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Trial · Interventional

CompletedPhase 2Registry data

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

NCTNCT06797869 (opens ClinicalTrials.gov in a new tab)Other idNN9388-7864Other idU1111-1306-9422Other id2023-509662-38Other id2023

Overview

Status
Completed
Phase
Phase 2
Enrollment
142 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
7 countries

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

Start
29 Jan 2025
Primary completion
26 Jun 2026
Completion
5 Aug 2026
First posted
29 Jan 2025
Last update posted
10 Sept 2026
Conditions
Diabetes Mellitus, Type 2 · Diabetic Peripheral Neuropathy

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202520262027
  1. Ph 2

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

    NCT06797869

    29 Jan 2025 to 5 Aug 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

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

Arms2

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · From baseline (week 0) to end of treatment (week 32)

    Registry description

    Measured as score on a scale.

Secondary outcomes(20)
  1. Number of participants reaching ≥30 percentage (%) reduction in PI-NRS

    Time frame · From baseline (week 0) to end of treatment (week 32)

    Registry description

    Measured as count of participants.

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

    Time frame · From baseline (week 0) to end of treatment (week 32)

    Registry description

    Measured as days.

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

    Time frame · From baseline (week 0) to end of treatment (week 32)

    Registry description

    Measured as count of participants.

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

    Time frame · From baseline (week 0) to end of treatment (week 32)

    Registry description

    Measured as days.

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

    Time frame · From baseline (week 0) to end of treatment (week 32)

    Registry description

    Measured as score on a scale.

  6. Change in Chronic Pain Sleep Inventory 3-item (CPSI 3)

    Time frame · From baseline (week 0) to end of treatment (week 32)

    Registry description

    Measured as score on a scale.

  7. Change in Michigan Neuropathy Screening Instrument (MNSI)

    Time frame · From baseline (week 0) to end of treatment (week 32)

    Registry description

    Measured as score on a scale.

  8. Change in systolic blood pressure

    Time frame · From baseline (week 0) to end of treatment (week 32)

    Registry description

    Measured as millimeters of mercury (mmHg).

  9. Change in diastolic blood pressure

    Time frame · From baseline (week 0) to end of treatment (week 32)

    Registry description

    Measured as mmHg.

  10. Change in glycated haemoglobin (HbA1c)

    Time frame · From baseline (week 0) to end of treatment (week 32)

    Registry description

    Measured as percentage of HbA1c.

  11. Change in Fasting Plasma Glucose (FPG)

    Time frame · From baseline (week 0) to end of treatment (week 32)

    Registry description

    Measured as millimole per liter (mmol/L).

  12. Relative change in body weight

    Time frame · From baseline (week 0) to end of treatment (week 32)

    Registry description

    Measured as percentage change.

  13. Change in waist circumference

    Time frame · From baseline (week 0) to end of treatment (week 32)

    Registry description

    Measured as centimeter (cm).

  14. Ratio to Baseline in Lipids: Total Cholesterol

    Time frame · From baseline (week 0) to end of treatment (week 32)

    Registry description

    Measured as ratio.

  15. Ratio to Baseline in Lipids: High-density lipoprotein (HDL) cholesterol

    Time frame · From baseline (week 0) to end of treatment (week 32)

    Registry description

    Measured as ratio.

  16. Ratio to Baseline in Lipids: Low-density lipoprotein (LDL) cholesterol

    Time frame · From baseline (week 0) to end of treatment (week 32)

    Registry description

    Measured as ratio.

  17. Ratio to Baseline in Lipids: Very low-density lipoprotein (VLDL) cholesterol

    Time frame · From baseline (week 0) to end of treatment (week 32)

    Registry description

    Measured as ratio.

  18. Ratio to Baseline in Lipids: Triglycerides

    Time frame · From baseline (week 0) to end of treatment (week 32)

    Registry description

    Measured as ratio.

  19. Ratio to Baseline in Lipids: Free fatty acids

    Time frame · From baseline (week 0) to end of treatment (week 32)

    Registry description

    Measured as ratio.

  20. Ratio to Baseline in Lipids: Non-HDL cholesterol

    Time frame · From baseline (week 0) to end of treatment (week 32)

    Registry description

    Measured as ratio.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Key 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). Key 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.

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