Phase 3 N=251 Randomized Double-blind Treatment

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

Metabolism and Nutrition Disorder · Obesity

Bottom Line

View on ClinicalTrials.gov: NCT02918279 ↗

Enrolled (actual)

251

Serious AEs

3.2%

Results posted

Apr 2020

Primary outcome: Primary: Change in BMI SDS (Week 0, Week 56) — -0.25; -0.02 SDS score — p=0.0022

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Liraglutide (Drug); Placebo (Drug)
Age: Pediatric · 12+ yrs
Sex: All
Sponsor: Novo Nordisk A/S
Primary completion: Feb 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in BMI SDS (Week 0, Week 56)	-0.25; -0.02	0.0022 sig
SECONDARY Percent of Subjects Achieving ≥5% Reduction in Baseline BMI	46.2; 14.7; 53.8; 85.3; 45.1; 19.0	—
SECONDARY Percent of Subjects Achieving ≥10% Reduction in Baseline BMI	24.4; 5.2; 75.6; 94.8; 29.2; 8.6	—
SECONDARY Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82))	-0.26; -0.04; -0.06; 0.07; 0.22; 0.08	—
SECONDARY Change in BMI	-1.8; -0.2; -1.6; 0.1; 1.5; 0.7	—
SECONDARY Change in Body Weight (kg)	-3.9; 0.4; -2.7; 2.1; 4.7; 2.4	—
SECONDARY Change in Body Weight (%)	-4.3; 0.4; -3.2; 2.2; 5.3; 2.3	—
SECONDARY Change in Body Weight (lb)	—	—
SECONDARY Change in Waist Circumference	-4.63; -2.01; -5.12; -1.51; 3.58; 1.24	—
SECONDARY Change in Waist-to-hip Circumference Ratio	-0.015; -0.018; -0.022; -0.023; 0.010; 0.003	—
SECONDARY Change in hsCRP	-0.22; -0.56; -0.25; -0.14; 1.51; 1.00	—
SECONDARY Change in Fasting Lipid: Total Cholesterol (Ratio to Baseline)	1.00; 0.98; 1.00; 1.00; 1.02; 1.02	—
SECONDARY Change in Fasting Lipid: LDL-cholesterol (Ratio to Baseline)	1.00; 1.00; 0.99; 1.02; 1.03; 1.04	—
SECONDARY Change in Fasting Lipid: HDL-cholesterol (Ratio to Baseline)	1.04; 1.01; 1.04; 1.02; 0.99; 1.00	—
SECONDARY Change in Fasting Lipid: Non-HDL Cholesterol (Ratio to Baseline)	0.98; 0.97; 0.98; 0.99; 1.03; 1.02	—
SECONDARY Change in Fasting Lipid: VLDL Cholesterol (Ratio to Baseline)	0.91; 0.90; 0.92; 0.93; 1.04; 0.97	—
SECONDARY Change in Fasting Lipid: Triglycerides (Ratio to Baseline)	0.91; 0.91; 0.92; 0.93; 1.04; 0.97	—
SECONDARY Change in Fasting Lipid: FFA (Ratio to Baseline)	0.96; 0.83; 1.00; 0.95; 0.99; 0.94	—
SECONDARY Change in Systolic and Diastolic Blood Pressure	-2; -1; -2; 1; 2; 1	—
SECONDARY Change in HbA1c	-0.1; -0.0; -0.1; -0.0; 0.1; 0.1	—
SECONDARY Change in FPG	-0.2; -0.0; -0.1; -0.0; 0.1; 0.1	—
SECONDARY Change in Fasting Insulin (Ratio to Baseline)	1.13; 1.14; 1.06; 1.10; 1.00; 1.08	—
SECONDARY Change in Fasting C-peptide (Ratio to Baseline)	1.12; 1.04; 0.98; 0.97; 0.92; 0.94	—
SECONDARY Change in Glycaemic Category	93; 93; 31; 32; 1; 1	—
SECONDARY Change in HOMA-B (Ratio to Baseline)	1.32; 1.17; 1.13; 1.11; 0.92; 1.02	—
SECONDARY Change in HOMA-IR (Ratio to Baseline)	1.08; 1.14; 1.04; 1.09; 1.03; 1.11	—
SECONDARY Change in IWQOL-Kids	10.62; 6.73; 13.33; 13.24; 2.53; -2.19	—
SECONDARY Change in BMI SDS (%)	-8.73; -1.70; -8.32; -0.68	—
SECONDARY Change in Nutritional Compliance	7.10; 7.07; 6.74; 6.51; 6.87; 6.45	—
SECONDARY Number of Treatment Emergent Adverse Events	777; 627	—
SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes (ADA/ISPAD Classification)	0; 0; 12; 17; 31; 6	—
SECONDARY Number of Treatment Emergent Hypoglycaemic Episodes (Novo Nordisk/ISPAD Classification)	0; 0; 1; 1; 4; 0	—
SECONDARY Occurrence of Anti-liraglutide Antibodies	0; 6; 5; 11; 6; 2	—
SECONDARY Change in Pulse	4; -1; 4; -1; -3; 2	—
SECONDARY Change in ECG	102; 100; 23; 26; 0; 0	—
SECONDARY Change in Haematology: Haemoglobin	0.2; 0.0; 0.3; 0.1; -0.1; -0.0	—
SECONDARY Change in Haematology: Haematocrit	0.7; 0.1; 1.2; 0.4; -0.4; -0.4	—
SECONDARY Change in Haematology: Thrombocytes, Leucocytes, Eosinophils, Neutrophils, Basophils, Lymphocytes and Monocytes	9; 14; 7; 7; -2; 3	—
SECONDARY Change in Haematology: Erythrocytes	0.0; -0.0; -0.0; -0.1; -0.1; 0.0	—
SECONDARY Change in Biochemistry: Creatinine and Bilirubin (Total)	1; 0; 2; 4; 2; 1	—
SECONDARY Change in Biochemistry: Creatinine Kinase, Amylase, Lipase, ALT, AST and ALP	13; 0; 32; 0; 28; 4	—
SECONDARY Change in Biochemistry: Urea (BUN), Sodium, Potassium, Calcium Total and Calcium Albumin-corrected	-0.06; 0.00; -0.26; -0.05; 0.23; 0.00	—
SECONDARY Change in Biochemistry: Albumin	0.1; 0.0; 0.1; 0.1; -0.0; -0.0	—
SECONDARY Change in Biochemistry: CEA	-0.0; -0.1; 0.0; -0.0; 0.0; 0.0	—
SECONDARY Change in Hormone Level: Calcitonin	0.1; 0.1; 0.0; -0.0; -0.1; 0.2	—
SECONDARY Change in Hormone Level: TSH and Prolactin	-0.35; -0.08; -0.42; -0.14; 0.38; 0.13	—
SECONDARY Change in Hormone Level: Free T4 and ACTH	0.6; 0.8; 0.3; 0.6; 0.0; 0.2	—
SECONDARY Change in Hormone Level: IGF-1 and Cortisol	10.61; 3.79; -4.60; 3.69; -14.60; -16.35	—
SECONDARY Change in Hormone Level: DHEAS	0.94; 0.57; 0.95; 0.89; -0.08; -0.05	—
SECONDARY Change in Hormone Level: LH and FSH	0.4; 0.7; 0.2; 0.6; 0.4; -0.5	—
SECONDARY Change in Hormone Level: Estradiol (Females)	-5.0; 20.2; 11.6; 14.1; -2.3; -1.7	—
SECONDARY Change in Hormone Level: Testosterone (Males)	8.13; 8.06; 10.00; 9.33; 10.55; 9.51	—
SECONDARY Change in NTX1	-2.4; -3.2; -3.7; -2.9; -2.8; -4.6	—
SECONDARY Change in CTX1	-7; -84; -36; -97; -107; -162	—
SECONDARY Change in P1NP	-35; -30; -55; -63; -30; -47	—
SECONDARY Change in Alkaline Phosphatase (Bone)	-15; -12; -17; -17; -1; -4	—
SECONDARY Change in Pubertal Status	2; 1; 6; 8; 23; 30	—
SECONDARY Change in Physical Examination	93; 101; 30; 23; 2; 2	—
SECONDARY Change in Height SDS	0.11; 0.13; 0.20; 0.24; 0.07; 0.06	—
SECONDARY Change in C-SSRS	2; 2; 0; 1; 0; 1	—
SECONDARY Change in PHQ-9	-1; -1; -1; -2; 0; -0	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02918279). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.