Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
Phase 3: testing CagriSema (Cagrilintide B and Semaglutide I) for Diabetes Mellitus, Type 2
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 dummy treatment (placebo), and in the second part participant will get CagriSema.
Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are CagriSema (Cagrilintide B and Semaglutide I), or Placebo matched to CagriSema (Cagrilintide B and Semaglutide I). The registry lists allocation as randomized. 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.
They plan to enroll about 80 people at 58 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.
Official title (unrewritten)
Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. Once Weekly Versus Placebo in Children and Adolescents With Type 2 Diabetes
Primary outcome (registry wording): Change in glycated haemoglobin (HbA1c)
Who it is for (from inclusion criteria)
Ages 10 Years to 18 Years
The child must sign and date the Child Assent Form or provide oral assent (according to local requirements)
Diagnosed with T2D (according to the latest International Society for Pediatric and Adolescent Diabetes \[ISPAD\] criteria) ≥ 30 days before screening
Treated with diet and exercise counselling alone or with a stable daily dose(a), in addition to diet and exercise counselling, of any of the following antidiabetic drugs or combination regimens:
Insulin (any regimen)
HbA1c 6.5%-11.0% (48 mmol/mol - 97 mmol/mol) (both inclusive) as determined by central laboratory at screening
Body weight ≥ 45 kg and body-mass index (BMI) ≥ 85th percentile(b). body-mass index (BMI) will be calculated in the electronic case report form based on height and body weight at screening
(b) Based on sex-specific body-mass index (BMI)-for-age percentiles for the given country or region. If not available for the country or region, the respective charts or tables on cdc.gov may be used
Who the registry excludes
Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method
Treatment with any antidiabetic or anti-obesity medication (irrespective of indication) other than stated in the who can join within 90 days before screening
Known or previous diagnosis of hypoparathyroidism
Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies as determined by central laboratory at screening or in medical history
Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator
Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8
HYPOTHESIS: Impaired glucose tolerance (IGT) and impaired fasting glucose (IFG) have distinct pathophysiologic etiologies. Therefore, therapeutic interventions designed to correct the specific underlying pathogenic abnormalities in IGT and IFG will be required to optimally prevent the progressive beta cell failure and development of overt type 2 diabetes.
Nonalcoholic fatty liver disease is the most common liver disease in Western countries, due in large part to its association with type 2 diabetes and obesity. The more advanced form of this disease is known as nonalcoholic steatohepatitis (NASH).
Metabolic surgery is an emerging option to treat obesity-related metabolic diseases (e.g., type 2 diabetes) and prevent cardiovascular disease (CVD). Metabolic surgery can profoundly alter the gut microbiota; meanwhile, gut microbiota may affect surgical outcomes.
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT07282613?
Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT07282613?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.