NCT07081178终止不适用
A Non-interventional Study Investigating Semaglutide in Combination With Lifestyle-based Modifications for the Management of Obesity in Real-World Clinical Practice in Germany Non-interventional.
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in relative body weight
研究概览
简要总结
Participants will be treated with commercially available semaglutide according to routine clinical practice at the discretion of the treating physician for the management of obesity. The purpose of this study is to collect data on the effect of Semaglutide under everyday conditions in participants. Participants and doctor had already decided that they will get semaglutide prescribed by doctor, independently of patient's participation in this study. The study will last for 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Common inclusion criteria for Group A and Group B:
- •Male or female, age above or equal to 18 years at the time signing informed consent.
- •Body mass index (BMI) more than or equal to (≥) 30 kilogram per meter square (kg/m^2) with at least one of the following diagnosed obesity-related comorbidities:
- •arterial hypertension, pre-diabetes, Obstructive Sleep Apnea (OSA) or coronary heart disease, chronic heart failure, or BMI ≥35 kg/m^
- •History of at least one self-reported unsuccessful attempt to lose weight.
- •Capable of completing informed consent.
- •Additional inclusion criteria for Group A:
- •The decision to initiate treatment with commercially available Wegovy has been made by the participant and the treating physician before and independently from the decision to include the participant in this study.
- •Initiation of treatment is not modified in any case due to participant's participation in the study.
排除标准
- •for Group A and Group B:
- •Previous participation in this study (participation is defined as having given informed consent in this study)
- •Treatment with an investigational drug within 30 days prior to enrolment into the study.
- •Participant has had a prior serious allergic reaction to semaglutide or any of the ingredients in Wegovy.
- •Women with pregnancy or breast-feeding.
- •Women of childbearing potential and not using an adequate contraceptive method.
- •Men and women in their pregnancy attempts.
- •Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
- •History of any Glucagon-like peptide-1 (GLP-1) treatment within 180 days.
- •History of type 1 or type 2 diabetes mellitus.
研究组 & 干预措施
Group B
Participants with lifestyle modification in the routine clinical practice will be included.
Group A
Participants will be treated with commercially available semaglutide along with lifestyle modification in the routine clinical practice.
干预措施: Semaglutide (Drug)
结局指标
主要结局
Change in relative body weight
时间窗: From baseline to month 6 and month 9
Percentage (%)
次要结局
- Change in total cholesterol(from baseline to month 3, month 6, month 9 and month 12)
- Change in high density lipoprotein (HDL)(from baseline to month 3, month 6, month 9 and month 12)
- Change in low density lipoprotein (LDL)(from baseline to month 3, month 6, month 9 and month 12)
- Change in very low density lipoprotein (VLDL)(from baseline to month 3, month 6, month 9 and month 12)
- Change in diastolic blood pressure (DBP)(from baseline to month 3, month 6, month 9 and month 12)
- Change in C-reactive protein (CRP) or high-sensitivity C-reactive protein (hs-CRP)(from baseline to month 3, month 6, month 9 and month 12)
- Change in platelet count(from baseline to month 3, month 6, month 9 and month 12)
- Change in gamma-glutamyl transferase (GGT)(from baseline to month 3, month 6, month 9 and month 12)
- Change in alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/GPT)(from baseline to month 3, month 6, month 9 and month 12)
- Change in relative body weight(From baseline to month 3 and 12)
- Change in body weight(from baseline to month 3, month 6, month 9 and month 12)
- Change in Haemoglobin A1c (HbA1c)(from baseline to month 3, month 6, month 9 and month 12)
- Change in fasting plasma glucose (FPG)(from baseline to month 3, month 6, month 9 and month 12)
- Change in lipoprotein A [Lp(a)](from baseline to month 3, month 6, month 9 and month 12)
- Change in triglycerides(from baseline to month 3, month 6, month 9 and month 12)
- Change in estimated glomerular filtration rate (eGFR) eGFR(from baseline to month 3, month 6, month 9 and month 12)
- Change in waist circumference(from baseline to month 3, month 6, month 9 and month 12)
- Change in systolic blood pressure (SBP)(from baseline to month 3, month 6, month 9 and month 12)
- Change in aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/GOT)(from baseline to month 3, month 6, month 9 and month 12)
研究者
研究点 (1)
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