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NCT06097663 · ClinicalTrials.gov registry record · Phase 2

A Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 and MAS825 for Inflammatory Marker Reduction in Adult Participants With Coronary Heart Disease and Clonal Hematopoiesis of Indeterminate Potential (CHIP)

A Phase 2 study of Coronary Heart Disease and Clonal Hematopoiesis of Indeterminate Potential (CHIP), sponsored by Novartis Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
31
Enrollment target
6
Study locations

NCT06097663 is a Phase 2 study of Coronary Heart Disease and Clonal Hematopoiesis of Indeterminate Potential (CHIP) that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 31 participants, below the 1,487-participant average among 19 other Coronary Heart Disease trials with a reported enrollment target (98% lower). The trial reports 6 study locations across 4 states.

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The verdict

NCT06097663, a Phase 2 study of Coronary Heart Disease and Clonal Hematopoiesis of Indeterminate Potential (CHIP), has completed, sponsored by Novartis Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
31 participants
Enrollment target
6
Study locations

Study Summary

This Phase 2a clinical trial will evaluate the effectiveness, safety, and tolerability of increasing dose strengths of an oral daily medication, DFV890, administered for 12 weeks, or a single s.c. dose of MAS825, to reduce key markers of inflammation related to CVD risk, such as IL-6 and IL-18, in approximately 28 people with known coronary heart disease and TET2 or DNMT3A CHIP (VAF ≥2%).

Conditions Studied

Coronary Heart Disease Clonal Hematopoiesis of Indeterminate Potential (CHIP)

Interventions

  • DRUG MAS825
  • DRUG DFV890
  • DRUG MAS825 Placebo
  • DRUG DFV890 placebo

Study Locations (6)

Other

  • Novartis Investigative Site - Bonn
  • Novartis Investigative Site - Frankfurt
  • Novartis Investigative Site - München

Missouri

  • Washington University - St Louis

Tennessee

  • Vanderbilt University Medical Cent - Nashville

Quebec

  • Novartis Investigative Site - Montreal

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2024-02-15
Est. Completion 2024-11-04
Phase Phase 2

Sponsor

Novartis Pharmaceuticals

1,375 total trials

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What the Registry Record Tells You About NCT06097663

The ClinicalTrials.gov registry entry for NCT06097663 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,487-participant average among 19 other Coronary Heart Disease trials with a reported enrollment target (98% lower). The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Coronary Heart Disease appearing as the primary indexed condition, and to 4 interventions - of which MAS825 is the first listed.

NCT06097663 reports 6 study locations spanning 4 distinct geographic areas - top geographies include Other, Missouri, Tennessee.

Frequently Asked Questions

What is clinical trial NCT06097663 about?

NCT06097663 is a clinical study titled "A Study to Investigate the Efficacy, Safety, and Tolerability of DFV890 and MAS825 for Inflammatory Marker Reduction in Adult Participants With Coronary Heart Disease and Clonal Hematopoiesis of Indeterminate Potential (CHIP)". This Phase 2a clinical trial will evaluate the effectiveness, safety, and tolerability of increasing dose strengths of an oral daily medication, DFV890, administered for 12 weeks, or a single s.c. dose of MAS825, to reduce key markers of inflammation related to CVD risk, such as IL-6 and IL-18, in a...

What is the current status of trial NCT06097663?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2024-02-15. Estimated completion is 2024-11-04.

What conditions does trial NCT06097663 study?

This clinical trial studies the following conditions: Coronary Heart Disease, Clonal Hematopoiesis of Indeterminate Potential (CHIP).

What interventions are being tested in trial NCT06097663?

The interventions under investigation include: MAS825 (DRUG), DFV890 (DRUG), MAS825 Placebo (DRUG), DFV890 placebo (DRUG).

Who is sponsoring clinical trial NCT06097663?

This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06097663 being conducted?

This trial has 6 study locations across Missouri, Tennessee, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.