A research study on how well liraglutide works in children with obesity

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novo Nordisk A/S

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

1 Mar 2021 → ongoing

Decision date (initial)

2024-02-01

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Novo Nordisk A/S

External identifiers

EU CT number

2023-508504-38-00

EudraCT number

2020-000546-34

WHO UTN

U1111-1247-8226

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy

"To compare the effect of liraglutide 3.0 mg s.c. once daily versus placebo on weight
management in children aged 6 to <12 years with obesity"

Secondary objectives 2

1. "To compare the effect of liraglutide 3.0 mg s.c. once daily versus placebo in children aged 6 to <12 years with obesity on: • Cardiovascular risk factors • Glucose metabolism"
2. "To evaluate the safety and tolerability of liraglutide 3.0 mg s.c. once daily versus placebo in children aged 6 to <12 years with obesity"

Conditions and MedDRA coding

Obesity

Regulatory references

EMA paediatric investigation plan (PIP)

EMEA-000128-PIP02-09

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. "Informed consent of parent(s) or legally acceptable representative of subject and child assent, as age-appropriate, obtained before any trial-related activities for the Main phase as well as for the Extension phase of the trial. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial"
2. Male or female, aged 6 to <12 years at the time of signing informed consent
3. Tanner stage 1-5 pubertal development at the time of signing informed consent
4. BMI ≥95th percentile, on gender and age-specific growth charts (CDC.gov)
5. History of failing to lose sufficient weight with lifestyle modification as judged by the investigator
6. For T2D Haemoglobin A1c (HbA1c) ≤10.0% (86 mmol/mol) as measured by central laboratory at screening

Exclusion criteria 1

1. Nothing written about Key Excl.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Relative change in BMI, from basekline (week 0) to week 56, in Percent

Secondary endpoints 12

1. Confirmatory secondary endpoints: Relative change in body weight, from week 0 to week 56 in Percent
2. Subjects achieving ≥5% reduction of BMI, from week 0 to week 56 in, Yes/No
3. Supportive secondary endpoints Effect endpoints: Change in body weight, From baseline (week 0) to week 56, in kg
4. Change in BMI standard deviation score (WHO.int)6, From baseline (week 0) to week 56, Unitless
5. Subjects achieving ≥10% reduction of BMI, From baseline (week 0) to week 56, Yes/No
6. "BMI percentage of the 95th percentile on gender and age-specific growth charts (CDC.gov), From baseline (week 0) to week 56, in Percent point"
7. Change in waist circumference, From baseline (week 0) to week 56, in cm
8. Change in systolic blood pressure, From baseline (week 0) to week 56, in mmHg
9. Change in diastolic blood pressure, From baseline (week 0) to week 56, in mmHg
10. Change in HbA1c, From baseline (week 0) to week 56, in Percent point
11. Safety endpoints: Treatment emergent adverse events (TEAEs), From baseline (week 0) to week 82, in Numbers
12. Treatment emergent serious adverse events (SAEs), From baseline (week 0) to week 82, in Numbers

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novo Nordisk A/S

Sponsor organisation

Novo Nordisk A/S

Address

Novo Alle 1

City

Bagsvaerd

Postcode

2880

Country

Denmark

Scientific contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission Hub

Public contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission Hub

Third parties 9

Locations

2 EU/EEA countries · 6 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 27 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications