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Investigating CagriSema for Type 2 Diabetes and Painful Neuropathy

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

Phase 2 Interventional Novo Nordisk A/S · NCT06797869

This study is testing if a new medication called CagriSema can help people with type 2 diabetes and painful nerve damage feel better compared to a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment134 (estimated)
Ages18 Years and up
SexAll
SponsorNovo Nordisk A/S Industry-sponsored
Locations48 sites (La Mesa, California and 47 other locations)
Trial IDNCT06797869 on ClinicalTrials.gov

What this trial studies

This study examines the effects of CagriSema, an investigational medication, in individuals with type 2 diabetes and painful diabetic peripheral neuropathy compared to a placebo. Participants will be randomly assigned to receive either the active medication or a placebo for approximately 10 months. The study aims to assess the efficacy and safety of CagriSema in alleviating symptoms associated with diabetic neuropathy. The findings could provide insights into new treatment options for this patient population.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of type 2 diabetes and a body mass index of 25 or higher.

Not a fit: Patients with type 2 diabetes who do not experience painful diabetic peripheral neuropathy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a new therapeutic option for managing pain associated with diabetic peripheral neuropathy in patients with type 2 diabetes.

How similar studies have performed: Other studies have shown promise in using similar approaches for managing diabetic neuropathy, but the specific use of CagriSema is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

  * 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 insulin (including neutral protamine Hagedorn (NPH) insulin) according to local guidelines.
* HbA1c ≤10.5 % (91 millimole per mole \[mmol/mol\]) and ≥6.5 % (48 mmol/mol), as determined by central laboratory at screening.
* Diagnosis of painful diabetic peripheral neuropathy (pDPN) based on the following criteria:

  * Participant with self-reported pain consistent with pDPN for a minimum of 3 months before screening, as judged by the investigator. AND
  * Michigan Neuropathy Screening Instrument (MNSI) q≥4 or e≥2.5 at screening. AND
  * Douleur Neuropathique en 4 Questions (DN4) (Question 1 and 2) ≥4 at screening.
* The weekly average in Pain Intensity-Numerical Rating Scale (PI-NRS) score must meet the following criteria in both weeks during the screening period (day -15 to -8 and day -7 to -1):

  * Completion of daily PI-NRS reporting in the eDiary for a minimum of 4 out of 7 days each week. AND
  * The weekly average PI-NRS score must be ≥4.0. AND
  * The standard deviation (SD) of the weekly average PI-NRS score must be ≤2.0.
* 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, 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.
* 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.

Where this trial is running

La Mesa, California and 47 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Diabetes Mellitus, Type 2Diabetic Peripheral Neuropathy
Last reviewed 2026-06-10 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.