Trial · Interventional
CompletedPhase 2Registry dataA Research Study to Investigate the Effects of CagriSema Compared to Placebo in People With Type 2 Diabetes and Painful Diabetic Peripheral Neuropathy
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
- 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
NCT0679786929 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.
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)
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.
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.
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.
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.
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.
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.
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.
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).
Change in diastolic blood pressure
Time frame · From baseline (week 0) to end of treatment (week 32)
Registry description
Measured as mmHg.
Change in glycated haemoglobin (HbA1c)
Time frame · From baseline (week 0) to end of treatment (week 32)
Registry description
Measured as percentage of HbA1c.
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).
Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 32)
Registry description
Measured as percentage change.
Change in waist circumference
Time frame · From baseline (week 0) to end of treatment (week 32)
Registry description
Measured as centimeter (cm).
Ratio to Baseline in Lipids: Total Cholesterol
Time frame · From baseline (week 0) to end of treatment (week 32)
Registry description
Measured as ratio.
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.
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.
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.
Ratio to Baseline in Lipids: Triglycerides
Time frame · From baseline (week 0) to end of treatment (week 32)
Registry description
Measured as ratio.
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.
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
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