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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity

NCTNCT02918279 (opens ClinicalTrials.gov in a new tab)Other idNN8022-4180Other id2014-004353-14Other idU1111-1162-7101Other id2014
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
251 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Double masking
Countries
5 countries

United States, Belgium, Mexico, Russia, Sweden

Start
29 Sept 2016
Primary completion
14 Feb 2019
Completion
8 Aug 2019
First posted
28 Sept 2016 (estimated)
Last update posted
27 Apr 2020
Conditions
Metabolism and Nutrition Disorder · Obesity

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20162017201820192020
  1. Ph 3

    Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity

    NCT02918279

    29 Sept 2016 to 8 Aug 2019

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • LiraglutideDrug
  • PlaceboDrug

Arms2

  • Experimental

    Liraglutide

  • Placebo comparator

    Placebo

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change in BMI SDS (Week 0, Week 56)

    Time frame · Week 0, week 56

    Registry description

    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.

Secondary outcomes(20)

  1. Percent of Subjects Achieving ≥5% Reduction in Baseline BMI

    Time frame · Weeks 30, 56 and 82

    Registry description

    Participants achieving more than or equal to 5% reduction in their baseline (week 0) BMI was evaluated at weeks 30, 56 and 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.

  2. Percent of Subjects Achieving ≥10% Reduction in Baseline BMI

    Time frame · Weeks 30, 56 and 82

    Registry description

    Participants achieving more than or equal to 10% reduction in their baseline (week 0) BMI was evaluated at weeks 30, 56 and 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.

  3. Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82))

    Time frame · (Week 0, week 30); (Week 0, week 82); (Week 56, week 82)

    Registry description

    Change in BMI SDS was evaluated from baseline (week 0) to weeks 30 and 82, and from week 56 to week 82. 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 Z (SDS) score was calculated based on age and sex referring to the values L, M and S. The method is described in the 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 trial period, week 0-30 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30 or 82, respectively.

  4. Change in BMI

    Time frame · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

    Registry description

    Change in BMI was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.

  5. Change in Body Weight (kg)

    Time frame · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

    Registry description

    Change in body weight (kg) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.

  6. Change in Body Weight (%)

    Time frame · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

    Registry description

    Relative change in body weight (kg) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on both participants who completed the trial period, week 0-30, week 0-56 or week 0-82, and participants who could not complete the corresponding trial period, but attended the follow-up visit at week 30, 56 or 82, respectively.

  7. Change in Body Weight (lb)

    Time frame · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

    Registry description

    Body weight was not analysed in pounds (lb). It was analysed for standard unit, 'kg' only.

  8. Change in Waist Circumference

    Time frame · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

    Registry description

    Change in waist circumference was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

  9. Change in Waist-to-hip Circumference Ratio

    Time frame · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

    Registry description

    Change in waist-to-hip circumference ratio was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

  10. Change in hsCRP

    Time frame · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

    Registry description

    Change in high sensitivity C reactive protein (hsCRP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

  11. Change in Fasting Lipid: Total Cholesterol (Ratio to Baseline)

    Time frame · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

    Registry description

    Change in total cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

  12. Change in Fasting Lipid: LDL-cholesterol (Ratio to Baseline)

    Time frame · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

    Registry description

    Change in low density lipoprotein (LDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

  13. Change in Fasting Lipid: HDL-cholesterol (Ratio to Baseline)

    Time frame · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

    Registry description

    Change in high density lipoprotein (HDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

  14. Change in Fasting Lipid: Non-HDL Cholesterol (Ratio to Baseline)

    Time frame · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

    Registry description

    Change in non-HDL cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

  15. Change in Fasting Lipid: VLDL Cholesterol (Ratio to Baseline)

    Time frame · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

    Registry description

    Change in very low density lipoprotein (VLDL) cholesterol from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

  16. Change in Fasting Lipid: Triglycerides (Ratio to Baseline)

    Time frame · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

    Registry description

    Change in triglycerides from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

  17. Change in Fasting Lipid: FFA (Ratio to Baseline)

    Time frame · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

    Registry description

    Change in free fatty acids (FFA) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

  18. Change in Systolic and Diastolic Blood Pressure

    Time frame · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

    Registry description

    Change in systolic blood pressure (SBP) and diastolic blood pressure (DBP) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

  19. Change in HbA1c

    Time frame · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

    Registry description

    Change in glycosylated haemoglobin (HbA1c) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

  20. Change in FPG

    Time frame · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

    Registry description

    Change in fasting plasma glucose (FPG) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are based on the participants who completed treatment for the corresponding treatment period (week 0-30, week 0-56 or week 0-82).

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· Week 0, week 56

Change in BMI SDS (Week 0, Week 56)

GroupValue (SDS score)Spread
Liraglutide 3.0 mg-0.250.51
Placebo-0.020.54
Secondary and other outcome results(7)
Secondary outcomeNumber· Weeks 30, 56 and 82

Percent of Subjects Achieving ≥5% Reduction in Baseline BMI

GroupValue (Percentage of participants)
Liraglutide 3.0 mg46.2
Placebo14.7
Secondary outcomeNumber· Weeks 30, 56 and 82

Percent of Subjects Achieving ≥10% Reduction in Baseline BMI

GroupValue (Percentage of participants)
Liraglutide 3.0 mg24.4
Placebo5.2
Secondary outcomeMean· (Week 0, week 30); (Week 0, week 82); (Week 56, week 82)

Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82))

GroupValue (SDS score)Spread
Liraglutide 3.0 mg-0.260.34
Placebo-0.040.33
Secondary outcomeMean· (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Change in BMI

GroupValue (kg/m^2)Spread
Liraglutide 3.0 mg-1.82.1
Placebo-0.22.2
Secondary outcomeMean· (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Change in Body Weight (kg)

GroupValue (kg)Spread
Liraglutide 3.0 mg-3.96.1
Placebo0.46.6
Secondary outcomeMean· (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Change in Body Weight (%)

GroupValue (Percentage change)Spread
Liraglutide 3.0 mg-4.36.5
Placebo0.46.2
Secondary outcome· (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Change in Body Weight (lb)

GroupValue
Liraglutide 3.0 mgnot posted
Placebonot posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Liraglutide 3.0 mgParticipants received liraglutide in a dose escalation manner for 56 weeks: 0.6 mg during week 1, 1.2 mg during week 2, 1.8 mg during week 3, 2.4 mg during week 4 and 3.0 mg from week 5 to week 56. There was a 26-week off-study-drug follow-up period (week 57-82). Liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.1 / 1253 / 125100 / 125
PlaceboSubjects received liraglutide matching placebo for 56 weeks. There was a 26-week off-study-drug follow-up period (week 57-82). Placebo for liraglutide was administered once daily by s.c. injection in the abdomen, thigh or upper arm irrespective of the timing of meals.0 / 1265 / 12684 / 126

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2023

3 results

Evaluating potential predictors of weight loss response to liraglutide in adolescents with obesity: A post hoc analysis of the randomized, placebo-controlled SCALE Teens trial.

Bensignor et al. 2023Pediatric obesitycited by 22

PMID 37264767PMC10926323DOI 10.1111/ijpo.13061PUB-37264767

CC BY3 results
Download PDFSee results (3)

Indexing hint: Randomized controlled trial · 2020

11 results

A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity.

Kelly et al. 2020The New England journal of medicinecited by 520

PMID 32233338DOI 10.1056/nejmoa1916038PUB-32233338

Full text at the publisher11 results
Publisher pageSee results (11)

Eligibility

Who could join, as posted.

Sex
All
Age
from 12 Years up to 17 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * 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 Exclusion Criteria: * 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

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