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

AstraZeneca61 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Congestive Heart Failure

Interventions

AC2592DRUG

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

placeboDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (29)

Research Site

Beverly Hills, California, United States

Outcomes

Primary Outcomes

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

Time frame: 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.

Time frame: 6 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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