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

15. april 2020 opdateret af: Novo Nordisk A/S

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

251

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
      • Brussels, Belgien, 1090
        • Novo Nordisk Investigational Site
      • Brussels, Belgien, 1200
        • Novo Nordisk Investigational Site
      • Edegem, Belgien, 2650
        • Novo Nordisk Investigational Site
      • Hasselt, Belgien, 3500
        • Novo Nordisk Investigational Site
      • Leuven, Belgien, 3000
        • Novo Nordisk Investigational Site
      • Namur, Belgien, 5000
        • Novo Nordisk Investigational Site
  • Den Russiske Føderation
      • Moscow, Den Russiske Føderation, 125373
        • Novo Nordisk Investigational Site
      • Novosibirsk, Den Russiske Føderation, 630048
        • Novo Nordisk Investigational Site
      • Rostov-on-Don, Den Russiske Føderation, 344013
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Den Russiske Føderation, 191144
        • Novo Nordisk Investigational Site
      • Samara, Den Russiske Føderation, 443079
        • Novo Nordisk Investigational Site
      • Stavropol, Den Russiske Føderation, 355035
        • Novo Nordisk Investigational Site
      • Tomsk, Den Russiske Føderation, 634050
        • Novo Nordisk Investigational Site
      • Ufa, Den Russiske Føderation, 450106
        • Novo Nordisk Investigational Site
  • Forenede Stater
    • Idaho
      • Meridian, Idaho, Forenede Stater, 83646
        • Novo Nordisk Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70808-4124
        • Novo Nordisk Investigational Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21229
        • Novo Nordisk Investigational Site
    • Minnesota
      • Minneapolis, Minnesota, Forenede Stater, 55455
        • Novo Nordisk Investigational Site
    • New York
      • Buffalo, New York, Forenede Stater, 14222
        • Novo Nordisk Investigational Site
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43213
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, Forenede Stater, 45406
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, Forenede Stater, 45419
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Forenede Stater, 15224
        • Novo Nordisk Investigational Site
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Novo Nordisk Investigational Site
      • Goose Creek, South Carolina, Forenede Stater, 29445
        • Novo Nordisk Investigational Site
      • Greenville, South Carolina, Forenede Stater, 29615
        • Novo Nordisk Investigational Site
    • Tennessee
      • Memphis, Tennessee, Forenede Stater, 38119
        • Novo Nordisk Investigational Site
  • Mexico
      • Puebla, Mexico, 72190
        • Novo Nordisk Investigational Site
    • Tamaulipas
      • Ciudad Madero, Tamaulipas, Mexico, 89440
        • Novo Nordisk Investigational Site
  • Sverige
      • Göteborg, Sverige, 416 85
        • Novo Nordisk Investigational Site
      • Huddinge, Sverige, 141 57
        • Novo Nordisk Investigational Site
      • Malmö, Sverige, 205 02
        • Novo Nordisk Investigational Site
      • Uppsala, Sverige, 751 85
        • Novo Nordisk Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

12 år til 17 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Medicin: Placebo
Administered once daily subcutaneously (s.c., under the skin)
Eksperimentel: Liraglutid
Medicin: Liraglutide
Administered once daily subcutaneously (s.c., under the skin)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in BMI SDS (Week 0, Week 56)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent of Subjects Achieving ≥5% Reduction in Baseline BMI
Tidsramme: Weeks 30, 56 and 82
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.
Weeks 30, 56 and 82
Percent of Subjects Achieving ≥10% Reduction in Baseline BMI
Tidsramme: Weeks 30, 56 and 82
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.
Weeks 30, 56 and 82
Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82))
Tidsramme: (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.
(Week 0, week 30); (Week 0, week 82); (Week 56, week 82)
Change in BMI
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Body Weight (kg)
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Body Weight (%)
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Body Weight (lb)
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Body weight was not analysed in pounds (lb). It was analysed for standard unit, 'kg' only.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Waist Circumference
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Waist-to-hip Circumference Ratio
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in hsCRP
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Fasting Lipid: Total Cholesterol (Ratio to Baseline)
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Fasting Lipid: LDL-cholesterol (Ratio to Baseline)
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Fasting Lipid: HDL-cholesterol (Ratio to Baseline)
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Fasting Lipid: Non-HDL Cholesterol (Ratio to Baseline)
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Fasting Lipid: VLDL Cholesterol (Ratio to Baseline)
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Fasting Lipid: Triglycerides (Ratio to Baseline)
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Fasting Lipid: FFA (Ratio to Baseline)
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Systolic and Diastolic Blood Pressure
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in HbA1c
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in FPG
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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).
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Fasting Insulin (Ratio to Baseline)
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Fasting C-peptide (Ratio to Baseline)
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Glycaemic Category
Tidsramme: Week -2, week 30, week 56 and week 82
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.
Week -2, week 30, week 56 and week 82
Change in HOMA-B (Ratio to Baseline)
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in HOMA-IR (Ratio to Baseline)
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in IWQOL-Kids
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in BMI SDS (%)
Tidsramme: (Week 0, week 30); (Week 0, week 56)
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.
(Week 0, week 30); (Week 0, week 56)
Change in Nutritional Compliance
Tidsramme: Week 0, week 30 and week 56
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.
Week 0, week 30 and week 56
Number of Treatment Emergent Adverse Events
Tidsramme: Week 0-56 + 14 days
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).
Week 0-56 + 14 days
Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification)
Tidsramme: Week 0-56 + 14 days
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.
Week 0-56 + 14 days
Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification)
Tidsramme: Week 0-56 + 14 days
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.
Week 0-56 + 14 days
Occurrence of Anti-liraglutide Antibodies
Tidsramme: Weeks 0, 30, 56, 58, 70 and 82
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.
Weeks 0, 30, 56, 58, 70 and 82
Change in Pulse
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in ECG
Tidsramme: Week -14, week 30, week 56 and week 82
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.
Week -14, week 30, week 56 and week 82
Change in Haematology: Haemoglobin
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Haematology: Haematocrit
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Haematology: Erythrocytes
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Biochemistry: Creatinine and Bilirubin (Total)
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Biochemistry: Albumin
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Biochemistry: CEA
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Hormone Level: Calcitonin
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Hormone Level: TSH and Prolactin
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Hormone Level: Free T4 and ACTH
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Hormone Level: IGF-1 and Cortisol
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Hormone Level: DHEAS
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Hormone Level: LH and FSH
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Hormone Level: Estradiol (Females)
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Hormone Level: Testosterone (Males)
Tidsramme: Week 0, week 30, week 56 and week 82
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.
Week 0, week 30, week 56 and week 82
Change in NTX1
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in CTX1
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in P1NP
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Alkaline Phosphatase (Bone)
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Pubertal Status
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in Physical Examination
Tidsramme: Week 0, week 30, week 56 and week 82
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.
Week 0, week 30, week 56 and week 82
Change in Height SDS
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in C-SSRS
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
Change in PHQ-9
Tidsramme: (Week 0, week 30); (Week 0, week 56); (Week 56, week 82)
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.
(Week 0, week 30); (Week 0, week 56); (Week 56, week 82)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Novo Nordisk A/S

Efterforskere

  • Studieleder: Global Clinical Registry (GCR), Novo Nordisk A/S

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

29. september 2016

Primær færdiggørelse (Faktiske)

14. februar 2019

Studieafslutning (Faktiske)

8. august 2019

Datoer for studieregistrering

Først indsendt

27. september 2016

Først indsendt, der opfyldte QC-kriterier

27. september 2016

Først opslået (Skøn)

28. september 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. april 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

15. april 2020

Sidst verificeret

1. april 2020

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • NN8022-4180
  • 2014-004353-14 (EudraCT nummer)
  • U1111-1162-7101 (Anden identifikator: WHO)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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