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临床试验/NCT06041217
NCT06041217已完成3 期

Efficacy and Safety of Semaglutide 2.4 mg Once-weekly in Adults With Overweight and Obesity

Novo Nordisk A/S34 个研究点 分布在 2 个国家目标入组 242 人开始时间: 2023年9月15日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
242
试验地点
34
主要终点
Relative change in body weight
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study will look at how the investigational dose of semaglutide works in helping people with excess body weight, to lose weight. This study will compare the weight loss in people taking semaglutide to people taking "dummy" medicine (placebo). The study will last for about 1 year. The participants will have 12 visits at the clinic and 3 remote visits by phone calls with the study doctor or staff.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

盲法说明

Sponsor staff involved in the clinical trial is masked according to company standard procedures.

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

  • •Age greater than or equal to 18 years at the time of signing informed consent.
  • •Body mass index (BMI) of greater than or equal to 24 and less than 28 kilogram per square meter ( kg/m^2) with the presence of at least one weight related complication (treated or untreated): Type 2 diabetes (T2D), hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease or BMI greater than or equal to 28 and less 30 kg/m^2, with or without weight related complications at screening.
  • •History of at least one self-reported unsuccessful dietary effort to lose body weight.
  • •For participants with T2D at screening:
  • •- Diagnosed with T2D greater than or equal to 180 days prior to the day of screening
  • •Treated with either:
  • •Diet and exercise alone or with 1-3 marketed oral antidiabetic drugs (metformin, alpha glucosidase, Sulfonylureas (SU), glinides, sodium-glucose co-transporter 2 inhibitors (SGLT2i) or glitazone as a single agent or in combination) according to local label.
  • •Treatment with oral anti-diabetic drugs should be stable (same drug(s) or active ingredient, dose, and dosing frequency) for at least 60 days before screening
  • •Glycated haemoglobin (HbA1c) of less than or equal to 10.0 percent (less than or equal to 86 millimoles per mol [mmol/mol]) as measured by the central laboratory at screening.

排除标准

  • •A self-reported change in body weight greater than 5 kilograms (kg) within 90 days before screening irrespective of medical records.
  • •Treatment with any medication for the indication of obesity within the past 90 days before screening.
  • •Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
  • •For participants without T2D at screening:
  • •- HbA1c greater than or equal to 6.5percent (48 mmol/mol) as measured by the laboratory.
  • •For participants with T2D at screening:
  • •Renal impairment with estimated Glomerular Filtration Rate (eGFR) value of less than 30 milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by Kidney Disease Improving Global Outcomes (KDIGO) 2012 classification by the central laboratory at screening.
  • •Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to 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.

研究组 & 干预措施

Semaglutide 2.4 milligram (mg)

Experimental

Participants will receive once-weekly subcutaneous (s.c) injection of semaglutide for 44 weeks.

干预措施: Semaglutide (Drug)

Placebo

Placebo Comparator

Participants will receive once-weekly subcutaneous (s.c) injection of placebo for 44 weeks.

干预措施: Placebo (Drug)

结局指标

主要结局

Relative change in body weight

时间窗: From baseline (week 0) to end of treatment (week 44)

Measured in percentage (%).

Body weight reduction ≥ 5% (yes/no)

时间窗: At end of treatment (week 44)

Measured as count of participants.

次要结局

  • Body weight reduction ≥ 10% (yes/no)(At end of treatment (week 44))
  • Change in waist circumference(From baseline (week 0) to end of treatment (week 44))
  • Change in body weight(From baseline (week 0) to end of treatment (week 44))
  • Change in body mass index(From baseline (week 0) to end of treatment (week 44))
  • Change in waist-height ratio (WtHR)(From baseline (week 0) to end of treatment (week 44))
  • Change in Glycated Haemoglobin (HbA1c) (Percent [%])(From baseline (week 0) to end of treatment (week 44))
  • Change in diastolic blood pressure(From baseline (week 0) to end of treatment (week 44))
  • Change in systolic blood pressure(From baseline (week 0) to end of treatment (week 44))
  • Change in low-density lipoprotein (LDL) cholesterol(From baseline (week 0) to end of treatment (week 44))
  • Change in very low-density lipoprotein (VLDL) cholesterol(From baseline (week 0) to end of treatment (week 44))
  • Change in triglycerides(From baseline (week 0) to end of treatment (week 44))
  • Change in free fatty acids(From baseline (week 0) to end of treatment (week 44))
  • Change in high-sensitivity c-reactive protein (hsCRP)(From baseline (week 0) to end of treatment (week 44))
  • Change in total cholesterol(From baseline (week 0) to end of treatment (week 44))
  • Change in high-density lipoprotein (HDL) cholesterol(From baseline (week 0) to end of treatment (week 44))
  • Change in HbA1c (mmol/mol)(From baseline (week 0) to end of treatment (week 44))
  • Change in fasting plasma glucose (mg/dL)(From baseline (week 0) to end of treatment (week 44))
  • Change in fasting plasma glucose (mmol/L)(From baseline (week 0) to end of treatment (week 44))
  • Number of Treatment-emergent Adverse Events (TEAEs)(From baseline (week 0) to end of treatment (week 44))
  • Number of Serious Adverse Events (SAEs)(From baseline (week 0) to end of treatment (week 44))
  • Change in pulse(From baseline (week 0) to end of treatment (week 44))
  • Number of clinically significant hypoglycaemic episodes (level 2) (less than [<] 3.0 millimole per liter [mmol/L]) confirmed by blood glucose [BG] meter)(From baseline (week 0) to end of study (week 49))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (34)

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