NCT04032197

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

Completed Phase 1 Last updated 29 April 2025

What this trial tests

Phase 1 trial testing Semaglutide in Diabetes Mellitus, Type 2 in 101 participants. Completed in 6 June 2023.

Timeline

12 August 2019

Primary endpoint
16 December 2022

6 June 2023

Quick facts

Lead sponsor	Novo Nordisk A/S
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	101
Start date	12 August 2019
Primary completion	16 December 2022
Estimated completion	6 June 2023
Sites	4 locations across Austria, Sweden, Denmark

Drugs / interventions tested

• Semaglutide (semaglutide) — full drug profile →
• Placebo (semaglutide)

Conditions studied

• Diabetes Mellitus, Type 2 — all drugs for Diabetes Mellitus, Type 2 →

Sponsor

Novo Nordisk A/S — full company profile →

Who can join

50 and older, any sex, with Diabetes Mellitus, Type 2. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

7 peer-reviewed publications reference this trial (live from Europe PMC):

1. Impact of semaglutide on high-sensitivity C-reactive protein: exploratory patient-level analyses of SUSTAIN and PIONEER randomized clinical trials.
   Mosenzon O, Capehorn MS, De Remigis A, Rasmussen S, et al · · 2022 · cited 49× · PMID 36056351 · DOI 10.1186/s12933-022-01585-7
2. Novel Positron Emission Tomography Tracers for Imaging Vascular Inflammation.
   Ćorović A, Wall C, Mason JC, Rudd JHF, et al · · 2020 · cited 24× · PMID 32772188 · DOI 10.1007/s11886-020-01372-4
3. Linking Kidney and Cardiovascular Complications in Diabetes-Impact on Prognostication and Treatment: The 2019 Edwin Bierman Award Lecture.
   Rossing P, Persson F, Persson F, Frimodt-Møller M, et al · · 2021 · cited 14× · PMID 33355308 · DOI 10.2337/dbi19-0038
4. Novel Tracers and Radionuclides in PET Imaging.
   Mason C, Gimblet GR, Lapi SE, Lewis JS. · · 2021 · cited 10× · PMID 34392925 · DOI 10.1016/j.rcl.2021.05.012
5. Semaglutide treatment attenuates vessel remodelling in ApoE-/- mice following vascular injury and blood flow perturbation.
   Jensen DM, Skovsted GF, Bonde MFB, Bentzon JF, et al · · 2022 · cited 9× · PMID 36644202 · DOI 10.1016/j.athplu.2022.05.004
6. Nonalcoholic Steatohepatitis (NASH) and Atherosclerosis: Explaining Their Pathophysiology, Association and the Role of Incretin-Based Drugs.
   Galatou E, Mourelatou E, Hatziantoniou S, Vizirianakis IS. · · 2022 · cited 9× · PMID 35739957 · DOI 10.3390/antiox11061060
7. 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 S, Christoffersen AD, David JP, Hacker M, et al · · 2025 · cited 3× · PMID 40345413 · DOI 10.1016/j.ahj.2025.05.001