CagriSema Awaits an FDA Decision: Its Trial Average Was 20% Weight Loss, Below the 25% Headlines

On October 20, 2026, Novo Nordisk presented data at The Menopause Society's annual meeting in San Diego showing that women in its CagriSema trial lost 25% of their body weight on average. The figure echoed an old forecast: Novo told CNBC in December 2024 that it had previously expected CagriSema to produce about 25% weight loss. When results arrived on December 20, 2024, the figure was 22.7%, and Novo's shares fell about 20% that day.

CagriSema is a once-weekly shot that pairs semaglutide, the drug in Wegovy and Ozempic, with cagrilintide, a long-acting copy of a hormone called amylin, and the FDA has not approved it. Novo filed it with the FDA on December 18, 2025, and said in February 2026 that it expects a decision by late 2026. Reuters reported on October 20 that the decision is expected in the fourth quarter.

So which number should a patient expect? Something lower than 25%: in the main trial, people on CagriSema lost 20.4% of their weight on average when everyone was counted, including those who stopped the shots. The rest of this guide explains where the higher figures come from and how CagriSema did when it was tested directly against Zepbound. We will update it after the FDA acts.

Semaglutide copies GLP-1, a gut hormone that signals fullness to the brain and slows the stomach. Amylin is a separate signal that the pancreas releases along with insulin after a meal. The FDA label for Symlin (pramlintide), an amylin drug approved in 2005 for diabetes, says amylin slows how fast food leaves the stomach and acts on the brain to cut how much people eat.

Symlin must be injected right before each major meal, whereas cagrilintide was built to last about a week, so it can share a weekly injection with semaglutide. Novo's bet is that the two signals together produce more fullness than either one alone.

In the trials, CagriSema held 2.4 mg of each drug. That is the usual Wegovy maintenance dose of semaglutide; a 7.2 mg Wegovy dose is now also approved, but it was not part of CagriSema's trials. Participants started on a low dose and stepped up to the full dose over 16 weeks, according to the trial registry. There is no approved label yet, so the dose steps for patients could differ.

Obesity trials now report results two ways, and Novo's headlines have used the larger figure. The 22.7% answers a what-if question: how much would people have lost if all of them had kept taking the shots? The 20.4% counts everyone assigned to CagriSema, whether they stayed on it, cut back, or quit. Placebo shifts too, from 2.3% under the first method to 3.0% under the second.

The main trial, REDEFINE 1, enrolled 3,417 adults with obesity, or with overweight plus a weight-related health problem, and it excluded people with diabetes. It ran 68 weeks, about 16 months, and the results were published in the New England Journal of Medicine in 2025.

For someone deciding whether to try a drug, the 20.4% is the better guide, since real patients also miss doses and stop. The average also hides a wide spread: counting everyone, 34.7% of people on CagriSema lost at least a quarter of their body weight, Novo reported, so about two in three people did not reach the 25% mark.

REDEFINE 1 let investigators keep people on a lower dose if they judged that best for the patient. By week 68, 57.3% of people on CagriSema were taking the full 2.4 mg/2.4 mg. In the same trial, 70.2% of people on semaglutide alone and 82.5% on cagrilintide alone were on their full doses, according to Novo's December 2024 announcement. Martin Holst Lange, Novo's head of development, said the result was achieved "even though only 57% of patients reached the highest CagriSema dose."

The side effect counts suggest why a lower dose might appeal: stomach and bowel problems affected 79.6% of people on CagriSema and 39.9% on placebo. Nausea was the most common of these, at 55% versus 12.6%, and about one in four people vomited, compared with one in 25 on placebo. The trial authors described most of those effects as mild to moderate and short-lived, and in the end 6% of people on CagriSema stopped because of side effects, compared with 3.7% on placebo.

Some of the weight lost was not fat: in 252 participants who had body scans, fat mass fell 35.7% and lean soft tissue fell 14.4%, Novo reported. Lean soft tissue includes muscle along with water and organs, so the scan does not measure muscle loss directly. (For ways to protect muscle while losing weight, see our guide to muscle loss on GLP-1 drugs.)

Comparing numbers from separate trials is risky, because the patients, trial lengths, and analysis methods differ. CagriSema has two direct comparisons that avoid most of that problem.

The first sits inside REDEFINE 1, which also assigned some people to semaglutide alone. Counting everyone, that group lost 14.9%, about 5.5 points less than the combination, so cagrilintide did add weight loss on top of 2.4 mg of semaglutide.

The second is REDEFINE 4, which Novo reported on February 23, 2026. It assigned 809 adults with obesity and at least one related health problem to CagriSema or to tirzepatide 15 mg, the top dose of Eli Lilly's Zepbound, for 84 weeks. If everyone had stayed on treatment, weight loss averaged 23.0% on CagriSema and 25.5% on tirzepatide. Counting people whether or not they stayed on treatment, the figures were 20.2% and 23.6%. Novo set out to show that CagriSema was "non-inferior," meaning not meaningfully worse than tirzepatide, and the trial failed to show it.

Patients and doctors in REDEFINE 4 knew which drug they were getting, which can affect who stays on treatment. Even so, it was a randomized test of both drugs at full doses, and Zepbound came out ahead. The biology behind that gap is the subject of our closer look at REDEFINE 4.

The new 25% figure comes from the 2,309 women in REDEFINE 1, about two-thirds of the trial. Women on CagriSema lost 25% on average at 68 weeks, compared with 3% on placebo, if everyone had stayed on treatment. Grouped by menopause stage, 1,902 women lost 26.7% before menopause, 24.8% during perimenopause, and 23.1% after it, compared with about 2% on placebo, CNBC reported.

Those results use the same what-if method as the trial's 22.7% headline, so the fair comparison is 25% against 22.7%. They also come from post hoc analyses, which are run after a trial ends, and Novo called them hypothesis-generating. Our article on Wegovy and CagriSema across menopause puts these numbers next to Wegovy's.

People with type 2 diabetes lost less weight in their own trial, REDEFINE 2, which enrolled 1,206 adults with type 2 diabetes and a BMI of 27 or more. After 68 weeks, the CagriSema group lost 13.7% of their weight, compared with 3.4% on placebo, counting everyone. Blood sugar improved too: 73.5% reached an A1C of 6.5% or lower, compared with 15.9% on placebo. Side effects led 8.4% of people on CagriSema to stop treatment, compared with 3% on placebo.

An approval would answer questions the trials cannot: the exact label wording, the dose steps, the price, and the rules for switching from another drug. Novo has not announced a price. CNBC reported on October 20 that the drug is expected to launch early next year.

Other questions will stay open. Wegovy's label includes a lower risk of heart attack, stroke, and cardiovascular death in adults with heart disease, based on a large outcomes trial. CagriSema's version of that trial, REDEFINE 3, has about 7,100 participants with cardiovascular disease, and ClinicalTrials.gov lists September 2027 as its estimated primary completion date. Novo said in February 2026 that it plans to start a Phase 3 trial of a higher CagriSema dose in the second half of 2026. It expects REDEFINE 11, an 80-week trial of the current dose in about 600 adults, to report in the first half of 2027.

If approved, CagriSema would be the first combination of GLP-1 and amylin drugs, Novo says, and several rivals are behind it, including Zealand and Roche's petrelintide (overview of amylin drugs).

For now, a fair expectation is about one-fifth of body weight lost over 16 months for the average trial participant without diabetes, with stomach or bowel side effects in about four of every five people. If CagriSema is approved, people weighing it against Wegovy or Zepbound can ask their clinician how the doses will step up and what happens if the top dose is hard to tolerate, since many trial participants stayed on a lower one.