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Metabolism and Nutrition DisorderPhase 3NCT02918279

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

A Phase 3 study testing Liraglutide in people with Metabolism and Nutrition Disorder and Obesity, run by Novo Nordisk A/S at 33 sites in 5 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 17 years
Conditions the study is for
Metabolism and Nutrition Disorder, Obesity
What is being tested?
Liraglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
251 participants
Where
33 sitesin 5 countries
Study dates
29 Sep 2016to 8 Aug 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • 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

Trial locations and contacts

33 sites in 5 countries.

33 sites in 5 countries

United States13 sites

  • Novo Nordisk Investigational Site

    Baltimore, Maryland, 21229

  • Novo Nordisk Investigational Site

    Baton Rouge, Louisiana, 70808-4124

  • Novo Nordisk Investigational Site

    Buffalo, New York, 14222

  • Novo Nordisk Investigational Site

    Charleston, South Carolina, 29425

  • Novo Nordisk Investigational Site

    Columbus, Ohio, 43213

  • Novo Nordisk Investigational Site

    Dayton, Ohio, 45406

  • Novo Nordisk Investigational Site

    Dayton, Ohio, 45419

  • Novo Nordisk Investigational Site

    Goose Creek, South Carolina, 29445

  • Novo Nordisk Investigational Site

    Greenville, South Carolina, 29615

  • Novo Nordisk Investigational Site

    Memphis, Tennessee, 38119

  • Novo Nordisk Investigational Site

    Meridian, Idaho, 83646

  • Novo Nordisk Investigational Site

    Minneapolis, Minnesota, 55455

  • Novo Nordisk Investigational Site

    Pittsburgh, Pennsylvania, 15224

Other trials in United States

Russia8 sites

  • Novo Nordisk Investigational Site

    Moscow, 125373

  • Novo Nordisk Investigational Site

    Novosibirsk, 630048

  • Novo Nordisk Investigational Site

    Rostov-on-Don, 344013

  • Novo Nordisk Investigational Site

    Saint Petersburg, 191144

  • Novo Nordisk Investigational Site

    Samara, 443079

  • Novo Nordisk Investigational Site

    Stavropol, 355035

  • Novo Nordisk Investigational Site

    Tomsk, 634050

  • Novo Nordisk Investigational Site

    Ufa, 450106

Other trials in Russia

Belgium6 sites

  • Novo Nordisk Investigational Site

    Brussels, 1090

  • Novo Nordisk Investigational Site

    Brussels, 1200

  • Novo Nordisk Investigational Site

    Edegem, 2650

  • Novo Nordisk Investigational Site

    Hasselt, 3500

  • Novo Nordisk Investigational Site

    Leuven, 3000

  • Novo Nordisk Investigational Site

    Namur, 5000

Other trials in Belgium

Sweden4 sites

  • Novo Nordisk Investigational Site

    Gothenburg, 416 85

  • Novo Nordisk Investigational Site

    Huddinge, 141 57

  • Novo Nordisk Investigational Site

    Malmö, 205 02

  • Novo Nordisk Investigational Site

    Uppsala, 751 85

Other trials in Sweden

Mexico2 sites

  • Novo Nordisk Investigational Site

    Ciudad Madero, Tamaulipas, 89440

  • Novo Nordisk Investigational Site

    Puebla City, 72190

Other trials in Mexico

About this study

Official title: Effect of Liraglutide for Weight Management in Pubertal Adolescent Subjects With Obesity. 56-week, Double-blind, Randomised, Parallel-group, Placebo-controlled Multi-national Trial Followed by a 26-week Period Off Study-drug

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.

Being tested
Liraglutide, Placebo
Medical subject headings
Nutrition Disorders, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LiraglutideDrug

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

  • PlaceboDrug

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

Study groups in NCT02918279
Study groupRoleWhat they receive
LiraglutideExperimentalNot described
Receives: Drug: Liraglutide
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Week 0, week 56

Secondary outcomes (60)

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

    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.

    Measured: Weeks 30, 56 and 82

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

    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.

    Measured: Weeks 30, 56 and 82

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

    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.

    Measured: (Week 0, week 30); (Week 0, week 82); (Week 56, week 82)

  4. Change in BMI

    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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  5. Change in Body Weight (kg)

    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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  6. Change in Body Weight (%)

    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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  7. Change in Body Weight (lb)

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

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  8. Change in Waist Circumference

    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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  9. Change in Waist-to-hip Circumference Ratio

    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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  10. Change in hsCRP

    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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

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

    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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

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

    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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

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

    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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

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

    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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

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

    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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

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

    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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

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

    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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  18. Change in Systolic and Diastolic Blood Pressure

    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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  19. Change in HbA1c

    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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  20. Change in FPG

    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).

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  21. Change in Fasting Insulin (Ratio to Baseline)

    Change in fasting insulin 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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  22. Change in Fasting C-peptide (Ratio to Baseline)

    Change in fasting C-peptide 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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  23. Change in Glycaemic Category

    Number of participants in glycaemic categories, "normoglycaemia, pre-diabetes and type 2 diabetes (T2DM)" at baseline (weeks -2), and weeks 30, 56 and 82 are presented. These categories were set as per the following criteria: 1) Normoglycaemia: FPG <5.6 mmol/L (<100 mg/dL) and/or HbA1c <5.7%. 2) Pre-diabetes: FPG 5.6-6.9 mmol/L (both inclusive), FPG 100-125 mg/dL (both inclusive) or HbA1c 5.7-6.4% (both inclusive). 3) Type 2 diabetes (T2DM): FPG ≥7.0 mmol/L (≥126 mg/dL) and/or HbA1c ≥6.5%. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

    Measured: Week -2, week 30, week 56 and week 82

  24. Change in HOMA-B (Ratio to Baseline)

    Change in homeostasis model assessment of beta-cell function (HOMA-B) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. HOMA-B was calculated as: Beta-cell function (%) = 20·fasting insulin[mU/L]/(FPG[mmol/L]-3.5). Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  25. Change in HOMA-IR (Ratio to Baseline)

    Change in homeostasis model assessment of insulin resistance (HOMA-IR) from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82 are presented as ratio to baseline. HOMA-IR was calculated as: Insulin resistance (%) = fasting insulin [mU/L] x FPG [mmol/L]/ 22.5. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  26. Change in IWQOL-Kids

    Change in Impact of Weight on Quality of Life-Kids (IWQOL-Kids) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. The IWQOL-Kids is a 27-item measure of weight-related quality of life. There are four domain scores (Physical Comfort, Body Esteem, Social Life and Family Life) and a total score. Scores for all domains and total score range from 0-100, with higher scores representing better health-related quality of life. IWQOL-kids data at week 82 was not collected, thus could not be evaluated. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  27. Change in BMI SDS (%)

    Relative change in BMI SDS was evaluated from baseline (week 0) to weeks 30 and 56. Results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56.

    Measured: (Week 0, week 30); (Week 0, week 56)

  28. Change in Nutritional Compliance

    This outcome measure presents "nutritional compliance results" recorded at baseline (week 0), week 30 and week 56. Nutritional compliance was recorded on a 0 to 10 numeric rating scale, with higher scores representing better compliance. Week 30 and 56 results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56.

    Measured: Week 0, week 30 and week 56

  29. Number of Treatment Emergent Adverse Events

    A treatment emergent adverse event (TEAE) was defined as an event that occurred in the "on-treatment" period. 'On-treatment' period: Events with onset date between the first day of trial product administration and any of the following date, whichever came first: 1) 14 days after the last day on trial product, or 2) follow-up visit (week 58) for participants who discontinued trial product, or 3) last study visit (participants withdrawn without follow-up visit).

    Measured: Week 0-56 + 14 days

  30. Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification)

    A hypoglycaemic episode was defined as treatment emergent if the onset of the episode was on or after the first day of exposure to randomised treatment and no later than 14 days after the last day on randomised treatment. Severe hypoglycaemia episodes were recorded as per international society for pediatric and adolescent diabetes (ISPAD) definition. And the following presented hypoglycaemia episodes were recorded as per American Diabetes Association (ADA) definition: asymptomatic hypoglycaemia, documented symptomatic hypoglycaemia, pseudo-hypoglycaemia and probable symptomatic hypoglycaemia.

    Measured: Week 0-56 + 14 days

  31. Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification)

    Severe hypoglycaemia episodes were recorded as per the ISPAD definition. And the following presented hypoglycaemia episodes were recorded as per Novo Nordisk definition: Symptomatic BG-confirmed: An episode that is blood glucose (BG) confirmed by plasma glucose (PG) value <3.1 mmol/L with symptoms consistent with hypoglycaemia. Asymptomatic BG-confirmed: An episode that is BG-confirmed by PG value <3.1 mmol/L without symptoms consistent with hypoglycaemia. 4) Severe or BG-confirmed symptomatic: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value <3.1 mmol/L with symptoms consistent with hypoglycaemia. 5) BG-confirmed: An episode that is BG-confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia. 6) Severe or BG-confirmed: An episode that is severe according to the ISPAD classification or BG-confirmed by a PG value <3.1 mmol/L with or without symptoms consistent with hypoglycaemia.

    Measured: Week 0-56 + 14 days

  32. Occurrence of Anti-liraglutide Antibodies

    This outcome measure is only applicable for the liraglutide 3.0 mg treatment arm. Number of participants who measured with anti-liraglutide binding antibodies at weeks 0, 30, 56, 58, 70 and 82 are presented.

    Measured: Weeks 0, 30, 56, 58, 70 and 82

  33. Change in Pulse

    Change in pulse 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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  34. Change in ECG

    This outcome measure presents number of subjects with electrocardiogram findings, "normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS)" recorded at baseline (week -14), week 30 and week 56. These findings were categorised by the investigator. Electrocardiogram (ECG) data at week 82 was not collected, thus could not be evaluated. Week 30 and 56 results are based on the participants who completed the corresponding trial period, week 0-30 or week 0-56.

    Measured: Week -14, week 30, week 56 and week 82

  35. Change in Haematology: Haemoglobin

    Change in haemoglobin 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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  36. Change in Haematology: Haematocrit

    Change in haematocrit 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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  37. Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes

    Change in haematological parameters, "thrombocytes, leucocytes, eosinophils, neutrophils, basophils, lymphocytes and monocytes" 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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  38. Change in Haematology: Erythrocytes

    Change in erythrocytes 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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  39. Change in Biochemistry: Creatinine and Bilirubin (Total)

    Change in creatinine and bilirubin (total) 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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  40. Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP

    Change in biochemistry parameters, "creatinine kinase, amylase, lipase, alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP)" 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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  41. Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected

    Change in biochemistry parameters, "urea (blood urea nitrogen [BUN]), sodium, potassium, calcium total and calcium (Ca) albumin-corrected" was evaluated from baseline (week [Wk] 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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  42. Change in Biochemistry: Albumin

    Change in albumin 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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  43. Change in Biochemistry: CEA

    Change in carcinoembryonic antigen (CEA) 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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  44. Change in Hormone Level: Calcitonin

    Change in calcitonin 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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  45. Change in Hormone Level: TSH and Prolactin

    Change in hormone levels, "thyroid stimulating hormone (TSH) and prolactin" 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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  46. Change in Hormone Level: Free T4 and ACTH

    Change in hormone levels, "thyroxine (T4) and adrenocorticotropic hormone (ACTH)" 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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  47. Change in Hormone Level: IGF-1 and Cortisol

    Change in hormone levels, "insulin-like growth factor-1 (IGF-1) and cortisol" 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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  48. Change in Hormone Level: DHEAS

    Change in dehydroepiandrosterone sulfate (DHEAS) 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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  49. Change in Hormone Level: LH and FSH

    Change in hormone levels, "luteinising hormone (LH) and follicle stimulating hormone (FSH)" 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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  50. Change in Hormone Level: Estradiol (Females)

    Change in estradiol (only for female) 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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  51. Change in Hormone Level: Testosterone (Males)

    This outcome measure presents "testosterone (only for males) results" for baseline (week 0), week 30, week 56 and week 82. ADVIA Centaur Testosterone (TSTO) assay was used for the evaluation of testosterone hormone. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

    Measured: Week 0, week 30, week 56 and week 82

  52. Change in NTX1

    Change in type I collagen N-telopeptide (NTX1) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Results are presented in "nmol bone collagen equivalents (BCE)/L". Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  53. Change in CTX1

    Change in type I collagen C-telopeptide (CTX1) 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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  54. Change in P1NP

    Change in procollagen 1 N-terminal propeptide (P1NP) 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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  55. Change in Alkaline Phosphatase (Bone)

    Change in alkaline phosphatase (bone specific) 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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  56. Change in Pubertal Status

    This outcome measure presents "pubertal status results" which is based on Tanner staging (Tanner stage 2-5), recorded at baseline (week 0), week 30, week 56 and week 82. Results are presented for the following categories: 1) For female: breast development and pubic hair development (by Tanner staging). 2) For male: penis development and pubic hair development (by Tanner staging). Each category shows number of participants in stages 2 to 5, where stage 2 represents "early pubertal development" and stage 5 represents "pubertal development equivalent to that of an adult". Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  57. Change in Physical Examination

    This outcome measure presents number of subjects with physical examination findings, "normal; abnormal, not clinically significant (NCS) or abnormal, clinically significant (CS)" at baseline (week 0), week 30, week 56 and week 82. These findings were categorised by the investigator. Results include examination of: "general appearance"; "head, ears, eyes, nose, throat, neck"; "respiratory system"; "cardiovascular system (CVS)"; "gastrointestinal (GI) system including mouth"; "musculoskeletal system"; "central nervous system (CNS) and peripheral nervous system (PNS)"; "skin"; "thyroid gland" and "lymph node palpation". Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

    Measured: Week 0, week 30, week 56 and week 82

  58. Change in Height SDS

    Change in height standard deviation score (SDS) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. Height 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' height 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 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. 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.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  59. Change in C-SSRS

    This outcome measure presents number of subjects with "suicidal ideation or suicidal behaviour on the Columbia Suicidality Severity Rating Scale (C-SSRS)" assessed at baseline (week 0), week 30, week 56 and week 82. Week 30, 56 and 82 results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

  60. Change in PHQ-9

    Change in Patient Health Questionnaire 9 (PHQ-9) was evaluated from baseline (week 0) to weeks 30 and 56, and from week 56 to week 82. The PHQ-9 questionnaire is a 9-item depression module included in the patient health questionnaire, a self-administered diagnostic tool used for assessment of mental disorders. The PHQ-9 total score ranges from 0-27; total scores of 1-4 represent no depression, total scores of 5-9 represent mild depression, total scores of 10-14 represent moderate depression, total scores of 15-19 represent moderately severe depression and total scores of 20-27 represent severe depression. Results are based on the participants who completed the corresponding trial period, week 0-30, week 0-56 or week 0-82.

    Measured: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2016 (estimated)
  2. Study start29 Sep 2016
  3. Primary completion14 Feb 2019
  4. Study completion8 Aug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
251 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02918279
Sponsor's protocol ID
NN8022-4180
Other IDs
2014-004353-14, U1111-1162-7101, 2014
Status last verified
Apr 2020
First submitted
27 Sep 2016
Last updated
27 Apr 2020
Data monitoring committee
Yes

Publications

  • Kelly AS, Auerbach P, Barrientos-Perez M, Gies I, Hale PM, Marcus C, Mastrandrea LD, Prabhu N, Arslanian S; NN8022-4180 Trial Investigators. A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity. N Engl J Med. 2020 May 28;382(22):2117-2128. doi: 10.1056/NEJMoa1916038. Epub 2020 Mar 31.

    PubMed 32233338

  • Bensignor MO, Bramante CT, Bomberg EM, Fox CK, Hale PM, Kelly AS, Mamadi R, Prabhu N, Harder-Lauridsen NM, Gross AC. 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. Pediatr Obes. 2023 Sep;18(9):e13061. doi: 10.1111/ijpo.13061. Epub 2023 Jun 1.

    PubMed 37264767

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Liraglutide in people with Metabolism and Nutrition Disorder and Obesity, run by Novo Nordisk A/S at 33 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in United States, Russia, Belgium, Sweden, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in BMI SDS (Week 0, Week 56) (time frame: Week 0, week 56). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02918279, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2020.

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