| Trial results
In REDEFINE 9, adults taking CagriSema at either of two lower doses lost about a fifth of their body weight over 68 weeks, according to Novo Nordisk. If everyone had stayed on treatment, the averages were 20.7% on 1.7 mg/1.7 mg and 21.0% on 1.0 mg/1.0 mg, against 2.0% on placebo. Counting everyone regardless of whether they stayed on treatment, they were 19.4% and 18.6%, against 4.6%. The trial was not designed to tell the two doses apart. These are company-reported results, published the same day in The Lancet Diabetes & Endocrinology.
Novo gave the 1.0 mg/1.0 mg figure in a topline announcement on September 21, 2026. The 1.7 mg/1.7 mg dose, the second way of counting and the other details below are new on November 14.
If everyone stayed on treatment
Average change in body weight. Every bar uses one scale, 0 to 25 percent.
Counting everyone as randomized
Average change in body weight. Every bar uses one scale, 0 to 25 percent.
Average change in body weight at week 68. Company-reported, from Novo Nordisk's release of November 14, 2026. The left panel is the efficacy estimand and the right panel is the treatment-regimen estimand, both explained below.
What the trial tested
REDEFINE 9 (NCT06388187) is a phase 3 trial that randomized 309 adults, per Novo. All had obesity, or overweight with at least one weight-related condition, and none had diabetes. The average starting weight was 109.5 kg. People were assigned 2:1:2:1 to CagriSema 1.7 mg/1.7 mg or its placebo, or to CagriSema 1.0 mg/1.0 mg or its placebo, with the two placebo groups pooled for the analysis. There were 104, 103 and 102 people in the three analysis groups. Everyone also got lifestyle support, meaning a reduced-calorie diet and more physical activity.
The two main goals, both at week 68, were the change in body weight and the share of people who lost at least 5%. CagriSema is a once-weekly injection that combines cagrilintide and semaglutide. The "1.7/1.7" and "1.0/1.0" labels give the milligrams of each. ClinicalTrials.gov lists 300 participants, so the registry and the release differ slightly on size.
The earlier REDEFINE 1 and 2 trials, and the FDA application the Atlas has recorded, used 2.4 mg of each medicine. These doses are lower. Novo calls REDEFINE 9 the first phase 3 weight-management trial of CagriSema below 2.4 mg/2.4 mg.
The results in more detail
If everyone stayed on treatment
| Lost at least | 1.7 mg / 1.7 mg | 1.0 mg / 1.0 mg | Placebo |
|---|---|---|---|
| 5% of body weight | 95.1% | 96.3% | 33.4% |
| 10% | 87.3% | 86.0% | 13.6% |
| 15% | 70.5% | 70.7% | 5.8% |
| 20% | 51.3% | 48.3% | 2.7% |
Share of people in each group. All CagriSema figures differed from placebo at p<0.0001, per Novo.
Counting everyone as randomized
| Lost at least | 1.7 mg / 1.7 mg | 1.0 mg / 1.0 mg | Placebo |
|---|---|---|---|
| 5% of body weight | 92.8% | 87.7% | 41.1% |
| 10% | 85.4% | 78.7% | 21.3% |
| 15% | 69.6% | 63.4% | 9.5% |
| 20% | 47.5% | 44.7% | 5.6% |
Share of people in each group, regardless of treatment discontinuation or use of a rescue weight-management intervention.
Compared with placebo, the estimated differences in weight change were 18.8 and 19.0 percentage points if everyone stayed on treatment, and 14.7 and 13.9 points counting everyone, for the 1.7 mg and 1.0 mg doses. Waist circumference fell by 17.2 cm and 17.5 cm on the two doses, against 3.6 cm on placebo.
Two ways of counting
Novo reports two sets of numbers. The efficacy estimand asks what would have happened if everyone had stayed on treatment as planned. The treatment-regimen estimand counts everyone as randomized, including people who stopped early or needed another weight-management treatment. The second method is closer to real life, and it gives smaller numbers. The placebo figure also moves, from 2.0% to 4.6%, which narrows the gap. See how to read trial numbers.
Do the two doses differ?
On these averages they are nearly the same, and which one comes out ahead depends on the method. The 1.0 mg/1.0 mg dose is 0.3 points ahead if everyone stayed on treatment, and the 1.7 mg/1.7 mg dose is 0.8 points ahead counting everyone. Novo states that the trial was not powered to detect differences between the two doses, so gaps this small cannot be read as one dose being better.
Nor can this trial say whether the lower doses match 2.4 mg/2.4 mg, because no group took the higher dose. In REDEFINE 1, a separate and much larger trial, the 2.4 mg/2.4 mg dose gave 20.4% weight loss counting everyone, against 3.0% on placebo. The figures look alike, but different people in different trials cannot be lined up this way. When Novo gave the first result in September, it framed it around people who do not reach or stay on the highest dose of current medicines.
Side effects
Novo says the safety profile matched earlier CagriSema trials, and that the most common side effects were stomach and bowel symptoms that were mild to moderate. Side effects led people to stop treatment for good in 2.9% on 1.7 mg/1.7 mg, 4.9% on 1.0 mg/1.0 mg and 4.9% on placebo. The release gives no rates for serious side effects or for individual stomach and bowel symptoms, so the Atlas cannot compare the doses on tolerability. For the side effects seen in the larger trials, see the CagriSema page.
What the numbers do not show
This is one trial of about 300 people that Novo sponsored, and the figures here come from Novo's release. The Atlas has read the release and its tables, not the paper in The Lancet Diabetes & Endocrinology. Group averages do not predict what one person would lose. The trial excluded people with diabetes, and in the earlier REDEFINE 2 trial, in type 2 diabetes, the average was lower.
CagriSema is not approved anywhere. Novo filed an application with the FDA in December 2025 for 2.4 mg/2.4 mg and says a decision is expected in the fourth quarter of 2026. The Atlas has seen nothing saying whether the lower doses are part of that application.
Worth knowing: These are company-reported results from one 68-week trial of about 300 adults without diabetes. The two doses were not compared with each other, and neither was compared with the 2.4 mg/2.4 mg dose. CagriSema is investigational. This page is general information, not medical advice.
Related: CagriSema medicine page | Cagrilintide | Novo Nordisk tracker
Source: Novo Nordisk press release, November 14, 2026 Company announcement, not peer reviewed. ClinicalTrials.gov record NCT06388187 Trial registry. Pharmacy Times on the September 21 topline results Trade press, secondary source.
