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Completed

NCT Number: NCT04032197

A Research Study of How Semaglutide Works in People With Disease Affecting the Heart and/or Blood Vessels and Type 2 Diabetes

This study looks into how the type 2 diabetes medicine, semaglutide, can prevent risk of heart disease complications and stroke. Participants will either get semaglutide or placebo ("dummy" medicine) - which treatment is decided by chance. Semaglutide is a new medicine to treat type 2 diabetes and can be prescribed by doctors in some countries. The study medicine will be in a pen, and must be injected with a needle in the stomach, thigh or upper arm once a week. The study will last for 57-63 weeks. Participants will have 10 clinic visits with the study doctor, 5 visits to the specialised clinic for imaging and at least 1 phone contact. Participants' health will be monitored carefully and blood samples will therefore be taken at the clinic visits. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Trials Unit / Center for Medical Research, Graz, Austria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, age above or equal to 50 years at the time of signing informed consent
  • Body mass index equal to or less than 39.9 kg/m^2
  • Diagnosed with type 2 diabetes 180 daysor more prior to the day of the first screening visit
  • HbA1c 6.0% - 9.0% (42-75 mmol/mol) (both inclusive)
  • Established cardiovascular disease

Exclusion criteria

  • Hospitalisation for unstable angina pectoris or transient ischaemic attack within 90 days prior to the day of the first screening visit
  • Planned coronary, carotid or peripheral artery revascularisation.
  • Presently classified as being in New York Heart Association (NYHA) equal to or above Class III
  • Treatment with glucagon-like peptide-1 receptor agonists (GLP-1 RAs) or systemic anti-inflammatory drugs within 90 days prior to the first screening visit. Stable treatment with acetylsalicylic acid for prevention of cardiovascular events and occasional use of propionic acid derivatives drugs (e.g. ibuprofen) is allowed

Treatment and study plan

semaglutide

Drug

Subcutaneous (s.c., under the skin) injections for 52 weeks. Participants will remain on their pre-study standard of care treatment (antidiabetic medication and CV medication).

Placebo (semaglutide)

Drug

Subcutaneous (s.c., under the skin) injections for 52 weeks. Participants will remain on their pre-study standard of care treatment (antidiabetic medication and CV medication).

Primary outcomes

  1. Change in maximum target-to-background ratio (TBR) for 18F-fluorodeoxyglucose (FDG) in the carotid arteries

    Time frame: From baseline (from 41 days before randomisation) to week 26

    Ratio

Secondary outcomes

  1. Change in maximum target-to-background ratio (TBR) for 68Ga-DOTATATE in the carotid arteries

    Time frame: From baseline (from 40 days before randomisation) to week 26

    Ratio

  2. Change in total wall volume of the most diseased carotid artery

    Time frame: From baseline (from 41 days before randomisation) to week 52

    mm3

  3. Change in lipid rich necrotic core (LRNC) volume of the atherosclerotic plaque in the most diseased carotid artery

    Time frame: From baseline (from 41 days before randomisation) to week 52

    mm3

  4. Change in average fibrous cap thickness (FCT) of the atherosclerotic plaque in the most diseased carotid artery

    Time frame: From baseline (from 41 days before randomisation) to week 52

    mm

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Trial Investigating the Effect of Semaglutide on Atherosclerosis in Patients With Cardiovascular Disease and Type 2 Diabetes

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Jul 25, 2019
Registry last updated
Apr 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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