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ACTIVE NOT RECRUITING
NCT06797869
PHASE2

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

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

142

Start Date

2025-01-29

Completion Date

2026-08-21

Last Updated

2025-12-05

Healthy Volunteers

No

Interventions

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.

Locations (54)

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