REDEFINE 2: CagriSema in adults with type 2 diabetes

Why this study matters

CagriSema is an experimental combination of two medicines. It is not approved in Canada as of September 2026, and this study is research only. It pairs cagrilintide, a long-acting version of the hormone amylin, with semaglutide (Wegovy, Ozempic), a GLP-1 receptor agonist. People with type 2 diabetes often lose less weight on weight-management medicines than people without diabetes, so trials in this group are run separately. REDEFINE 2 is the phase 3 trial of the combination in people with type 2 diabetes, and it is the companion to REDEFINE 1, which enrolled people without diabetes.

Who was in the study

The trial enrolled 1206 adults with type 2 diabetes. They had a BMI of 27 or more and an HbA1c of 7 to 10%. BMI, or body mass index, is weight in kilograms divided by height in metres squared. HbA1c is a blood test that reflects average blood sugar over about three months. The trial ran for 68 weeks in 12 countries. The published summary we reviewed does not report the age range, the specific countries, or the average starting weight.

What the researchers did

This was a phase 3a, randomized, double-blind, placebo-controlled trial. Randomized means people were assigned to groups by chance. Double-blind means neither participants nor staff knew who was getting the medicine. A placebo is an inactive injection.

Participants were assigned in a 3:1 ratio to once-weekly cagrilintide-semaglutide at 2.4 mg of each (904 people) or placebo (302 people). Both groups also received a lifestyle intervention. The two primary end points were the percentage change in body weight and the share of people losing at least 5% of their body weight over 68 weeks. Changes in blood sugar measures and safety were additional end points. A subgroup wore continuous glucose monitors.

The results were analysed with the treatment-policy estimand, which is consistent with the intention-to-treat principle. An estimand is the precise question the statistics answer. This one counts everyone who was randomized, whether or not they stayed on the injections.

What they found

At week 68, the estimated average change in body weight was -13.7% with cagrilintide-semaglutide and -3.4% with placebo. The estimated difference was -10.4 percentage points (95% confidence interval -11.2 to -9.5), with P below 0.001. A confidence interval is the range of values the data are reasonably consistent with (R32-C68).

More people in the combination group than in the placebo group lost at least 5% of their body weight, and the same was true for at least 10%, 15% and 20%. The published summary we reviewed does not give the percentages for each target.

On blood sugar, 73.5% of people in the combination group had an HbA1c of 6.5% or lower at the end of the trial, compared with 15.9% in the placebo group.

Side effects and people who stopped

Gastrointestinal adverse events, meaning stomach and bowel symptoms, were reported by 72.5% of people on cagrilintide-semaglutide and 34.4% of people on placebo. Most were temporary and mild or moderate (R32-C69). The published summary we reviewed does not report how many people stopped treatment, or how many stopped because of side effects.

What this study does not tell you

• CagriSema is not approved in Canada as of September 2026.
• Our summary is based on the abstract only. Age, countries, starting weight and stopping rates are not available to us.
• The trial compared the combination with placebo only. It does not tell you how the combination compares with semaglutide alone in people with diabetes.
• The trial ran for 68 weeks. It does not show what happens after that, or when the injections stop.
• Weight loss in people with type 2 diabetes is typically measured in its own trials for a reason. Do not compare the -13.7% figure with REDEFINE 1 or with trials of other medicines.
• The intention-to-treat analysis includes people who stopped the injections, so the effect among people who kept taking them may differ.
• The trial was funded by the company developing the combination.

What it means in Canada

CagriSema is not approved in Canada as of September 2026. Semaglutide on its own is available and is covered on our semaglutide in Canada page. For emerging medicines, see our medicines page. For how weight-management medicines are paid for, see public drug coverage by province.

Related reading

Other studies in this library that bear on the same question.

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