CompletedPhase 2

PROCLAIM: Effect of AC2592 Administered by Continuous Subcutaneous Infusion in Subjects With Advanced Chronic Congestive Heart Failure

PROCLAIM: A Phase 2, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Examine the Effects of AC2592 Administered by Continuous Subcutaneous Infusion in Subjects With Advanced Chronic Congestive Heart Failure

Lead sponsor

AstraZeneca

Asset

AC2592

Subcutaneous · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Heart failure

Eligibility highlights

•HbA1c ≤11%

Primary endpoints

•Safety and tolerability of AC2592 administered by continuous subcutaneous•Effect of AC2592 administered by continuous subcutaneous infusion on oxygen

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT00099580

Org study ID2592-101 (PROCLAIM)

Timeline

Milestones

Study first posted2004-12-20estimated

Last update posted2015-01-19estimated

Study start2005-03 (month precision)

Primary completion2006-09actual (month precision)

Study completion2006-09actual (month precision)

Assets

Investigational agents

AC2592

Who this study enrolls

Heart failure

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Eligibility criteria

Main Inclusion Criteria:

•Has heart failure classified as New York Heart Association (NYHA) Class III or Class IV at screening despite treatment with standard therapy.

•Is able to perform a treadmill test.

•Has an HbA1c of <= 11%.

•Is physically and mentally capable of operating the continuous subcutaneous infusion (CSCI) pump (i.e., adequate vision, manual dexterity, and mental capacity), or has a dedicated caretaker or adult family member who meets this requirement.

Main Exclusion Criteria:

•Has received metformin or nesiritide within 2 weeks prior to screening visit.

•Is currently participating in any other clinical study, or has received an investigational drug within 1 month of the screening period.

•Has participated previously in a study using GLP-1, exenatide, or exenatide LAR.

•Is using a left ventricular assist device or other mechanical circulatory support.

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Heart failure

3 endpoints

Primary/protocol endpoint

To examine the safety and tolerability of AC2592 administered by continuous subcutaneous infusion in subjects with chronic congestive heart failure.

Time frame:6 weeks

descriptive

Primary/protocol endpoint

To assess the effect of AC2592 administered by continuous subcutaneous infusion on oxygen consumption during maximal tolerated exercise in adult subjects with chronic congestive heart failure.

Time frame:6 weeks

descriptive

Secondary/protocol endpoint

To assess the effect of AC2592 administered by continuous subcutaneous infusion on pharmacokinetics, pharmacodynamics, and clinical outcomes in adult subjects with chronic congestive heart failure.

Time frame:6 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateNovember 5, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.