A Trial Investigating the Effect of Semaglutide on Atherosclerosis in Patients With Cardiovascular Disease and Type 2 Diabetes
Overview
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novo Nordisk A/S
- Enrollment
- 101
- Locations
- 4
- Primary Endpoint
- Change in maximum target-to-background ratio (TBR) for 18F-fluorodeoxyglucose (FDG) in the carotid arteries
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Semaglutide (Drug)
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.
Intervention: Placebo (semaglutide) (Drug)
Outcomes
Primary Outcomes
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
- Change in maximum target-to-background ratio (TBR) for 68Ga-DOTATATE in the carotid arteries(From baseline (from 40 days before randomisation) to week 26)
- Change in total wall volume of the most diseased carotid artery(From baseline (from 41 days before randomisation) to week 52)
- Change in lipid rich necrotic core (LRNC) volume of the atherosclerotic plaque in the most diseased carotid artery(From baseline (from 41 days before randomisation) to week 52)
- Change in average fibrous cap thickness (FCT) of the atherosclerotic plaque in the most diseased carotid artery(From baseline (from 41 days before randomisation) to week 52)