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

Novo Nordisk A/S617 enrolled

Overview

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. 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. * At 6 of the visits participants will have blood samples taken. * At 5 of the visits participants will be asked to fill in a questionnaire * At 4 of the visits participants will have to do a 6-minute walking test * At 3 of the visits participants will have a test to check the heart. * participants will have their eyes checked before or at the start of the study and at the end of the study Women cannot take part if pregnant, breast-feeding or plan to become pregnant during the study period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

617

Conditions

Heart Failure With Preserved Ejection Fraction (HFpEF) and Diabetes Mellitus, Type 2

Interventions

SemaglutideDRUG

Participants will receive semaglutide subcutaneous (s.c.; under the skin) injection(s) once-weekly for 52 weeks. Dose will be gradually increased to 2.4 mg: 0.25 mg from week 1 to 4, 0.5 mg from week 5 to 8, 1.0 mg from week 9 to 12, 1.7 mg from week 13 to 16 and 2.4 mg from week 17 to week 52.

Placebo (Semaglutide)DRUG

Participants will receive semaglutide matching placebo s.c. injection(s) once-weekly for 52 weeks.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (180)

Eastern Shore Rsrch Inst, LLC

Fairhope, Alabama, United States

Mobile Heart Specialists

Mobile, Alabama, United States

National Heart Institute Cal

Beverly Hills, California, United States

John Muir Physicians Network

Concord, California, United States

Valley Clinical Trials

Covina, California, United States

Outcomes

Primary Outcomes

Change in KCCQ (Kansas City Cardiomyopathy Questionnaire) clinical summary score

Score on a scale of 0 to 100 where the score 100 means the least burden for the participant.

Time frame: From baseline (week 0) to end of treatment (week 52)

Change in body weight

Percentage (%)

Time frame: From baseline (week 0) to end of treatment (week 52)

Secondary Outcomes

Change in 6-minute walking distance

Measured in metres

Time frame: From baseline (week 0) to end of treatment (week 52)

Hierarchical composite of time to all-cause death

Measured as total wins for each treatment group.

Time frame: From baseline (week 0) to end of study (week 57)

Hierarchical composite of number of heart failure events requiring hospitalisation or urgent heart failure visit

Measured as total wins for each treatment group

Time frame: From baseline (week 0) to end of study (week 57)

Hierarchical composite of time to first heart failure event requiring hospitalisation or urgent heart failure visit

Measured as total wins for each treatment group.

Time frame: From baseline (week 0) to end of study (week 57)

Hierarchical composite of difference at least 15 inKansas City Cardiomyopathy Questionnaire (KCCQ) clinical summary score change from baseline to 52 weeks

Measured as total wins for each treatment group.

Time frame: From baseline (week 0) to end of study (week 57)

Hierarchical composite of difference at least 10 in KCCQ clinical summary score change from baseline to 52 weeks

Measured as total wins for each treatment group.

Time frame: From baseline (week 0) to end of study (week 57)

Hierarchical composite of difference at least 5 in KCCQ clinical summary score change from baseline to 52 weeks

Measured as total wins for each treatment group.

Time frame: From baseline (week 0) to end of study (week 57)

Hierarchical composite of difference at least 30 metres in six-minute walking distance change from baseline to 52 weeks (assessed by the win ratio)

Measured as total wins for each treatment group.

Time frame: From baseline (week 0) to end of study (week 57)

Change in C-Reactive Protein

Presented as ratio to baseline

Time frame: From baseline (week -2) to end of treatment (week 52)

Participant achieving 10% weight loss or more (Yes/No)

Count of participants

Time frame: From baseline (week 0) to end of treatment (week 52)

Participant achieving 15% weight loss or more (Yes/No)

Count of participants

Time frame: From baseline (week 0) to end of treatment (week 52)

Participant achieving 20% weight loss or more (Yes/No)

Count of participants

Time frame: From baseline (week 0) to end of treatment (week 52)

Participant improving 5 points or more in KCCQ clinical summary score

Count of participants

Time frame: From baseline (week 0) to end of treatment (week 52)

Participant improving 10 points or more in KCCQ clinical summary score (Yes/No)

Count of participants

Time frame: From baseline (week 0) to end of treatment (week 52)

Change in KCCQ overall summary score

Score on a scale of 0 to 100 where the score 100 means the least burden for the participant.

Time frame: From baseline (week 0) to end of treatment (week 52)

Participant achieving threshold for clinically meaningful within-subject change in KCCQ-CSS

Count of participants

Time frame: From baseline (week 0) to end of treatment (week 52)

Participant achieving threshold for clinically meaningful within-subject change in 6MWD

Count of participants

Time frame: From baseline (week 0) to end of treatment (week 52)

Change in waist circumference

Measured in centimetre (cm)

Time frame: From baseline (week 0) to end of treatment (visit 52)

Change in systolic blood pressure

Measured in millimetre of mercury (mmHg)

Time frame: From baseline (week -2) to end of treatment (week 52)

Change in glycated haemoglobin (HbA1c)

Measured in percentage (%)-point

Time frame: From baseline (week 0) to end of treatment (week 52)

Number of treatment emergent severe or clinically significant hypoglycaemia episodes

Count of events

Time frame: From baseline (week 0) to end of trial (week 57)

Data from ClinicalTrials.gov

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