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New combo drug aims to ease nerve pain in diabetes

NCT ID NCT06797869

Symptom relief Sponsor: Novo Nordisk A/S Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This study tests whether a new medicine called CagriSema can reduce nerve pain in people with type 2 diabetes. About 142 adults with painful diabetic neuropathy will receive either CagriSema or a placebo for around 10 months. The main goal is to see if the drug lowers weekly pain scores.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

142 people

The number who actually took part.

Started

Jan 2025

Finished

Aug 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: * Male or female. * Age 18 years or above at the time of signing the informed consent. * Body mass index (BMI) ≥25.0 kilogram per square meter (kg/m\^2) at screening. * Diagnosis of type 2 diabetes (T2D) ≥180 days before screening. \-- For participants on anti-diabetic drugs: Stable daily and/or weekly dose(s) ≥90 days before screening of any of the following anti-diabetic drug(s) or combination regimen(s) at effective or maximum tolerated dose, as judged by the investigator: * Treatment with 1-3 marketed oral anti-diabetic drugs (OADs) (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose co-transporter 2 inhibitors (SGLT2i), thiazolidinediones, or sulphonylureas (SU) as a single agent or in combination) according to local guidelines. * Treatment with basal or basal-bolus insulin (including premixed insulin formulations) according to local guidelines. * HbA1c ≤10.5 % (91 millimole per mole \[mmol/mol\]) and ≥6.0 % (42 mmol/mol), as determined by central laboratory at screening. * Diagnosis of painful diabetic peripheral neuropathy (pDPN) at screening as well as at the following criteria: \-- Participant with self-reported pain consistent with pDPN for a minimum of 3 months before screening, as judged by the investigator. * Stable pharmacological and non-pharmacological treatment of pain for a minimum of 3 months before screening, in the opinion of the investigator. The treatment regimen should adhere to local guidelines (if available). Key Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method. * Use of any glucagon-like peptide-1 receptor agonist (GLP-1 RA), including medication with GLP-1 RA activity, (DPP-4), or amylin analogue within 60 days before screening. * Significant use of opioids, cannabinoids or benzodiazepines within 30 days before screening, in the opinion of the investigator. Significant use is defined as use that renders it unlikely that the participant is able to comply with protocol requirements for discouraged medications. * Anticipated initiation or clinically relevant change in concomitant medications (for more than 14 consecutive days during the study) known to affect weight or glucose metabolism (e.g., orlistat, thyroid hormones or oral corticosteroids). * Planned initiation or change in anti-depressant, anti-psychotic or anti-epileptic medication. If participants are already taking such medication, they should have stable and optimised treatment for at least 8 weeks before screening. * Presence or history of epilepsy and fibromyalgia. * Presence of non-diabetic neuropathies, in the opinion of the investigator. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination and OCT assessment performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. * Any other painful medical condition(s) where the pain is significantly more severe than the diabetic peripheral neuropathy pain, as judged by the investigator (participants will not be excluded if the pain is transient in nature). * History of suicidal attempt within 5 years before screening * Suicidal behaviour within 1 month before screening. * Renal impairment with estimated Glomerular Filtration Rate (eGFR) \<30 ml/min/1.73 m2 as determined by central laboratory at screening. * Exposure to an investigational medicinal product within 90 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.

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Conditions

The condition(s) this trial relates to.

diabetic neuropathy type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus type 2 Diabetic peripheral neuropathy

Contacts and locations

Locations

  • Aarhus Universitetshospital, Steno Diabetes Center Aarhus

    Aarhus N, 8200, Denmark

  • Aintree University Hospital

    Liverpool, L9 7AL, United Kingdom

  • Amicis Centers of Clinical Research

    St Louis, Missouri, 63128, United States

  • Aphp-Hopital La Pitie Salpetriere

    Paris, 75013, France

  • Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque

    Pessac, 33600, France

  • Centre de Recherche Clinique Portes Du Sud

    Vénissieux, 69200, France

  • Centricity Clinical Research Burlington

    Burlington, Ontario, L7M 4Y1, Canada

  • Centricity Research Brampton Endocrinology

    Brampton, Ontario, L6S 0C6, Canada

  • Centricity Research Etobicoke Endocrinology

    Etobicoke, Ontario, M9R 4E1, Canada

  • Clinical Res Collaborative

    Cumberland, Rhode Island, 02864, United States

  • Complejo Hospitalario Universitario A Coruña

    A Coruña, 15006, Spain

  • Ctr de Med Metab de Lanaudiere

    Terrebonne, Quebec, J6X 4P7, Canada

  • DM Clinical

    Albuquerque, New Mexico, 87106, United States

  • DM Clinical

    Houston, Texas, 77081, United States

  • DM Clinical

    San Antonio, Texas, 78207, United States

  • DM Clinical Research

    San Antonio, Texas, 78207, United States

  • Diabetes Heart Research Centre

    Toronto, Ontario, M6G 1M2, Canada

  • Foot & Ankle Center of Illinois

    Springfield, Illinois, 62704, United States

  • G.A. Research Associates Ltd.

    Moncton, New Brunswick, E1G 1A7, Canada

  • Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu

    Le Creusot, 71200, France

  • H. Infanta Luisa_Endocrino y Obesidad

    Seville, 41010, Spain

  • Haukeland Universitetssykehus

    Bergen, 5021, Norway

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

  • Hospital Nisa Sevilla Aljarafe (To be inactivated when NN9388-7864 is in closing status)

    Castilleja de la Cuesta, Andalusia, 41950, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario de la Princesa

    Madrid, 28006, Spain

  • Hospital Vall d'Hebron

    Barcelona, 08035, Spain

  • Ipswich Hospital - Diabetes

    Ipswich, IP4 5PD, United Kingdom

  • King's College Hospital - Renal

    London, SW9 8RR, United Kingdom

  • Kolding Sygehus Karkirurgi

    Kolding, 6000, Denmark

  • Les Hopitaux de Chartres-Hopital Louis Pasteur

    Le Coudray, 28630, France

  • Lillestol Research LLC

    Fargo, North Dakota, 58104, United States

  • Linda Vista Health Care Ctr

    San Diego, California, 92111, United States

  • Manchester Royal Infirmary - Diabetes

    Manchester, M13 9WL, United Kingdom

  • My Preferred Research

    Miami, Florida, 33155, United States

  • New Horizon Research Center

    Miami, Florida, 33165, United States

  • Oregon Health & Science University

    Portland, Oregon, 97239, United States

  • Oslo universitetssykehus, Ullevål

    Oslo, 0450, Norway

  • Piedmont Healthcare/Research

    Statesville, North Carolina, 28625, United States

  • Premier Clinical Trial Research Network (PCTRN)

    Hamilton, Ontario, L8L 5G4, Canada

  • Radiance Clinical Research

    Lampasas, Texas, 76550, United States

  • Renstar Medical Research

    Ocala, Florida, 34470, United States

  • Renstar Medical Research

    Ocala, Florida, 34471, United States

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF, United Kingdom

  • Southgate Medical Group, LLP

    West Seneca, New York, 14224, United States

  • St Pancras Clinical Research

    London, EC2Y 8EA, United Kingdom

  • Stavanger Universitetssykehus, Helse Stavanger HF

    Stavanger, NO-4011, Norway

  • Steno Diabetes Center Copenhagen

    Herlev, 2730, Denmark

  • Steno Diabetes Center Nordjylland

    Gistrup, 9260, Denmark

  • Steno Diabetes Center Odense

    Odense C, 5000, Denmark

  • Sykehuset Innlandet HF Hamar

    Hamar, 2318, Norway

  • Tameside General Hospital

    Ashton-under-Lyne, Greater Manchester, OL6 9RW, United Kingdom

  • Velocity Clinical Research Portsmouth

    Suffolk, Virginia, 23435, United States

  • Velocity Clinical Research Rockville

    Rockville, Maryland, 20854, United States

  • eStudySite

    La Mesa, California, 91942, United States

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