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临床试验/EUCTR2017-003726-32-IT
EUCTR2017-003726-32-IT进行中(未招募)1 期

Two-year effect and safety of semaglutide 2.4 mg once-weekly in subjects with overweight or obesity - NN9536-4378

OVO NORDISK. S.P.A.0 个研究点目标入组 300 人开始时间: 2021年6月15日最近更新:

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
300

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1. Male or female, age 18 years or older at the time of signing informed consent
  • 2. Body mass index (BMI) equal to or above 30 kg/sqm or equal to or above 27 kg/sqm with the presence of at least one of the following weight-related comorbidities (treated or untreated): hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease
  • 3. History of at least one self-reported unsuccessful dietary effort to lose body weight
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 270
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 30

排除标准

  • 1. HbA1c equal to or above 48 mmol/mol (6.5%) as measured by the central laboratory at screening
  • 2. A self-reported change in body weight above 5 kg (11 lbs) within 90 days before screening irrespective of medical records

研究者

发起方
OVO NORDISK. S.P.A.

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