Novo Nordisk announced on October 20, 2026, that its experimental obesity medication, CagriSema, helped adult women lose an average of 25.0% of their body weight over 68 weeks in a late-stage study analysis. Presented at The Menopause Society 2026 Annual Meeting in San Diego, the findings come from two post-study evaluations of women enrolled in the Phase 3 REDEFINE 1 clinical trial. The data offers a closer look at how the dual-action injection performs across different reproductive stages, including premenopause, perimenopause, and postmenopause, as the Danish pharmaceutical maker seeks to expand its weight-management portfolio beyond existing single-hormone therapies.

In the primary post-study evaluation of 2,309 women with obesity or overweight, those treated with a 2.4 mg / 2.4 mg dose of CagriSema achieved a 25.0% average weight reduction at week 68, compared with a 3.0% reduction among women given a placebo, according to Novo Nordisk. In addition to overall weight reduction, participants receiving the active medication showed improvements in waist circumference, a secondary trial measure used to track abdominal fat.

How CagriSema Works and Compares to Current Treatments

CagriSema is an investigational, once-weekly injectable therapy that merges two distinct mechanisms into a single treatment. It pairs semaglutide—the GLP-1 receptor agonist that serves as the active ingredient in Novo Nordisk's widely prescribed medications Wegovy and Ozempic—with cagrilintide, a dual amylin and calcitonin receptor agonist. While GLP-1 medications mimic gut hormones to regulate blood sugar and slow digestion, amylin analogs mimic a hormone released by the pancreas alongside insulin to promote feelings of fullness and manage hunger signals.

By targeting two separate appetite and metabolic pathways simultaneously, researchers aim to achieve greater weight reduction than single-ingredient drugs can provide alone. In the 2,309-woman subgroup evaluation, CagriSema outperformed both of its individual components. According to Pharmacy Times, the estimated 68-week weight reductions for women were 25.0% with the CagriSema combination, compared to 19.0% with semaglutide alone, 13.4% with cagrilintide alone, and 3.0% with a placebo.

Weight Loss Across Menopause Stages

A separate post-study analysis examined 1,902 women from the REDEFINE 1 trial grouped specifically by their menopausal status. Hormonal shifts during the transition into menopause—particularly declining estrogen levels—frequently slow down metabolism, make muscle mass harder to maintain, and trigger an accumulation of abdominal fat. According to CNBC, U.S. Census Bureau figures show that more than 86 million women in the United States are aged 40 and older, placing them in the primary age bracket for perimenopause, menopause, and postmenopause. Despite this large population, reproductive life stages are rarely isolated and studied as distinct variables in obesity drug trials.

When broken down by reproductive stage at week 68, women taking CagriSema experienced substantial weight reductions across all three groups:

  • Premenopausal women: 26.7% average weight loss with CagriSema, compared with 2.1% on placebo.
  • Perimenopausal women: 24.8% average weight loss with CagriSema, compared with 1.7% on placebo.
  • Postmenopausal women: 23.1% average weight loss with CagriSema, compared with 2.6% on placebo.

"Many women with obesity or overweight experience weight gain as they move through menopause, and it is important to explore investigational products such as CagriSema across the reproductive lifespan," said Michelle Skinner Moore, PharmD, MBA, interim head of clinical development, medical and regulatory affairs at Novo Nordisk, in the company's announcement. Moore noted that CagriSema has the potential to become the first combination therapy uniting an amylin analog and a GLP-1 medication for weight management.

Context and Limitations of the Trial Data

While the 25.0% figure highlights strong performance among female participants, health experts and financial analysts emphasize important context regarding how these numbers were calculated. The new findings represent post hoc analyses—meaning the data was sliced and examined after the main trial had already concluded—rather than a newly conducted clinical study. Novo Nordisk noted that additional research is required to formally confirm the hypotheses generated by these post-study evaluations, as formal statistical testing comparing male and female responses was not performed.

Different reports also highlight the distinction between this female-specific subset and the broader trial population. While Novo Nordisk's post hoc announcement focuses on the 25.0% average weight loss among women, Reuters and CNBC report that the initial, full REDEFINE 1 trial readout across more than 3,400 adults (both men and women, with women making up roughly 67% of participants) showed a lower overall average weight loss of 22.7% at 68 weeks, compared with 2.3% for the placebo group. That earlier 22.7% broad result had fallen slightly short of the company's initial 25% target for the overall study population.

Furthermore, the 25.0% and menopause-stage figures rely on what researchers call an "efficacy estimand." As CNBC and Novo Nordisk explain, this statistical model calculates results based on an ideal scenario in which every patient adhered strictly to the treatment regimen for the full 68 weeks without interruption. It does not reflect the average weight loss when factoring in patients who discontinued the medication early due to side effects or other reasons.

What This Means for Patients and Next Steps

CagriSema remains an investigational medication in the United States and has not yet been approved for public prescription. According to Pharmacy Times, Novo Nordisk submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for CagriSema in December 2025. A regulatory decision from the FDA is anticipated in the fourth quarter of 2026, with CNBC reporting that the medication is expected to launch commercially in early 2027 if cleared by regulators.

How does the ideal-adherence result compare with outcomes that include patients who stop treatment?

The 25.0% weight loss figure is based on an efficacy estimand, which measures the drug's effect assuming all participants remained on their assigned dose for the entire 68-week period. In real-world clinical settings and broader trial measurements (known as treatment-policy estimands), averages are typically slightly lower because they include data from individuals who pause or stop taking the medication.

Were the menopause subgroup comparisons designed before the trial started?

No. The evaluations of the 2,309 women overall and the 1,902 women grouped by menopausal status were conducted post hoc, meaning researchers organized and analyzed the subgroup data after the main Phase 3 trial had finished. Because the study was not originally designed to test differences between reproductive stages or between sexes, the company stated that further research is needed to confirm these specific findings.

When will the FDA decide on CagriSema, and what will the label include?

Following Novo Nordisk's application filing in December 2025, an FDA decision is expected during the fourth quarter of 2026. Standard FDA drug labels typically prioritize the primary results from the full trial population (the 22.7% overall adult average in REDEFINE 1), though regulators will determine during their review whether specific subgroup data will be included in the prescribing information.

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