Novo Nordisk declares war on Eli Lilly again! CagriSema outperforms Telboride head-to-head, achieving a 12.4% weight loss.

Novo Nordisk's weight loss drug CagriSema achieved greater weight loss in a head-to-head Phase III trial against Eli Lilly's Tirzepatide, adding new leverage to its competitiveness in the GLP-1 drug market.

On September 21, at its Capital Markets Day investor briefing, Novo Nordisk released top-line data from two Phase 3 clinical trials of CagriSema. The REIMAGINE 5 trial showed that patients with type 2 diabetes in the CagriSema 1.0 mg/1.0 mg group experienced an average weight loss of 12.4%, higher than the 9.1% in the Tirzepatide 5 mg group. The REDEFINE 9 trial showed that the drug achieved an average weight loss of 21.0% in overweight or obese individuals, compared to 2.0% in the placebo group.

Both trials met their primary efficacy endpoints. REIMAGINE 5 not only compared the weight loss effects of the two drugs, but CagriSema also met the non-inferiority standard in terms of HbA1c reduction.

The above data was released as CagriSema is in a critical stage of regulatory approval in the United States. Novo Nordisk submitted a New Drug Application (NDA) for the weight management indication to the FDA in December 2025, and the FDA is expected to make a decision in the fourth quarter of 2026. If approved, the drug will directly compete with Tirzepatide in the weight loss and diabetes treatment markets.

Impressive weight loss results, CagriSema's positive challenge comes with a gift.

REIMAGINE 5 is a phase 3 trial that directly compares CagriSema with Tirzepatide. Subjects were adult patients with type 2 diabetes whose glycemic control was still not up to standard after receiving metformin, SGLT2 inhibitors, or a combination of both.

At week 60, the average weight loss was 12.4% in the CagriSema 1.0 mg/1.0 mg group and 9.1% in the Tirzepatide 5 mg group; HbA1c decreased by 1.71% and 1.67%, respectively, meeting the non-inferiority criteria for CagriSema. It is worth noting that this trial used a relatively low dose of CagriSema, and Tirzepatide 5 mg is a lower-dose regimen within the CagriSema regimen.

Another trial, REDEFINE 9, targeted overweight or obese adults. At week 68, the CagriSema 1.0 mg/1.0 mg group showed an average weight loss of 21.0%, compared to only 2.0% in the placebo group. Improvements were also observed in indicators such as systolic blood pressure, waist-to-height ratio, and fasting blood lipids.

FDA approval is imminent, with no new safety signals yet.

CagriSema is a fixed-dose combination formulation consisting of semaglutide and the long-acting amyloid receptor agonist caglintide, administered subcutaneously once weekly.

Novo Nordisk submitted its New Drug Application (NDA) for weight management to the FDA in December 2025, and the regulatory agency is expected to make a decision in the fourth quarter of 2026. Currently, CagriSema has not been approved in any market. At this Capital Markets Day, Novo Nordisk also disclosed for the first time data on the drug for the treatment of painful peripheral neuropathy in type 2 diabetes, stating that preliminary results showed promising prospects.

Regarding safety, CagriSema was generally well-tolerated in both trials, with safety characteristics consistent with previous studies, and no new safety signals were identified. The company has not yet disclosed specific adverse reaction rates; detailed data will be released later.

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