Type 2 DiabetesPhase 2NCT04826159
IMPROVE-DiCE: Study to Evaluate Effect of IMB-1018972 on Cardiac Energetics in T2DM & Obesity (Pt 1) With HFpEF (Pt 2)
A Phase 2 study testing IMB-1018972 in people with Type 2 Diabetes and Diabetic Cardiomyopathies, run by Imbria Pharmaceuticals, Inc. at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the activity of IMB-1018972 on cardiac energetic reserve at rest and during stress and to assess safety and tolerability Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Type 2 Diabetes, Diabetic Cardiomyopathies, HFpEF - Heart Failure With Preserved Ejection Fraction
- What is being tested?
- IMB-1018972
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Apr 2021to 6 Aug 2024
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 2 diabetes
- Elevated HbA1c
- Elevated BMI
- Preserved left ventricular ejection fraction
- Diagnosis of HFpEF (Stage 2 only)
Who cannot join
- Uncontrolled hypertension
- Contraindication to magnetic resonance scanning
- More than mild to moderate valvular heart disease
- Atrial fibrillation
- History of sustained ventricular tachycardia or cardiac arrest
- Inability to exercise (Stage 2 only)
- 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
1 site in 1 country.
About this study
Official title: A Pharmacodynamic Study to Evaluate the Effects of IMB-1018972 on Myocardial Energetics, Metabolism, and Function in Patients With Type 2 Diabetes.
The purpose of this study is to assess the activity of IMB-1018972 on cardiac energetic reserve at rest and during stress and to assess safety and tolerability
- Conditions
- Type 2 Diabetes, Diabetic Cardiomyopathies, HFpEF - Heart Failure With Preserved Ejection Fraction
- Being tested
- IMB-1018972
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Cardiomyopathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IMB-1018972Drug
Modified release tablet for oral administration
| Study group | Role | What they receive |
|---|---|---|
| IMB-1018972 200 mg | Experimental | Not described Receives: Drug: IMB-1018972 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cardiac PCr/ATP ratio at rest (Stage 1 and Stage 2) measured by 31P-MRS at baseline and at EOT with 200 mg BID of IMB-1018972.
Measured: Baseline, End of Treatment (up to 16 weeks)
Change in cardiac PCr/ATP ratio with dobutamine stress (Stage 1 only) measured by 31P-MRS at baseline and at EOT with 200 mg BID of IMB-1018972
Measured: Baseline, End of Treatment (up to 8 weeks)
Secondary 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
Measured: Baseline through End of Treatment (up to 16 weeks)
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 start21 Apr 2021
- Primary completion6 Aug 2024
- Study completion6 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imbria Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Oxford
- Responsible party
- Sponsor
- Investigators
- Arash Yavari, BSc, MBBS, DPhil, Study chair, Imbria Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826159
- Sponsor's protocol ID
- IMB101-005
- Status last verified
- Jun 2025
- First submitted
- 18 Mar 2021
- Last updated
- 29 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hundertmark MJ, Birkhoelzer SM, Portwood C, Siu AG, Matthews V, Lewis AJ, Grist J, Mozes F, Henry JA, Patel J, Chamberlin P, Sarwar R, Yavari A, Dehbi HM, Rao P, Shi X, Zheng S, Robbins JM, Gerszten RE, Frenneaux MP, Valkovic L, Miller JJJJ, Neubauer S, Tyler DJ, Rider OJ. IMPROVE-DiCE, a 2-Part, Open-Label, Phase 2a Trial Evaluating the Safety and Effectiveness of Ninerafaxstat in Patients With Cardiometabolic Syndromes. Circulation. 2026 Feb 24;153(8):550-563. doi: 10.1161/CIRCULATIONAHA.125.074041. Epub 2025 Dec 18.
PubMed 41410037
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pharmacodynamic Study to Evaluate the Effects of IMB-1018972 on Myocardial Energetics, Metabolism, and Function in Patients With Type 2 Diabetes.
- ClinicalTrials.gov ID
- NCT04826159
- Acronym / sponsor ID
- IMB101-005
- Conditions
- Type 2 Diabetes, Diabetic Cardiomyopathies, HFpEF - Heart Failure With Preserved Ejection Fraction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Imbria Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Oxford
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 6 Aug 2024 (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 activity of IMB-1018972 on cardiac energetic reserve at rest and during stress and to assess safety and tolerability
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMB-1018972 200 mg | Experimental | Drug: IMB-1018972 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of type 2 diabetes
- Elevated HbA1c
- Elevated BMI
- Preserved left ventricular ejection fraction
- Diagnosis of HFpEF (Stage 2 only)
Key exclusion criteria (7 listed)
- Uncontrolled hypertension
- Contraindication to magnetic resonance scanning
- More than mild to moderate valvular heart disease
- Atrial fibrillation
- History of sustained ventricular tachycardia or cardiac arrest
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 tablet for oral administration | Drug | IMB-1018972 200 mg |
Primary outcome
Change in cardiac PCr/ATP ratio at rest (Stage 1 and Stage 2) measured by 31P-MRS at baseline and at EOT with 200 mg BID of IMB-1018972.
Time frame: Baseline, End of Treatment (up to 16 weeks)
Change in cardiac PCr/ATP ratio with dobutamine stress (Stage 1 only) measured by 31P-MRS at baseline and at EOT with 200 mg BID of IMB-1018972
Time frame: Baseline, End of Treatment (up to 8 weeks)
1 secondary 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: Baseline through End of Treatment (up to 16 weeks)
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 29 Jun 2025.
- Derived from this study: PubMed 41410037Hundertmark MJ, Birkhoelzer SM, Portwood C, Siu AG, Matthews V, Lewis AJ, Grist J, Mozes F, Henry JA, Patel J, Chamberlin P, Sarwar R, Yavari A, Dehbi HM, Rao P, Shi X, Zheng S, Robbins JM, Gerszten RE, Frenneaux MP, Valkovic L, Miller JJJJ, Neubauer S, Tyler DJ, Rider OJ. IMPROVE-DiCE, a 2-Part, Open-Label, Phase 2a Trial Evaluating the Safety and Effectiveness of Ninerafaxstat in Patients With Cardiometabolic Syndromes. Circulation. 2026 Feb 24;153(8):550-563. doi: 10.1161/CIRCULATIONAHA.125.074041. Epub 2025 Dec 18.
- 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.
Arash Yavari, BSc, MBBS, DPhil study chair
Imbria Pharmaceuticals, Inc.
1 site in 1 country: 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 Type 2 Diabetes and Diabetic Cardiomyopathies, run by Imbria Pharmaceuticals, Inc. at 1 site in United Kingdom.
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 5 inclusion and 7 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 29 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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. 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?
Change in cardiac PCr/ATP ratio at rest (Stage 1 and Stage 2) measured by 31P-MRS at baseline and at EOT with 200 mg BID of IMB-1018972. (time frame: Baseline, End of Treatment (up to 16 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04826159, which also lists 1 linked publication.
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 29 Jun 2025.