2025-524626-18-00招募中3 期
Efficacy and safety of once daily oral semaglutide in adults with overweight or obesity
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 315
- 试验地点
- 100
- 主要终点
- Relative change in body weight
研究概览
简要总结
To demonstrate the superiority of oral semaglutide 00 mg and/or 00 mg once daily versus placebo as an adjunct to reduced-calorie diet and increased physical activity on weight loss in adults with overweight or obesity.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Informed consent 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.
- •Female or male (sex at birth).
- •Age 18 years or above at the time of signing the informed consent.
- •Body mass index (BMI) of a) ≥ 27.0 kg/m2 with the presence of at least one weight-related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or CV disease OR b) ≥ 30.0 kg/m2
- •History of at least one self-reported unsuccessful dietary effort to lose body weight.
排除标准
- •A self-reported change in body weight > 5 % within 90 days before screening irrespective of medical records
- •HbA1c ≥ 6.5% (48 mmol/mol) as measured by the central laboratory at screening
- •Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening, OR any consistent use of GLP-1 receptor agonists, including medication with glucagon like peptide-1 receptor agonist (GLP-1 RA) activity like dual GLP-1/gastric inhibitory peptide RAs, or amylin analogues 00 before screening. Consistent use is defined as treatment 00.
研究组 & 干预措施
Placebo for semaglutide D tablet
Placebo
干预措施: Placebo for semaglutide D tablet (Drug)
Rybelsus 1.5 mg tablets, Rybelsus 9 mg tablets, Rybelsus 4 mg tablets
Test
干预措施: Rybelsus 1.5 mg tablets (Drug)
Rybelsus 1.5 mg tablets, Rybelsus 9 mg tablets, Rybelsus 4 mg tablets
Test
干预措施: Rybelsus 9 mg tablets (Drug)
Rybelsus 1.5 mg tablets, Rybelsus 9 mg tablets, Rybelsus 4 mg tablets
Test
干预措施: Rybelsus 4 mg tablets (Drug)
结局指标
主要结局
Relative change in body weight
Relative change in body weight
次要结局
- CCI
- Achievement of body weight reduction ≥ 5% (Yes/No)
- Achievement of body weight reduction ≥ 10% (Yes/No)
- Achievement of body weight reduction ≥ 15% (Yes/No)
- Change in waist circumference
- Change in body weight
- Change in hsCRP
- Change in Glycaemic status
- Change in lipids: Total cholesterol HDL cholesterol Non-HDL cholesterol LDL cholesterol VLDL cholesterol Triglycerides Free fatty acids
- Change in systolic blood pressure
- Change in diastolic blood pressure
- Change in FPG
- Change in HbA1c
- Change in waist-height ratio (WtHR)
- Number of treatment emergent adverse events
- Number of treatment emergent serious adverse events
- Number of treatment emergent adverse events leading to permanent treatment discontinuation
研究者
EU Submission Hub
Scientific
Novo Nordisk A/S
研究点 (100)
Loading locations...
相似试验
招募中
3 期
A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE Plus)2023-506918-45-00Novo Nordisk A/S798
尚未招募
不适用
Studying the Safety and Benefits of Oral Semaglutide for People with Diabetes and Obesity.CTRI/2025/04/085464Sri Ramachandra Institute Of Higher Education and Research45
招募中
3 期
An interventional, multi-center, randomized, double blinded, placebo controlled study to investigate semaglutide add-on treatment for metabolic control in antipsychotic-using patients (STABIL-NOR – study).2023-506109-20-00Helse Bergen HF140
已完成
4 期
Efficacy of Once Weekly Semaglutide in Patients With Type 2 Diabetes: a Non Randomized Clinical TrialType 2 DiabetesNCT07732218Rehman Medical Institute - RMI95
已完成
3 期
A Research Study Investigating Semaglutide in People With Early Alzheimer's Disease (EVOKE)Mild cognitive impairment (MCI) or mild dementia, both of the Alzheimer’s type2023-506919-18-00Novo Nordisk A/S873