CagriSema Averaged 25% Weight Loss in Women. Its Trial Found Gut Effects in 80%

Picture a woman who starts at about 224 pounds and, over roughly 15 months of weekly shots, ends up around 56 pounds lighter. That is the average result Novo reported on Tuesday for women in its trial of CagriSema, its experimental two-hormone weekly injection. We read the company’s release line by line, the trial’s published paper and two new reviews of how these drugs act on the gut, to answer the question people type most after the headline number: what does CagriSema do to the stomach?

The short version: the weight loss in women was large, and so was the digestive cost. Four in five people on the drug in the trial had a gut side effect, against four in ten on placebo. Below are the women’s numbers, the gut ledger, why two hormones that both slow the stomach add up the way they do, and what this analysis cannot tell anyone.

The finding: Women on CagriSema lost 25.0% of their weight on average, against 3.0% on placebo

According to Novo’s October 20 release, the first analysis took all 2,309 women in REDEFINE 1, the 68-week phase 3 trial of CagriSema in adults with obesity or overweight and without type 2 diabetes. The 1,441 women on CagriSema lost 25.0% of their body weight on average. Women on semaglutide alone, the ingredient in Wegovy, lost 19.0%; on cagrilintide alone, 13.4%; on placebo, 3.0%. Their average starting weight on CagriSema was 101.5 kg, so 25.0% works out to about 25.4 kg, or 56 pounds, by our arithmetic.

The release also reports that 93.3% of women on CagriSema lost at least a tenth of their weight and 68.7% lost at least a fifth, against 12.7% and 1.8% on placebo. Waists shrank by 20.5 cm on average, about 8 inches, against 4.7 cm on placebo.

The second analysis sorted 1,902 women by menopause stage. Novo reports average losses of 26.7% before menopause, 24.8% around it and 23.1% after it, against 2.1%, 1.7% and 2.6% on placebo. The stages were assigned after the trial from age, medical history and recorded symptoms, not from hormone tests. The analyses were presented at The Menopause Society’s annual meeting in San Diego, the same meeting where a Canadian study found above-normal bloating in two in three women at every stage of menopause.

The gut ledger: Four in five people on CagriSema had a digestive side effect, against four in ten on placebo

The safety numbers come from the whole REDEFINE 1 trial, men and women together: 3,417 adults with an average age of 47, about two-thirds of them women. The trial’s paper in the New England Journal of Medicine (Garvey and colleagues, 2025) reports gastrointestinal side effects in 79.6% of people on CagriSema and 39.9% on placebo, “mainly transient and mild-to-moderate in severity.” Novo’s release breaks out the three most common:

Two things stand out in that table. The first is the placebo column: four in ten people on dummy injections also reported a gut complaint over 68 weeks, a reminder that nausea, constipation and stomach upsets are common in everyday life, and that the useful figure is the gap. The second is that most people kept going: 5.9% of those on CagriSema stopped because of side effects, against 3.5% on placebo. The release does not give the gut figures for women separately, so the women’s 25.0% and the trial’s 79.6% describe overlapping but different groups.

The mechanism: Two hormones, two brakes on the same stomach

CagriSema is two drugs in one weekly shot. Semaglutide copies GLP-1, a hormone the gut releases after a meal. Cagrilintide copies amylin, a hormone the pancreas releases alongside insulin. A 2026 review in Pharmacological Research from the University of Southern California describes amylin as a hormone that “slows gastric emptying, suppresses glucagon secretion, and promotes satiation through actions in the central nervous system,” and places particular emphasis on the nausea and vomiting these drugs can cause.

A separate 2026 review led by Cleveland Clinic gastroenterologists in Nutrition in Clinical Practice puts gut side effects with GLP-1 drugs at roughly 30% to 50% of patients, “typically during initiation and dose escalation,” and lists four causes: a slower-emptying stomach, the brain’s nausea centres switching on, changes in how the intestines move, and the effects of losing weight quickly. It says the early data on cagrilintide-semaglutide suggest a similar pattern, while noting the evidence is still limited.

Our reading of the two together: food sitting longer in the stomach is part of why people on these drugs feel full sooner, and it is also part of why some feel queasy. Stacking a second hormone that does the same job is one reason CagriSema lost more weight than semaglutide alone in this trial, and one plausible reason the trial’s 79.6% sits above that 30% to 50% range, though a review’s range and one trial’s count of any gut complaint over 68 weeks are not measured the same way. Slower movement further down the gut fits the constipation figure. For what that feels like in daily life, our pages on bowel habits on GLP-1 drugs and fiber on GLP-1 drugs set out the published research.

The limits: What the women’s analysis can and cannot say

Novo is plain about the limits, and they matter. Both analyses were post hoc, meaning they were run after the trial on groups it was not designed to compare, and the company calls them “hypothesis generating.” The 25.0% figure assumes every woman stayed on treatment and used nothing else to lose weight; the trial’s main published result, which counts everyone who was randomised, was 20.4% for the whole trial. The p-values were not adjusted for running many comparisons, and no formal test was done of whether women respond differently from men. The trial was funded by Novo.

CagriSema is not approved in the United States. Novo filed for approval with the FDA in December 2025 and says a decision is expected in the fourth quarter of 2026. We will add a dated update to this page when that decision comes.

How we checked this: Sources and method

We read Novo’s release of October 20, 2026 at source on PR Newswire, including its two data tables and its footnotes on the efficacy estimand and menopause staging, and quote it directly. The overall trial results and gut side-effect rate come from the REDEFINE 1 paper, Garvey and colleagues, New England Journal of Medicine, August 14, 2025 (PubMed 40544433; registered as NCT05567796). The mechanism comes from Fischer and Borner, Pharmacological Research, October 2026 (PubMed 42586227) and Singhani and colleagues, Nutrition in Clinical Practice, October 2026 (PubMed 42808923); each PubMed number was matched to the paper’s title. Conversions to pounds and inches, the ratios to placebo and the 39.7-point gap are our arithmetic. This article is educational, describes what the cited sources say, and is not medical advice.