A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
Recruiting · NCT07253285 · Interventional (participants receive a specific treatment) · Lead sponsor: Novo Nordisk A/S
View the official record on ClinicalTrials.gov →Interventions studied
What this trial 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.
Who can take part
Age range
8 Years to 18 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 19 US states.
- 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
- Synexus Clinical Research US-MN - 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
- Coastal Carolina Research Ctr - North Charleston, South Carolina, United States
- Monument Health Clinical Rsrch - Rapid City, South Dakota, United States
- LifeDoc Health - Memphis, Tennessee, United States
- DM Clinical - Houston, Texas, United States
- DM Clinical - San Antonio, Texas, United States
- The Texas Liver Institute - San Antonio, Texas, United States
- Pinnacle Clinical Research - San Antonio, Texas, United States
- Consano Clin Res-Shavano Park - Shavano Park, Texas, United States
- Texas Valley Clinical Research - Weslaco, Texas, United States
- AMR Clinical - Layton, Utah, United States
- Jeroen Bosch Zkh - 's-Hertogenbosch, Netherlands
- Aalborg Universitetshospital - Børne og Ungeafdelingen - Aalborg, Denmark
- Meander MC - Amersfoort, Netherlands
- Spitalul Judetean de Urgenta Dr. Constantin Opris Baia Mare - Baia Mare, Romania
- King Chulalongkorn Memorial Hospital_Ped-Nutrition - Bangkok, Thailand
- Hosp. Vall d'Hebrón_Endocrinología pediatríca - Barcelona, Spain
- University Children's Hospital Tirsova - Belgrade, Serbia
- Institute for Mother and Child Health Care of Serbia - Belgrade, Serbia
- Birmingham Children's Hospital - Birmingham, United Kingdom
- Fundación Santa Fe de Bogotá - Bogotá, Colombia
- Narodny Ustav Detskych Chorob - Bratislava, Slovakia
- UZ Brussel - Universitair Ziekenhuis Brussel - Brussels, Belgium
- Kilostop Junior SRL - Bucharest, Romania
- Spitalul Clinic de Urgenta pentru Copii "M.S.Curie" - Bucharest, Romania
- Észak-Közép-budai Centrum, Szent János Kórház és Szakrendelő - Budapest, Hungary
- Semmelweis Egyetem ÁOK - Budapest, Hungary
- Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej im. Dzieci Warszawy w Dziekanowie Lesnym - Dziekanów Leśny, Poland
- UZA - Universitair Ziekenhuis Antwerpen - Edegem, Belgium
- Hospital Sant Joan de Déu - Esplugues de Llobregat, Spain
- Rambam MC - Department of Pediatrics A - Haifa, Israel
- Holbæk Sygehus - Børne- og Ungeafdelingen - Holbæk, Denmark
- Universitätsklinik Kinder-Jugendheilkunde Innsbruck - Innsbruck, Austria
- Shaare Zedek MC - Endocrinology Department - Jerusalem, Israel
- Chang Gung Memorial Hospital - Kaohsiung Branch - Kaohsiung City, Taiwan
- Excel Endocrine Centre - Kolhāpur, India
- Detska Fakultna nemocnica Kosice - Košice, Slovakia
Showing 60 of 121 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →