Research and trials

Novo Nordisk tests CagriSema for painful diabetic nerve damage

Novo Nordisk is testing CagriSema against placebo for nerve pain in type 2 diabetes, a complication that current diabetes drugs treat poorly.

By the Semaglutides news desk·

Novo Nordisk has disclosed a study testing whether CagriSema, its weekly combination of semaglutide and cagrilintide, can reduce nerve pain in people who have type 2 diabetes and painful diabetic peripheral neuropathy [1][2]. The trial compares the injection with a placebo, and its main measure is how participants rate their pain intensity each week [1][2].

The study is registered as NCT06797869 under the title "Efficacy and Safety of co Administered Cagrilintide and Semaglutide (CagriSema) Once Weekly Versus Placebo in Participants With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy" [1][2]. It is a phase 2 trial enrolling 134 adults with type 2 diabetes and overweight or obesity who have been diagnosed with painful diabetic peripheral neuropathy [2]. Participants are randomly assigned to CagriSema or a dummy shot, and neither they nor their doctors know who receives which treatment [1].

CagriSema pairs semaglutide, which is approved as Ozempic, Wegovy and Rybelsus, with cagrilintide, which is not yet approved [2]. In earlier trials, participants taking the combination reduced their A1C by an average of 2.2 percentage points and lost almost 16% of their body weight, with time-in-range improvements of 43% [2]. Those results cover blood sugar and weight, not nerve pain.

The neuropathy study is one of several CagriSema trials in Novo Nordisk's REDEFINE program [2]. Others include a phase 3 obesity trial enrolling 400 participants with an estimated completion in 2028, and a phase 1 bone-health study in 144 postmenopausal women with obesity, available only in Denmark, also estimated to finish in 2028 [2].

The timing is not clear

The two available descriptions of the neuropathy trial disagree on where it stands. One report says the study began after submission on January 27, 2025, ran for about 10 months for each person, and is now listed as completed, with its latest update posted on September 7, 2026, signaling that data are locked and ready for analysis [1]. A second description lists the trial as recruiting and estimates it will last until August 2026 [2]. Novo Nordisk has not reported results from the neuropathy trial, and no outcome data have been disclosed.

Why it matters for patients

Painful diabetic peripheral neuropathy is a common and difficult complication of long-term diabetes, and existing diabetes drugs do not address it well [1]. If CagriSema were shown to lower nerve pain, it would represent a use beyond blood sugar and weight control for this drug class. That has not been shown. No pain results from this trial have been released, so it is not known whether the combination helps, does nothing, or causes side effects in this group.

The trial is also designed around pain intensity rather than A1C or body weight, which means any eventual result would speak to a different question than the weight-loss and glucose data already reported for CagriSema [1][2]. People currently taking semaglutide or another GLP-1 for diabetes or obesity have no evidence from this study about nerve pain, because results have not been reported.

What happens next

One listing estimates the neuropathy trial runs until August 2026 [2]; another says it is already completed as of a September 7, 2026 update [1]. If the study is finished, the next step would be publication or presentation of the pain-intensity results, but no date for that has been announced. The larger CagriSema obesity trial and the bone-health study are both estimated to finish in 2028 [2].

Sources

  1. https://www.tipranks.com/news/company-announcements/novo-nordisks-cagrisema-trial-targets-painful-diabetic-nerve-damage
  2. https://diatribe.org/diabetes-research/join-ongoing-trials-type-2-diabetes-and-obesity

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