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

NCT06797869 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2025-12-05

No results posted yet for this study

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

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Transparency (dept. 2834) · Novo Nordisk A/S

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-29
Primary Completion
2026-08-21
Completion
2026-08-21
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06797869 on ClinicalTrials.gov