Clinical Trials at Saint Michael’s Medical Center
Advancing Medical Science, Improving Patient Care
At Saint Michael’s Medical Center, we are committed to providing our patients with access to the most advanced therapies and treatment options available. Our robust clinical trials program plays a crucial role in this mission, offering cutting-edge research opportunities that may shape the future of healthcare.
For more information, please call (973) 877-2663.
What Are Clinical Trials?
Clinical trials are carefully designed research studies that evaluate new medical approaches, including:
- Medications
- Devices
- Treatment strategies
- Prevention methods
These trials help determine the safety and effectiveness of new interventions, potentially leading to breakthrough treatments for various conditions.
Why Participate in a Clinical Trial?
Participating in a clinical trial offers several benefits:
- Access to novel treatments not yet widely available
- Contribute to the advancement of medical knowledge
- Receive expert medical care and close monitoring
- Play an active role in your own healthcare
- Help future patients by contributing to medical research
Our Current Clinical Trials
Saint Michael’s Medical Center is proud to offer a diverse range of clinical trials across multiple medical specialties. Some of our current studies include:
Cardiology Trials (Dr. Abbas Shehadeh)
- Phase III trial evaluating dapagliflozin for heart failure with reduced ejection fraction
- Study on olpasiran for atherosclerotic cardiovascular disease with elevated Lipoprotein(a)
- Research on ziltivekimab for heart failure with mildly reduced or preserved ejection fraction
- Trial of flecainide acetate inhalation solution for atrial fibrillation
Current Cardiology Clinical Trails (12/20/25)
PI- Abbas Shehadeh
Phase III
20180244
A Doubleblind, Randomized, Placebocontrolled, Multicenter Study Assessing the Impact of Olpasiran on Major Cardiovascular Events in Patients with Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein (a)
HERMES
Effects of ziltivekimab versus placebo on morbidity and mortality in patients with heart failure with mildly reduced or preserved ejection fraction and systemic inflammation
ID-076A301
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial of Flecainide Acetate
Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation to Sinus Rhythm (RESTORE-1)
202302227
A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maridebart Cafraglutide on Mortality and Morbidity in Participants Living With Heart Failure With Preserved or Mildly Reduced Ejection Fraction and Obesity (MARITIME-HF)
HIV/AIDS and Infectious Disease Trials (Dr. Jihad Slim)
- Multiple phase II and III trials evaluating new antiretroviral therapies and treatment strategies
- Studies on long-acting HIV medications and novel drug combinations
- Observational study on multidrug-resistant HIV patient outcomes
Current Clinical Trails (08/12/24)
Phase II
GSK209639
A study to investigate the virologic efficacy and safety of VH3810109 + Cabotegravir compared to SOC in male and female adults with HIV infection EMBRACE: Efficacy of Monoclonal anti-Body Regimen VH3810109 And CabotEgravir
M19-965
A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-controlled Study to Evaluate Efficacy, Safety, Tolerability, and Pharmacokinetics of Budigalimab and/or ABBV-382 in People Living with HIV on Stable Antiretroviral Therapy Undergoing Analytical Treatment Interruption.
STP-P0C-001
A Phase 2a, Randomized, Double-Blinded, Placebo-Controlled, Multicenter Study to Investigate the Antiviral Effect, Safety, Tolerability, and Pharmacokinetics of STP0404 in Treatment-Naïve Adults with HIV-1 Infection.
GSK222638
A Phase 2b Randomized, Open-Label Active Controlled Study Evaluating the Safety and Efficacy of oral VH4524184 co-administered with Emtricitabine and Tenofovir Alafenamide in Treatment Naïve Viremic Persons with HIV-1
Phase III
GS-US-621-6289
An Operationally Seamless Phase 2/3 Randomized, Open-Label, Multicenter, Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Stable Baseline Regimen in Virologically Suppressed People with HIV-1 on Stable Complex Treatment Regimens.
GS-US-621-6290
A Phase 3 Double-blind Multicenter Randomized Active-Controlled Study to Evaluate the Safety and Efficacy of Bictegravir/Lenacapavir Versus Biktarvy® (Bictegravir/Emtricitabine/Tenofovir Alafenamide) in Virologically Suppressed People With HIV1
GS-US-563-5926
A Phase 3, Randomized, Open-Label, ActiveControlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV1 Who Are Virologically Suppressed on Standard of Care
GS-US-563-5925
A Phase 3, Randomized, Double-blind, Active-controlled Study to Evaluate a Switch to an Oral Weekly Islatravir/Lenacapavir Regimen in People With HIV-1 Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir (B/F/TAF)
GSK221611
A Phase 3b, open-label, single arm with an external control arm, multicenter, superiority study evaluating the efficacy, safety and tolerability of injectable CAB LA + RPV LA in viremic participants living with HIV-1.
MK4482-023
A Phase 3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adults With COVID-19 at High Risk for Disease Progression.
Current Cardiology Clinical Trails (12/20/25)
PI- Addi Suleiman, MD
Phase III
20180222
A Double-blind, Randomized, Placebocontrolled, Multicenter Study Assessing Olpasiran Use to Prevent First Major Cardiovascular Events in Participants with Elevated Lipoprotein(a)
CVP-1670-01
Assessment of the Carillon Mitral Contour System®in Treating Heart Failure with Functional Mitral Regurgitation
Current Podiatry Clinical Trails (12/20/25)
PI- Michael Demarco, DPM
Investigator Initiated
Phase III
Pilot study
Single arm, open-label, protocol for safety and efficacy of a topical human recombinant cytokine preparation and cell modulator Cymac-P001 in the treatment of Diabetic and Non Diabetic Ulcerations
The Clinical Trial Process
Clinical trials typically progress through four phases:
Phase I
Initial safety testing in a small group of participants
Phase II
Further safety assessment and early efficacy testing in a larger group
Phase III
Large-scale testing to confirm effectiveness, monitor side effects, and compare to standard treatments
Phase IV
Post-approval studies to gather additional information on the treatment’s risks, benefits, and optimal use
Participation and Safety
Your safety is our top priority. All our clinical trials:
- Follow strict protocols approved by regulatory bodies
- Are closely monitored by experienced medical professionals
- Adhere to rigorous ethical standards
Participation is always voluntary, and you can withdraw at any time.
Learn More and Get Involved
If you’re interested in participating in a clinical trial or want to learn more about our research programs, please contact our clinical research department.
Contact James Fallon, Director of Research at
Phone: (973) 877-2663 or email jfallon@primehealthcare.com
For a complete list of our current clinical trials, visit clinicaltrials.gov and search for Saint Michael’s Medical Center.
Join us in our mission to advance medical science and improve patient care through innovative clinical research
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