CagriSema misses blood sugar goal in head-to-head trial against tirzepatide

Novo Nordisk reported on Aug. 4, 2026 that CagriSema missed one of two goals in a head-to-head trial against tirzepatide in adults with type 2 diabetes. The company disclosed the 68-week REIMAGINE 4 results inside its second-quarter financial report rather than in a separate data release ^[1].

In the open-label trial, CagriSema produced 15.2% weight loss and a 1.9 percentage point reduction in HbA1c, a measure of average blood sugar over the previous two to three months. Tirzepatide 15 mg produced 15.8% weight loss and a 2.2 percentage point HbA1c reduction. Both sets of figures were calculated on the efficacy estimand, which estimates how a drug performs when taken as directed ^[1].

REIMAGINE 4 enrolled roughly 1,000 adults with type 2 diabetes whose blood sugar was not adequately controlled on metformin, with or without an SGLT2 inhibitor ^[1]. Weight loss and HbA1c reduction together formed a dual primary endpoint. CagriSema met non-inferiority — meaning it was judged no worse than the comparator by the trial's preset statistical margin — on weight loss, but missed that threshold on HbA1c. Because both measures had to be met, the trial did not succeed on its stated terms ^[1].

The results landed in an earnings disclosure alongside Novo Nordisk's broader quarterly numbers. The company reported adjusted operating profit of DKK 33,389 million for the second quarter of 2026 and raised its full-year outlook for adjusted sales and adjusted operating profit, citing increased expectations for GLP-1 product sales ^[2]. Wegovy pill prescriptions topped 265,000 for the week ending July 17, with more than 5 million prescriptions since launch ^[2].

CagriSema is a once-weekly combination of a GLP-1 and an amylin analog. It is not approved in the United States. Novo Nordisk filed for FDA approval in weight management in December 2025 and has said it expects a decision by late 2026 ^[1]. The company has also guided to a higher-dose CagriSema trial beginning in the second half of 2026 ^[1].

Several things are not yet known. Full safety and tolerability results from REIMAGINE 4 have not been disclosed, and no separate data release or peer-reviewed publication of the complete results has been announced ^[1]. Whether the HbA1c miss affects the FDA's ongoing weight-management review, or the design of the higher-dose trial, has not been reported.

Why it matters for patients

For people with type 2 diabetes, CagriSema is not an available option. It remains under FDA review and has not been approved for any use in the US ^[1]. The trial compared it against tirzepatide 15 mg, the highest approved dose of the drug sold as Mounjaro for type 2 diabetes and Zepbound for weight management.

The blood sugar result is the part that missed. Weight loss came in close to tirzepatide and was judged non-inferior, but the trial was not powered to declare a winner on either measure — meeting non-inferiority means the result fell within a preset margin, not that the two drugs performed equally in every patient ^[1].

How well patients tolerated CagriSema in this trial has not been disclosed, which matters for a drug that combines two active ingredients rather than one ^[1]. The result also does not change the approvals or labels of semaglutide products such as Ozempic, Wegovy and Rybelsus, which are separate medicines.

The FDA review now pending is for weight management, a different question from the type 2 diabetes population studied in REIMAGINE 4. On weight, the trial met its non-inferiority bar ^[1].

What happens next

Novo Nordisk expects an FDA decision on CagriSema in weight management by late 2026 ^[1]. A higher-dose CagriSema trial is guided to begin dosing in the second half of 2026 ^[1]. No date has been set for a fuller release of the REIMAGINE 4 data, including safety information ^[1].