Novo Nordisk advances a new injectable obesity candidate into Phase 3

Novo Nordisk has started a new Phase 3 trial for cagrilintide, the amylin-analog injectable that is one half of its combination obesity drug CagriSema, according to a company filing dated September 3, 2026 ^[1]. The study, listed on ClinicalTrials.gov as NCT07745504, compares two device presentations of cagrilintide against placebo in people with overweight or obesity, and it is double-blind, meaning neither patients nor staff know who gets the active drug ^[1]. Recruitment began after an initial filing on July 30, 2026, and participants will be followed for about nine months ^[1].

This new trial is separate from, but related to, Novo's already-filed drug CagriSema, which pairs cagrilintide 2.4 mg with Wegovy semaglutide 2.4 mg. CagriSema is under FDA review for weight management, with a decision expected in the fourth quarter of 2026 ^[2]. In the REDEFINE 1 study, CagriSema produced average weight loss of 22.7% at 68 weeks among people who stayed on treatment, compared with 16.1% for Wegovy alone and 11.8% for cagrilintide alone ^[2]. In REDEFINE 2, which included people with type 2 diabetes, CagriSema produced 15.7% weight loss ^[2]. But in a head-to-head trial called REDEFINE 4, CagriSema reached 23% weight loss at 84 weeks versus 25.5% for Eli Lilly's Zepbound (tirzepatide 15 mg), and it did not meet the statistical bar for matching Zepbound's effect ^[2].

To try to close that gap, Novo has said it plans to start a Phase 3 study of a higher-dose CagriSema, combining cagrilintide 2.4 mg with Wegovy HD semaglutide 7.2 mg, sometime in the second half of 2026 ^[2]. Separately, the REDEFINE 11 study, testing the current 2.4 mg/2.4 mg combination in adults with obesity, is expected to report results in the first half of 2027 ^[2]. Novo has also flagged that it will lay out more of its pipeline strategy at a Capital Markets Day on September 21, as it works to defend market share against Eli Lilly, which analysts say now holds about 60% of the global obesity-drug market compared with roughly 38% for Novo ^[1].

Why it matters for patients

None of this changes what is available at the pharmacy today. Wegovy, Ozempic, and CagriSema (if approved) remain separate from this newly started trial, which is testing cagrilintide on its own using different injection devices ^[1]. For people currently using Wegovy or considering CagriSema once it is reviewed, the mixed head-to-head results matter: CagriSema showed more weight loss than semaglutide alone in some studies, but it did not clearly beat Zepbound in a direct comparison ^[2]. Whether a higher-dose version closes that gap, and whether it carries different side effects, is not yet known, since that trial has not started results reporting.

Patients weighing options should understand that headline percentages describe averages from people who stayed on treatment throughout a study, and results vary by individual and by underlying health conditions, such as type 2 diabetes ^[2]. The new device-comparison trial for cagrilintide is aimed partly at how the drug is delivered, which can affect ease of use, but it does not test a new molecule ^[1].

What happens next

An FDA decision on CagriSema for weight management is expected in the fourth quarter of 2026 ^[2]. Novo has said it will start the high-dose CagriSema Phase 3 study, pairing cagrilintide 2.4 mg with Wegovy HD semaglutide 7.2 mg, in the second half of 2026 ^[2]. The REDEFINE 11 study of the standard-dose combination is expected to report in the first half of 2027 ^[2]. Novo's Capital Markets Day, where more pipeline details are expected, is scheduled for September 21, 2026 ^[1].