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A Study to Evaluate the Safety and Efficacy of AC01 Compared to Placebo in Participants With Chronic Heart Failure

NCT07584967 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-05-13

No results posted yet for this study

Summary

The primary purpose of the study is to evaluate the safety and efficacy of 2 doses of AC01 compared to placebo over 12 weeks in participants with chronic advanced HFrEF.

Conditions

  • Heart Failure With Reduced Ejection Fraction (HFrEF)

Interventions

DRUG

AC01

AC01 tablets for oral administration.

OTHER

Placebo

AC01 matching placebo tablets for oral administration.

Sponsors & Collaborators

  • AnaCardio AB

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-15
Primary Completion
2028-04-22
Completion
2028-05-22
FDA Drug
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07584967 on ClinicalTrials.gov