Current partner codePEPTIDESDE
NCT06797869·Phase 2·INTERVENTIONAL

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

Status

Active, not recruiting

Phase

Phase 2

Enrollment

142

Locations

54

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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.

Interventions

Treatment arms and agents.

DRUG

CagriSema (Cagrilintide B and Semaglutide I)

Cagrilintide B and Semaglutide I will be administered subcutaneously using DV3384 pen-injector.

DRUG

Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)

Placebo matched to Cagrilintide B and Placebo matched to Semaglutide I will be administered subcutaneously using DV3384 pen-injector.

Timeline

From registration to results.

  1. First posted

    Jan 29, 2025

  2. Study start

    Jan 29, 2025

  3. Primary completion

    Aug 21, 2026

  4. Study completion

    Aug 21, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Dec 5, 2025

Outcomes

What the study measures.

Primary outcomes

Change in weekly average Pain Intensity-Numerical Rating Scale (PI-NRS)

Time frame · From baseline (week 0) to end of treatment (week 32)

Measured as score on a scale.

Secondary outcomes

Number of participants reaching ≥30 percentage (%) reduction in PI-NRS

Time frame · From baseline (week 0) to end of treatment (week 32)

Measured as count of participants.

Time to achieve ≥30% reduction in weekly average PI-NRS

Time frame · From baseline (week 0) to end of treatment (week 32)

Measured as days.

Number of participants reaching ≥50 % reduction in PI-NRS

Time frame · From baseline (week 0) to end of treatment (week 32)

Measured as count of participants.

Time to achieve ≥50% reduction in weekly average PI-NRS

Time frame · From baseline (week 0) to end of treatment (week 32)

Measured as days.

Change in Brief Pain Inventory-Short Form (BPI-SF)

Time frame · From baseline (week 0) to end of treatment (week 32)

Measured as score on a scale.

Change in Chronic Pain Sleep Inventory 3-item (CPSI 3)

Time frame · From baseline (week 0) to end of treatment (week 32)

Measured as score on a scale.

Change in Michigan Neuropathy Screening Instrument (MNSI)

Time frame · From baseline (week 0) to end of treatment (week 32)

Measured as score on a scale.

Change in systolic blood pressure

Time frame · From baseline (week 0) to end of treatment (week 32)

Measured as millimeters of mercury (mmHg).

Change in diastolic blood pressure

Time frame · From baseline (week 0) to end of treatment (week 32)

Measured as mmHg.

Change in glycated haemoglobin (HbA1c)

Time frame · From baseline (week 0) to end of treatment (week 32)

Measured as percentage of HbA1c.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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.

Study locations

54 registered sites.

Canada · Denmark · France · Norway · Spain · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.

eStudySite

La Mesa, California, United States

Linda Vista Health Care Ctr

San Diego, California, United States

My Preferred Research

Miami, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Foot & Ankle Center of Illinois

Springfield, Illinois, United States

Velocity Clinical Research Rockville

Rockville, Maryland, United States

Amicis Centers of Clinical Research

St Louis, Missouri, United States

DM Clinical - CyFair

Albuquerque, New Mexico, United States

Southgate Medical Group, LLP

West Seneca, New York, United States

Piedmont Healthcare/Research

Statesville, North Carolina, United States

Lillestol Research LLC

Fargo, North Dakota, United States

Oregon Health & Science University

Portland, Oregon, United States

Clinical Res Collaborative

Cumberland, Rhode Island, United States

DM Clinical - CyFair

Houston, Texas, United States

Radiance Clinical Research

Lampasas, Texas, United States

DM Clinical - CyFair

San Antonio, Texas, United States

DM Clinical Research

San Antonio, Texas, United States

Velocity Clinical Research Portsmouth

Suffolk, Virginia, United States

G.A. Research Associates Ltd.

Moncton, New Brunswick, Canada

Centricity Research Brampton

Brampton, Ontario, Canada

Centricity Clinical Research Burlington

Burlington, Ontario, Canada

Centricity Research Etobicoke

Etobicoke, Ontario, Canada

Premier Clinical Trial Research Network (PCTRN)

Hamilton, Ontario, Canada

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Cagrilintide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.