IschemiaPhase 2NCT04826172
Exploratory Study on the Safety, Tolerability, and Pharmacodynamics of IMB-1018972 in Subjects With Angina Due to Obstructive Coronary Artery Disease (IMPROVE-Ischemia)
A Phase 2 study testing IMB-1018972 in people with Ischemia and Coronary Artery Disease, run by Imbria Pharmaceuticals, Inc. at 3 sites in 3 countries.
Trial summary
The purpose of this study is to assess the safety and tolerability of IMB-1018972 in subjects with obstructive CAD and inducible ischemia. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Ischemia, Coronary Artery Disease
- What is being tested?
- IMB-1018972
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 23 Apr 2021to 21 Sep 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: 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.
- Conditions
- Ischemia, Coronary Artery Disease
- Being tested
- IMB-1018972, Placebo
- Medical subject headings
- Ischemia, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMB-1018972Drug
Modified release (MR) oral tablet
PlaceboDrug
Matching oral tablet
| Study group | Role | What they receive |
|---|---|---|
| IMB-1018972 200mg | Experimental | Not described Receives: Drug: IMB-1018972 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 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
Measured: Baseline through Week 8
Change in inducible perfusion defect expressed as % of myocardium as measured by adenosine stress 15O-H2O PET
Measured: Baseline through Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start23 Apr 2021
- Primary completion21 Sep 2023
- Study completion21 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IschemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imbria Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, MD, Study chair, Imbria Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826172
- Sponsor's protocol ID
- IMB101-006
- Status last verified
- Apr 2024
- First submitted
- 18 Mar 2021
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04826172
- Acronym / sponsor ID
- IMB101-006
- Conditions
- Ischemia, Coronary Artery Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Imbria Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 21 Sep 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 1 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and tolerability of IMB-1018972 in subjects with obstructive CAD and inducible ischemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IMB-1018972 200mg | Experimental | Drug: IMB-1018972 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IMB-1018972Modified release (MR) oral tablet | Drug | IMB-1018972 200mg |
| PlaceboMatching oral tablet | Drug | Placebo |
Primary outcome
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
Time frame: Randomization through Week 10 Safety Follow-up
3 secondary outcomes
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
Time frame: 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
Time frame: Baseline through Week 8
Change in inducible perfusion defect expressed as % of myocardium as measured by adenosine stress 15O-H2O PET
Time frame: Baseline through Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor, MD study chair
Imbria Pharmaceuticals, Inc.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing IMB-1018972 in people with Ischemia and Coronary Artery Disease, run by Imbria Pharmaceuticals, Inc. at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark, Finland, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Randomization through Week 10 Safety Follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.