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Trial · Interventional

CompletedPhase 1Registry data

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

NCTNCT04032197 (opens ClinicalTrials.gov in a new tab)Other idNN9535-4430Other idU1111-1215-4058Other id2018-002289-38Other id2018
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
101 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Randomized · Quadruple masking
Countries
3 countries

Austria, Denmark, Sweden

Start
12 Aug 2019
Primary completion
16 Dec 2022
Completion
6 Jun 2023
First posted
25 Jul 2019
Last update posted
29 Apr 2025
Conditions
Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021202220232024
  1. Ph 1

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

    NCT04032197

    12 Aug 2019 to 6 Jun 2023

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • SemaglutideDrug
  • Placebo (semaglutide)Drug

Arms2

  • Experimental

    Semaglutide

    Semaglutide injected once-weekly. Standard dose escalations every 4 weeks will be applied, until the maximum dose of 1.0 mg semaglutide is reached.

  • Placebo comparator

    Placebo

    Placebo injected once-weekly. Standard dose escalations every 4 weeks will be applied, until the maximum dose of 1.0 mg placebo is reached.

Primary outcomes1

Outcomes the sponsor listed as primary.

  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

    Registry description

    Ratio

Secondary outcomes(4)

  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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    mm

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2025

2 results

Effect of once-weekly subcutaneous semaglutide on arterial inflammation in people with type 2 diabetes and cardiovascular disease using PET-MRI: Primary results of a randomized, double-blind, placebo-controlled trial.

James et al. 2025American heart journalcited by 5

PMID 40345413DOI 10.1016/j.ahj.2025.05.001PUB-40345413

Full text at the publisher2 results
Publisher pageSee results (2)

Eligibility

Who could join, as posted.

Sex
All
Age
from 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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