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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: Completed Phase 2 study of Coronary Heart Disease and Clonal Hematopoiesis of Indeterminate Potential (CHIP), sponsored by Novartis Pharmaceuticals.
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. According to ClinicalTrials.gov, the official US trial registry.
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%).
Primary Outcome
Serum levels of IL-6 at 3 weeks after the start of a dosing period for DFV890. The circulating serum levels of the cytokine IL-6 were measured by a validated enzyme-linked immunosorbent assay (ELISA) assay at a qualified vendor. The Emax model selected for IL-6 analysis was a model with 2 covariates (IL-6 baseline and bodyweight) and 1 random effect.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2024-02-15 |
| Est. Completion | 2024-11-04 |
| Phase | Phase 2 |
What the finished NCT06097663 record still lists
NCT06097663 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 1,487-participant average among 19 other Coronary Heart Disease trials with a reported enrollment target (98% lower).
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 lists 6 locations in 4 states (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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