A Study to Evaluate the Safety, Tolerability, and Efficacy of IMB-1018972 in Patients With Refractory Angina

NCT04306237 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: CIMB-8972-201
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objectives of the study are to assess the safety, tolerability, and potential efficacy of IMB-1018972 on patients with refractory angina. Study will assess functional capacity employing a modified Bruce Protocol treadmill ETT, patient reports of angina symptoms via an electronic diary, and activity using an accelerometer.

Conditions

Refractory Angina

Outcome Measures

Primary Outcomes (2)

• Modified Bruce Protocol Treadmill ETT

  Change from baseline to Week 8 in total exercise duration (seconds)

  8 weeks

• Safety and Tolerability of IMB-1018972 in Patients with Refractory Angina

  Incidence of AEs, changes from baseline in physical examinations, vital signs, clinical laboratories, and ECG

  16 weeks

Secondary Outcomes (3)

• Assess the benefit of IMB-1018972 on patient report of angina symptoms employing an electronic diary

  16 weeks

• Assess the potential treatment benefit of IMB-1018972 on patient report of rescue NTG use employing an electronic diary

  16 weeks

• Assess the potential treatment benefit of IMB-1018972 on patient activity employing a wearable device

  16 weeks

Study Arms (2)

IMB-1018972

EXPERIMENTAL

Participants will receive IMB-1018972 (200 mg) MR tablets twice daily for 16 weeks

Drug: IMB-1018972

Placebo

PLACEBO COMPARATOR

Participants will receive matching placebo tablets twice daily for 16 weeks

Drug: Placebo oral tablet

Interventions

IMB-1018972 DRUG

IMB-1018972 200 mg tablet for oral administration

IMB-1018972

Placebo oral tablet DRUG

Matched placebo tablet for oral administration

Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is between the ages of 18 and 85 years, inclusive.
• Is capable of understanding the written informed consent, and providing signed, dated, and witnessed written informed consent.
• Has complied with and is willing to continue to comply with the specified procedures (eg, angina diary during screening) and complete specific follow-up evaluations.
• Has coronary artery disease confirmed by at least one of the following:
• Documented prior MI, CABG surgery, or PCI -OR-
• Angiography performed within the 24 months prior to Visit 1 confirming CAD (eg, evidence of ≥70% stenosis of at least one major coronary artery or diffuse CAD).
• Has evidence of stress induced ischemia documented by either:
• Protocol-specified ETT ECG demonstrating at least 0.5 mm exercise-induced ST segment depression with onset \<9 minutes on at least 1 of the screening ETTs -OR-
• Prior evidence of stress-induced reversible perfusion defect in the last 24 months (without intervening revascularization) identified by at least one of the following:
• Radionuclide imaging study
• Echocardiographic imaging study
• FFR \<0.8
• IFR \<0.89
• FFR CT \<0.8
• CFR \<2.5

You may not qualify if:

• If any of the following have occurred:
• Use of TMZ anytime in prior history
• In the prior 6 months:
• Diagnosis of NYHA Class 3 or 4 (heart failure)
• Hospitalization for heart failure
• Coronary artery bypass graft surgery
• Cardiac resynchronization therapy placement or adjustments to CRT parameters
• Implantable cardioverter defibrillator or biventricular pacemaker placement
• In the prior 3 months:
• Hospitalization for a cardiovascular indication
• Cerebral vascular accident
• Transient ischemic attack
• Percutaneous coronary intervention
• In the prior 1 month:
• Use of perhexiline or meldonium.

Sponsors & Collaborators

• Imbria Pharmaceuticals, Inc.: lead

Study Sites (1)

Imbria Investigational Site

Boston, Massachusetts, 02110, United States

Location

MeSH Terms

Conditions

Angina Pectoris

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Paul Chamberlin, MD

  Imbria Pharmaceuticals

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 8, 2020
• First Posted: March 12, 2020
• Study Start: May 1, 2020
• Primary Completion: February 1, 2025
• Study Completion: April 1, 2025
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)