Dose-finding Study of YMI024 to Assess Efficacy, Safety, and Tolerability in Adults With Stable Coronary Artery Disease and Elevated hsCRP

Part of paid clinical trials in Fairhope, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT07830719
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • YMI024 — DRUG
    YMI024 in different doses
  • Placebo — DRUG
    matching placebo

Study Details

The purpose of this Phase 2b study is to investigate the efficacy in reducing systemic inflammation, safety, tolerability, and dose response of five doses of YMI024, as compared to placebo in adult participants with stable coronary artery disease (CAD) and residual inflammatory risk defined by elevated high-sensitivity C-reactive protein (hsCRP) (≥2 mg/L)

Key Dates

First listed
Sep 21, 2026
Start date
Sep 18, 2026
Status verified
Oct 2026
Primary completion
Aug 15, 2027
Completion
Aug 15, 2027

Study Design

Enrollment
180 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: YMI024 Dose 1
    Participants receive YMI024 Dose 1 in addition to standard-of-care therapies.
  • Experimental: YMI024 Dose 2
    Participants receive YMI024 Dose 2 in addition to standard-of-care therapies.
  • Experimental: YMI024 Dose 3
    Participants receive YMI024 Dose 3 in addition to standard-of-care therapies.
  • Experimental: YMI024 Dose 4
    Participants receive YMI024 Dose 4 in addition to standard-of-care therapies.
  • Experimental: YMI024 Dose 5
    Participants receive YMI024 Dose 5 in addition to standard-of-care therapies.
  • Placebo Comparator: Placebo
    Participants receive a matching placebo in addition to standard-of-care therapies

Primary Outcome Measure

Change from baseline in log-transformed IL-6 [ Time Frame: Baseline and approximately 3 months ]

Central Contacts

  • Novartis Pharmaceuticals
    1-888-669-6682
    [email protected]
  • Novartis Pharmaceuticals
    +41613241111

Locations (9)

FacilityCityStateZIPSite coordinators
Eastern Shore Research InstituteFairhopeAlabama36532
Creagh Williams
[email protected]
+1 251 928 8804
Michael S Pursley (PRINCIPAL_INVESTIGATOR)
G and L Research LLCFoleyAlabama36535
Christine S Fuller
[email protected]
Nidal Morrar (PRINCIPAL_INVESTIGATOR)
Biopharma Informatic LLCLos AngelesCalifornia90035
Sanjana Andem
[email protected]
+1 919 233 0059
Christian Assad-Kottner (PRINCIPAL_INVESTIGATOR)
AMR MiamiCoral GablesFlorida33134
Ronitza Odreman
[email protected]
Abid Chaudhry (PRINCIPAL_INVESTIGATOR)
Alliance for Multispecialty ResearchWichitaKansas67207
Loria Awadallah
[email protected]
+1 630 376 7858
Saifullah Nasir (PRINCIPAL_INVESTIGATOR)
Anderson Medical ResearchFt. WashingtonMaryland20744
Ann-Marie Cobb
[email protected]
Felton Anderson (PRINCIPAL_INVESTIGATOR)
MD Medical ResearchOxon HillMaryland20745
Marie Edwards
[email protected]
+1 301 839 2008
Stephen T Ong (PRINCIPAL_INVESTIGATOR)
Pharma Tex ResearchAmarilloTexas79106
Salma Villarreal
[email protected]
+1 806 355 2581
David Brabham (PRINCIPAL_INVESTIGATOR)
Selma Medical AssociatesWinchesterVirginia22601
Heather Neff
[email protected]
+1 540 678 2800
Philip O Donnell (PRINCIPAL_INVESTIGATOR)

Find similar trials in Fairhope, AL

By research site
Eastern Shore Research Institute· Fairhope, ALG and L Research LLC· Foley, ALBiopharma Informatic LLC· Los Angeles, CAAMR Miami· Coral Gables, FLAlliance for Multispecialty Research· Wichita, KSAnderson Medical Research· Ft. Washington, MD

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