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

Part of paid clinical trials in La Mesa, California.

Sponsor
Novo Nordisk A/S
Study ID
NCT06797869
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 29, 2025
Status verified
Dec 2025
Primary completion
Aug 21, 2026
Completion
Aug 21, 2026

Study Design

Enrollment
142 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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 Outcome Measure

Change in weekly average Pain Intensity-Numerical Rating Scale (PI-NRS) [ Time Frame: From baseline (week 0) to end of treatment (week 32) ]

Locations (19)

FacilityCityStateZIPSite coordinators
eStudySiteLa MesaCalifornia91942-
Linda Vista Health Care CtrSan DiegoCalifornia92111-
My Preferred ResearchMiamiFlorida33155-
New Horizon Research CenterMiamiFlorida33165-
Renstar Medical ResearchOcalaFlorida34471-
Foot & Ankle Center of IllinoisSpringfieldIllinois62704-
Velocity Clinical Research RockvilleRockvilleMaryland20854-
Amicis Centers of Clinical ResearchSt LouisMissouri63128-
DM Clinical - CyFairAlbuquerqueNew Mexico87106-
Southgate Medical Group, LLPWest SenecaNew York14224-
Piedmont Healthcare/ResearchStatesvilleNorth Carolina28625-
Lillestol Research LLCFargoNorth Dakota58104-
Oregon Health & Science UniversityPortlandOregon97239-
Clinical Res CollaborativeCumberlandRhode Island02864-
DM Clinical - CyFairHoustonTexas77081-
Radiance Clinical ResearchLampasasTexas76550-
DM Clinical - CyFairSan AntonioTexas78207-
DM Clinical ResearchSan AntonioTexas78207-
Velocity Clinical Research PortsmouthSuffolkVirginia23435-

Find similar trials in La Mesa, CA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
eStudySite· La Mesa, CALinda Vista Health Care Ctr· San Diego, CAMy Preferred Research· Miami, FLNew Horizon Research Center· Miami, FLRenstar Medical Research· Ocala, FLFoot & Ankle Center of Illinois· Springfield, IL

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