Research Study to Look at How Well Semaglutide Works in People Living With Heart Failure, Obesity and Type 2 Diabetes

Overview

About this study

The purpose of this study is to look at how participants' daily life is affected by their heart failure. The study will also look at the change in participants' body weight. This study will compare the effect of semaglutide (a new medicine) compared to "dummy" medicine on body weight and heart failure symptoms. Participants will either get semaglutide or "dummy" medicine, which treatment participants get is decided by chance. Participants will need to take 1 injection once a week. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Male or female, age above or equal to 18 years at the time of signing informed consent.
  • Body mass index (BMI) greater than or equal to 30.0 kg/m^2.
  • New York Heart Association (NYHA) Class II-IV.
  • Left ventricular ejection fraction (LVEF) greater than or equal to 45% at screening -Diagnosed with T2D greater than or equal to 90 days prior to the day of screening.
  • HbA1c of below or equal to 10.0% as measured at the screening visit.

Exclusion Criteria:

  • A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records.
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

Eligibility last updated 9/7/21. Questions regarding updates should be directed to the study team contact.

 

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Barry Borlaug, M.D.

Open for enrollment

Contact information:

RST Borlaug Study Team

(507) 255-2200

More information

Publications

Publications are currently not available
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CLS-20525618

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