Semaglutide for Heart Disease Prevention in Type 2 Diabetes
(SOUL Trial)

Recruiting in Palo Alto (17 mi)

+864 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novo Nordisk A/S

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 6 Jurisdictions

Trial Summary

What is the purpose of this trial?

The researchers are doing this study to look whether the type 2 diabetes medicine, semaglutide, has a positive effect on heart disease. Participants will either get semaglutide tablets or placebo tablets ("dummy" medicine) - which treatment is decided by chance. Participants must take one tablet with water every morning on an empty stomach and not eat or drink anything for at least 30 minutes. The study will last for about 3.5-5 years. Participants will have up to 25 clinic visits and 1 phone call with the study doctor. Women cannot be in the study if pregnant, breast-feeding or if they plan to become pregnant during the study period.

Research Team

Clinical Reporting Anchor and Disclosure (1452)

Principal Investigator

Novo Nordisk A/S

Eligibility Criteria

This trial is for people over 50 with type 2 diabetes and heart disease or related conditions, but not those who've had recent severe cardiovascular events or used similar diabetes medications recently. Pregnant or breastfeeding women are excluded.

Inclusion Criteria

I have heart, brain blood vessel, leg artery problems, or chronic kidney disease.

Your HbA1c level is between 6.5% and 10.0%. This is a test that shows your average blood sugar level over the past few months.

I have been diagnosed with type 2 diabetes.

See 2 more

Exclusion Criteria

My heart failure is severe, limiting my ability to carry out any physical activity without discomfort.

I haven't taken any GLP-1 receptor agonist drugs in the last 30 days.

I haven't had a heart attack, stroke, or severe chest pain in the last 60 days.

See 1 more

Treatment Details

Interventions

Placebo (semaglutide) (Other)
Semaglutide (GLP-1 Receptor Agonist)

Trial OverviewThe study tests if semaglutide tablets can benefit heart health in type 2 diabetes patients compared to placebo. Participants will be randomly assigned to either the drug or dummy pills for up to five years, with regular clinic visits and a phone call check-in.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Oral semaglutideExperimental Treatment1 Intervention

One tablet daily for 3.5 to 5 years

Group II: PlaceboPlacebo Group1 Intervention

One tablet daily for 3.5 to 5 years

Semaglutide is already approved in Canada, Japan for the following indications: