Novo Nordisk (NVO) presented positive Phase 3 results from the REIMAGINE 1-3 trials, in which its investigational candidate, CagriSema 2.4 mg/2.4 mg, demonstrated significant reductions in HbA1c and weight in adults with type 2 diabetes (T2D). Meanwhile, gastrointestinal-related adverse events were recorded in the key findings.
Type 2 diabetes is a chronic condition that affects how the body processes blood glucose for energy. According to the Centres for Disease Control data, in the US, 40.1 million people have diabetes, with type 2 diabetes representing 90% to 95%, or an estimated 36 - 38 million people living with type 2 diabetes.
CagriSema is an investigational once-weekly subcutaneous therapy developed for the treatment of adults with overweight or obesity and type 2 diabetes. In the REDEFINE clinical program, CagriSema is being studied in adults with overweight or obesity, while in the REIMAGINE program, it is being assessed in adults with type 2 diabetes.
Trial Details
REIMAGINE 1
-40-week phase 3 trial evaluated the safety and efficacy of CagriSema in doses 2.4 mg/2.4 mg and 1 mg/1 mg once weekly versus dose-matched placebo in 189 adults with T2D inadequately controlled on diet and exercise.
-The primary endpoint was the change in HbA1c (percentage points) from baseline to week 40. Confirmatory secondary endpoints included the relative change in body weight (%) from baseline to week 40.
REIMAGINE 2
-68-week phase 3 trial evaluated the safety and efficacy of CagriSema in doses 2.4 mg/2.4 mg and 1 mg/1 mg once weekly versus semaglutide 2.4 mg, semaglutide 1 mg, cagrilintide 2.4 mg, and dose-matched placebo in 2,713 adults with T2D inadequately controlled with metformin with or without an SGLT2 inhibitor.
-The primary endpoint was change in HbA1c (%-points) from baseline to week 68 with CagriSema 2.4 mg/2.4 mg versus semaglutide 2.4 mg. Confirmatory secondary endpoints included additional HbA1c comparisons and relative change in bodyweight (%) from baseline to week 68.
REIMAGINE 3
-40-week phase 3 trial evaluated the safety and efficacy of CagriSema 2.4 mg/2.4 mg and 1 mg/1 mg once weekly versus dose-matched placebo as add-on to once-daily basal insulin with or without metformin in 274 adults.
-The primary endpoint was change in HbA1C from baseline to week 40. Confirmatory secondary endpoints included the relative change in body weight (%) from baseline to week 40.
Key Findings -The REIMAGINE trials each met their primary endpoint, demonstrating significant reductions in HbA1c, and met their confirmatory secondary endpoints for reductions in body weight in adults with type 2 diabetes.
-In REIMAGINE 1, under the efficacy estimand at week 40, CagriSema 2.4 mg/2.4 mg showed a 1.8 percentage-point reduction in HbA1c compared with 1.5 percentage points in CagriSema 1 mg/1 mg and 0.1 percentage point in placebo.
-In REIMAGINE 1, CagriSema 2.4 mg/2.4 mg showed a 13.8% change in bodyweight compared to 11.8% in CagriSema 1 mg/1 mg and 1.4% in placebo.
-In REIMAGINE 2, under the efficacy estimand at week 68, Cagrisema 2.4 mg/2.4 mg showed a 1.91 percentage-point HbA1c reduction compared to 1.75 percentage points with Semaglutide 2.4 mg, and a numerically greater HbA1c reduction vs all comparators.
-In REIMAGINE 2, Cagrisema 2.4 mg/2.4 mg showed a 14.2% change in body weight compared to 10.2% with Semaglutide 2.4 mg, and numerically greater HbA1c reduction vs all comparators.
-In REIMAGINE 3, under the efficacy estimand at week 40, Cagrisema 2.4 mg/2.4 mg showed a 2.33 percentage-point reduction in HbA1c compared with 2.10 percentage points for Cagrisema 1 mg/1 mg.
-In REIMAGINE 3, Cagrisema 2.4 mg/2.4 mg showed a 12.0% change in body weight, compared with 10.4% for Cagrisema 1 mg/1 mg.
Adverse Events and Findings
The most commonly reported adverse events (AEs) were gastrointestinal (GI)-related,
-In the REIMAGINE 1 trial, 33/62 (53%) participants in the CagriSema 2.4 mg/2.4 mg group, 28/63 (44%) participants in the CagriSema 1 mg/1 mg group, and 13/64 (20%) participants in the placebo group reported GI-related adverse events.
-In the REIMAGINE 2 trial, GI-related adverse events took place in 405/603 (67.2%) participants in the CagriSema 2.4 mg/2.4 mg group, 326/605 (53.9%) participants in the semaglutide 2.4 mg group, 60/152 (39.5%) participants in the Cagrilintide 2.4 mg group, 329/594 (55.4%) participants in the CagriSema 1 mg/1 mg group, 288/608 (47.4%) participants in the semaglutide 1 mg group, and 42/149 (28.2%) participants in the placebo group.
-In the REIMAGINE 3 trial, the most commonly reported GI-related AEs occurred in 51/90 (57%) participants in the CagriSema 2.4 mg/2.4 mg group, 42/93 (45%) participants in the CagriSema 1 mg/1 mg group, and 21/91 (23%) participants in the placebo group.
Data from the REIMAGINE clinical development program were presented at the American Diabetes Association (ADA) meeting in New Orleans alongside the simultaneous publication in The Lancet.
The FDA decision on the NDA for CagriSema is expected in the fourth quarter of 2026.
According to Grand View Research, the global type 2 diabetes mellitus treatment market size was estimated at $57.47 billion in 2023 and is projected to reach $91.97 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 6.9% from 2024 to 2030.
NVO has traded between $35.12 and $ 81.44 over the last Year. The stock closed Friday's (05-06-2026) trade at $42.96, down 1.81%.
In the overnight market, NVS is down 1.07% at $42.50.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.