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

NCT04826172 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: IMB101-006
• Study Type: interventional
• Target: 58
• Locations: 3 countries
• Sites: 3

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.

Conditions

Ischemia; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

Study Arms (2)

IMB-1018972 200mg

EXPERIMENTAL

Drug: IMB-1018972

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

IMB-1018972 DRUG

Modified release (MR) oral tablet

IMB-1018972 200mg

Placebo DRUG

Matching oral tablet

Placebo

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imbria Pharmaceuticals, Inc.: lead

Study Sites (3)

Imbria Investigational Site

Aarhus, Denmark

Location

Imbria Investigational Site

Turku, Finland

Location

Imbria Investigational Site

Uppsala, Sweden

Location

MeSH Terms

Conditions

Ischemia; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Medical Monitor, MD

  Imbria Pharmaceuticals, Inc.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: April 1, 2021
• Study Start: April 23, 2021
• Primary Completion: September 21, 2023
• Study Completion: September 21, 2023
• Last Updated: April 23, 2024

Record last verified: 2024-04

Locations

DK (1); FI (1); SE (1)