ATR 1072 in Participants With PRKAG2 Syndrome

Part of paid clinical trials in Kansas City, Missouri.

Sponsor
Atrium Therapeutics
Study ID
NCT07738107
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Cardiac Glycogenosis
  • Cardiomyopathy
  • Hypertrophic
  • Wolff-Parkinson-White Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • ATR 1072 — DRUG
    ATR 1072 is an investigational therapy that delivers an siRNA to reduce PRKAG2 gene expression. Administered as an intravenous (IV) infusion every 6 weeks (Q6W). Formulated as a sterile liquid for injection.

Study Details

ATR 1072 is an investigational medicine being studied in adults with PRKAG2 Syndrome. This study will evaluate the safety of ATR 1072 and how the body processes the drug. Researchers will also assess how ATR 1072 affects PRKAG2 activity and measures of heart disease.

Key Dates

First listed
Jul 31, 2026
Start date
Sep 14, 2026
Status verified
Sep 2026
Primary completion
May 31, 2028
Completion
Oct 31, 2028

Study Design

Enrollment
37 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A - MAD Dose Escalation Description Three sequential ascending dose
    Three sequential ascending dose cohorts (Dose Level 1, Dose Level 2 and Dose Level 3) with approximately 4 evaluable participants per cohort. ATR 1072 administered intravenously (IV) every 6 weeks (Q6W) for up to 8 doses (48-week treatment period).
  • Experimental: Part B - Expansion Cohort at the Recommended Phase 2 Dose
    Approximately 25 participants enrolled at the recommended phase 2 dose determined in Part A. ATR 1072 administered IV Q6W to further evaluate safety, PK, and pharmacodynamics.

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: From first dose through end of study (approximately 48 weeks per participant) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
St Luke's Mid American Heart InstituteKansas CityMissouri64111
Michael Nassif, MD
[email protected]
816-932-3458
Micheal Nassif, MD (PRINCIPAL_INVESTIGATOR)

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By research site
St Luke's Mid American Heart Institute· Kansas City, MO

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