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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Congestive Heart Failure

Intervention / Treatment
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* Drug: AC2592
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: AC2592<br>* continuous subcutaneous infusion (via pump), dose based on subject body weight<br>|
| Placebo Comparator: 2<br> | Drug: placebo<br>* continuous subcutaneous infusion (via pump), dose based on subject body weight<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Congestive Heart Failure, AC2592, GLP-1, Amylin, metabolic abnormality