Brief Summary

This trial is conducted globally. The aim of this trial is to investigate the effect of liraglutide for weight management in pubertal adolescent subjects with obesity.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

251

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Sep 2016

Typical duration for phase_3

Geographic Reach

5 countries

33 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

2.9 years study duration

First Submitted

Initial submission to the registry

September 27, 2016

Completed

1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed

1 day until next milestone

Study Start

First participant enrolled

September 29, 2016

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2019

Completed

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2019

Completed

9 months until next milestone

Results Posted

Study results publicly available

April 27, 2020

Completed

Last Updated

April 27, 2020

Status Verified

April 1, 2020

Enrollment Period

2.4 years

First QC Date

September 27, 2016

Results QC Date

February 6, 2020

Last Update Submit

April 15, 2020

Conditions

Metabolism and Nutrition Disorder Obesity

Outcome Measures

Primary Outcomes (1)

Change in BMI SDS (Week 0, Week 56)
Change from baseline (week 0) in BMI SDS was evaluated at week 56. BMI SDS was calculated using the following formula: Z=\[(value /M)\^L - 1\] / S\*L; where L, M and S are median (M), skewness (L) and variation coefficient (S) of children/adolescents' BMI provided for each sex and age. For each subject, a standard deviation score Z (SDS) was calculated based on age and sex referring to the values L, M and S. The method is described in the world health organisation (WHO) Multicentre Growth Reference, which also contains the values for L, M and S by age and sex. For Z (SDS) scores below -3 and above 3, the score was adjusted as described in the WHO instruction. All available data were used for the analysis including data collected after treatment discontinuation. Results are based on both participants who completed the week 0-56 trial period and participants who prematurely discontinued the trial product but attended the follow-up visit at 56.
Week 0, week 56

Secondary Outcomes (60)

Percent of Subjects Achieving ≥5% Reduction in Baseline BMI
Weeks 30, 56 and 82
Percent of Subjects Achieving ≥10% Reduction in Baseline BMI
Weeks 30, 56 and 82
Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82))
(Week 0, week 30); (Week 0, week 82); (Week 56, week 82)
Change in BMI
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Body Weight (kg)
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
+55 more secondary outcomes

Study Arms (2)

Liraglutide

EXPERIMENTAL

Drug: Liraglutide

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

LiraglutideDRUG

Administered once daily subcutaneously (s.c., under the skin)

Liraglutide

PlaceboDRUG

Administered once daily subcutaneously (s.c., under the skin)

Placebo

Eligibility Criteria

Age12 Years - 17 Years

Sexall

Healthy VolunteersNo

Age GroupsChild (0-17)

You may qualify if:

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
Male or female, age 12 to less than 18 years at the time of signing informed consent and less than 18 years at date of randomisation
BMI corresponding to equal to or above 30 kg/m\^2 for adults by international cut-off points and equal or above the 95th percentile for age and sex (for diagnosis of obesity)
Stable body weight during the previous 90 days before screening V2 (below 5 kg self-reported weight change)
History of failing to lose sufficient weight with lifestyle modification as judged by the investigator and documented in subject's medical record

You may not qualify if:

Pre-pubertal subjects (Tanner stage 1) at screening V2
Type 1 diabetes mellitus (T1DM)
Family or personal history of multiple endocrine neoplasia type 2 (MEN2)
Medullary thyroid carcinoma (MTC)
History of pancreatitis (acute or chronic)
Subjects with secondary causes of obesity (i.e., hypothalamic, genetic or endocrine causes)
Treatment with medications within 90 days before screening V2 that, based on the investigator's judgement, may cause significant weight change. This should also include treatment with any of the following medications: pramlintide, orlistat, zonisamide, topiramate, lorcaserin, phenteremine, bupropion, naltrexone, glucagon-like peptide-1 (GLP-1) receptor agonists, or metformin (used as treatment for obesity)
Anti-diabetic treatment other than metformin
History of major depressive disorder within 2 years before screening V2

Contact the study team to confirm eligibility.