Pharmaceutical manufacturer Novo Nordisk has released new clinical trial analyses showing that its next-generation experimental weight-loss medication, CagriSema, helped women with obesity or overweight lose an average of 25% of their body weight over 68 weeks. Presented at the annual meeting of The Menopause Society in San Diego, the late-stage study data offers patients, physicians, and investors a detailed look at how the dual-action weekly injection performs compared to existing treatments like Ozempic and Wegovy as the company awaits federal regulatory approval.
The newly released findings come from a post-hoc analysis of the Phase 3 REDEFINE 1 clinical trial. According to data reported by ABC News and ConsumerAffairs, the sub-study evaluated 2,309 women who received a 2.4-milligram once-weekly dose of CagriSema alongside lifestyle changes. While women taking a placebo lost an average of 3% of their body weight after 68 weeks, those who remained on CagriSema continuously achieved an estimated 25% reduction. For a patient starting treatment at 220 pounds, a 25% reduction equates to a loss of 55 pounds.
How CagriSema Compares to Ozempic and Wegovy
Both patients and market analysts have closely tracked Novo Nordisk's development pipeline to see how its upcoming therapies improve upon its established blockbusters, Ozempic and Wegovy. Both Ozempic—approved for type 2 diabetes—and Wegovy—approved for chronic weight management—rely on a single active ingredient: semaglutide. Semaglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist that mimics a natural gut hormone to regulate blood sugar, slow digestion, and reduce appetite.
CagriSema builds upon this foundation by combining 2.4 milligrams of semaglutide with a newly developed active ingredient called cagrilintide in a single weekly injection. Cagrilintide is an investigational amylin analog that mimics amylin, a hormone produced by the pancreas that promotes a feeling of fullness and helps regulate glucose levels. By targeting two separate hormone pathways simultaneously, researchers aim to produce greater weight reduction than GLP-1 therapy alone while helping Novo Nordisk maintain its footing against rival pharmaceutical maker Eli Lilly before Wegovy's patents begin expiring after 2030.
In the broader REDEFINE 1 clinical trial—which enrolled 3,417 adults without diabetes across both male and female populations—overall weight loss was lower than the women-only estimate. In the full trial population, CagriSema produced an average weight loss of 22.7% among patients who adhered to treatment, and 20.4% when researchers included all participants regardless of whether they completed the medication regimen, according to results published in the New England Journal of Medicine.
Consistent Weight Reduction Across Menopause Stages
A secondary focus of the San Diego presentation examined how CagriSema performed in women across different reproductive stages, a period when hormonal shifts frequently contribute to metabolic changes and weight gain. Researchers conducted a separate post-hoc evaluation of 1,902 overweight or obese women from the trial, categorizing them retrospectively by menopausal status.
The data demonstrated substantial weight reduction across all groups at the 68-week mark. Premenopausal women experienced an estimated average weight loss of 26.7%, women in perimenopause lost an average of 24.8%, and postmenopausal women achieved an average reduction of 23.1%.
"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," Michelle Skinner Moore, vice president of medical affairs at Novo Nordisk, said in a statement regarding the trial results. However, researchers noted that because menopause categories were assigned retrospectively after the trial met its primary goals, the findings are exploratory and do not prove that reproductive stage directly caused the slight variations in weight loss.
Side Effects, Safety Profile, and Broader Health Context
As with established GLP-1 medications, gastrointestinal side effects remain a primary consideration for patients evaluating CagriSema. In the overall REDEFINE 1 trial, 79.6% of participants receiving CagriSema reported gastrointestinal symptoms, compared to 39.9% of those in the placebo group. The most common adverse events included nausea, vomiting, diarrhea, constipation, and abdominal pain. Trial investigators noted that these symptoms were generally temporary and mild to moderate in severity.
The push for more effective metabolic treatments comes as clinical researchers increasingly emphasize the connection between chronic conditions—such as obesity and sleep disorders—and long-term neurological and cardiovascular outcomes. For example, separate research highlighted by ABC News from the journal Sleep Medicine Reviews found that chronic insomnia is associated with a 26% higher risk of stroke and nearly 30% higher odds of hospitalization, underscoring the medical community's focus on addressing underlying systemic health risks early.
Across the broader pharmaceutical sector, major drugmakers are similarly advancing combination therapies in late-stage clinical trials to outperform single-agent standards of care, according to industry trial updates published by The Manila Times.
What Patients Can Expect Next
CagriSema remains an investigational medication and is not yet approved for public prescription. Novo Nordisk submitted its formal application to the U.S. Food and Drug Administration (FDA) in December 2025. A regulatory decision from the FDA regarding the approval of CagriSema for chronic weight management is expected in the fourth quarter of 2026.
Health officials and clinical investigators advise patients that post-hoc trial analyses assume continuous treatment alongside structured diet and exercise modifications. Individuals interested in medical weight management should consult a licensed healthcare provider to discuss currently approved therapies, evaluate personal risk factors, and determine the safest clinical approach for their long-term health.
