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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00099580

Enrollment

Registered

2004-12-20

Start date

2005-03-31

Completion date

2006-09-30

Last updated

2015-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure

Keywords

Congestive Heart Failure, AC2592, GLP-1, Amylin, metabolic abnormality

Brief summary

This Phase 2, randomized, placebo-controlled, multicenter outpatient study is designed to test the safety and tolerability of AC2592 as well as examine the effect of AC2592 on oxygen consumption during maximal tolerated exercise in adult subjects with chronic congestive heart failure.

Interventions

DRUGAC2592

continuous subcutaneous infusion (via pump), dose based on subject body weight

DRUGplacebo

continuous subcutaneous infusion (via pump), dose based on subject body weight

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
To examine the safety and tolerability of AC2592 administered by continuous subcutaneous infusion in subjects with chronic congestive heart failure.	6 weeks
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.	6 weeks

Secondary

Measure	Time frame
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.	6 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026