Exploratory Study on the Safety, Tolerability, and Pharmacodynamics of IMB-1018972 in Subjects With Angina Due to Obstructive Coronary Artery Disease (IMPROVE-Ischemia)

A Randomized, Double-Blind, Placebo-Controlled, Exploratory Study on the Safety, Tolerability, and Pharmacodynamics of IMB-1018972 in Subjects With Angina Due to Obstructive Coronary Artery Disease

The purpose of this study is to assess the safety and tolerability of IMB-1018972 in subjects with obstructive CAD and inducible ischemia.

Study Overview

• Status: Completed
• Conditions: Ischemia; Coronary Artery Disease
• Intervention / Treatment: Drug: IMB-1018972; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Phase 2

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark
    • Imbria Investigational Site
• Finland
  • Turku, Finland
    • Imbria Investigational Site
• Sweden
  • Uppsala, Sweden
    • Imbria Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Documented history of stable angina (CCS grading I-III) or anginal equivalent for ≥1 month prior to screening
• Ability to safely abstain from beta blockers for 48 hours prior to echo examinations in the opinion of the Investigator
• Preserved LV systolic function, defined as LVEF≥50% by any imaging modality
• Obstructive CAD and recent evidence of stress-induced myocardial ischemia

Exclusion Criteria:

• Women of childbearing potential or who are currently pregnant or breast-feeding
• Clinically indicated for coronary revascularization (PCI/CABG) at time of screening or clinically significant LMS or proximal LAD stenosis likely to warrant revascularization during the study period in the opinion of the investigator.
• Type 1 insulin dependent diabetes mellitus (IDDM)
• Presence of pacemaker, cardiac resynchronization therapy and/or implantable cardioverter defibrillator
• Severe or clinically significant valvular heart disease
• Clinically significant concurrent condition which could prevent the patient from performing any of the protocol-specified assessments, represent a safety concern if the patient participates in the trial or could confound trial assessments of safety or tolerability

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Matching oral tablet
Experimental: IMB-1018972 200mg	Drug: IMB-1018972; Modified release (MR) oral tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and tolerability of IMB-1018972 as measured by incidence and severity of treatment emergent AEs (including AEs leading to study drug discontinuation and AEs leading to death), as well as incidence of treatment emergent SAEs	Randomization through Week 10 Safety Follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in number of ischemic segments during hyperemia (ischemia defined as absolute MBF ≤2.0 ml/kg/min) as measured by adenosine stress 15O-H2O PET	Ischemia score defined on the basis of absolute hyperemic MBF as: (1) MBF 2.0-2.3 ml/g/min; (2) 1.7- 2.0 ml/g/min; (3) MBF <1.7 ml/g/min	Baseline through Week 8
Change in total ischemia burden measured as ischemia score summed across all segments as measured by adenosine stress 15O-H2O PET		Baseline through Week 8
Change in inducible perfusion defect expressed as % of myocardium as measured by adenosine stress 15O-H2O PET		Baseline through Week 8

Collaborators and Investigators

• Sponsor: Imbria Pharmaceuticals, Inc.
• Investigators: Study Chair: Medical Monitor, MD, Imbria Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 23, 2021
• Primary Completion (Actual): September 21, 2023
• Study Completion (Actual): September 21, 2023

Study Registration Dates

• First Submitted: March 18, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): April 1, 2021

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia
• Other Study ID Numbers: IMB101-006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes