COPENHAGEN, Denmark — Novo Nordisk has unveiled promising new findings for its next-generation experimental obesity medication CagriSema, reporting an estimated 25% average reduction in body weight among women after 68 weeks of treatment.
The findings, announced October 20, 2026, could strengthen the Danish drugmaker’s efforts to develop a successor to its blockbuster weight-management medicine Wegovy as competition intensifies in the global obesity treatment market.
In an exploratory analysis of 2,309 women with obesity or overweight who participated in the phase 3 REDEFINE 1 clinical trial, women assigned to CagriSema showed an estimated average weight reduction of 25% at week 68, compared with 3% for those assigned to placebo.
The company also reported encouraging results across reproductive life stages, including women before, during and after menopause.
But the figures come with significant scientific qualifications.
The analyses were performed after the original trial design, and the headline result estimates what would happen if participants remained on treatment and did not use other weight-loss therapies.
Moreover, CagriSema has not yet received U.S. Food and Drug Administration approval.
The biggest question is whether these findings can translate into a successful regulatory decision and meaningful clinical benefits—or whether side effects, competition and earlier trial disappointments will limit the drug’s market potential.
Novo Reports 25% Weight Loss Among Women
Novo Nordisk presented the new analyses at The Menopause Society’s 2026 Annual Meeting in San Diego.
The data were drawn from REDEFINE 1, a late-stage clinical trial that originally enrolled 3,417 adults with obesity or overweight and at least one weight-related condition, excluding people with type 2 diabetes.
Women made up roughly two-thirds of the study population.
The new analysis examined 2,309 female participants across the trial’s treatment groups.
Among women assigned to the combination treatment, estimated average weight reduction reached 25% after 68 weeks.
The comparable placebo group showed a 3% reduction.
The analysis therefore suggests a substantial difference between the experimental treatment and placebo.
However, the percentage represents an estimated group average under specific modeling assumptions.
It does not mean every woman lost one-quarter of her body weight.
Individual responses can vary, and some participants may discontinue treatment because of side effects or other reasons.
CagriSema Combines Two Hormone-Based Medicines
CagriSema is a once-weekly injectable combination of two medicines.
The first is semaglutide, a glucagon-like peptide-1 receptor agonist already used in Novo Nordisk’s established diabetes and weight-management products.
The second is cagrilintide, an investigational long-acting amylin analogue.
The combination is designed to affect appetite through two different hormonal pathways.
Semaglutide helps regulate appetite and food intake through GLP-1 receptor activity.
Cagrilintide acts through mechanisms associated with amylin, a hormone involved in satiety.
By combining the two, Novo hopes to produce greater weight reduction than either component alone.
The dose studied in the main REDEFINE 1 analysis contained 2.4 milligrams of cagrilintide and 2.4 milligrams of semaglutide.
But CagriSema should not be confused with an already marketed product.
It remains an investigational combination whose safety, efficacy and appropriate clinical use are still subject to regulatory review.
Results Differ Across Menopause Stages
One of the more notable findings concerns women at different reproductive stages.
In a separate exploratory analysis involving 1,902 women assigned to either CagriSema or placebo, investigators grouped participants according to estimated menopause status.
Women classified as premenopausal showed an average estimated weight reduction of 26.7%.
The perimenopausal group recorded 24.8%.
Postmenopausal women recorded 23.1%.
The corresponding placebo results were approximately 2.1%, 1.7% and 2.6%.
These findings are relevant because hormonal changes around menopause can affect body composition and the distribution of body fat.
But the numerical differences between groups should not be interpreted as proof that CagriSema works substantially better before menopause.
The study did not conduct the formal interaction testing needed to establish that treatment effects differ reliably by menopause status.
Reproductive stages were also assigned retrospectively using age, medical history and reported symptoms rather than prospectively measured hormone status.
The results therefore provide a basis for additional research, not a definitive hierarchy of treatment effectiveness across menopause stages.
CagriSema Outperforms Semaglutide in the Women’s Analysis
Novo’s presentation included comparisons with the separate active-treatment groups in REDEFINE 1.
At week 68, the estimated average weight reductions among women were:
- CagriSema combination: 25.0%.
- Semaglutide alone: 19.0%.
- Cagrilintide alone: 13.4%.
- Placebo: 3.0%.
The findings are consistent with the company’s strategy of combining hormonal treatments to achieve greater weight reduction.
Novo also reported that approximately 68.7% of women receiving CagriSema achieved at least 20% weight loss under the analysis assumptions.
For comparison, the corresponding proportion was 38% for semaglutide alone.
These results are promising, but readers should distinguish numerical comparisons from formally established conclusions.
The reported significance testing was against placebo, and Novo said the p-values were not adjusted for multiple comparisons.
The female subgroup results should not be used to make unsupported claims that CagriSema has demonstrated superiority over every marketed obesity treatment.
Waist Circumference Also Declined
The analysis reported improvements in waist circumference.
Women receiving CagriSema showed an estimated average reduction of 20.5 centimeters.
The semaglutide group recorded a reduction of 17.4 centimeters.
The cagrilintide group recorded 11.7 centimeters, while placebo participants showed a 4.7-centimeter reduction.
Waist circumference is clinically relevant because it can provide information about abdominal size and cardiometabolic risk.
But it is not a direct measurement of visceral fat.
A smaller waist does not by itself prove a specific percentage reduction in abdominal fat or establish that the treatment prevents heart attacks and strokes.
Additional research is needed to determine the full clinical implications of these changes.
The 25% Figure Comes With a Critical Qualification
The headline result uses what researchers call an efficacy estimand.
This estimates treatment effects under an idealized scenario in which participants continue taking the treatment and do not use other weight-loss therapies.
It is useful for understanding the potential effect of a drug when treatment is maintained.
But real-world outcomes can differ.
Some patients stop treatment.
Others may miss doses, struggle with side effects or require additional medical care.
Novo’s broader REDEFINE 1 trial previously reported average CagriSema weight reduction of 22.7% using the same efficacy-based approach across the full study population.
The new 25% figure reflects the women’s subgroup analysis.
It is not evidence that the overall trial result has been revised upward.
It is also not the result of a newly completed randomized clinical trial conducted exclusively among women.
These distinctions are essential for accurately reporting the science.
Side Effects Remain a Significant Concern
Weight-loss benefits must be considered alongside tolerability.
In the overall REDEFINE 1 trial, adverse events were frequently gastrointestinal.
Novo reported gastrointestinal adverse events in 79.6% of participants receiving CagriSema, compared with 39.9% in the placebo group.
Nausea was reported in 55% of CagriSema recipients.
Constipation occurred in 30.7%.
Vomiting affected 26.1%.
Most gastrointestinal events were described as temporary and mild to moderate.
However, 5.9% of participants receiving CagriSema discontinued because of adverse events, compared with 3.5% of those receiving placebo.
These are overall-trial safety figures, not new adverse-event rates calculated specifically for the women’s subgroup.
The frequency of nausea, vomiting and other symptoms is especially relevant because tolerability can influence whether patients remain on long-term therapy.
The FDA’s evaluation will examine the overall benefit-risk profile rather than weight reduction alone.
Earlier Trial Results Disappointed Investors
The new women’s analysis arrives after CagriSema faced a significant competitive setback.
In February 2026, Novo reported results from REDEFINE 4, an 84-week head-to-head trial comparing CagriSema with tirzepatide, the active ingredient in Eli Lilly’s Zepbound and Mounjaro.
CagriSema produced an estimated 23% average weight reduction under the trial’s efficacy assumptions.
The tirzepatide group recorded 25.5%.
The study failed its primary objective of demonstrating that CagriSema was non-inferior to tirzepatide.
That result disappointed expectations surrounding Novo’s next-generation obesity treatment.
The company nevertheless continued evaluating the combination across different doses and patient groups.
The October women’s analysis offers encouraging information about one subgroup, but it does not reverse REDEFINE 4’s failure to meet its primary endpoint.
The two studies involved different designs, participants and treatment durations.
Their results should not be combined into an artificial head-to-head comparison.
Novo Faces Fierce Competition From Eli Lilly
The obesity medication market has become one of the pharmaceutical industry’s most competitive segments.
Novo Nordisk established an important position through semaglutide-based products including Wegovy and Ozempic.
Eli Lilly has competed aggressively with tirzepatide-based products, including Zepbound and Mounjaro.
Drug developers are racing to improve weight reduction, tolerability, dosing convenience and outcomes related to obesity-associated diseases.
For Novo, CagriSema represents an opportunity to offer a combination therapy using two different hormonal mechanisms.
It may also help protect the company’s position as existing products face increasing competitive and future patent-related pressures.
However, a promising clinical trial result does not guarantee commercial success.
Regulatory approval, manufacturing capacity, insurance coverage, pricing and physician confidence will influence adoption.
Novo has not established the final U.S. selling price of CagriSema because the product remains investigational.
FDA Decision Expected Before the End of 2026
Novo submitted its CagriSema application for U.S. weight-management approval in December 2025.
The company expects an FDA decision in the fourth quarter of 2026.
That makes the latest data particularly timely.
The regulator will consider the evidence submitted to support safety and effectiveness, including pivotal clinical trial results.
Approval is not assured simply because a product has demonstrated substantial weight reduction.
The agency may evaluate adverse events, product labeling, manufacturing matters and other regulatory requirements.
An approval could establish a pathway to commercial launch.
A delay or request for additional information could affect the company’s timeline.
As of October 21, 2026, CagriSema is not approved for use in the United States.
There is also no basis for assuming that the drug is already authorized for sale in the Philippines.
Further Studies Could Clarify Its Potential
Novo continues to investigate CagriSema through its broader REDEFINE and REIMAGINE clinical development programs.
The trials examine different patient populations, treatment doses and health outcomes.
One upcoming readout, REDEFINE 11, is expected during the first half of 2027.
The company is also studying higher-dose combinations to explore whether additional weight reduction is possible.
Other trials investigate CagriSema among people with type 2 diabetes and in studies evaluating longer-term outcomes.
These programs could provide evidence beyond changes on the weighing scale.
For clinicians, questions remain about treatment persistence, safety, the durability of weight loss and broader effects on health.
The results of ongoing trials must be assessed independently rather than assuming that promising findings in one analysis will carry across all patient groups.
What the Results Mean for Women
The latest findings could be particularly interesting for researchers studying obesity across women’s reproductive life stages.
Weight gain, changes in fat distribution and metabolic risks can become more challenging for some women during midlife.
The inclusion of premenopausal, perimenopausal and postmenopausal groups helps draw attention to the need for more detailed research.
But the trial did not establish a CagriSema treatment recommendation based on menopause status.
Nor should the results be interpreted as a reason for people to obtain experimental medicine outside regulated clinical settings.
Anyone considering medical treatment for obesity should discuss the risks, benefits and approved options with a qualified healthcare professional.
The new data are promising research findings, not a substitute for individualized medical care.
The Bigger Test: Can Novo Turn Promising Data Into a Successful Treatment?
CagriSema’s latest analysis provides Novo Nordisk with encouraging evidence about weight reduction in women.
The estimated 25% average weight loss at week 68 is substantial, and reductions were observed across menopause-stage subgroups.
The combination also showed favorable numerical results compared with semaglutide alone in the women’s analysis.
But significant uncertainties remain.
The subgroup findings are exploratory.
The headline result assumes continued treatment.
Gastrointestinal side effects are common.
And the company’s earlier head-to-head trial did not meet its primary objective against tirzepatide.
The expected FDA decision will be a crucial regulatory milestone, but long-term commercial and clinical success will require more than approval alone.
Novo Nordisk’s experimental CagriSema has demonstrated an estimated 25% average weight reduction in women under trial efficacy assumptions. The bigger question is whether the company can turn those promising findings into an approved, tolerable and competitive obesity treatment—without allowing a headline percentage to overshadow the limitations of the evidence.
