Phase 3 · Liraglutide

NCT02918279 trial results

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

Change in BMI SDS (Week 0, Week 56) (SDS score), Week 0, week 56. Liraglutide 3.0 mg: -0.25; Placebo: -0.02.

Participants: 251
Status: completed
Completed: 2019-08-08
Sponsor: Novo Nordisk A/S

As posted on ClinicalTrials.gov (NCT02918279), updated at source Apr 27, 2020. Read again whenever the registry updates it. Registry figures can differ from a published paper, which may use another analysis.

Primary outcome

What NCT02918279 measured first

Change in BMI SDS (Week 0, Week 56)SDS score · Week 0, week 56 · mean

Liraglutide 3.0 mgn=113	Placebon=105
-0.25(0.51)	-0.02(0.54)

Side effects by arm

Side effects in NCT02918279

Percent of participants affected, Week 0-56 + 14 days. Results are based on the SAS which included all randomised participants exposed to at least one dose of trial product.. The most common events the registry lists.

Event	Liraglutide 3.0 mg	Placebo
Any serious event	2.4%	4%
Nausea	42.4%	14.3%
Vomiting	34.4%	4%
Nasopharyngitis	27.2%	30.2%
Headache	23.2%	27.8%
Diarrhoea	22.4%	14.3%
Abdominal pain upper	13.6%	13.5%
Gastroenteritis	12.8%	4.8%
Oropharyngeal pain	8.8%	11.9%
Dizziness	10.4%	3.2%
Influenza	8.8%	9.5%
Upper respiratory tract infection	8.8%	8.7%
Abdominal pain	8%	8.7%
Pyrexia	8%	7.1%
Arthralgia	2.4%	6.3%
Dysmenorrhoea	3.2%	6.3%
Pharyngitis	3.2%	5.6%

Secondary outcomes

What else it measured

Percent of Subjects Achieving ≥5% Reduction in Baseline BMIPercentage of participants · Weeks 30, 56 and 82 · number

Measure	Liraglutide 3.0 mgn=125	Placebon=126
Week 30 (Yes)	46.2	14.7
Week 30 (No)	53.8	85.3
Week 56 (Yes)	45.1	19.0
Week 56 (No)	54.9	81.0
Week 82 (Yes)	29.5	18.6
Week 82 (No)	70.5	81.4

Percent of Subjects Achieving ≥10% Reduction in Baseline BMIPercentage of participants · Weeks 30, 56 and 82 · number

Measure	Liraglutide 3.0 mgn=125	Placebon=126
Week 30 (Yes)	24.4	5.2
Week 30 (No)	75.6	94.8
Week 56 (Yes)	29.2	8.6
Week 56 (No)	70.8	91.4
Week 82 (Yes)	18.8	10.8
Week 82 (No)	81.3	89.2

Change in BMI SDS ((Week 0, Week 30); (Week 0, Week 82); (Week 56, Week 82))SDS score · (Week 0, week 30); (Week 0, week 82); (Week 56, week 82) · mean

Measure	Liraglutide 3.0 mgn=125	Placebon=126
Change from week 0 to week 30	-0.26(0.34)	-0.04(0.33)
Change from week 0 to week 82	-0.06(0.53)	0.07(0.66)
Change from week 56 to week 82	0.22(0.28)	0.08(0.27)

Change in BMIkg/m^2 · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) · mean

Measure	Liraglutide 3.0 mgn=125	Placebon=126
Change from week 0 to week 30	-1.8(2.1)	-0.2(2.2)
Change from week 0 to week 56	-1.6(3.1)	0.1(3.4)
Change from week 56 to week 82	1.5(1.7)	0.7(1.7)

Change in Body Weight (kg)kg · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) · mean

Measure	Liraglutide 3.0 mgn=125	Placebon=126
Change from week 0 to week 30	-3.9(6.1)	0.4(6.6)
Change from week 0 to week 56	-2.7(9.1)	2.1(10.2)
Change from week 56 to week 82	4.7(4.6)	2.4(4.9)

Change in Body Weight (%)Percentage change · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) · mean

Measure	Liraglutide 3.0 mgn=125	Placebon=126
Change from week 0 to week 30	-4.3(6.5)	0.4(6.2)
Change from week 0 to week 56	-3.2(9.4)	2.2(9.5)
Change from week 56 to week 82	5.3(5.7)	2.3(4.9)

Change in Waist Circumferencecm · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) · mean

Measure	Liraglutide 3.0 mgn=125	Placebon=126
Change from week 0 to week 30	-4.63(6.24)	-2.01(5.94)
Change from week 0 to week 56	-5.12(7.87)	-1.51(8.20)
Change from week 56 to week 82	3.58(4.30)	1.24(5.60)

Change in Waist-to-hip Circumference RatioRatio · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) · mean

Measure	Liraglutide 3.0 mgn=125	Placebon=126
Change from week 0 to week 30	-0.015(0.042)	-0.018(0.042)
Change from week 0 to week 56	-0.022(0.053)	-0.023(0.051)
Change from week 56 to week 82	0.010(0.031)	0.003(0.049)

Change in hsCRPmg/L · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) · mean

Measure	Liraglutide 3.0 mgn=125	Placebon=126
Change from week 0 to week 30	-0.22(5.04)	-0.56(4.68)
Change from week 0 to week 56	-0.25(4.54)	-0.14(3.44)
Change from week 56 to week 82	1.51(7.61)	1.00(4.22)

Change in Fasting Lipid: Total Cholesterol (Ratio to Baseline)Ratio of total cholesterol · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) · geometric mean

Measure	Liraglutide 3.0 mgn=125	Placebon=126
Change from week 0 to week 30	1.00(12.8)	0.98(13.0)
Change from week 0 to week 56	1.00(14.2)	1.00(13.0)
Change from week 56 to week 82	1.02(14.7)	1.02(14.9)

Change in Fasting Lipid: LDL-cholesterol (Ratio to Baseline)Ratio of LDL-cholesterol · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) · geometric mean

Measure	Liraglutide 3.0 mgn=125	Placebon=126
Change from week 0 to week 30	1.00(19.8)	1.00(26.1)
Change from week 0 to week 56	0.99(21.8)	1.02(23.6)
Change from week 56 to week 82	1.03(22.5)	1.04(20.6)

Change in Fasting Lipid: HDL-cholesterol (Ratio to Baseline)Ratio of HDL-cholesterol · (Week 0, week 30); (Week 0, week 56); (Week 56, week 82) · geometric mean

Measure	Liraglutide 3.0 mgn=125	Placebon=126
Change from week 0 to week 30	1.04(15.3)	1.01(20.5)
Change from week 0 to week 56	1.04(17.4)	1.02(18.9)
Change from week 56 to week 82	0.99(15.8)	1.00(15.2)

The trial

How NCT02918279 was run

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.

Liraglutide
Placebo

Who could join the trial

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

Published papers

Papers from NCT02918279

Trial averages do not predict what one person will experience. Results are shown as the registry posts them, without interpretation.

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