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临床试验 NCT05726227 (STEP Young) 针对肥胖症目前进行中但不再招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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诺和诺德A Research Study on How Well Semaglutide Helps Children and Teenagers With Excess Body Weight Lose Weight (STEP Young)
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临床试验NCT05726227 (STEP Young)旨在研究治疗，主要针对肥胖症。这是一项III期 (第三期) 干预性研究试验，目前试验状态为进行中但不再招募。试验始于2023年7月7日，计划招募210名患者。该研究由诺和诺德主导，预计于2026年12月7日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年11月24日。
简要概括
This study will look at how well semaglutide helps children and teenagers losing weight. This will be tested by comparing the effect on body weight in children and teenagers taking semaglutide in comparison to placebo, a "dummy" medicine. In addition to taking the medicine, the child's parent and the child will have talks with study staff about healthy food choices, how to be more physically active and what your child can do to try to lose weight. The child will either get semaglutide or a "dummy" medicine. Which treatment the child will get is decided by chance. Semaglutide is an approved medicine for type 2 diabetes and weight management in adults.
The child will get one injection once a week. The study medicine is injected with a thin needle in the stomach, thighs or upper arms. The study will last for about 2 ½ years (132 weeks).
官方标题
Long-term Safety and Efficacy of Semaglutide s.c. Once-weekly on Weight Management in Children and Adolescents (Aged 6 to <18 Years) With Obesity or Overweight
疾病
肥胖症其他研究标识符
- STEP Young
- NN9536-4512
- U1111-1266-3808 (其他标识符) (World Health Organization (WHO))
- 2022-502922-41 (EudraCT 编号)
NCT编号
实际开始日期
2023-07-07
最近更新发布
2025-11-24
预计完成日期
2026-12-07
计划入组人数
210
研究类型
干预性研究
试验分期 (阶段)
III期 (第三期)
试验状态
进行中但不再招募
主要目的
治疗方法
分配方式
随机
干预模型
平行
盲法
四盲
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
实验性Group Kids Participants in the age group 6 to less than (\<) 12 years will receive once weekly subcutaneous (s.c.) injection of either semaglutide or placebo matched to semaglutide in dose escalation fashion for 16 weeks (0.25 mg from weeks 0-4, 0.5 mg from weeks 5-8, 1.0 mg from weeks 9-12 and 1.7 mg from weeks 13-16) followed by 2.4 mg as maintenance dose for 88 weeks as an adjunct to a reduced-calorie diet and increased physical activity. | Semaglutide Semaglutide will be administered subcutaneously once weekly. 安慰剂 Placebo will be administered subcutaneously once-weekly. |
实验性Group Teens Participants in the age group 12 to \< 18 years will receive once weekly s.c. injection of either semaglutide or placebo matched to semaglutide in dose escalation fashion for 16 weeks (0.25 mg from weeks 0-4, 0.5 mg from weeks 5-8, 1.0 mg from weeks 9-12 and 1.7 mg from weeks 13-16) followed by 2.4 mg as maintenance dose for 88 weeks as an adjunct to a reduced-calorie diet and increased physical activity. | Semaglutide Semaglutide will be administered subcutaneously once weekly. 安慰剂 Placebo will be administered subcutaneously once-weekly. |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Group Kids: Change in body mass index (BMI) | Measured in percentage (%) | From baseline (week 0) to week 68 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Group Kids: Improvement in weight category | Measured as count of participants. Weight categories based on growth charts from Center for Disease Control (CDC).gov: Normal weight= BMI less than (\<) 85th percentile, Overweight= BMI greater than or equal to (\>=) 85th - \<95th percentile, Obesity class I= BMI \>=95th - \<120% of the 95th percentile, Obesity class II= BMI \>=120% - \<140% of the 95th percentile, Obesity class III= BMI \>=140% of the 95th percentile. | From baseline (week 0) to week 68 |
Group Teens: Change in BMI | Measured in % | From week 0 to week 68 |
Group Kids and Group Teens: Change in BMI | Measured in % | From week 0 to week 104 |
Group Teens: Improvement in weight category | Measured as count of participants. Weight categories based on growth charts from CDC.gov: Normal weight= BMI less than (\<) 85th percentile, Overweight= BMI greater than or equal to (\>=) 85th - \<95th percentile, Obesity class I= BMI \>=95th - \<120% of the 95th percentile, Obesity class II= BMI \>=120% - \<140% of the 95th percentile, Obesity class III= BMI \>=140% of the 95th percentile. | From week 0 to week 68 |
Group Kids and Group Teens: Improvement in weight category | Measured as count of participants. Weight categories based on growth charts from CDC.gov: Normal weight= BMI less than (\<) 85th percentile, Overweight= BMI greater than or equal to (\>=) 85th - \<95th percentile, Obesity class I= BMI \>=95th - \<120% of the 95th percentile, Obesity class II= BMI \>=120% - \<140% of the 95th percentile, Obesity class III= BMI \>=140% of the 95th percentile. | From week 0 to week 104 |
Group Kids and Group Teens: Change in body weight | Measured in percentage | From week 0 to week 68 |
Group Kids and Group Teens: Change in body weight | Measured in percentage | From week 0 to week 104 |
Group Kids and Group Teens: Change in body weight | Measured in kilograms (kg) | From week 0 to week 68 |
Group Kids and Group Teens: Change in body weight | Measured in kilograms (kg) | From week 0 to week 104 |
Group Kids and Group Teens: Change in BMI percentage of the 95th percentile | Measured in percentage points | From week 0 to week 68 |
Group Kids and Group Teens: Change in BMI percentage of the 95th percentile | Measured in percentage points | From week 0 to week 104 |
Group Kids and Group Teens: Change in BMI Standard deviation score (SDS) | Measured as score on a scale. 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. | From week 0 to week 68 |
Group Kids and Group Teens: Change in BMI SDS | Measured as score in a scale. 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. | From week 0 to week 104 |
Group Kids and Group Teens: Change in waist circumference | Measured in centimeters (cm) | From week 0 to week 68 |
Group Kids and Group Teens: Change in waist circumference | Measured in centimeters (cm) | From week 0 to week 104 |
Group Kids and Group Teens: Change in systolic blood pressure | Measured in millimeters of mercury (mmHg) | From week 0 to week 68 |
Group Kids and Group Teens: Change in systolic blood pressure | Measured in millimeters of mercury (mmHg) | From week 0 to week 104 |
Group Kids and Group Teens: Change in diastolic blood pressure | Measured in mmHg | From week 0 to week 68 |
Group Kids and Group Teens: Change in diastolic blood pressure | Measured in mmHg | From week 0 to week 104 |
Group Kids and Group Teens: Change in total cholesterol | Measured in % | From week 0 to week 68 |
Group Kids and Group Teens: Change in total cholesterol | Measured in % | From week 0 to week 104 |
Group Kids and Group Teens: Change in high density lipoprotein (HDL) | Measured in % | From week 0 to week 68 |
Group Kids and Group Teens: Change in high density lipoprotein (HDL) | Measured in % | From week 0 to week 104 |
Group Kids and Group Teens: Change in low density lipoprotein (LDL) | Measured in % | From week 0 to week 68 |
Group Kids and Group Teens: Change in low density lipoprotein (LDL) | Measured in % | From week 0 to week 104 |
Group Kids and Group Teens: Change in very low density lipoprotein (VLDL) | Measured in % | From week 0 to week 68 |
Group Kids and Group Teens: Change in very low density lipoprotein (VLDL) | Measured in % | From week 0 to week 104 |
Group Kids and Group Teens: Change in triglycerides | Measured in % | From week 0 to week 68 |
Group Kids and Group Teens: Change in triglycerides | Measured in % | From week 0 to week 104 |
Group Kids and Group Teens: Change in high sensitivity C-reactive protein (hs-CRP) | Measured in % | From week 0 to week 68 |
Group Kids and Group Teens: Change in high sensitivity C-reactive protein (hs-CRP) | Measured in % | From week 0 to week 104 |
Group Kids and Group Teens: Change in glycated haemoglobin (HbA1c) | Measured in % point | From week 0 to week 68 |
Group Kids and Group Teens: Change in glycated haemoglobin (HbA1c) | Measured in % point | From week 0 to week 104 |
Group Kids and Group Teens: Change in fasting plasma glucose | Measured in millimoles per liter (mmol/L) | From week 0 to week 68 |
Group Kids and Group Teens: Change in fasting plasma glucose | Measured in millimoles per liter (mmol/L) | From week 0 to week 104 |
Group Kids and Group Teens: Change in fasting plasma glucose | Measured in milligrams per deciliter (mg/dL) | From week 0 to week 68 |
Group Kids and Group Teens: Change in fasting plasma glucose | Measured in milligrams per deciliter (mg/dL) | From week 0 to week 104 |
Group Kids and Group Teens: Change in fasting insulin | Measured in % | From week 0 to week 68 |
Group Kids and Group Teens: Change in fasting insulin | Measured in % | From week 0 to week 104 |
Group Kids and Group Teens: Change in alanine transaminase (ALT) | Measured in milliunits per liter (mU/L) | From week 0 to week 68 |
Group Kids and Group Teens: Change in alanine transaminase (ALT) | Measured in milliunits per liter (mU/L) | From week 0 to week 104 |
Group Kids and Group Teens: Change in total fat mass, by Dual energy X-ray absorptiometry (DXA) relative to total body mass | Measured in % points | From week 0 to week 68 |
Group Kids and Group Teens: Change in total fat mass, by Dual energy X-ray absorptiometry (DXA) relative to total body mass | Measured in % points | From week 0 to week 104 |
Group Kids and Group Teens: Change in lean body mass, by DXA relative to total body mass | Measured in % points | From week 0 to week 68 |
Group Kids and Group Teens: Change in lean body mass, by DXA relative to total body mass | Measured in % points | From week 0 to week 104 |
Group Kids and Group Teens: Relative change in visceral fat mass by DXA | Measured in % | From week 0 to week 68 |
Group Kids and Group Teens: Relative change in visceral fat mass by DXA | Measured in % | From week 0 to week 104 |
Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 5% reduction of BMI (yes/no) | Measured in count of participants | From week 0 to week 68 |
Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 5% reduction of BMI (yes/no) | Measured in count of participants | From week 0 to week 104 |
Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 10% reduction of BMI (yes/no) | Measured in count of participants | From week 0 to week 68 |
Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 10% reduction of BMI (yes/no) | Measured in count of participants | From week 0 to week 104 |
Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 15% reduction of BMI (yes/no) | Measured in count of participants | From week 0 to week 68 |
Group Kids and Group Teens: Number of participants achieving greater than or equal to (>=) 15% reduction of BMI (yes/no) | Measured in count of participants | From week 0 to week 104 |
Group Kids and Group Teens: Number of treatment emergent adverse events (AEs) | Measured as count of events | From week 0 to week 68 |
Group Kids and Group Teens: Number of treatment emergent adverse events (AEs) | Measured as count of events | From week 0 to week 111 |
Group Kids and Group Teens: Number of treatment emergent serious adverse events (SAEs) | Measured as count of events | From week 0 to week 68 |
Group Kids and Group Teens: Number of treatment emergent serious adverse events (SAEs) | Measured as count of events | From week 0 to week 111 |
Group Kids and Group Teens: Change in pulse | Measured as beats per minute | From week 0 to week 68 |
Group Kids and Group Teens: Change in pulse | Measured as beats per minute | From week 0 to week 104 |
Group Kids and Group Teens: Change in amylase | Measured as units per liter (U/L) | From week 0 to week 68 |
Group Kids and Group Teens: Change in amylase | Measured as units per liter (U/L) | From week 0 to week 104 |
Group Kids and Group Teens: Change in lipase | Measured as U/L | From week 0 to week 68 |
Group Kids and Group Teens: Change in lipase | Measured as U/L | From week 0 to week 104 |
Group Kids and Group Teens: Change in calcitonin | Measured as nanograms per liter (ng/L) | From week 0 to week 68 |
Group Kids and Group Teens: Change in calcitonin | Measured as nanograms per liter (ng/L) | From week 0 to week 104 |
Group Kids and Group Teens: Change in bone mineral density, by DXA | Measured as grams per square centimeter (g/cm\^2) | From week 0 to week 68 |
Group Kids and Group Teens: Change in bone mineral density, by DXA | Measured as grams per square centimeter (g/cm\^2) | From week 0 to week 104 |
Group Kids and Group Teens: Number of treatment emergent hypoglycaemic episodes (for T2D only) | Measured as count of episodes | From week 0 to week 68 |
Group Kids and Group Teens: Number of treatment emergent hypoglycaemic episodes (for T2D only) | Measured as count of episodes | From week 0 to week 111 |
资格标准
适龄参与研究
儿童, 成人
最低年龄要求
6 Years
适龄性别
全部
- Informed consent of parent(s) or legally acceptable representative (LAR) of participant and child assent, as age-appropriate, obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. a) The parents or LAR of the child must sign and date the Informed Consent Form (according to local requirements) b) The child must sign and date the Child Assent Form or provide oral assent (according to local requirements)
- Age at the time of signing informed consent. a)Group Kids: 6 to less than 12 years. b) Group Teens: 12 to less than 18 years and Tanner stage greater than 1
- Body mass index (BMI), at screening and randomisation, corresponding to a) Group Kids: greater than or equal to 95th percentile. b) Group Teens: greater than or equal to 95th percentile or greater than or equal to 85th percentile with the presence of at least 1 weight-related comorbidity (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or type 2 diabetes mellitus (T2D)
- History of at least one unsuccessful effort to lose sufficient body weight after participation in a structured lifestyle modification programme (diet and exercise counselling) for at least 3 months
- Body weight of greater than 45 kilogram (kg) at screening and randomisation
- For participants with T2D at screening, the following additional criterion applies: glycated haemoglobin (HbA1c) less than or equal to 10.0 percent (86 millimoles per mole [mmol/mol]) as measured by central laboratory at screening
- Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening
- Previous or planned (during the study period) obesity treatment with surgery or a weight loss device. However, the following are allowed: a) liposuction and/or abdominoplasty, if performed greater than 1 year prior to screening. b) adjustable gastric banding, if the band has been removed greater than 1 year prior to screening. c) intragastric balloon, if the balloon has been removed greater than 1 year prior to screening. d)duodenal-jejunal bypass liner (e.g., nonbarrier), if the sleeve has been removed greater than 1 year prior to screening
- Type 1 diabetes mellitus or monogenic diabetes
- Participants with endocrine, hypothalamic, or syndromic obesity
- For participants with T2D at screening, the following additional key criterion applies: Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
诺和诺德134 个活跃的临床试验可供探索没有联系数据。
56 位于 10 个国家/地区的研究中心
California
Neighborhood Healthcare, Escondido, California, 92025, United States
Connecticut
Yale School of Medicine, New Haven, Connecticut, 06519, United States
Georgia
Columbus Research Foundation, Columbus, Georgia, 31904, United States
Eastside Bariatric and Gen Surg, Snellville, Georgia, 30078, United States
Idaho
Solaris Clinical Research, Meridian, Idaho, 83646, United States
Louisiana
Pennington Biom Res Ctr, Baton Rouge, Louisiana, 70808, United States
Clinical Trials of America LLC, Monroe, Louisiana, 71201, United States
IMA Clinical Research, Monroe, Louisiana, 71201, United States
Maryland
Barry J. Reiner, MD LLC, Baltimore, Maryland, 21229, United States
Massachusetts
Massachusetts General Hospital_Cary, Boston, Massachusetts, 02114, United States
Minnesota
University of Minnesota, Minneapolis, Minnesota, 55414, United States
Mississippi
Mississippi Center for Advanced Medicine, Madison, Mississippi, 39110, United States
Mississippi CTR for ADV MED, Madison, Mississippi, 39110, United States
New York
UBMD Peds-Div of Endo/Diabetes, Buffalo, New York, 14203, United States
North Carolina
WakeMed Childn Endo-Dbt_Raleig, Raleigh, North Carolina, 27610, United States
North Dakota
Valley Weight Loss Clinic, Fargo, North Dakota, 58104, United States
Ohio
Centricity Research - Ohio, Columbus, Ohio, 43213, United States
Pennsylvania
UPMC Child Hosp-Pittsburgh, Pittsburgh, Pennsylvania, 15224, United States
Tennessee
Vanderbilt University Medical Center, Nashville, Tennessee, 37212, United States
Tullahoma Pediatrics PLLC, Tullahoma, Tennessee, 37388, United States
Texas
Texas Diabetes & Endocrinology, Austin, Texas, 78731, United States
Univ Of Texas Hlth Science Cntr, San Antonio, Texas, 78207, United States
Virginia
Health Res of Hampton Roads, Newport News, Virginia, 23606, United States
Wisconsin
Marshfield Clinic, Marshfield, Wisconsin, 54449, United States
Universitätsklinik Kinder-Jugendheilkunde Innsbruck, Innsbruck, 6020, Austria
Universitätsklinik für Kinder und Jugendheilkunde Haus E, Salzburg, 5020, Austria
UZ Brussel, Brussels, 1090, Belgium
UZ Antwerpen - UZA - Kinderziekenhuis, Edegem, 2650, Belgium
UZA - UZ Antwerpen - Kinderziekenhuis, Edegem, 2650, Belgium
UZ Leuven - Kindergeneeskunde, Leuven, 3000, Belgium
Aalborg Universitetshospital, Aalborg, 9000, Denmark
Aarhus Universitetshospital, Steno Diabetes Center Aarhus, Aarhus, 8200, Denmark
Holbæk Sygehus - Børne- og Ungeafdelingen, Holbæk, 4300, Denmark
Universitätsklinikum Halle - Innere Medizin II, Halle, 06120, Germany
Hannoversche Kinderheilanstalt "Auf der Bult" - Diabeto-, Endokrino-, Gastroenterologie und Klinische Forschung, Hanover, 30173, Germany
Kinder- und Jugendkrankenhaus, Hanover, 30173, Germany
Uniklinik Leipzig - Klinik und Poliklinik für Kinder- und Jugendmedizin, Leipzig, 04103, Germany
Universitätsklinikum Leipzig, Klinik und Poliklinik für Kinder- und Jugendmedizin, Leipzig, 04103, Germany
Uniklinik Ulm - Dt. Zentrum für Kinder- und Jugendgesundheit (DZKJ), Ulm, 89075, Germany
Universitätsklinikum Ulm für Kinder- und Jugendmedizin, Ulm, 89075, Germany
Rambam MC - Department of Pediatrics A, Haifa, 31096, Israel
Schneider MC - Endrocrinology and Diabetes, Petah Tikva, 49202, Israel
Shamir MC - Pediatric and Adolescents Endocrinology unit, Ẕerifin, 7033001, Israel
Consultorio de Endocrinología y Pediatría, Puebla City, 72190, Mexico
Hospital Da Luz S.A., Lisbon, 1500-650, Portugal
Unidade Local de Saúde de Santo António, E.P.E, Porto, 4050-342, Portugal
Hospital CUF Porto S.A., Porto, 4100-180, Portugal
Drottning Silvias barnsjukhus, Gothenburg, 41650, Sweden
Hallands sjukhus Halmstad, Halmstad, 30233, Sweden
Akademiska sjukhuset Uppsala, Uppsala, 75185, Sweden
Uppsala universitetssjukhus, Uppsala, 75185, Sweden
Birmingham Children's Hospital, Birmingham, B4 6NH, United Kingdom
University Hospitals Bristol & Weston NHS Foundation Trust, Bristol, BS2 8BJ, United Kingdom
Leeds Children's Hospital, Leeds, LS1 3EX, United Kingdom
Alder Hey Children's Hospital, Liverpool, L12 2AP, United Kingdom
Southampton General Hospital, Southampton, SO16 6YD, United Kingdom