Efficacy of Semaglutide s.c. Once-weekly on Weight Loss and Management in Adolescents With Monogenic Obesity in Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 10
- 主要终点
- Proportion of participants achieving ≥10% BMI reduction from baseline (week 0) to week 68.
研究概览
简要总结
This observational study aims to assess the effect of once-weekly s.c. semaglutide 2.4 mg as an adjunct to a calorie-reduced diet and increased physical activity on weight loss, change in hunger, body composition, depression, and quality of life after 68 weeks of treatment in adolescents diagnosed with monogenic obesity in routine clinical care.
详细描述
The primary objective of this prospective, non-interventional observational study is to evaluate the effect of once-weekly s.c. semaglutide 2.4 mg in routine clinical care as an adjunct to a calorie-reduced diet and increased physical activity on weight loss after 68 weeks of treatment in adolescents diagnosed with monogenic obesity.
The secondary objectives of this prospective, non-interventional observation are to evaluate treatment compliance and to assess the influence of once-weekly s.c. semaglutide 2.4 mg in clinical practice on hunger score, body mass parameters, body composition, and depression score after 68 weeks of treatment in adolescents diagnosed with monogenic obesity. In addition, we will document the known parameters of safety and tolerability to determine safety and tolerability in clinical practice.
The exploratory objective of this prospective, non-interventional observation is to assess user satisfaction by measuring change in subjective hunger score, quality of life, and perceptions and attitudes regarding treatment with semaglutide in adolescents diagnosed with monogenic obesity treated in routine clinical practice with once-weekly s.c. semaglutide 2.4 mg after 68 weeks of treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment with semaglutide as prescribed in routine clinical practice according to summary of product characteristics.
- •Informed consent of the patient, their parents, or legally acceptable representative (LAR) of participant and adolescent assent, as age-appropriate.
- •Age at time of signing informed consent: ≥12 to <21 years.
- •BMI ≥95th percentile as defined on sex- and age-specific BMI growth charts (CDC.gov)
- •Body weight of >60 kg.
- •Diagnosis of monogenic obesity by a Clinical Laboratory Improvement Amendments (CLIA)/ College of American Pathologists (CAP)/International Organisation for Standardization (ISO) 1518-certified laboratory using ACMG criteria as pathogenic (P), likely pathogenic (LP) and variant of uncertain significance (VUS).
排除标准
- •Participation in any interventional clinical trials at the time of enrolment.
- •Females of childbearing potential who are not using adequate contraceptive methods (as required by local law or practice)
- •Hypersensitivity to the active substance or to any of the excipients listed:
- •Disodium phosphate, dihydrate
- •Propylene glycol
- •Hydrochloric acid (for pH adjustment)
- •Sodium hydroxide (for pH adjustment)
- •Water for injection
- •The safety and efficacy of Wegovy have not been investigated in patients:
- •treated with other products for weight management,
- •with type 1 diabetes,
- •with severe renal impairment (see section 4.2),
- •with severe hepatic impairment (see section 4.2),
- •with congestive heart failure New York Heart Association (NYHA) class IV. Use in these patients is not recommended
研究组 & 干预措施
Patients with biallelic variants in the LEPR, PCSK1, POMC, and MC4R gene
干预措施: Semaglutide (administered by PDS290 pen-injector) (Drug)
Patients with monoallelic variants in the LEPR gene
干预措施: Semaglutide (administered by PDS290 pen-injector) (Drug)
Patients with monoallelic variants in the PCSK1 gene
干预措施: Semaglutide (administered by PDS290 pen-injector) (Drug)
Patients with monoallelic variants in the POMC gene
干预措施: Semaglutide (administered by PDS290 pen-injector) (Drug)
Patients with monoallelic variants in the MC4R gene
干预措施: Semaglutide (administered by PDS290 pen-injector) (Drug)
Patients with monoallelic variants in the SH2B1 gene or with 16p11.2 deletions
干预措施: Semaglutide (administered by PDS290 pen-injector) (Drug)
结局指标
主要结局
Proportion of participants achieving ≥10% BMI reduction from baseline (week 0) to week 68.
时间窗: 68 weeks
The study evaluates the effect of once-weekly subcutaneous (s.c.) semaglutide 2.4 mg administered as an adjunct to a calorie-reduced diet and increased physical activity in adolescents diagnosed with monogenic obesity. This measure focuses on weight loss effectiveness, with the goal of assessing the impact of the treatment on BMI reduction in a real-world clinical setting after 68 weeks of treatment. The study aims to provide insight into the potential of semaglutide in managing weight in this specific patient population.
次要结局
- Secondary Endpoints for Weight and Health Parameters(68 weeks)
研究者
Prof. Dr. Martin Wabitsch
Principal Investigator
University of Ulm