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

Official title

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

Overview

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

• 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.

Primary outcome measures

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

Secondary outcome measures (12)

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

Eligibility 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 34 centers

• 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
• … and 26 more centers

China · 9 centers

• Capital Center for Children's Health, Capital Medical University — Beijing
• Beijing Children's Hospital, Capital Medical University — Beijing
• Henan Children's Hospital Zhengzhou Children's Hospital — Zhengzhou
• Wuhan Children Hospital — Wuhan
• Union Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan
• The First Bethune Hospital of Jilin University-Pediatric — Changchun
• Shandong Provincial Hospital-Pediatric — Jinan
• Children's Hospital of Fudan University — Shanghai
• … and 1 more center

India · 9 centers

• 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
• … and 1 more center

Bulgaria · 4 centers

• 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

Israel · 4 centers

• 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

Italy · 4 centers

• 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
• … and 1 more center

Poland · 4 centers

Center list to be confirmed — check the primary protocol.

Romania · 4 centers

Center list to be confirmed — check the primary protocol.

Taiwan · 4 centers

Center list to be confirmed — check the primary protocol.

Australia · 3 centers

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

Croatia · 3 centers

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

Hungary · 3 centers

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

Malaysia · 3 centers

Center list to be confirmed — check the primary protocol.

Mexico · 3 centers

Center list to be confirmed — check the primary protocol.

Portugal · 3 centers

Center list to be confirmed — check the primary protocol.

Serbia · 3 centers

Center list to be confirmed — check the primary protocol.

Slovakia · 3 centers

Center list to be confirmed — check the primary protocol.

Spain · 3 centers

Center list to be confirmed — check the primary protocol.

United Kingdom · 3 centers

Center list to be confirmed — check the primary protocol.

Austria · 2 centers

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

Belgium · 2 centers

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

Colombia · 2 centers

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

Denmark · 2 centers

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

Netherlands · 2 centers

Center list to be confirmed — check the primary protocol.

Sweden · 2 centers

Center list to be confirmed — check the primary protocol.

Thailand · 2 centers

Center list to be confirmed — check the primary protocol.

Identifiers

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

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗