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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

Efficacy and Safety of Co-administered Cagrilintide and Semaglutide (CagriSema) s.c. Once Weekly Versus Placebo in Children and Adolescents With Type 2 Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
10 Years to 18 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 1 year

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The study will last for about 1 year and 3 months."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well CagriSema lowers blood sugar and body weight in children ages 10–17 with type 2 diabetes. At first, participants get either CagriSema or a placebo (a treatment with no active medicine) by chance; later, everyone gets CagriSema. The study lasts about 1 year and 3 months.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • A parent or legal guardian must give written permission before any study activities. The child must also agree, as required for their age and local rules.
  • Be 10–17 years old when consent is signed.
  • Have been diagnosed with type 2 diabetes at least 30 days before screening.
  • Receive diet and exercise counseling, either alone or with insulin, metformin, SGLT2 inhibitors (a type of diabetes medicine), or a combination of these.
  • If taking metformin, use at least 1,000 mg daily or the highest dose you can tolerate for at least 56 days. If taking an SGLT2 inhibitor, use the same daily dose for at least 56 days.
  • If using insulin, the dose must have stayed within 25% of the screening dose for at least 30 days.
  • Have an HbA1c of 6.5%–11.0% at screening. This blood test measures average blood sugar.
  • Weigh at least 45 kg (about 99 pounds). BMI, a measure based on height and weight, must be at or above the 85th percentile for your age and sex.

Who can't join

  • Be pregnant, breastfeeding, planning pregnancy, or able to become pregnant without using highly effective birth control.
  • Have used diabetes or weight-loss medicines other than those allowed above within 90 days before screening.
  • Have or have had hypoparathyroidism, a condition in which the body makes too little parathyroid hormone.
  • Have had or plan to have weight-loss surgery or a weight-loss device during the study. Exceptions include liposuction or a tummy tuck done over a year before screening, or a lap band, stomach balloon, or intestinal bypass sleeve removed over a year before screening.
  • Have a positive test now or in the past for IA-2 or anti-GAD antibodies, immune proteins linked to diabetes.
  • Have had repeated episodes of severely low blood sugar in the past year, as judged by the study doctor.
  • Have trouble noticing when blood sugar is low, based on the study doctor's assessment.
  • Have uncontrolled diabetes-related eye damage that may worsen, as checked by an eye exam and scan.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 10 to \< 18 years at the time of signing the informed consent. * 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) * Metformin * SGLT2i * 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 BMI ≥ 85th percentile(b). BMI will be calculated in the electronic case report form based on height and body weight at screening. * (a) For metformin, a stable dose is defined as at least 1000 mg daily or the maximum tolerated dose for ≥ 56 days prior to screening. For Sodium-Glucose Transport protein 2 inhibitor (SGLT2i), a stable dose is defined as the same total daily dose for ≥ 56 days prior to screening. For insulin, it is defined as the dose ± 25% of that taken at screening for ≥ 30 days prior to screening. * (b) Based on sex-specific 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. Key Exclusion Criteria: * 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 inclusion criteria within 90 days before screening. * Known or previous diagnosis of hypoparathyroidism. * Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: (1) liposuction and/or abdominoplasty, if performed \>1 year before screening, (2) lap banding, if the band has been removed \>1 year before screening, (3) intragastric balloon, if the balloon has been removed \>1 year before screening or (4) duodenal-jejunal bypass sleeve, if the sleeve has been removed \> 1 year before screening. * 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. * Uncontrolled and potentially unstable diabetic retinopathy maculopathy. Verified by a fundus examination and optical coherence tomography (OCT) assessment performed within 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Study sites (21)

CT

FL

GA

IA

IL

IN

MI

NY

PA

SD

TN

TX

VA

WA