This trial is active, not recruiting.

Condition acute coronary syndromes
Treatments cer-001, placebo
Phase phase 2
Sponsor Cerenis Therapeutics, SA
Collaborator South Australian Health and Medical Research Institute
Start date August 2015
End date November 2016
Trial size 301 participants
Trial identifier NCT02484378, CER-001-CLIN-010


The purpose of this study is to assess the impact of ten intravenous infusions of 3 mg/kg CER 001 vs. placebo, given at weekly intervals for ten weeks, on atherosclerotic plaque volume as measured by coronary IVUS, when administered to subjects presenting with Acute Coronary Syndrome (ACS) with significant plaque volume.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
CER-001 infusion
cer-001 CAS 1383435-67-3
Engineered pre-beta HDL particle
(Placebo Comparator)
Placebo infusion
placebo Placebo for CER-001
Normal saline

Primary Outcomes

Nominal Change in Percent Atheroma Volume (PAV)
time frame: Baseline to 12 weeks

Secondary Outcomes

Nominal Change in Normalized Total Atheroma Volume (TAV)
time frame: Baseline to 12 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Male or female greater than 18 years of age - Acute coronary syndrome (myocardial infarction or unstable agina) - Angiographic evidence of coronary artery disease with suitable "target" coronary artery for IVUS evaluation Exclusion Criteria: - Females of child-bearing potential - Angiographic evidence of >50% stenosis of the left main artery - Uncontrolled diabetes (HbA1C>10%) - Hypertriglyceridemia (>500 mg/dL) - Congestive heart failure (NYHA class III or IV) - Ejection fraction <35% - Uncontrolled hypertension (SBP >180 mm Hg) - Known major hematologic, renal, hepatic, metabolic, gastrointestinal or endocrine dysfunction

Additional Information

Official title CER-001 Atherosclerosis Regression ACS Trial; A Phase II Multi-Center, Double-Blind, Placebo-Controlled, Dose-Focusing Trial Of Cer-001 In Subjects With Acute Coronary Syndrome
Description Subjects will be required to have at least one epicardial coronary artery suitable for IVUS imaging. A suitable target artery for IVUS imaging will be determined at baseline as having stenosis of up to 50% and meeting all angiographic inclusion criteria. Subjects having met all eligibility criteria will be randomized to receive an intravenous infusion of CER 001 (3 mg/kg) or placebo within 14 days of event presentation. Randomized subjects will then return at 7 day intervals for nine additional infusions. A follow up IVUS will be conducted at 14 days after the last infusion. The total study duration from randomization to follow up IVUS for a completed study can range from approximately 9 to 12 weeks.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Cerenis Therapeutics, SA.