RECRUITING

A Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy

Conditions

Diabetes Mellitus, Type 2 Diabetic Peripheral Neuropathy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study will look at the effects of CagriSema in people with both type 2 diabetes and painful diabetic peripheral neuropathy, compared to placebo. Participants will either get an active medicine or a "dummy" medicine (placebo). Which treatment participants get is decided by chance. In this study the active, investigational medicine is called CagriSema. Doctors cannot yet prescribe CagriSema. For each participant, the study will last for about 10 months.

Official 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

Quick Facts

Study Start:2025-01-29

Study Completion:2026-08-21

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06797869

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* 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.

Inclusion Criteria

Exclusion 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).

* 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.

Contacts and Locations

Study Contact

Novo Nordisk

CONTACT

(+1) 866-867-7178

clinicaltrials@novonordisk.com

Principal Investigator

Clinical Transparency (dept. 2834)

STUDY_DIRECTOR

Novo Nordisk A/S

Study Locations (Sites)

eStudySite

La Mesa, California, 91942

United States

Linda Vista Health Care Ctr

San Diego, California, 92111

United States

My Preferred Research

Miami, Florida, 33155

United States

New Horizon Research Center

Miami, Florida, 33165

United States

Renstar Medical Research

Ocala, Florida, 34471

United States

Foot & Ankle Center of Illinois

Springfield, Illinois, 62704

United States

Velocity Clinical Research Rockville

Rockville, Maryland, 20854

United States

Amicis Centers of Clinical Research

Saint Louis, Missouri, 63128

United States

Southgate Medical Group, LLP

West Seneca, New York, 14224

United States

Piedmont Healthcare/Research

Statesville, North Carolina, 28625

United States

Lillestol Research LLC

Fargo, North Dakota, 58104

United States

Oregon Health & Science University

Portland, Oregon, 97239

United States

Clinical Res Collaborative

Cumberland, Rhode Island, 02864

United States

Radiance Clinical Research

Lampasas, Texas, 76550

United States

DM Clinical Research

San Antonio, Texas, 78207

United States

Velocity Clinical Research Portsmouth

Suffolk, Virginia, 23435

United States

Collaborators and Investigators

Sponsor: Novo Nordisk A/S

Clinical Transparency (dept. 2834), STUDY_DIRECTOR, Novo Nordisk A/S

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-29

Study Completion Date2026-08-21

Study Record Updates

Study Start Date2025-01-29

Study Completion Date2026-08-21

Terms related to this study

Additional Relevant MeSH Terms

Diabetes Mellitus, Type 2
Diabetic Peripheral Neuropathy