Semaglutide Effects on Heart Disease and Stroke in Patients With Overweight or Obesity

Completed · Phase 3 · Has a placebo group

Conditions studied: Overweight, Obesity

In brief

The researchers are doing the study to see if semaglutide may reduce the risk of having cardiovascular events in patients with overweight or obesity and with prior cardiovascular disease. The participant will either get semaglutide (active medicine) or placebo ("dummy" medicine). Which treatment the participants get is decided by chance. The participant's chance of getting semaglutide or placebo is the same. The participant will get the study medicine in a pen. The participants will need to use the pen to inject the study medicine in a skinfold once a week. The study will last for about 2.5 to 5 years. Participants will have up to 25 clinic visits with the study doctor.

Key facts

Study ID

NCT03574597

Run by

Novo Nordisk A/S

People needed

17604

Starts

2018-10-24

Expected to finish

2023-06-29

Last updated by the study team

2024-08-30

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
• Male or female, age greater than or equal to 45 years at the time of signing informed consent
• Body mass index (BMI) greater than or equal to 27 kg/m\^2
• Have established cardiovascular (CV) disease as evidenced by at least one of the following: prior myocardial infarction; prior stroke (ischemic or haemorrhagic stroke); or symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) less than 0.85 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease

You may not qualify if…

• Cardiovascular-related:
• Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 60 days prior to the day of screening
• Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
• Presently classified as being in New York Heart Association (NYHA) Class IV heart failure
• Glycaemia-related:
• HbA1c greater than or equal to 48 mmol/mol (6.5 %) as measured by the central laboratory at screening
• History of type 1 or type 2 diabetes (history of gestational diabetes is allowed)
• Treatment with glucose-lowering agents within 90 days before screening
• Treatment with any glucagon-like-peptide-1 receptor agonist (GLP-1 RA) within 90 days before screening
• General safety:
• History or presence of chronic pancreatitis
• Presence of acute pancreatitis within the past 180 days prior to the day of screening
• Personal or first degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
• End stage renal disease or chronic or intermittent haemodialysis or peritoneal dialysis
• Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed
• Severe psychiatric disorder which in the investigator's opinion could compromise compliance with the protocol
• Known or suspected hypersensitivity to trial products or related products
• Previous participation in this trial. Participation is defined as randomisation
• Receipt of any investigational medicinal product within 30 days before screening
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method
• Any disorder, unwillingness or inability, which in the investigator's opinion, might jeopardise the participant's safety or compliance with the protocol

Where it is running

• Univ of Alabama Birmingham — Birmingham, Alabama, United States
• Healthscan Clinical Trials,LLC. — Montgomery, Alabama, United States
• Synexus Clinical Research US, Inc./Tatum — Glendale, Arizona, United States
• Synexus Clinical Research — Glendale, Arizona, United States
• Synexus Rsch /Cnt Phnx Med C — Phoenix, Arizona, United States
• National Heart Institute Cal — Beverly Hills, California, United States
• FDRC — Costa Mesa, California, United States
• Valley Clinical Trials — Covina, California, United States
• Scripps Whittier Diabetes Inst — La Jolla, California, United States
• First Valley Medical Group — Lancaster, California, United States
• Torrance Clin Res Inst, Inc. — Lomita, California, United States
• Long Beach VA healthcare System — Long Beach, California, United States
• Angel City Research, Inc. — Los Angeles, California, United States
• VAGLAHS Clinical Research Center (CRC) — Los Angeles, California, United States
• Riverside University Health System Medical Center — Moreno Valley, California, United States
• Valley Clinical Trials, Inc. — Northridge, California, United States
• Desert Oasis Hlthcr Med Group — Palm Springs, California, United States
• Western University of Health Sciences — Pomona, California, United States
• Quartz Hill Walk-in Medical Group, inc. — Quartz Hill, California, United States
• TriWest Research Associates — San Diego, California, United States
• San Diego Family Care — San Diego, California, United States
• Mills-Peninsula Medical Center — San Mateo, California, United States
• NorCal Endocrinology and Internal Medicine — San Ramon, California, United States
• Encompass Clinical Research_Spring Valley — Spring Valley, California, United States
• Central Alabama Research — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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