Plainsboro, New Jersey, United States, and Bagsværd, Denmark, October 20, 2026
Novo Nordisk has announced promising findings from two post hoc analyses of its Phase 3 REDEFINE 1 clinical trial, showing that its investigational weight-management candidate CagriSema was associated with an average weight reduction of 25% at Week 68 among women with overweight or obesity. The findings were presented at The Menopause Society 2026 Annual Meeting in San Diego, California. The analyses examined weight-loss outcomes among women overall and across premenopausal, perimenopausal, and postmenopausal stages. CagriSema is a once-weekly injectable combination of semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, and cagrilintide, a long-acting amylin analogue. These medicines act through complementary biological pathways involved in appetite regulation and weight management. In the analysis of 2,309 women, the combination was associated with an average weight reduction of 25.0%, compared with 3.0% for placebo, under an analysis estimating outcomes if participants remained on treatment. A separate analysis found substantial weight reduction across all three menopause stages. The findings are relevant to obesity research because hormonal changes during midlife can influence body composition, abdominal fat distribution, and cardiometabolic risk. CagriSema remains investigational, and its safety and efficacy for weight management have not been established through regulatory approval in the United States.
CagriSema Shows Significant Weight Loss in Women
The first post hoc analysis evaluated 2,309 women with overweight or obesity participating in REDEFINE 1. At Week 68, participants receiving CagriSema 2.4 mg semaglutide plus 2.4 mg cagrilintide experienced an average weight reduction of 25.0%, compared with 3.0% among participants receiving placebo. The combination was also associated with improvements in waist circumference, a measure commonly used to assess abdominal fat. Average waist circumference decreased by 20.5 centimetres in the CagriSema group, compared with 4.7 centimetres in the placebo group. Furthermore, 93.3% of participants receiving CagriSema achieved at least 10% weight loss, while 68.7% achieved at least 20% weight loss. In comparison, 12.7% and 1.8% of participants receiving placebo achieved these respective thresholds. The analysis also included semaglutide and cagrilintide treatment groups, allowing researchers to examine the combination’s results alongside its individual components. The weight-loss findings were statistically significant compared with placebo. However, these estimates used an efficacy-based analysis that assumed participants continued treatment and did not use additional weight-loss therapies. The results should therefore not be interpreted as the expected outcome for every patient in routine clinical practice.
Weight Reduction Observed Across Menopause Stages
The second analysis examined outcomes among 1,902 women grouped according to menopausal status. The results indicated that CagriSema was associated with weight loss across all three stages. Premenopausal women experienced an average weight reduction of 26.7%, compared with 2.1% with placebo. Among perimenopausal women, average weight reduction was 24.8%, compared with 1.7% with placebo. Postmenopausal women experienced an average reduction of 23.1%, compared with 2.6% with placebo. All three comparisons were statistically significant. The findings are notable because the menopausal transition can coincide with changes in body composition, abdominal fat accumulation, and metabolic health. Nevertheless, the subgroup analysis was exploratory, and menopause status was determined retrospectively using age, medical history, and recorded symptoms rather than prospective reproductive staging or biochemical confirmation. Formal treatment-by-subgroup interaction testing was not performed. The results do not establish that CagriSema works differently according to menopause status, and further research is needed to understand how reproductive aging may influence weight-management outcomes.
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Novo Nordisk Advances Combination Obesity Treatment
CagriSema combines two investigationally paired mechanisms: semaglutide activates GLP-1 receptors, while cagrilintide acts as a long-acting amylin analogue. The combination is designed to support appetite regulation and sustained weight management. REDEFINE 1 was a 68-week, double-blind, Phase 3 trial involving 3,417 adults with overweight or obesity and at least one weight-related complication, excluding people with type 2 diabetes. Safety findings from the overall trial showed that adverse events leading to treatment discontinuation occurred in 5.9% of participants receiving CagriSema, compared with 3.5% receiving placebo. Gastrointestinal events were common and included nausea, constipation, and vomiting. The company filed a New Drug Application with the U.S. Food and Drug Administration in December 2025, with a regulatory decision expected in the fourth quarter of 2026, according to its October announcement. CagriSema is not approved for use in the United States, and its safety and efficacy have not yet been established by regulatory approval. The post hoc findings add to the clinical evidence being investigated for this combination, while future research and regulatory review will determine its potential role in obesity treatment.
Source: Novo Nordisk press release
