Novo Nordisk cagrilintide injection enters Phase 3 obesity trial

Novo Nordisk has moved a once-weekly injectable form of cagrilintide for overweight and obesity into a Phase 3 trial that is now recruiting, according to a study update the company filed on Sept. 3, 2026 ^[1]. Cagrilintide is investigational and is not approved for weight management in the United States ^[1].

What the trial is testing

The study is listed as "A Placebo-controlled Comparability Study to Compare Two Presentations of Cagrilintide for Weight Management in Participants With Overweight or Obesity" ^[1]. It tests cagrilintide injections against placebo injections, and it also compares two injection devices, which the company describes as relevant to patient use ^[1].

The trial is randomized and double-blind, meaning participants, doctors and trial staff do not know who receives the active drug or the placebo ^[1]. It was submitted on July 30, 2026, participants are followed for about nine months, and it is registered as NCT07745504 ^[1]. The number of participants and the doses being tested have not been reported in these materials.

Where cagrilintide already appears

Cagrilintide is a long-acting amylin analog and one half of CagriSema, a once-weekly injectable that pairs cagrilintide 2.4 mg with Wegovy (injectable semaglutide) 2.4 mg for obesity and type 2 diabetes ^[2]. Novo Nordisk has already filed CagriSema for weight management, with an FDA decision expected in the fourth quarter of 2026 ^[2].

The combination has produced mixed results in late-stage testing. In the Phase 3 REDEFINE 1 study, CagriSema produced a mean weight loss of 22.7% after 68 weeks, assuming all participants adhered to treatment, compared with 16.1% for Wegovy and 11.8% for cagrilintide alone ^[2]. In REDEFINE 2, which enrolled people with obesity or overweight and type 2 diabetes, CagriSema produced 15.7% mean weight loss under the same assumption ^[2]. In the head-to-head REDEFINE 4 study against Zepbound (tirzepatide 15 mg), CagriSema reached 23% weight loss after 84 weeks while Zepbound reached 25.5%, and CagriSema did not demonstrate non-inferiority to Zepbound ^[2].

Novo Nordisk is also testing whether higher dosing improves results. The company plans to begin a Phase 3 study in the second half of 2026 pairing cagrilintide 2.4 mg with Wegovy HD (injectable semaglutide 7.2 mg) ^[2]. Separately, the Phase 3 REDEFINE 11 study is evaluating the existing 2.4 mg/2.4 mg combination in adults with obesity, with results expected in the first half of 2027 ^[2].

Why it matters for patients

Cagrilintide on its own is not an approved treatment, and no results from this new trial have been reported, so it is not known how it would compare with currently available options for weight management ^[1]. The trial is a comparability study that includes a device comparison rather than a head-to-head test against an approved obesity drug ^[1].

Anyone tracking this drug should keep two things separate. The product under FDA review right now is CagriSema, the cagrilintide-plus-semaglutide combination, with a decision expected in the fourth quarter of 2026 ^[2]. The trial that just began is testing cagrilintide alone ^[1].

Whether a different injection device changes how easy or comfortable the weekly shot is for patients has not been reported, and the trial's effect on that question will not be answered until data are available ^[1].

What happens next

• Sept. 21, 2026: Novo Nordisk has said it will present a detailed business strategy at a Capital Markets Day ^[1].
• Fourth quarter of 2026: FDA decision expected on CagriSema for weight management ^[2].
• Second half of 2026: Planned start of a Phase 3 study of high-dose CagriSema combining cagrilintide 2.4 mg with Wegovy HD semaglutide 7.2 mg ^[2].
• First half of 2027: Results expected from the REDEFINE 11 study of the existing 2.4 mg/2.4 mg combination in adults with obesity ^[2].

No completion date for the newly registered cagrilintide trial has been disclosed ^[1].