A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in Children and Adolescents With Type 2 Diabetes

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Novo Nordisk A/S
Study ID
NCT07282613
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
10 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this clinical study is to look into how well a study medicine called CagriSema helps children and adolescents living with diabetes lower their blood sugar and body weight. The study has 2 parts: in the first part participant will get either CagriSema or placebo, and in the second part participant will get CagriSema. In the first part, which treatment participant gets is decided by chance and second part is open label and all participants will get CagriSema during this part. The study will last for about 1 year and 3 months.

Key Dates

Start date
Aug 4, 2026
Status verified
May 2026
Primary completion
Sep 7, 2029
Completion
Mar 30, 2030

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: CagriSema
    Participants will receive CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 1.
  • Placebo Comparator: Part 1: Placebo
    Participants will receive placebo matched to CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 1.
  • Experimental: Part 2: CagriSema
    Participants who received placebo in Part 1 will receive CagriSema (Cagrilintide B + Semaglutide I) subcutaneously once weekly for 26 weeks in Part 2.

Primary Outcome Measure

Change in glycated haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to end of double-blinded treatment (week 26) ]

Central Contacts

Locations (21)

FacilityCityStateZIPSite coordinators
Yale School of MedicineNew HavenConnecticut06511-
Encore Medical Research Boynton BeachBoynton BeachFlorida33436-
Nemours Chld Clnc JacksonvilleJacksonvilleFlorida32207-
Innovus ClinicalKissimmeeFlorida34741-
D&H National Research CentersTamaracFlorida33321-
Clinical Research Trials of FloridaTampaFlorida33607-
Columbus Research FoundationColumbusGeorgia31904-
Eastside Bariatric and Gen SurgSnellvilleGeorgia30078-
SIU MedicineSpringfieldIllinois62702-
Riley Hospital For ChildrenIndianapolisIndiana46202-
University of IowaIowa CityIowa52242-
Great Lakes Research Inst.SouthfieldMichigan48075-
UBMD PediatricsBuffaloNew York14203-
NYU Langone Orthopedic CenterNew YorkNew York10016-
Children's Hosptl PhiladelphiaPhiladelphiaPennsylvania19104-
Monument Health Clinical RsrchRapid CitySouth Dakota57701-
LifeDoc HealthMemphisTennessee38115-
Amir Ali Hassan, MD, PAHoustonTexas77089-
Consano Clinical Research, LLCShavano ParkTexas78231-
UVA Health SystemsCharlottesvilleVirginia22903-
Seattle Children's Research InstituteSeattleWashington98105-

Find similar trials in New Haven, CT

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Yale School of Medicine· New Haven, CTEncore Medical Research Boynton Beach· Boynton Beach, FLNemours Chld Clnc Jacksonville· Jacksonville, FLInnovus Clinical· Kissimmee, FLD&H National Research Centers· Tamarac, FLClinical Research Trials of Florida· Tampa, FL

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