Novo's CagriSema Helped Women Lose 25% of Body Weight in REDEFINE 1; FDA Decision Expected This Quarter

Weight loss ranged from 23.1% after menopause to 26.7% before it. Bigger losses make protein and food quality more important, not less.

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By Lew Kizer — 2026-10-21 — Health & Nutrition

The short answer

On October 20, 2026, Novo Nordisk presented analyses of the REDEFINE 1 trial at The Menopause Society meeting showing that 2,309 women on CagriSema 2.4 mg lost an average of 25% of body weight at 68 weeks, versus 3% on placebo. Across more than 3,400 adults overall, average loss was 22.7%. An FDA decision on CagriSema for weight management is expected in the fourth quarter of 2026.

Key facts

  • REDEFINE 1: more than 3,400 adults; 68 weeks; overall average weight loss 22.7%.
  • Women (n=2,309): 25% average weight loss vs 3% on placebo.
  • By menopause stage: 26.7% premenopausal, 24.8% perimenopausal, 23.1% postmenopausal.
  • Novo called the menopause analyses post hoc and hypothesis-generating.
  • CagriSema combines cagrilintide and semaglutide in a weekly injection.
  • FDA decision expected in Q4 2026, according to Reuters.

KINGSPORT, Tenn., Oct. 21, 2026 — The next generation of weight-loss medicines is getting closer to pharmacies, and new data suggest it may work especially well for women.

On October 20, Novo Nordisk presented analyses of its REDEFINE 1 trial at the annual meeting of The Menopause Society in San Diego.

This article reports research news and is not medical advice. Talk with your clinician before changing your diet or medicines.

The numbers

GroupAverage weight loss at 68 weeks
All adults (3,400+)22.7%
Women on CagriSema (2,309)25%
Women on placebo3%
Premenopausal26.7%
Perimenopausal24.8%
Postmenopausal23.1%

The menopause breakdown came from 1,902 women and was a post hoc analysis, which means it was not the trial's main question. Novo said it is hypothesis-generating.

“Many women with obesity or overweight experience weight gain as they move through menopause” — Michelle Skinner Moore, Vice President of Medical Affairs, Novo Nordisk

What CagriSema is

CagriSema pairs semaglutide, the ingredient in Wegovy and Ozempic, with cagrilintide, a long-acting amylin analog, in one weekly injection. The overall result of 22.7% was below the 25% Novo had targeted, but it is still among the largest averages reported for a weight-loss drug. An FDA decision is expected in the fourth quarter of 2026.

Why food matters more at 25%

Larger weight loss means a longer stretch of eating far less. Earlier body-scan data from semaglutide's STEP 1 trial found fat mass fell 19.3% and lean mass fell 9.7% from baseline. Protein and resistance exercise are the tools most often recommended to protect muscle; ask your care team for targets that fit you. Our guide to tracking muscle and fat on a GLP-1 explains what to measure.

“When you're on a GLP-1 medication, what you eat matters more, not less. You need high-protein, portion-controlled, nutrient-dense food — and you need to know it's safe. That's exactly what we do.” — Lew Kizer, Founder, SmashMeals

See our GLP-1 meal planning page or order this week's meals.

Commentary, not medical advice

The SmashMeals perspective

A quarter of body weight is a life-changing number. It also means eating much less food for a long time, and every bite has to work harder. In the STEP 1 body-scan study of semaglutide, lean mass fell 9.7% from baseline. Women going through menopause are already losing muscle with age. Protein at every meal, real vegetables and steady strength work are the parts of the plan the medicine cannot do for you.

Frequently asked questions

How much weight did women lose on CagriSema?

In REDEFINE 1, 2,309 women on CagriSema 2.4 mg lost an average of 25% of body weight at 68 weeks, compared with 3% on placebo.

Is CagriSema FDA-approved?

Not yet. An FDA decision on CagriSema for weight management is expected in the fourth quarter of 2026.

Does menopause change results on CagriSema?

In a post hoc analysis, average loss was 26.7% before menopause, 24.8% during perimenopause and 23.1% after menopause. Novo said these results need further study.

Sources and credits

Follow the original sources for context and verification. A reference is not an endorsement of SmashMeals.

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