Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. Once Weekly Versus Placebo in Children and Adolescents With Type 2 Diabetes
Novo Nordisk A/S
Summary
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.
Eligibility
- Age range
- 10–18 years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: * Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. * The parent(s) or LAR of the child must sign and date the Informed Consent Form (according to local requirements) * The child must sign and date the Child Assent Form or provide oral assent (according to local requirements) * Male or female. * Age…
Interventions
- DrugCagriSema (Cagrilintide B and Semaglutide I)
Cagrilintide B and Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
- DrugPlacebo 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.
Locations (55)
- Yale School of MedicineNew Haven, Connecticut
- Encore Medical Research Boynton BeachBoynton Beach, Florida
- Nemours Chld Clnc JacksonvilleJacksonville, Florida
- Innovus ClinicalKissimmee, Florida
- D&H National Research CentersTamarac, Florida
- Clinical Research Trials of FloridaTampa, Florida