EX9536-4773: Effect of Semaglutide 2.4 mg once-weekly on function and symptoms in subjects with obesity related heart failure with preserved ejection fraction, and type 2 diabetes

  • STATUS
    Recruiting
Updated on 18 May 2022
ejection fraction
hemoglobin a1c

Summary

This study will look at how participants' daily life is affected by their heart failure. The study will also look at the change in participants' body weight.

Description

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. The study medicine is injected with a thin needle in a skin fold in the stomach area, thigh or upper arm.
During the study participants will have talks with the study staff about healthy lifestyle and physical activity.
The study will last for about 59 weeks, that is a little more than 1 year. Participants will have 12 clinic visits with the study doctor

Details
Condition Heart Failure, Diabetes Mellitus Types I and II
Clinical Study IdentifierTX299754
Last Modified on18 May 2022

Eligibility

Yes No Not Sure

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 randomization. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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