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

Официальное название

Efficacy, Safety and Pharmacokinetics of Cagrilintide s.c. 2.4 mg as Monotherapy and in Combination With Semaglutide s.c. 2.4 mg (CagriSema) Once Weekly for Weight Management in Chidren and Adolescents With Overweight or Obesity

Обзор

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.

Вмешательства

• Препарат Cagrilintide
  Participants will receive cagrilintide subcutaneously.
• Препарат Semaglutide
  Participants will receive semaglutide subcutaneously.
• Препарат Placebo cagrilintide
  Participants will receive placebo matched to cagrilintide subcutaneously.
• Препарат Placebo semaglutide
  Participants will receive placebo matched to semaglutide subcutaneously.

Первичные конечные точки

• Relative change in body mass index (BMI) [Срок оценки: Baseline (week 0), week 68]

Вторичные конечные точки (12)

• Relative change in body weight [Срок оценки: Baseline (week 0), week 68]
• Change in BMI Standard Deviation Score (SDS) [Срок оценки: Baseline (week 0), week 68]
• Relative change in BMI [Срок оценки: Baseline (week 0), week 68 and week 224]
• Number of participants in weight category reduction [Срок оценки: Baseline (week 0), week 68]
• Number of participants who achieved greater than or equal to (>=) 5 percent (%) reduction of body weight (yes/no) [Срок оценки: Baseline (week 0), week 68]
• Number of participants who achieved >=10% reduction of body weight (yes/no) [Срок оценки: Baseline (week 0), week 68]
• Number of participants who achieved >=15% reduction of body weight (yes/no) [Срок оценки: Baseline (week 0), week 68]
• Number of participants who achieved >=20% reduction of body weight (yes/no) [Срок оценки: Baseline (week 0), week 68]
• Number of participants who achieved >=25% reduction of body weight (yes/no) [Срок оценки: Baseline (week 0), week 68]
• Number of participants who achieved >=5% reduction of BMI (yes/no) [Срок оценки: Baseline (week 0), week 68]
• Number of participants who achieved >=10% reduction of BMI (yes/no) [Срок оценки: Baseline (week 0), week 68]
• Number of participants who achieved >=15% reduction of BMI (yes/no) [Срок оценки: Baseline (week 0), week 68]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 34 центра

• Neighborhood Healthcare — Escondido
• Encore Medical Research LLC — Hollywood
• Jacksonville Ctr for Clin Res — Jacksonville
• Encore Medical Research of Weston — Weston
• Children's Healthcare Atlanta — Atlanta
• Columbus Research Foundation — Columbus
• Accel Research Sites-NeuroStudies — Decatur
• Eastside Bariatric and Gen Surg — Snellville
• … и ещё 26 центров

Китай · 9 центров

• Capital Center for Children's Health, Capital Medical University — Пекин
• Beijing Children's Hospital, Capital Medical University — Пекин
• Henan Children's Hospital Zhengzhou Children's Hospital — Чжэнчжоу
• Wuhan Children Hospital — Ухань
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Ухань
• The First Bethune Hospital of Jilin University-Pediatric — Changchun
• Shandong Provincial Hospital-Pediatric — Цзинань
• Children's Hospital of Fudan University — Шанхай
• … и ещё 1 центр

Индия · 9 центров

• Endolife Specialty Hospitals — Guntur
• BAPS Pramukh Swami Hospital — Surat
• Indira Gandhi Institute of child health — Bangalore
• Sir Ganga Ram Hospital — New Delhi
• Maulana Azad Medical College — Delhi
• Regency Hospital — Kanpur
• Institute of Child Health — Kolkata
• Excel Endocrine Centre — Kolhāpur
• … и ещё 1 центр

Болгария · 4 центра

• UMHAT Sveti Georgi EAD, Plovdiv, Clinic of Pediatrics — Plovdiv
• SHATPD - Prof. Ivan Mitev EAD, Pediatric Endocrinology and Metabolic Diseases — Sofia
• Medical center Children's Health EOOD — Sofia
• UMHAT Sveta Marina EAD, First Pediatric Clinic — Varna

Израиль · 4 центра

• Rambam MC - Department of Pediatrics A — Haifa
• Shaare Zedek MC - Endocrinology Department — Jerusalem
• Schneider MC - Endrocrinology and Diabetes — Petah Tikva
• Shamir MC - Pediatric and Adolescents Endocrinology unit — Ẕerifin

Италия · 4 центра

• Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico - UO Endocrinologia — Milan
• AOU Maggiore della Carità di Novara - Dipartimento Interaziendale Strutturale Materno Infa — Novara
• A.O.U.I Verona - Ospedale Donna Bambino Borgo Trento - Pediatria B — Verona
• … и ещё 1 центр

Польша · 4 центра

Список центров уточняется — проверьте первичный протокол.

Румыния · 4 центра

Список центров уточняется — проверьте первичный протокол.

Тайвань · 4 центра

Список центров уточняется — проверьте первичный протокол.

Австралия · 3 центра

• The Children's Hospital at Westmead - Clinical Research Centre — Westmead
• Queensland Children's Hospital — South Brisbane
• Perth Children's Hospital — Nedlands

Хорватия · 3 центра

• Clinical Hospital Centre Rijeka_Pediatric — Rijeka
• KBC "Sestre Milosrdnice" — Zagreb
• Klinika Za Djecje Bolesti Zagreb_Endocrinology — Zagreb

Венгрия · 3 центра

• Észak-Közép-budai Centrum, Szent János Kórház és Szakrendelő — Budapest
• Semmelweis Egyetem ÁOK — Budapest
• Szegedi Tudományegyetem Gyermekgyógyászati Klinika — Szeged

Малайзия · 3 центра

Список центров уточняется — проверьте первичный протокол.

Мексика · 3 центра

Список центров уточняется — проверьте первичный протокол.

Португалия · 3 центра

Список центров уточняется — проверьте первичный протокол.

Сербия · 3 центра

Список центров уточняется — проверьте первичный протокол.

Словакия · 3 центра

Список центров уточняется — проверьте первичный протокол.

Испания · 3 центра

Список центров уточняется — проверьте первичный протокол.

Великобритания · 3 центра

Список центров уточняется — проверьте первичный протокол.

Австрия · 2 центра

• Universitätsklinik Kinder-Jugendheilkunde Innsbruck — Innsbruck
• Universitätsklinik für Kinder und Jugendheilkunde Haus E — Salzburg

Бельгия · 2 центра

• UZ Brussel - Universitair Ziekenhuis Brussel — Brussels
• UZA - Universitair Ziekenhuis Antwerpen — Edegem

Колумбия · 2 центра

• Servicios de Salud Ips Suramericana S.A.S. — Medellín
• Fundación Santa Fe de Bogotá — Bogotá

Дания · 2 центра

• Aalborg Universitetshospital - Børne og Ungeafdelingen — Aalborg
• Holbæk Sygehus - Børne- og Ungeafdelingen — Holbæk

Нидерланды · 2 центра

Список центров уточняется — проверьте первичный протокол.

Швеция · 2 центра

Список центров уточняется — проверьте первичный протокол.

Таиланд · 2 центра

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07253285 · NN9838-4968 · U1111-1299-4751 · 2023-509176-42

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗