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

Plain English Summary

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 is a Phase 3 clinical trial sponsored by Novo Nordisk A/S studying Diabetes Mellitus, Type 2. This study tests if a new medication combination called CagriSema can lower blood sugar and body weight in children and adolescents with type 2 diabetes. It is for young people aged 10 to under 18 who have been diagnosed with type 2 diabetes and are currently on diet, exercise, or certain diabetes medications. Participants will receive either CagriSema or a placebo (inactive substance) for the first part, and then all participants will receive CagriSema for the second part. The study lasts about 1 year and 3 months. Alternatives include continuing current diabetes management (diet, exercise, existing medications) or other approved diabetes medications for this age group. The trial aims to enroll 80 participants.

Official 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.

Who Can Participate

Here is what you need to know about eligibility for this trial. Children and adolescents aged 10 to under 18 years old. Must have a confirmed diagnosis of type 2 diabetes for at least 30 days. Must be on diet and exercise, or stable doses of insulin, metformin, or SGLT2 inhibitors. Cannot be pregnant, breastfeeding, or of childbearing potential without using effective contraception; cannot have certain other medical conditions like hypoparathyroidism or specific antibody markers for diabetes. This trial is studying Diabetes Mellitus, Type 2, so participants generally need a confirmed diagnosis.

What They're Measuring

The primary outcome measures how much the study drug lowers HbA1c, a key indicator of long-term blood sugar control, helping to assess its effectiveness in managing diabetes. The specific primary outcome measures are: Change in glycated haemoglobin (HbA1c) (From baseline (week 0) to end of double-blinded treatment (week 26)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.

Why This Trial Matters

This trial addresses a critical need for new treatment options to manage type 2 diabetes in children and adolescents, a growing health concern. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Diabetes Mellitus, Type 2, where improved treatment options are needed.

Investor Insight

This trial signals a significant investment in pediatric diabetes care, targeting a growing market with a novel combination therapy, potentially offering a new standard of care if successful. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.

Is This Trial Right for Me?

Ask your doctor about the study's goals, potential benefits, and risks. Understand that participation involves regular clinic visits, blood tests, and injections. Be aware that treatment assignment is random in the first part, and you may receive a placebo. The trial is being conducted at 20 sites. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: QUADRUPLE
• Enrollment: 80 participants

Interventions

• DRUG: CagriSema (Cagrilintide B and Semaglutide I) — Cagrilintide B and Semaglutide I will be administered subcutaneously using DV3384 pen-injector.
• DRUG: Placebo 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.

Primary Outcomes

• Change in glycated haemoglobin (HbA1c) (From baseline (week 0) to end of double-blinded treatment (week 26))

Secondary Outcomes

• Relative change in body mass index (BMI) (From baseline (week 0) to end of double-blinded treatment (week 26))
• Number of participants with achievement of HbA1c target values of less than (<) 7.0% (< 53 millimole per mole [mmol/mol]) (At end of double-blinded treatment (week 26))
• Number of participants with achievement of HbA1c target values of less than or equal to (≤) 6.5% (≤48 mmol/mol) (At end of double-blinded treatment (week 26))
• Change in time in range (TIR) 3.9-10.0 millimole per liter (mmol/L) (70-180 milligram per deciliter (mg/dL) measured using continuous glucose monitoring (CGM) (From baseline (collected during week -3, -2 and -1) to end-of-double-blinded treatment (collected during week 22, 23, 24, and 25))
• Change in time in tight target range (TITR) 3.9-7.8 mmol/L (70-140 mg/dL) measured using CGM (From baseline (collected during week -3, -2 and -1) to end-of-double-blinded treatment (collected during week 22, 23, 24, and 25))

Full 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.

Trial Locations

• Yale School of Medicine, New Haven, Connecticut, United States
• Encore Medical Research Boynton Beach, Boynton Beach, Florida, United States
• Nemours Chld Clnc Jacksonville, Jacksonville, Florida, United States
• Innovus Clinical, Kissimmee, Florida, United States
• D&H National Research Centers, Tamarac, Florida, United States
• Clinical Research Trials of Florida, Tampa, Florida, United States
• Columbus Research Foundation, Columbus, Georgia, United States
• Eastside Bariatric and Gen Surg, Snellville, Georgia, United States
• SIU Medicine, Springfield, Illinois, United States
• Riley Hospital For Children, Indianapolis, Indiana, United States
• ...and 10 more locations

Frequently Asked Questions

Related Conditions

• Type 2 Diabetes
• Pediatric Diabetes
• Obesity
• Metabolic Syndrome
• Insulin Resistance
• Adolescent Health
• Glycemic Control
• Cardiovascular Risk Factors
• Endocrinology
• Pediatric Endocrinology

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