Current partner codePEPTIDESDE
NCT07253285·Phase 3·INTERVENTIONAL

A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight

Status

Recruiting

Phase

Phase 3

Enrollment

460

Locations

120

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This study will look at how well CagriSema and cagrilintide help children and adolescents with excess body weight lose weight. The study has 2 parts: main and extension study. In the main study, participants will either get CagriSema (a new study drug), cagrilintide (a new study drug), semaglutide (a drug that doctors can already prescribe to adolescents and adults) or placebo (a placebo looks like the treatment being tested, but doesn't have any active ingredients in it). Which treatment participants will get is decided by chance. Participants who get semaglutide in the main study will not take part in the extension study. If participants take part in the extension study, they will get either CagriSema or cagrilintide in this part of the study. Like all drugs, the study drugs may have side effects. The total time participants will be in the main study is about 1 year and 6 months. If participants take part in the extension study, the total time is about 4 years and 10 months.

Interventions

Treatment arms and agents.

DRUG

Cagrilintide

Participants will receive cagrilintide subcutaneously.

DRUG

Semaglutide

Participants will receive semaglutide subcutaneously.

DRUG

Placebo cagrilintide

Participants will receive placebo matched to cagrilintide subcutaneously.

DRUG

Placebo semaglutide

Participants will receive placebo matched to semaglutide subcutaneously.

Timeline

From registration to results.

  1. First posted

    Nov 28, 2025

  2. Study start

    Jan 8, 2026

  3. Primary completion

    Mar 20, 2030

  4. Study completion

    Sep 20, 2033

  5. Results posted

    Not reported

  6. Registry updated

    Jul 17, 2026

Outcomes

What the study measures.

Primary outcomes

Relative change in body mass index (BMI)

Time frame · Baseline (week 0), week 68

Measured in percentage (%).

Secondary outcomes

Relative change in body weight

Time frame · Baseline (week 0), week 68

Measured in %.

Change in BMI Standard Deviation Score (SDS)

Time frame · Baseline (week 0), week 68

Measured as SDS score.

Relative change in BMI

Time frame · Baseline (week 0), week 68 and week 224

Measured in %.

Number of participants in weight category reduction

Time frame · Baseline (week 0), week 68

Measured as count of participants.

Number of participants who achieved greater than or equal to (>=) 5 percent (%) reduction of body weight (yes/no)

Time frame · Baseline (week 0), week 68

Measured as count of participants.

Number of participants who achieved >=10% reduction of body weight (yes/no)

Time frame · Baseline (week 0), week 68

Measured as count of participants.

Number of participants who achieved >=15% reduction of body weight (yes/no)

Time frame · Baseline (week 0), week 68

Measured as count of participants.

Number of participants who achieved >=20% reduction of body weight (yes/no)

Time frame · Baseline (week 0), week 68

Measured as count of participants.

Number of participants who achieved >=25% reduction of body weight (yes/no)

Time frame · Baseline (week 0), week 68

Measured as count of participants.

Number of participants who achieved >=5% reduction of BMI (yes/no)

Time frame · Baseline (week 0), week 68

Measured as count of participants.

Eligibility

Who can take part.

Minimum age
8 Years
Maximum age
18 Years
Sex
ALL
Healthy volunteers
No

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. * Aged 8 to less than (\<) 18 years at the time of signing the informed consent. * Body mass index (BMI), at screening, corresponding to: * Greater than or equal to (\>=) 95th percentile for children aged 8 to \< 12 years (Tanner stage 1-5) * \>= 95th percentile or \>= 85th percentile with the presence of at least one obesity-related complication including, but not limited to, type 2 diabetes (T2D), hypertension, dyslipidaemia or obstructive sleep apnoea for adolescents aged 12 to \< 18 years (Tanner stage 2-5). * Laboratory parameters, as measured by the central lab at screening, within normal sex- and age-specific ranges of total calcium, phosphate, alkaline phosphatase, parathyroid hormone. * History of at least one unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification programme (diet and exercise counselling) for at least 3 months. * Body weight greater than (\>) 45 kilograms (kg) at screening. For participants with T2D at screening the following inclusion criteria also apply * Glycated haemoglobin (HbA1c) less than or equal to (\<=)10.0 percent (%) (86 millimoles per mole \[mmol/mol\]) as measured by central laboratory at screening. * Treatment with lifestyle intervention or treatment with metformin according to local label. * Treatment with metformin should be stable (same dose and dosing frequency) for at least 56 days before screening. Key exclusion criteria: * Treatment with any medication prescribed for obesity or weight management within 90 days before screening. * Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: * Liposuction and/or abdominoplasty, if performed \> 1 year before screening. * Adjustable gastric banding, if the band has been removed \> 1 year before screening. * Intragastric balloon, if the balloon has been removed \> 1 year before screening. * Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed \>1 year before screening. * Uncontrolled thyroid disease. * Endocrine, hypothalamic, or syndromic obesity. * A self-reported (or by parent(s)/LAR, where applicable) change in body weight \> 5 % within 90 days before screening irrespective of medical records. * Type 1 diabetes or monogenic diabetes. For participants without T2D at screening the following exclusion criteria also apply * HbA1c greater than or equal to 6.5% (48 mmol/mol) as measured by the central laboratory at screening. * Treatment with glucose-lowering agent(s) prescribed for the indication of diabetes or pre-diabetes within 90 days before screening. For participants with T2D at screening the following exclusion criteria also apply * Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire. * Recurrent severe hypoglycaemic episodes within 1 year before screening, as judged by the investigator. * Positive insulinoma associated protein-2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies. * Treatment with any medication for the indication of diabetes other than those stated in the inclusion criteria within 90 days before screening. * Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination 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 locations

120 registered sites.

Australia · Austria · Belgium · Bulgaria · China · Colombia · Croatia · Denmark · Hungary · India · Israel · Italy · Malaysia · Mexico · Netherlands · Poland · Portugal · Romania · Serbia · Slovakia · Spain · Sweden · Taiwan · Thailand · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.

Neighborhood Healthcare

Escondido, California, United States

Encore Medical Research LLC

Hollywood, Florida, United States

Jacksonville Ctr for Clin Res

Jacksonville, Florida, United States

Encore Medical Research of Weston

Weston, Florida, United States

Children's Healthcare Atlanta

Atlanta, Georgia, United States

Columbus Research Foundation

Columbus, Georgia, United States

Accel Research Sites-NeuroStudies

Decatur, Georgia, United States

Eastside Bariatric and Gen Surg

Snellville, Georgia, United States

Solaris Clinical Research

Meridian, Idaho, United States

IU Health - Riley Physicians Endo-Diab

Indianapolis, Indiana, United States

Cotton O'Neil Clinical Research Center

Topeka, Kansas, United States

Pennington Biomed Res Ctr

Baton Rouge, Louisiana, United States

Barry J. Reiner, MD LLC

Baltimore, Maryland, United States

University of Minnesota

Minneapolis, Minnesota, United States

AES Minneapolis DRS

Richfield, Minnesota, United States

UBMD Physicians Group - Pediatrics - Conventus

Buffalo, New York, United States

SUNY Upstate Medical Univ - Syracuse

Syracuse, New York, United States

Advantage Clinical Trials

The Bronx, New York, United States

Valley Weight Loss Clinic

Fargo, North Dakota, United States

Centricity Research - Ohio

Columbus, Ohio, United States

PriMed Clinical Research

Dayton, Ohio, United States

Children's Physicians OU

Oklahoma City, Oklahoma, United States

UPMC Child Hosp-Pittsburgh

Pittsburgh, Pennsylvania, United States

Prisma Health-Ped Endo

Greenville, South Carolina, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Semaglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.