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Novo’s CagriSema was associated with 25% weight loss on average for women in a post hoc analysis of REDEFINE 1 presented at The Menopause Society Annual Meeting
- Investigational CagriSema 2.4 mg / 2.4 mg showed significant weight loss among women overall and across pre-, peri- and postmenopausal stages in two post hoc analyses from REDEFINE 1, a phase 3 trial in adults with obesity or overweight1,2
- Across the two analyses, CagriSema use was associated with reductions in abdominal fat, as measured by waist circumference, among women overall and across menopause stages1,2
- CagriSema is an investigational once-weekly combination of semaglutide, a GLP-1 receptor agonist (RA), and cagrilintide, a long-acting amylin analog
PLAINSBORO, N.J. and BAGSVÆRD, Denmark, Oct. 20, 2026 /PRNewswire/ -- Today, Novo announced results from two post hoc analyses of the REDEFINE 1 trial presented at The Menopause Society 2026 Annual Meeting in San Diego. In an analysis of 2,309 women with obesity or overweight, CagriSema 2.4 mg / 2.4 mg (cagrilintide 2.4 mg and semaglutide 2.4 mg) was associated with an average weight loss of 25.0% at week 68, compared with 3.0% with placebo, if all patients adhered to treatment (efficacy estimand*).1 In a second analysis of 1,902 women with overweight or obesity assigned post hoc by menopausal status, average weight loss at week 68 was 26.7%, 24.8% and 23.1% in premenopausal, perimenopausal and postmenopausal women, compared with 2.1%, 1.7% and 2.6% with placebo, respectively (efficacy estimand*).2
“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 and vice president, medical affairs at Novo. “CagriSema has the potential to be the first amylin analog and GLP-1 RA combination therapy for weight management, and these REDEFINE 1 data show it was associated with significant weight loss for women with obesity or overweight. These findings add to the body of evidence from the REDEFINE clinical program.”
Women experience major hormonal shifts throughout the different stages of menopause, which can increase abdominal fat accumulation and impact body composition, weight and cardiometabolic risk.2,3 More than 86 million women in the U.S. are aged 40 and older, the years in which perimenopause, menopause and postmenopause occur,4 yet reproductive stage is rarely evaluated as a factor in obesity research.5
In the post hoc analysis of all 2,309 women enrolled in the REDEFINE 1 trial, treatment with CagriSema 2.4 mg / 2.4 mg was associated with an average weight loss of 25.0% at week 68, compared with 3.0% with placebo, as well as meaningful improvements in waist circumference – a secondary endpoint of the REDEFINE 1 trial and a measure associated with abdominal fat.1
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Change in bodyweight and waist circumference, and achievement of weight-loss targets, among women in REDEFINE 1 at week 68, efficacy estimand results*¹ |
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Outcome at week 68 |
CagriSema 2.4 mg / 2.4 mg (n=1,441) |
Semaglutide 2.4 mg (n=199) |
Cagrilintide 2.4 mg (n=208) |
Placebo (n=461) |
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Baseline bodyweight, mean |
101.5 kg |
100.2 kg |
101.4 kg |
102.2 kg |
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Change in bodyweight |
–25.0% ª |
–19.0% |
–13.4% |
–3.0% |
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Change in waist circumference |
–20.5 cm ª |
–17.4 cm |
–11.7 cm |
–4.7 cm |
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Achieved ≥10% bodyweight loss |
93.3% ª |
82.2% |
62.0% |
12.7% |
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Achieved ≥20% bodyweight loss |
68.7% ª |
38.0% |
17.9% |
1.8% |
ª Statistically significant compared with placebo, estimated mean, p<0.0001; p values were not adjusted for multiplicity and formal treatment-by-sex interaction testing was not performed
In a separate post hoc analysis, 1,902 women with overweight or obesity in REDEFINE 1 who received CagriSema 2.4 mg / 2.4 mg or placebo were evaluated by menopausal stage. Menopause status was derived post hoc using age, medical history, and recorded symptoms and was not based on prospectively collected reproductive staging or biochemical confirmation. CagriSema was associated with clinically meaningful weight loss across all menopause stages, with an average weight loss at week 68 of 26.7% in premenopausal women, 24.8% in perimenopausal women and 23.1% in postmenopausal women.2
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Change in bodyweight from baseline to week 68, efficacy estimand results*² |
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Post hoc analysis group by menopause status (CagriSema n / placebo n) |
CagriSema 2.4 mg / 2.4 mg (change from baseline) |
Placebo (change from baseline) |
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Premenopausal (408 / 122; baseline 104.3 / 107.1 kg) |
–26.7% ª |
–2.1% |
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Perimenopausal (256 / 81; baseline 102.7 / 99.6 kg) |
–24.8% ª |
–1.7% |
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Postmenopausal (530 / 168; baseline 99.1 / 99.3 kg) |
–23.1% ª |
–2.6% |
ª Statistically significant compared with placebo, estimated mean, p<0.0001; p values were not adjusted for multiplicity and formal treatment-by-subgroup interaction testing was not performed
“This post hoc analysis from REDEFINE 1 offers new insight into weight loss with investigational CagriSema in women grouped by reproductive life stage,” said Maria D. Hurtado Andrade, M.D., Ph.D., Assistant Professor, Mayo Clinic Alix School of Medicine, and lead author of the analyses. “The weight loss observed in each group is encouraging, and the numerical differences among the groups highlight the need for further research to better understand how reproductive aging may influence weight loss outcomes in women.”
In the REDEFINE 1 trial, discontinuation due to adverse events occurred in 5.9% of participants receiving CagriSema versus 3.5% with placebo.6 Adverse events were mainly gastrointestinal (79.6% in the CagriSema group vs 39.9% with placebo) including nausea (55% vs 12.6%), constipation (30.7% vs 11.6%), vomiting (26.1% vs 4.1%) and were mostly transient and mild-to-moderate in severity.6
Exploratory post hoc analyses are hypothesis generating, and further work investigating the clinical validity of these results would be of value.
Novo filed a New Drug Application with the U.S. Food and Drug Administration in December 2025 for CagriSema for weight management. A decision is expected in Q4 2026. CagriSema is not approved for use in the United States. Safety and efficacy are not established.
*Based on the efficacy estimand: estimated efficacy in an idealized scenario in which all patients stayed on treatment and took no other weight loss therapies.
About REDEFINE 1
REDEFINE 1 was a 68-week, double-blind, placebo- and active-controlled efficacy and safety phase 3 trial of once-weekly CagriSema, cagrilintide 2.4 mg and semaglutide 2.4 mg versus placebo in 3,417 adults with obesity or overweight with one or more comorbidities and without type 2 diabetes.6
Participants in REDEFINE 1 had a mean age of 47 years, and approximately two-thirds were women.6 For the post hoc analysis by menopause status, women were grouped as premenopausal (<45 years with no indication of menopause), perimenopausal (45–54 years with no evidence of menopause, or 40–54 years with menopause symptoms or clinical suspicion of menopause) or postmenopausal (55 years and older, or 40–54 years with a documented history of menopause or bilateral oophorectomy). Categorization was not based on prospectively collected reproductive staging or biochemical confirmation.2 Women using hormone therapy (HT) were evaluated as a separate group, regardless of age, menopausal status, or indication for HT.2
About CagriSema
CagriSema is being investigated by Novo as a once-weekly subcutaneous injectable treatment for adults with overweight or obesity (REDEFINE program) and as a treatment for adults with type 2 diabetes (REIMAGINE program). CagriSema is a fixed-dose combination of a long-acting amylin analog, cagrilintide and a GLP-1 receptor agonist, semaglutide.
About obesity
Obesity is a serious, chronic, progressive, and complex disease that requires long-term management.7-9 One key misunderstanding is that this is a disease of just a lack of willpower, when in fact there is underlying biology that may impede people with obesity from losing weight and keeping it off.7,9 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.10,11
About Novo
Novo is the global healthcare company that believes lasting health starts now. For over a century, we've combined leading scientific expertise with a deep understanding of people's lives. We develop treatments and support that help millions of people make progress they can see, feel and sustain now and in the future. Every day, over 67,000 employees around the world advance our purpose to drive change for lasting health. Through our partnerships, programs and investments, we're working to prevent disease, expand access to treatments and reduce our environmental impact to help even more people live healthier lives. In the United States, Novo has a 40-year presence, is headquartered in New Jersey and employs approximately 10,000 people. For more information, visit novonordisk-us.com and novonordisk.com and follow us on Instagram, LinkedIn, TikTok, Facebook, X and YouTube.
Contacts for further information
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Novo Media: |
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Ambre James-Brown (Global)
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Liz Skrbkova (US)
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Novo Investors: |
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Michael Novod (Global)
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Sina Meyer (Global)
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Max Ung (Global)
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Christoffer Togo Solgaard-Tullin (Global)
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Alex Bruce (US)
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Mads Berner Bruun (Global)
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Ida Schaap Melvold (Global)
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Frederik Taylor Pitter (US)
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© 2026 Novo Nordisk All rights reserved. US26CSOB00264 October 2026
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References
- Hurtado Andrade MD, Martins Mazini Tavares C, Contreras CKO, et al. Effect of CagriSema on body weight reduction and cardiometabolic risk factors in women: a post hoc analysis of the REDEFINE 1 trial. Presented at The Menopause Society 2026 Annual Meeting. [Poster P-51].
- Hurtado Andrade MD, Martins Mazini Tavares C, Contreras CKO, et al. Effect of CagriSema on body weight reduction and cardiometabolic risk factors in women by menopause status and hormone therapy use: a post hoc analysis of the REDEFINE 1 trial. Presented at The Menopause Society 2026 Annual Meeting. [Poster P-50].
- Kapoor E, Collazo-Clavell ML, Faubion SS. Weight gain in women at midlife: a concise review of the pathophysiology and strategies for management. Mayo Clin Proc. 2017;92(10):1552–1558.
- U.S. Census Bureau. 2024 American Community Survey 1-Year Estimates, Table S0101: Age and Sex. Accessed September 2026. Available at: https://data.census.gov/table/ACSST1Y2024.S0101.
- The North American Menopause Society. The 2023 nonhormone therapy position statement of The North American Menopause Society. Menopause. 2023;30(6):573–590.
- Garvey WT, Blüher M, Osorto Contreras CK, et al. Coadministered Cagrilintide and Semaglutide in Adults with Overweight or Obesity. N Engl J Med. 2025;393(7):635–647.
- Kaplan LM, Golden A, Jinnett K, et al. Perceptions of barriers to effective obesity care: results from the national ACTION study. Obesity. 2018;26(1):61–69.
- Bray GA, Kim KK, Wilding JPH; World Obesity Federation. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Obes Rev. 2017;18(7):715–723.
- Garvey WT, Mechanick JI, Brett EM, et al. American association of clinical endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Endocr Pract. 2016;22 (Suppl 3):1–203.
- Centers for Disease Control and Prevention. Adult obesity facts. Accessed September 2026. Available at: https://www.cdc.gov/obesity/adult-obesity-facts/index.html.
- Centers for Disease Control and Prevention. Risk Factors for Obesity. Accessed September 2026. Available at: https://www.cdc.gov/obesity/risk-factors/risk-factors.html.
SOURCE NOVO NORDISK INC.
SOURCE NOVO NORDISK INC.