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

Phase 2

Completed

• Conditions: Ischemia; Coronary Artery Disease
• Interventions: Drug: IMB-1018972; Drug: Placebo

• Registration Number: NCT04826172
• Lead Sponsor: Imbria Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-18
• Study First Submitted QC: 2021-03-29
• Study First Posted: 2021-04-01
• Study Start: 2021-04-23
• Primary Completion: 2023-09-21
• Study Completion: 2023-09-21
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IMB-1018972 200mg	IMB-1018972	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	Baseline through Week 8	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
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

Trial Locations

Locations (1)

Imbria Investigational Site; 🇸🇪 Uppsala, Sweden