THE APEX TIMES
Eli Lilly reports weight-loss pill results across menopause stages from ATTAIN analysis
In post-hoc data from two Phase 3 trials, women taking Foundayo (orforglipron) showed weight loss benefits in perimenopause and post-menopause, including results up to 30.4 pounds in one subgroup at the highest dose.
Eli Lilly and Company said its once-daily oral weight-loss drug Foundayo (orforglipron) produced substantial weight reduction in women across menopausal stages, including perimenopause and post-menopause, based on new post-hoc analyses from its Phase 3 ATTAIN program.
The findings, presented at the American Diabetes Association 86th Scientific Sessions, draw from more than 1,500 female participants pooled across ATTAIN-1 and ATTAIN-2. ATTAIN-1 tested the drug as monotherapy in adults with obesity or overweight without diabetes, while ATTAIN-2 studied adults with obesity or overweight who had type 2 diabetes.
In ATTAIN-1, women in perimenopause who received the highest dose of Foundayo lost up to 30.4 pounds (14.4%). Women in post-menopause lost up to 28.2 pounds (14.1%). Across these groups, Lilly said a higher share of participants also achieved clinically meaningful weight loss, including up to 51.5% of women in perimenopause reaching at least 15% weight loss at the highest dose. Lilly also reported reductions in waist circumference, a common proxy for abdominal fat and cardiometabolic risk, with decreases of up to 4.9 inches (12.5 cm) at 72 weeks in ATTAIN-1.
In ATTAIN-2, which included participants living with type 2 diabetes, Lilly reported weight loss across menopause stages as well. Women taking Foundayo at the highest dose lost up to 23.4 pounds (11.3%) in pre-menopause, up to 18.5 pounds (8.9%) in perimenopause, and up to 27.8 pounds (13.6%) in post-menopause. Lilly said up to 44.2% of women in ATTAIN-2 reached at least 15% weight loss at the highest dose.
Lilly framed the results around menopause as a “major, yet often overlooked” driver of weight gain, pointing to hormonal changes that can increase fat accumulation, particularly around the abdomen, and make weight loss harder to achieve and sustain. Rachel Batterham, Lilly’s senior vice president of medical innovation and external engagement, said the data show Foundayo was associated with meaningful weight loss “in women at every stage of menopause,” and suggested the results could help patients who experience weight becoming more difficult to manage during midlife.
Foundayo is an FDA-approved medication for adults with obesity, or some adults with overweight who also have weight-related medical problems, to reduce excess body weight and maintain weight loss long term, alongside a reduced-calorie diet and increased physical activity. In its announcement, Lilly described Foundayo (orforglipron) as a once-daily oral small molecule GLP-1 receptor agonist that can be taken any time of day without restrictions on food or water intake.
Still, the company emphasized these are post-hoc analyses, meaning they were conducted after the original studies were completed to explore how outcomes varied by menopause status, rather than serving as a pre-specified primary endpoint. Lilly did not disclose, in the announcement, detailed safety and tolerability results broken out by menopausal stage, nor did it specify whether these subgroup findings were powered or statistically adjusted for multiple comparisons. The company also did not provide guidance on how clinicians should use menopause staging to tailor dosing or expectations.
Next for the program, investors and clinicians will likely look for fuller subgroup reporting in peer-reviewed publication, including additional detail on durability of weight loss, changes in cardiometabolic measures beyond waist circumference, and safety outcomes by menopausal status. For Lilly, the goal is to strengthen evidence that its oral incretin-based approach can deliver consistent weight-management benefits in a patient population that is often underrepresented in obesity trials.
Why It Matters
- Menopause can be a period when patients experience weight changes that are harder to manage, and Lilly’s results suggest the company’s oral GLP-1 approach may work across that transition.
- Subgroup evidence like this can influence how payers, clinicians, and trial designers think about obesity treatment responsiveness outside of a single “average” population.
- Because these are post-hoc analyses rather than primary endpoints, the broader impact depends on how consistently the findings hold up in further reporting and how safety is characterized by menopausal stage.
Sources
Key Facts
- Lilly said its new analyses were based on post-hoc results from more than 1,500 women across ATTAIN-1 and ATTAIN-2.
- In ATTAIN-1, women in perimenopause taking the highest dose of Foundayo lost up to 30.4 pounds (14.4%), and women in post-menopause lost up to 28.2 pounds (14.1%).
- Lilly reported that at the highest dose in ATTAIN-1, up to 51.5% of women in perimenopause achieved at least 15% weight loss.
- In ATTAIN-2, women with type 2 diabetes lost up to 23.4 pounds (11.3%) in pre-menopause, 18.5 pounds (8.9%) in perimenopause, and 27.8 pounds (13.6%) in post-menopause at the highest dose.
- Lilly said waist circumference decreased by up to 4.9 inches (12.5 cm) in ATTAIN-1 and by up to 4.3 inches (11.0 cm) in ATTAIN-2 at 72 weeks.
- Lilly described Foundayo (orforglipron) as an FDA-approved once-daily oral GLP-1 receptor agonist for weight loss that can be taken without food or water intake restrictions.
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