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

NCT ID: NCT06797869

Last Updated: 2025-12-05

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-29
• Study Completion Date: 2026-08-21

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2; Diabetic Peripheral Neuropathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

CagriSema

Participants will receive CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 32 weeks.

Group Type: EXPERIMENTAL

CagriSema (Cagrilintide B and Semaglutide I)

Intervention Type: DRUG

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

Placebo

Participants will receive placebo matched to CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 32 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)

Intervention Type: DRUG

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

Interventions

CagriSema (Cagrilintide B and Semaglutide I)

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

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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).

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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

Diabetes Heart Research Centre

Toronto, Ontario, Canada

Ctr de Med Metab de Lanaudiere

Terrebonne, Quebec, Canada

Aarhus Universitetshospital, Steno Diabetes Center Aarhus

Aarhus N, , Denmark

Steno Diabetes Center Nordjylland

Gistrup, , Denmark

Steno Diabetes Center Copenhagen

Herlev, , Denmark

Kolding Sygehus Karkirurgi

Kolding, , Denmark

Steno Diabetes Center Odense

Odense C, , Denmark

Les Hopitaux de Chartres-Hopital Louis Pasteur

Le Coudray, , France

Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-1

Le Creusot, , France

Aphp-Hopital La Pitie Salpetriere-1

Paris, , France

Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-1

Pessac, , France

Centre de Recherche Clinique Portes Du Sud

Vénissieux, , France

Haukeland Universitetssykehus

Bergen, , Norway

Sykehuset Innlandet HF Hamar

Hamar, , Norway

Oslo universitetssykehus, Ullevål

Oslo, , Norway

Stavanger Universitetssykehus, Helse Stavanger HF

Stavanger, , Norway

Hospital Nisa Sevilla Aljarafe

Castilleja de La Cuesta. Sevilla, Andalusia, Spain

Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Complejo Hospitalario Universitario A Coruña

A Coruña, , Spain

Hospital Vall d'Hebron

Barcelona, , Spain

Hospital Universitario de la Princesa

Madrid, , Spain

Hospital Universitario Marqués de Valdecilla

Santander, , Spain

Hospital Infanta Luisa

Seville, , Spain

Tameside General Hospital

Ashton-under-Lyne, Greater Manchester, United Kingdom

Ipswich Hospital - Diabetes

Ipswich, , United Kingdom

Aintree University Hospital

Liverpool, , United Kingdom

St Pancras Clinical Research

London, , United Kingdom

Kings College Hospital - Renal

London, , United Kingdom

Manchester Royal Infirmary - Diabetes

Manchester, , United Kingdom

Royal Hallamshire Hospital

Sheffield, , United Kingdom

Countries

United States; Canada; Denmark; France; Norway; Spain; United Kingdom

Other Identifiers

U1111-1306-9422

Identifier Type: OTHER

Identifier Source: secondary_id

2023-509662-38

Identifier Type: OTHER

Identifier Source: secondary_id

NN9388-7864

Identifier Type: -

Identifier Source: org_study_id