ATTAIN trials presented at ADA, across both ATTAIN‑1 and ATTAIN‑2, orforglipron was associated with significant reductions in body weight at 72 weeks across menopausal stages. In ATTAIN‑1, 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 orforglipron. In ATTAIN‑2, women with type 2 diabetes who were pre‑, peri‑ and post‑menopausal lost up to 23.4 lbs (11.3%), 18.5 lbs (8.9%) and 27.8 lbs (13.6%) respectively.
At the highest dose, up to 51.5% of women in ATTAIN-1 and up to 44.2% in ATTAIN-2 experienced ≥15% weight loss. Women also experienced meaningful reductions in waist circumference, with decreases of up to 4.9 inches (12.5 cm) in ATTAIN‑1 and up to 4.3 inches (11.0 cm) in ATTAIN‑2 at 72 weeks.
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