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Clinical Trials List

Protocol NumberEX9536-4388
NCT Number(ClinicalTrials.gov Identfier)NCT03574597

2018-10-24 - 2024-03-31

Phase III

Recruiting4

Terminated2

ICD-10E66

Overweight and obesity

ICD-9278.00

Obesity unspecified

SELECT - Semaglutide effects on cardiovascular outcomes in people with overweight or obesity

  • Trial Applicant

    NOVO NORDISK PHARMA (TAIWAN) LTD.

  • Sponsor

    Novo Nordisk A/S

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2025/08/20

Investigators and Locations

Principal Investigator Hung-I Yeh Division of Cardiovascular Diseases
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Principal Investigator 李統立 Division of Cardiovascular Diseases
E-DA Hospital

Co-Principal Investigator

  • 蔡幸珊 Division of Cardiovascular Diseases
  • 宣錦峰 Division of Cardiovascular Diseases
  • 曾維功 Division of Cardiovascular Diseases
  • 梁懷文 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 劉銘恩 Division of Cardiovascular Diseases
Hsinchu Mackay Memorial Hospital

Co-Principal Investigator

  • 林柏霖 Division of Cardiovascular Diseases
  • 賴堯暉 Division of Cardiovascular Diseases
  • 吳敘平 Division of Cardiovascular Diseases
  • 劉俞旻 Division of Cardiovascular Diseases
  • 楊翔惟 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator I-Chang Hsieh Division of Cardiovascular Diseases
Linkou Chang Gung Medical Foundation

Taiwan National PI

謝宜璋

Co-Principal Investigator

  • 謝明哲 Division of Cardiovascular Diseases
  • 陳東藝 Division of Cardiovascular Diseases
  • 陳俊吉 Division of Cardiovascular Diseases

The Actual Total Number of Participants Enrolled

22 Recruiting

Audit

None

Principal Investigator Chau-Chung Wu Division of Cardiovascular Diseases
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Hung-I Yeh Division of Cardiovascular Diseases
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Completed

Condition/Disease

Obesity

Objectives

Primary objective To demonstrate that semaglutide subcutaneously (s.c) 2.4 mg once-weekly lowers the incidence of major adverse cardiovascular events (MACE) versus semaglutide placebo, both added to standard of care in subjects with established CV disease and overweight or obesity. Key secondary objectives To compare the effect of semaglutide s.c. 2.4 mg once-weekly versus semaglutide placebo, both added to standard of care in subjects with established CV disease and overweight or obesity with regards to:  Mortality

Test Drug

Semaglutide B 3.0 mg/mL PDS290 or Semaglutide placebo

Active Ingredient

Semaglutide B

Dosage Form

Dosage

3 mg/mL

Endpoints

1. Primary endpoint(s):
The primary endpoint is time from randomisation to first occurrence of a composite endpoint
consisting of: CV death, non-fatal myocardial infarction, or non-fatal stroke
2. Secondary endpoints:
Confirmatory secondary endpoints
Time from randomisation to:
 CV death
 All-cause death

Inclution Criteria

Key inclusion criteria
• Male or female, age ≥ 45 years at the time of signing informed consent
• Body mass index (BMI) ≥ 27 kg/m2
• Have established CV disease as evidenced by at least one of the following:
• prior myocardial infarction
• prior stroke (ischemic or haemorrhagic stroke) or
• symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication
with ankle-brachial index (ABI) < 0.85 (at rest), or peripheral arterial revascularization
procedure, or amputation due to atherosclerotic disease

Exclusion Criteria

Key exclusion criteria
• Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris
or transient ischaemic attack within the past 60 days prior to the day of screening
• HbA1c ≥ 48 mmol/mol (6.5 %) as measured by the central laboratory at screening
• History of type 1 or type 2 diabetes (history of gestational diabetes is allowed)

The Estimated Number of Participants

  • Taiwan

    155 participants

  • Global

    17500 participants

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