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

NCT06797869 | Active Not Recruiting Phase 2 FDA Drug

• 3 other identifiers: NN9388-7864U1111-1306-94222023-509662-38
• Study Type: interventional
• Target: 142
• Locations: 7 countries
• Sites: 54

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

Outcome Measures

Primary Outcomes (1)

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

  Measured as score on a scale.

  From baseline (week 0) to end of treatment (week 32)

Secondary Outcomes (25)

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

  From baseline (week 0) to end of treatment (week 32)

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

  From baseline (week 0) to end of treatment (week 32)

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

  From baseline (week 0) to end of treatment (week 32)

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

  From baseline (week 0) to end of treatment (week 32)

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

  From baseline (week 0) to end of treatment (week 32)

Study Arms (2)

CagriSema

EXPERIMENTAL

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

Drug: CagriSema (Cagrilintide B and Semaglutide I)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo matched to CagriSema (Cagrilintide B and Semaglutide I)

Interventions

CagriSema (Cagrilintide B and Semaglutide I) DRUG

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

CagriSema

Placebo matched to CagriSema (Cagrilintide B and Semaglutide I) DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (54)

eStudySite

La Mesa, California, 91942, United States

Location

Linda Vista Health Care Ctr

San Diego, California, 92111, United States

Location

My Preferred Research

Miami, Florida, 33155, United States

Location

New Horizon Research Center

Miami, Florida, 33165, United States

Location

Renstar Medical Research

Ocala, Florida, 34471, United States

Location

Foot & Ankle Center of Illinois

Springfield, Illinois, 62704, United States

Location

Velocity Clinical Research Rockville

Rockville, Maryland, 20854, United States

Location

Amicis Centers of Clinical Research

St Louis, Missouri, 63128, United States

Location

DM Clinical - CyFair

Albuquerque, New Mexico, 87106, United States

Location

Southgate Medical Group, LLP

West Seneca, New York, 14224, United States

Location

Piedmont Healthcare/Research

Statesville, North Carolina, 28625, United States

Location

Lillestol Research LLC

Fargo, North Dakota, 58104, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Clinical Res Collaborative

Cumberland, Rhode Island, 02864, United States

Location

DM Clinical - CyFair

Houston, Texas, 77081, United States

Location

Radiance Clinical Research

Lampasas, Texas, 76550, United States

Location

DM Clinical - CyFair

San Antonio, Texas, 78207, United States

Location

DM Clinical Research

San Antonio, Texas, 78207, United States

Location

Velocity Clinical Research Portsmouth

Suffolk, Virginia, 23435, United States

Location

G.A. Research Associates Ltd.

Moncton, New Brunswick, E1G 1A7, Canada

Location

Centricity Research Brampton

Brampton, Ontario, L6S 0C6, Canada

Location

Centricity Clinical Research Burlington

Burlington, Ontario, L7M 4Y1, Canada

Location

Centricity Research Etobicoke

Etobicoke, Ontario, M9R 4E1, Canada

Location

Premier Clinical Trial Research Network (PCTRN)

Hamilton, Ontario, L8L 5G4, Canada

Location

Diabetes Heart Research Centre

Toronto, Ontario, M6G 1M2, Canada

Location

Ctr de Med Metab de Lanaudiere

Terrebonne, Quebec, J6X 4P7, Canada

Location

Aarhus Universitetshospital, Steno Diabetes Center Aarhus

Aarhus N, 8200, Denmark

Location

Steno Diabetes Center Nordjylland

Gistrup, 9260, Denmark

Location

Steno Diabetes Center Copenhagen

Herlev, 2730, Denmark

Location

Kolding Sygehus Karkirurgi

Kolding, 6000, Denmark

Location

Steno Diabetes Center Odense

Odense C, 5000, Denmark

Location

Les Hopitaux de Chartres-Hopital Louis Pasteur

Le Coudray, 28630, France

Location

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

Le Creusot, 71200, France

Location

Aphp-Hopital La Pitie Salpetriere-1

Paris, 75013, France

Location

Centre Hospitalier Universitaire de Bordeaux-Hopital Haut Leveque-1

Pessac, 33600, France

Location

Centre de Recherche Clinique Portes Du Sud

Vénissieux, 69200, France

Location

Haukeland Universitetssykehus

Bergen, 5021, Norway

Location

Sykehuset Innlandet HF Hamar

Hamar, 2318, Norway

Location

Oslo universitetssykehus, Ullevål

Oslo, 0450, Norway

Location

Stavanger Universitetssykehus, Helse Stavanger HF

Stavanger, NO-4011, Norway

Location

Hospital Nisa Sevilla Aljarafe

Castilleja de La Cuesta. Sevilla, Andalusia, 41950, Spain

Location

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Complejo Hospitalario Universitario A Coruña

A Coruña, 15006, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario de la Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

Location

Hospital Infanta Luisa

Seville, 41010, Spain

Location

Tameside General Hospital

Ashton-under-Lyne, Greater Manchester, OL6 9RW, United Kingdom

Location

Ipswich Hospital - Diabetes

Ipswich, IP4 5PD, United Kingdom

Location

Aintree University Hospital

Liverpool, L9 7AL, United Kingdom

Location

St Pancras Clinical Research

London, EC2Y 8EA, United Kingdom

Location

Kings College Hospital - Renal

London, SW9 8RR, United Kingdom

Location

Manchester Royal Infirmary - Diabetes

Manchester, M13 9WL, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, S10 2JF, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: January 29, 2025
• Study Start: January 29, 2025
• Primary Completion (Estimated): August 21, 2026
• Study Completion (Estimated): August 21, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

CA (7); NO (4); DK (5); ES (7); US (19); GB (7); FR (5)