Clinical trial

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

Recruiting now · Phase 3 · 11 countries · Registry ID NCT07253285

Recruiting nowPhase 3Interventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age8 Years to 18 Years
SexAll
Healthy volunteersNot accepted
ConditionOverweight, Obesity

Full registry criteria

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.

Treatments and study arms

Cagrilintide

Drug

Participants will receive cagrilintide subcutaneously.

Semaglutide

Drug

Participants will receive semaglutide subcutaneously.

Placebo cagrilintide

Drug

Participants will receive placebo matched to cagrilintide subcutaneously.

Placebo semaglutide

Drug

Participants will receive placebo matched to semaglutide subcutaneously.

Primary outcomes

Relative change in body mass index (BMI)Baseline (week 0), week 68

Measured in percentage (%).

Study locations

121 locations were listed when this page was built. The first 40 are shown.

Perth Children's Hospital🇦🇺 Nedlands, Western Australia, Australia
Queensland Children's Hospital🇦🇺 South Brisbane, Queensland, Australia
The Children's Hospital at Westmead - Clinical Research Centre🇦🇺 Westmead, New South Wales, Australia
Universitätsklinik Kinder-Jugendheilkunde Innsbruck🇦🇹 Innsbruck, Austria
Universitätsklinik für Kinder und Jugendheilkunde Haus E🇦🇹 Salzburg, Austria
UZ Brussel - Universitair Ziekenhuis Brussel🇧🇪 Brussels, Belgium
UZA - Universitair Ziekenhuis Antwerpen🇧🇪 Edegem, Belgium
UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics🌐 Plovdiv, Bulgaria
Medical center Children's Health EOOD🌐 Sofia, Bulgaria
SHATPD - Prof. Ivan Mitev EAD, Pediatric Endocrinology and Metabolic Diseases🌐 Sofia, Bulgaria
UMHAT Sveta Marina EAD, First Pediatric Clinic🌐 Varna, Bulgaria
Beijing Children's Hospital, Capital Medical University🇨🇳 Beijing, Beijing Municipality, China
Capital Center for Children's Health, Capital Medical University🇨🇳 Beijing, Beijing Municipality, China
The First Bethune Hospital of Jilin University-Pediatric🇨🇳 Changchun, Jilin, China
Chengdu Women's and Children's Central Hospital🇨🇳 Chengdu, Sichuan, China
Shandong Provincial Hospital-Pediatric🇨🇳 Jinan, Shandong, China
Children's Hospital of Fudan University🇨🇳 Shanghai, Shanghai Municipality, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology🇨🇳 Wuhan, Hubei, China
Wuhan Children Hospital🇨🇳 Wuhan, Hubei, China
Henan Children's Hospital Zhengzhou Children's Hospital🇨🇳 Zhengzhou, Henan, China
Fundación Santa Fe de Bogotá🇨🇴 Bogotá, Colombia
Servicios de Salud Ips Suramericana S.A.S.🇨🇴 Medellín, Antioquia, Colombia
Clinical Hospital Centre Rijeka_Pediatric🌐 Rijeka, Croatia
KBC "Sestre Milosrdnice"🌐 Zagreb, Croatia
Klinika Za Djecje Bolesti Zagreb_Endocrinology🌐 Zagreb, Croatia
Aalborg Universitetshospital - Børne og Ungeafdelingen🇩🇰 Aalborg, Denmark
Holbæk Sygehus - Børne- og Ungeafdelingen🇩🇰 Holbæk, Denmark
Semmelweis Egyetem ÁOK🇭🇺 Budapest, Hungary
Észak-Közép-budai Centrum, Szent János Kórház és Szakrendelő🇭🇺 Budapest, Hungary
Szegedi Tudományegyetem Gyermekgyógyászati Klinika🇭🇺 Szeged, Hungary
Indira Gandhi Institute of child health🇮🇳 Bangalore, Karnataka, India
Maulana Azad Medical College🇮🇳 Delhi, New Delhi, India
Endolife Specialty Hospitals🇮🇳 Guntur, Andhra Pradesh, India
Regency Hospital🇮🇳 Kanpur, Uttar Pradesh, India
Excel Endocrine Centre🇮🇳 Kolhāpur, India
Institute of Child Health🇮🇳 Kolkata, West Bengal, India
All India Institute of Medical Sciences (AIIMS)🇮🇳 New Delhi, India
Sir Ganga Ram Hospital🇮🇳 New Delhi, National Capital Territory of Delhi, India
BAPS Pramukh Swami Hospital🇮🇳 Surat, Gujarat, India
Rambam MC - Department of Pediatrics A🇮🇱 Haifa, Israel