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

Status: Active_not_recruiting
Location: See all (54) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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).

Locations
United States
California
eStudySite
La Mesa
Linda Vista Health Care Ctr
San Diego
Florida
My Preferred Research
Miami
New Horizon Research Center
Miami
Renstar Medical Research
Ocala
Illinois
Foot & Ankle Center of Illinois
Springfield
Maryland
Velocity Clinical Research Rockville
Rockville
Missouri
Amicis Centers of Clinical Research
St Louis
North Carolina
Piedmont Healthcare/Research
Statesville
North Dakota
Lillestol Research LLC
Fargo
New Mexico
DM Clinical - CyFair
Albuquerque
New York
Southgate Medical Group, LLP
West Seneca
Oregon
Oregon Health & Science University
Portland
Rhode Island
Clinical Res Collaborative
Cumberland
Texas
DM Clinical - CyFair
Houston
Radiance Clinical Research
Lampasas
DM Clinical - CyFair
San Antonio
DM Clinical Research
San Antonio
Virginia
Velocity Clinical Research Portsmouth
Suffolk
Other Locations
Canada
Centricity Research Brampton
Brampton
Centricity Clinical Research Burlington
Burlington
Centricity Research Etobicoke
Etobicoke
Premier Clinical Trial Research Network (PCTRN)
Hamilton
G.A. Research Associates Ltd.
Moncton
Ctr de Med Metab de Lanaudiere
Terrebonne
Diabetes Heart Research Centre
Toronto
Denmark
Aarhus Universitetshospital, Steno Diabetes Center Aarhus
Aarhus N
Steno Diabetes Center Nordjylland
Gistrup
Steno Diabetes Center Copenhagen
Herlev
Kolding Sygehus Karkirurgi
Kolding
Steno Diabetes Center Odense
Odense C
France
Les Hopitaux de Chartres-Hopital Louis Pasteur
Le Coudray
Groupe Sos Sante-Hopital Le Creusot-Hotel Dieu-1
Le Creusot
Aphp-Hopital La Pitie Salpetriere-1
Paris
Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-1
Pessac
Centre de Recherche Clinique Portes Du Sud
Vénissieux
Norway
Haukeland Universitetssykehus
Bergen
Sykehuset Innlandet HF Hamar
Hamar
Oslo universitetssykehus, Ullevål
Oslo
Stavanger Universitetssykehus, Helse Stavanger HF
Stavanger
Spain
Complejo Hospitalario Universitario A Coruña
A Coruña
Hospital Germans Trias i Pujol
Badalona
Hospital Vall d'Hebron
Barcelona
Hospital Nisa Sevilla Aljarafe
Castilleja De La Cuesta. Sevilla
Hospital Universitario de la Princesa
Madrid
Hospital Universitario Marqués de Valdecilla
Santander
Hospital Infanta Luisa
Seville
United Kingdom
Tameside General Hospital
Ashton-under-lyne
Ipswich Hospital - Diabetes
Ipswich
Aintree University Hospital
Liverpool
Kings College Hospital - Renal
London
St Pancras Clinical Research
London
Manchester Royal Infirmary - Diabetes
Manchester
Royal Hallamshire Hospital
Sheffield
Time Frame
Start Date: 2025-01-29
Completion Date: 2026-08-21
Participants
Target number of participants: 142
Treatments
Experimental: CagriSema
Participants will receive CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 32 weeks.
Placebo_comparator: Placebo
Participants will receive placebo matched to CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 32 weeks.
Sponsors
Leads: Novo Nordisk A/S

This content was sourced from clinicaltrials.gov