GLP-1 Peptide Atlas, by Delfa

Enrolling by invitationPhase 2

Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction

Evaluation of the Cardiac and Metabolic Effects of Semaglutide in Heart Failure With Preserved Ejection Fraction (CAMEO-SEMA) A Phase II, Prospective, Double-Blind Randomized Trial

Lead sponsor

Mayo Clinic

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

estimated

Study population

Heart failure, Obesity / overweight

Key I/E criteria

•BMI ≥30•EF ≥50%

Primary endpoint

•Pulmonary Capillary Wedge Pressure (PCWP)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05371496

Org study ID22-000522

Timeline

Milestones

Study first posted2022-05-12actual

Study start2022-09-06actual

Last update posted2026-03-06actual

Primary completion2026-08estimated (month precision)

Study completion2026-08estimated (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Heart failureObesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•BMI ≥ 30.0 kg/m2.

•NYHA Class II-IV.

•LVEF ≥ 50 % within the preceding year.

•No hospitalizations due to heart failure in the preceding 30 days.

•At least one of the following:

1. Mean PCWP ≥ 15 mmHg or left ventricular end diastolic pressure (LVEDP) ≥ 15 mmHg documented during catheterization at rest, or PCWP or LVEDP ≥ 25 mmHg documented during catheterization at exercise.

2. If BMI < 35.0: NT-proBNP ≥ 220 pg/mL (for patients with sinus rhythm) or NT-proBNP ≥ 660 pg/mL (for patients with persistent/permanent atrial fibrillation); if BMI ≥ 35.0: NT-proBNP ≥ 125 pg/mL (for patients in sinus rhythm) or NT-proBNP ≥ 375 pg/mL (for patients with persistent/ permanent atrial fibrillation) at screening (NT-proBNP analyzed by the central laboratory) in combination with at least one of the following (documented by echocardiography within 12 months prior to or at screening):

i.Septal é < 7 cm/sec or lateral é < 10 cm/sec or average E/é ≥ 15.

ii.PA systolic pressure > 35 mmHg.

iii.Left atrial (LA) enlargement (LA width ≥ 3.8 cm or LA length ≥ 5.0 cm or LA area ≥ 20.0 cm2 or LA volume ≥ 55 mL or LA volume index ≥ 29 mL/m2).

iv.LV hypertrophy with septal thickness or posterior wall thickness ≥ 1.2 cm

3. Hospitalization with a primary diagnosis of decompensated heart failure which required intravenous (IV) loop diuretic treatment, within the previous 12 months in combination with at least two of the following (documented by echocardiography within 12 months prior to or at screening):

i.Septal é < 7 cm/sec or lateral é < 10 cm/sec or average E/é ≥ 15.

ii.PA systolic pressure > 35 mmHg.

iii.LA enlargement (LA width ≥ 3.8 cm or LA length ≥ 5.0 cm or LA area ≥ 20.0 cm2 or LA volume ≥ 55 mL or LA volume index ≥ 29 mL/m2).

iv.LV hypertrophy with septal thickness or posterior wall thickness ≥ 1.2 cm.

v.Ongoing use of diuretic therapy for at least 30 days prior to screening.

Exclusion criteria

Cardiovascular-related:

•Myocardial infarction, stroke, hospitalization for heart failure, unstable angina pectoris or transient ischemic attack within 30 days prior to the day of screening.

•Systolic blood pressure > 160 mmHg at screening.

•Planned coronary, carotid or peripheral artery revascularization.

•Any other condition judged by the investigator to be the primary cause of dyspnea (such as heart failure due to restrictive cardiomyopathy or infiltrative conditions (e.g., amyloidosis), hypertrophic obstructive cardiomyopathy, primary pulmonary arterial hypertension, chronic obstructive pulmonary disease, right heart failure due to pulmonary disease, complex congenital heart disease, anemia, or more than moderate mitral or aortic heart valve disease).

–Amyloid cardiomyopathy may be present in 5-15% of patients presenting with the clinical syndrome of HFpEF,60-62 and patients with amyloid may respond differently to WL intervention. To enhance the scientific rigor of the trial by ensuring a homogenous population of true primary HFpEF, we will carefully evaluate for the presence of amyloid using the approach outlined in a recent scientific statement from the AHA,63 which is also consistent with our current clinical practice.

–Specifically, potential participants will be evaluated for clues or risk factors for underlying cardiac amyloid including intolerance to antihypertensives, hypotension, orthostatic intolerance, persistent low-grade elevation in troponin, low QRS voltage on ECG, unexplained AV block or prior pacemaker, unexplained LV or RV wall thickening, impaired LV global longitudinal strain with apical sparing by echocardiography, family history of cardiomyopathy, neuropathy, autonomic dysfunction, carpal tunnel syndrome, lumbar spinal stenosis, family history of polyneuropathy, or black race. Patients with these risk factors will undergo screening evaluation for amyloid prior to consent in CAMEO-SEMA as part of best clinical practice. This includes screening for monoclonal light chain as first step, followed by hematology consultation if the screen is positive. Patients with risk factors but no monoclonal light chain will then undergo Tc-99m-PYP scan to rule out cardiac amyloid.

Obesity-related:

•Bariatric surgery prior to screening within 5 years of screening or planned bariatric surgery within the trial time course.

•A self-reported change in body weight > 5 kg (11 lbs) within 90 days before screening irrespective of medical records.

Glycemia-related:

•HbA1c ≥ 10.0% based on latest available value from medical records, not older than 3 months

•History of type 1 diabetes (history of gestational diabetes is allowed).

•Treatment with any GLP-1 receptor agonist within 90 days prior to the day of screening.

General health and safety:

•Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.

•Presence of acute pancreatitis within the last 180 days prior to screening.

•History or presence of chronic pancreatitis.

•End-stage renal disease or chronic or intermittent hemodialysis or peritoneal dialysis.

•Presence or history of malignant neoplasm within 5 years prior to the day of screening. Basal and squamous cell cancer and any carcinoma in-situ are allowed.

•Known or suspected hypersensitivity to trial product(s) or related products.

•Participation in any clinical trial of an approved or non-approved device for the treatment of heart failure or obesity within 30 days before screening.

•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.

•Major surgery scheduled for the duration of the trial, affecting walking ability in the opinion of the investigator.

•Any disorder, including severe psychiatric disorder, suicidal behavior within 90 days before screening, and suspected drug abuse, which in the investigator´s opinion might jeopardize subject´s safety or compliance with the protocol.

Endpoints (18)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Other (unclassified)

Heart failure

Weight & body composition

Cardiometabolic biomarkers

Weight & body composition

3 endpoints

Secondary/protocol endpoint

Myocardial fat content

Time frame:Baseline, 12 months

change from baseline, improvement

Secondary/protocol endpoint

Body fat mass

Time frame:Baseline, 12 months

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Visceral fat content

Time frame:Baseline, 12 months

Visceral fat, change

change from baseline, improvement

Heart failure

5 endpoints

Primary/protocol endpoint/low confidence

Pulmonary Capillary Wedge Pressure (PCWP)

Time frame:Baseline, 12 months

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Left ventricular (LV) global longitudinal strain

Time frame:Baseline, 12 months

change from baseline, improvement

Secondary/protocol endpoint

Left Atrial (LA) reservoir strain

Time frame:Baseline, 12 months

change from baseline, improvement

Secondary/protocol endpoint

Right Ventricular (RV) free wall strain

Time frame:Baseline, 12 months

change from baseline, improvement

Secondary/protocol endpoint

Change in Quality of Life (QOL) as assessed by Kansas City Cardiomyopathy Questionnaire (KCCQ)

Time frame:Baseline, 12 months

KCCQ total score

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints

Secondary/protocol endpoint

Trans-cardiac uptake of free fatty acids (FFA) at rest

Time frame:Baseline, 12 months

Free fatty acids, change

change from baseline, improvement

Secondary/protocol endpoint

Trans-cardiac uptake of free fatty acids (FFA) during exercise

Time frame:Baseline, 12 months

Free fatty acids, change

change from baseline, improvement

Other (unclassified)

8 endpoints

Secondary/protocol endpoint/low confidence

Trans-cardiac uptake of glucose at rest

Time frame:Baseline, 12 months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Trans-cardiac uptake of glucose during exercise

Time frame:Baseline, 12 months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Trans-cardiac uptake of ketone bodies at rest

Time frame:Baseline, 12 months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Trans-cardiac uptake of ketone bodies during exercise

Time frame:Baseline, 12 months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Myocardial mass

Time frame:Baseline, 12 months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Myocardial volume

Time frame:Baseline, 12 months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Total blood volume

Time frame:Baseline, 12 months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Total plasma volume

Time frame:Baseline, 12 months

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.