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Glucagon-like peptide-1 receptor agonist

Semaglutide + Lifestyle Counseling for Heart Failure

Phase 2
Recruiting
Led By Barry Borlaug, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
NYHA Class II-IV
NT-proBNP levels and echocardiography criteria based on BMI at screening
Must not have
Recent cardiovascular events or planned revascularization procedures
Presence of amyloid cardiomyopathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 months
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions

Summary

This trial will test if weight loss can help improve heart function in obese people with heart failure.

Who is the study for?
This trial is for adults with obesity-related heart issues (HFpEF) who have a BMI of 30 or higher, experience certain types of heart failure symptoms, and haven't been hospitalized for heart failure in the last month. People can't join if they've had bariatric surgery, used GLP-1 receptor agonists recently, have specific health risks like pancreatitis or severe psychiatric disorders, are pregnant or not using effective contraception, plan major surgery that affects walking ability during the trial period.
What is being tested?
The study tests whether an aggressive weight loss intervention combined with Semaglutide improves symptoms in patients with HFpEF compared to a placebo group. Participants will also receive counseling on healthy lifestyle changes as part of the treatment process.
What are the potential side effects?
Semaglutide may cause side effects such as digestive problems (nausea and vomiting), potential inflammation of organs like the pancreas (pancreatitis), allergic reactions if sensitive to ingredients, and possibly affect blood sugar levels.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have moderate to severe heart condition symptoms.
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My heart function tests are within the required range for my body size.
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I was hospitalized for worsening heart failure in the last year and had an echocardiogram.
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I have not been hospitalized for heart failure in the last 30 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had recent heart problems or plan to undergo a procedure to improve blood flow.
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I have heart disease caused by amyloid buildup.
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My main breathing issue is caused by a specific condition.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pulmonary Capillary Wedge Pressure (PCWP)
Secondary study objectives
Body fat mass
Change in Quality of Life (QOL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)
Left Atrial (LA) reservoir strain
+14 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Semaglutide TreatmentActive Control2 Interventions
Subjects will receive Semaglutide once weekly in addition to counselling on healthy lifestyle intervention
Group II: Placebo TreatmentPlacebo Group2 Interventions
Subjects will receive matching placebo once weekly in addition to counselling on healthy lifestyle intervention

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,343 Previous Clinical Trials
3,062,268 Total Patients Enrolled
5 Trials studying Cardiomyopathy
1,628 Patients Enrolled for Cardiomyopathy
United States Department of DefenseFED
910 Previous Clinical Trials
333,650 Total Patients Enrolled
Barry Borlaug, MDPrincipal InvestigatorMayo Clinic
9 Previous Clinical Trials
1,378 Total Patients Enrolled

Media Library

Semaglutide (Glucagon-like peptide-1 receptor agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05371496 — Phase 2
Cardiomyopathy Research Study Groups: Semaglutide Treatment, Placebo Treatment
Cardiomyopathy Clinical Trial 2023: Semaglutide Highlights & Side Effects. Trial Name: NCT05371496 — Phase 2
Semaglutide (Glucagon-like peptide-1 receptor agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05371496 — Phase 2
~35 spots leftby Aug 2026
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