Active Enrollment Open
Advancing Cardiovascular
Medicine Together
Cardio Metabolic Institute is at the forefront of cardiovascular research. Our active clinical trials offer eligible patients access to cutting-edge treatments while contributing to science that improves heart health for millions.
14+
Active Trials
20+
Years of Research
1
Research Location
Somerset, NJ
Somerset, NJ
18+
Completed Studies
Participation Process
How to Join a Clinical Trial
Joining a clinical trial at CMI is straightforward. Here's what to expect from your first inquiry through enrollment.
1
Browse & Find a Trial
Review our active trials below. Each listing includes a plain-language description and the study's focus area.
2
Check Eligibility Criteria
Expand the eligibility section on any trial card to review key inclusion and exclusion criteria before reaching out.
3
Express Your Interest
Complete our short inquiry form. Our research coordinators review every submission promptly and confidentially.
4
Screening Consultation
Our team will contact you to schedule a no-obligation screening visit to confirm eligibility and answer your questions.
Filter by:
Actively Enrolling Trials
Patients currently being screened and enrolled at CMI.
BalanceD-HF: Balcinrenone + Dapagliflozin in Heart Failure with Impaired Kidney Function
AstraZeneca · Phase III · NCT06307652
Tests whether adding balcinrenone (a mineralocorticoid receptor modulator) to dapagliflozin reduces cardiovascular death and worsening heart failure events in patients with chronic heart failure and reduced kidney function.
✔ Key Inclusion Criteria
- Age ≥ 18 years
- Chronic heart failure (HFrEF or HFmrEF) with recent HF event
- eGFR 20–60 mL/min/1.73m² (impaired kidney function)
- Elevated NT-proBNP
- On stable, guideline-directed HF therapy
✕ Key Exclusion Criteria
- Active dialysis or prior kidney transplant
- Serum potassium > 5.0 mEq/L at screening
- Recent MI or stroke (< 3 months)
- Severe hepatic impairment
PREVENT-HF: Baxdrostat + Dapagliflozin for Incident Heart Failure Prevention in T2DM
AstraZeneca · Phase III · NCT06677060
Evaluates whether baxdrostat (an aldosterone synthase inhibitor) combined with dapagliflozin reduces the risk of developing new-onset heart failure and cardiovascular death in adults with type 2 diabetes, hypertension, and established CV disease.
✔ Key Inclusion Criteria
- Age ≥ 40 years
- Type 2 diabetes with established cardiovascular disease
- History of hypertension with SBP ≥ 130 mmHg at screening
- At least one additional risk factor for heart failure
- Potassium within acceptable range at screening
✕ Key Exclusion Criteria
- Existing diagnosis of symptomatic heart failure
- eGFR < 25 mL/min/1.73m²
- Potassium > 5.5 mEq/L
- Recent hospitalization for HF (< 3 months)
AZURE-CVOT: AZD0780 (Oral PCSK9 Inhibitor) on Major Adverse CV Events in ASCVD
AstraZeneca · Phase III · NCT07000357
Tests AZD0780, a novel once-daily oral PCSK9 inhibitor, in patients with established ASCVD or at high risk for a first event. This would be the first oral PCSK9 inhibitor to reach a Phase 3 cardiovascular outcomes trial.
✔ Key Inclusion Criteria
- Age ≥ 18 years
- Established ASCVD (prior MI, stroke, or PAD) OR high risk for first event
- LDL-C above target despite current lipid-lowering therapy
- On stable background lipid-lowering treatment
✕ Key Exclusion Criteria
- Currently using injectable PCSK9 inhibitor or RNA-based lipid therapy
- Recent ACS or revascularization (< 3 months)
- Severe hepatic or renal impairment
EASi-HF™ (HFrEF): Vicadrostat + Empagliflozin in Heart Failure with Reduced Ejection Fraction
Boehringer Ingelheim · Phase III · NCT06935370
Tests vicadrostat (BI 690517), a selective aldosterone synthase inhibitor, combined with empagliflozin versus placebo plus empagliflozin in patients with HFrEF (LVEF < 40%). Aims to reduce cardiovascular death and heart failure hospitalizations.
✔ Key Inclusion Criteria
- Age ≥ 18 years
- Chronic heart failure diagnosed ≥ 3 months
- Left ventricular ejection fraction (LVEF) < 40%
- NYHA Class II–IV symptoms
- On stable, optimized guideline-directed medical therapy
✕ Key Exclusion Criteria
- Recent ACS or cardiac surgery (< 3 months)
- Significant renal impairment (eGFR < 20)
- Serum potassium > 5.0 mEq/L at screening
- Prior treatment with an aldosterone synthase inhibitor
EASi-HF™ (HFpEF): Vicadrostat + Empagliflozin in Heart Failure with Preserved Ejection Fraction
Boehringer Ingelheim · Phase III · NCT06424288
Companion study to EASi-HF HFrEF, testing vicadrostat combined with empagliflozin in patients with HFpEF (LVEF ≥ 40%). Elevated aldosterone may worsen HFpEF; this trial evaluates whether lowering aldosterone production improves outcomes.
✔ Key Inclusion Criteria
- Age ≥ 18 years
- Chronic heart failure with LVEF ≥ 40%
- Symptomatic heart failure (NYHA Class II–IV)
- Evidence of elevated filling pressures or structural heart disease
✕ Key Exclusion Criteria
- Recent ACS or stroke (< 3 months)
- Severe renal impairment (eGFR < 20)
- Serum potassium > 5.0 mEq/L
- Recent cardiac surgery or device implant (< 3 months)
EASi-PROTECT™: Vicadrostat + Empagliflozin in Type 2 Diabetes, Hypertension & Established CVD
Boehringer Ingelheim · Phase III
A Phase 3 superiority trial evaluating vicadrostat (BI 690517) combined with empagliflozin in patients with type 2 diabetes, hypertension, and established cardiovascular disease who are at risk for adverse cardiorenal outcomes.
✔ Key Inclusion Criteria
- Type 2 diabetes mellitus
- Hypertension (on antihypertensive therapy)
- Established cardiovascular disease (prior MI, stroke, or PAD)
- Age ≥ 18 years
✕ Key Exclusion Criteria
- Symptomatic heart failure (NYHA III–IV)
- Severe renal impairment
- Hyperkalemia (potassium > 5.0 mEq/L)
ATTAIN-OA PAIN: Orforglipron (Oral GLP-1) for Obesity & Osteoarthritis Knee Pain
Eli Lilly · Phase III · NCT07153471
Studies orforglipron — a once-daily oral, non-peptide GLP-1 receptor agonist — in overweight or obese adults with painful osteoarthritis of the knee. Takes any time without food restrictions, offering a convenient alternative to injectable GLP-1 therapies.
✔ Key Inclusion Criteria
- Age ≥ 18 years
- BMI ≥ 27 kg/m² (overweight or obese)
- Diagnosis of osteoarthritis (OA) of the knee with pain
- Willing to follow a reduced-calorie diet and increased physical activity
✕ Key Exclusion Criteria
- Used any GLP-1 receptor agonist medication within 180 days of screening
- NYHA Class IV heart failure
- Recent cardiac event (< 3 months)
- Type 1 diabetes or active diabetic complications
MOVE-Lp(a): Muvalaplin (Oral Lp(a) Inhibitor) on Major Cardiovascular Events in Elevated Lipoprotein(a)
Eli Lilly · Phase III · NCT07157774
Tests muvalaplin — a first-in-class once-daily oral small molecule that inhibits Lp(a) particle formation — in adults with elevated Lp(a) and established or high-risk ASCVD. Lp(a) is largely genetic and currently has no approved treatment. This is one of the largest Lp(a) cardiovascular outcomes trials ever conducted, enrolling ~10,450 participants worldwide.
✔ Key Inclusion Criteria
- Age ≥ 18 years
- Lp(a) ≥ 175 nmol/L at screening
- Prior ASCVD event (MI, stroke, or coronary revascularization) within 10 years, OR at risk for a first ASCVD event with documented CAD, carotid stenosis, or PAD
- On optimized background lipid-lowering therapy
✕ Key Exclusion Criteria
- Major cardiovascular event or cardiac surgery within 90 days of screening
- Currently using any Lp(a)-specific therapy
- Severe renal or hepatic impairment
- Active malignancy within past 2 years
HF-POLARIS: NNC0487-0111 (Zenagamtide) in HFpEF/HFmrEF and Obesity
Novo Nordisk · Phase III · NN9490-8266
Tests zenagamtide (NNC0487-0111), a novel amylin + GLP-1 receptor co-agonist, in patients with heart failure with preserved or mildly reduced ejection fraction who are also obese. Aims to reduce morbidity and mortality by addressing both obesity and heart failure simultaneously.
✔ Key Inclusion Criteria
- Age ≥ 18 years
- BMI ≥ 30 kg/m²
- Diagnosed HFpEF or HFmrEF (LVEF ≥ 40%)
- NYHA Class II–IV symptoms
- On stable guideline-directed heart failure therapy
✕ Key Exclusion Criteria
- Currently using a GLP-1 receptor agonist or amylin analog
- Recent hospitalization for HF (< 30 days)
- Planned cardiac surgery or device implantation
- Severe kidney impairment
MARITIME-CV: Maridebart Cafraglutide (MariTide) on Cardiovascular Outcomes in ASCVD + Obesity
Amgen · Phase III · NCT07037433
Investigates MariTide (maridebart cafraglutide, AMG 133), a once-monthly injectable that activates GLP-1 receptors and blocks GIP receptors, in adults with established atherosclerotic cardiovascular disease and obesity. Primary goal: reduce major cardiovascular events while achieving significant weight loss.
✔ Key Inclusion Criteria
- Age ≥ 18 years
- BMI ≥ 27 kg/m²
- Established ASCVD (prior MI, stroke, coronary revascularization, or PAD)
- No active GLP-1 receptor agonist use
✕ Key Exclusion Criteria
- Type 1 diabetes or uncontrolled Type 2 diabetes
- Recent ACS, stroke, or cardiac surgery (< 3 months)
- History or family history of medullary thyroid carcinoma or MEN2
- Personal or family history of pancreatitis
MARITIME-HF: Maridebart Cafraglutide (MariTide) in HFpEF/HFmrEF + Obesity
Amgen · Phase III · NCT07037459
Tests MariTide (maridebart cafraglutide, once-monthly injection) in adults with heart failure with preserved or mildly reduced ejection fraction (LVEF ≥ 40%) who are obese (BMI ≥ 30). Targets HF hospitalizations, urgent HF visits, and CV death.
✔ Key Inclusion Criteria
- Age ≥ 18 years
- BMI ≥ 30 kg/m²
- Chronic symptomatic HFpEF or HFmrEF (LVEF ≥ 40%)
- NYHA Class II–IV
- HF diagnosed ≥ 30 days
✕ Key Exclusion Criteria
- Currently on a GLP-1 receptor agonist
- Recent acute heart failure hospitalization (< 30 days)
- History of medullary thyroid carcinoma or MEN2
- Planned cardiac surgery
OCEAN(a)-Outcomes: Olpasiran for Major CV Events in ASCVD with Elevated Lp(a)
Amgen · Phase III · NCT05581303
Tests olpasiran (AMG 890), a twice-yearly siRNA injection that reduces Lp(a) by over 95%, in patients with ASCVD and elevated Lp(a). Lp(a) is primarily genetic and currently has no approved treatment. This is one of the first trials powered to show cardiovascular event reduction through Lp(a) lowering.
✔ Key Inclusion Criteria
- Age 18–85 years
- Lp(a) ≥ 200 nmol/L at screening
- History of MI and/or coronary revascularization (PCI) plus ≥ 1 additional CV risk factor
- On optimized lipid-lowering therapy
✕ Key Exclusion Criteria
- History of hemorrhagic stroke
- History of major bleeding disorder
- Severe renal dysfunction
- Planned cardiac surgery or revascularization
LILAC-TIMI 76: Abelacimab in Atrial Fibrillation Patients Unsuitable for Oral Anticoagulation
Anthos Therapeutics · Phase III · NCT05712200
Evaluates abelacimab — a dual-action Factor XI/XIa inhibitor — for stroke prevention in high-risk atrial fibrillation patients who cannot take traditional blood thinners (warfarin, DOACs) due to bleeding risk or other concerns. May offer protection with lower bleeding risk than current anticoagulants.
✔ Key Inclusion Criteria
- Age 65–74 with CHA₂DS₂-VASc ≥ 4, OR age ≥ 75 with CHA₂DS₂-VASc ≥ 3
- Diagnosed atrial fibrillation or flutter (documented on ECG)
- Deemed unsuitable for oral anticoagulation by their physician or by personal choice
✕ Key Exclusion Criteria
- Received any oral anticoagulant within 60 days of randomization
- Intracranial bleed within 3 months or any history of spontaneous intracerebral hemorrhage
- Stroke or TIA within 14 days / 3 days of randomization respectively
- Mechanical heart valve or dialysis at screening
ICONIC-HF: Ferric Derisomaltose (Monofer® IV Iron) in Iron-Deficient Chronic Heart Failure
Pharmacosmos · Phase III · NCT06929806
Tests intravenous ferric derisomaltose (Monofer®) — a high-dose IV iron formulation — versus no IV iron in patients with chronic heart failure and iron deficiency. Iron deficiency affects ~50% of HF patients and worsens symptoms and prognosis independent of anemia.
✔ Key Inclusion Criteria
- Age ≥ 18 years
- Symptomatic chronic heart failure (NYHA Class II–IV)
- Iron deficiency: ferritin < 100 ng/mL, or ferritin 100–299 with transferrin saturation < 20%
- Willing and able to receive IV infusion therapy
✕ Key Exclusion Criteria
- Currently on erythropoiesis-stimulating agents or IV iron supplements
- Active infection currently treated with antibiotics
- Active bleeding or known iron overload disorder
- Hypersensitivity to ferric derisomaltose or any excipients
Trials in Maintenance Phase
These trials are active but no longer enrolling new patients. Enrolled participants continue their study visits at CMI.
LIBREXIA-ACS: Milvexian (Factor XIa Inhibitor) After Recent Acute Coronary Syndrome
BMS / Janssen · Phase III · NCT05754957
LIBREXIA-ACS evaluates milvexian, a novel oral Factor XIa inhibitor, for reducing recurrent cardiovascular events following ACS with potentially less bleeding risk than existing antithrombotic therapies. Enrollment is closed; current patients continue follow-up at CMI.
PREVAIL: Obicetrapib (CETP Inhibitor) for CV Outcomes in Established CVD
NewAmsterdam Pharma · Phase III · NCT05202509
PREVAIL tests obicetrapib, a CETP inhibitor that significantly raises HDL-C and lowers LDL-C, in patients with established CVD on maximally tolerated statin therapy. Enrollment is complete; enrolled patients continue follow-up.
VICTORION-PLAQUE: Inclisiran on Atherosclerotic Plaque Progression in Non-Obstructive CAD
Novartis · Phase III · NCT05360446
An imaging-based trial using coronary CT to assess whether inclisiran (twice-yearly siRNA, ~50% LDL-C reduction) can slow plaque build-up in patients with non-obstructive CAD without a prior cardiovascular event. No longer enrolling.
VICTORION-2 PREVENT: Inclisiran to Prevent CV Events in Established Cardiovascular Disease
Novartis · Phase III · NCT05030428
Outcomes trial testing whether inclisiran (twice-yearly injection, ~50% LDL-C reduction) prevents major cardiovascular events such as MI and stroke in patients with established ASCVD on statin therapy. Enrollment is closed; follow-up ongoing.
ACCLAIM-Lp(a): Lepodisiran for Elevated Lp(a) and Major Adverse CV Events
Eli Lilly · Phase III · NCT06292013
ACCLAIM-Lp(a) tests lepodisiran — a twice-yearly siRNA injection that dramatically lowers Lp(a) — for reducing major adverse cardiovascular events in adults with elevated Lp(a) and established ASCVD or at risk for a first event. Enrollment is closed; follow-up ongoing.
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Research History
Completed & Past Trials
These studies have concluded. CMI's participation contributed to peer-reviewed findings that continue to shape cardiovascular care.
ACCELERATE — Evacetrapib (CETP Inhibitor) in High-Risk Atherosclerotic Cardiovascular Disease
Eli Lilly · Phase III
CIRT — Cardiovascular Inflammation Reduction Trial (Low-Dose Methotrexate) in Coronary Artery Disease
Brigham & Women's Hospital · Phase III
CLEAR Outcomes — Bempedoic Acid in Hypercholesterolemia / ASCVD
Esperion Therapeutics · Phase III
DAL-GENE — Dalcetrapib in Acute Coronary Syndrome
DalCor Pharmaceuticals · Phase III
DAPA-HF — Dapagliflozin in Heart Failure with Reduced Ejection Fraction
AstraZeneca · Phase III
GLORIA-AF — Dabigatran / Anticoagulation Registry in Atrial Fibrillation
Boehringer Ingelheim · Phase IV / Registry
VICTORIA — Vericiguat in Chronic Heart Failure with Reduced Ejection Fraction
Merck & Co. · Phase III
ODYSSEY Outcomes — Alirocumab (PCSK9 Inhibitor) in Acute Coronary Syndrome / Dyslipidemia
Regeneron / Sanofi · Phase III
ORBIT-AF II — Rivaroxaban Observational Registry in Atrial Fibrillation
Janssen Pharmaceuticals · Observational Registry
SPIRE-1 — Bococizumab (PCSK9 Inhibitor) in Hyperlipidemia
Pfizer · Phase III
THEMIS — Ticagrelor in Type 2 Diabetes with Coronary Artery Disease
AstraZeneca · Phase III
THERACOS — Oral Insulin in Type 2 Diabetes Mellitus
Theracos Sub LLC · Phase III
DECLARE-TIMI 58 — Dapagliflozin Cardiovascular Outcomes in Type 2 Diabetes
AstraZeneca · Phase III
CAMELLIA-TIMI 61 — Lorcaserin in Obesity / Cardiovascular Risk Reduction
Eisai · Phase III
ELIXA — Lixisenatide (GLP-1) in Type 2 Diabetes after Acute Coronary Syndrome
Sanofi · Phase III
GALACTIC-HF — Omecamtiv Mecarbil in Heart Failure with Reduced Ejection Fraction
Amgen · Phase III
Naltrexone / Bupropion (Contrave) in Obesity
Takeda Pharmaceutical · Phase III
VOYAGER PAD — Rivaroxaban + Aspirin in Peripheral Artery Disease
Bayer HealthCare · Phase III