Hypertrophic Cardiomyopathy Without ObstructionEarly Phase 1SOTA-CROSS HCMNCT06433050
Sodium Glucose Co-transporter (SGLT) Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy
A Early Phase 1 study testing Sotagliflozin in people with Hypertrophic Cardiomyopathy Without Obstruction, run by University of Pennsylvania at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn if sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, works to treat symptomatic, nonobstructive hypertrophic cardiomyopathy (noHCM) in adult patients. It will also learn about the safety of sotagliflozin in this patient population. The main questions it aims to answer are: 1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertrophic Cardiomyopathy Without Obstruction
- What is being tested?
- Sotagliflozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2024to Jun 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at least 18 years, both sexes
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Ability to take oral medication and be willing to adhere to the study intervention.
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 2 weeks after the end of administration of study drug.
- Diagnosis of HCM with NYHA Class II-III functional class or New York Heart Association (NYHA) Class I with peak VO2 < 90% on cardiopulmonary exercise stress testing performed at Visit 1.
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- Left ventricular outflow tract gradient < 50 mmHg at rest, with valsalva, and with exercise.
- 7. Left ventricular ejection fraction > 50% by echocardiogram or cardiac MRI based on the most recent assessment in the past year prior to screening and confirmed during Visit 1 echocardiogram.
- 8. Stable medical therapy for at least 1 month prior to study enrollment.
Who cannot join
- Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrollment or previous intolerance of an SGLT2 inhibitor
- Type 1 diabetes mellitus
- Age <18 years old
- Pregnant or lactating women: Women of childbearing potential will undergo a urine pregnancy test during the screening visit.
- Uncontrolled atrial fibrillation, as defined by a resting heart rate > 100 beats per minute at the time of the baseline assessment
- Paroxysmal atrial fibrillation (Afib) or flutter with plans to attempt to restore sinus rhythm (with drug therapy, ablation, or DC cardioversion) during the study period.
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- Unable to attain a respiratory exchange ratio of at least 1.05 on cardiopulmonary exercise test (CPET) on the day of screening.
- Septal reduction therapy within the previous 3 months.
- Implantable cardio-defibrillator (ICD) implantation planned during the study period.
- Implantation of a cardiac resynchronization therapy (CRT) device within 12 weeks prior to enrollment or intent to implant a CRT device during the study period
- Hemoglobin < 10 g/dL
- Estimated glomerular filtration rate (eGFR) < 25 mL/min/1.73m^2, or unstable or rapidly progressing renal disease at the time of randomization
- Subject inability/unwillingness to exercise
- Greater than moderate left sided valvular disease (mitral regurgitation, aortic stenosis, aortic regurgitation), moderate or greater mitral stenosis, or severe right-sided valvular disease based on baseline echo at the time of enrollment
- Current angina due to clinically significant epicardial coronary disease, as per investigator judgment
- Acute coronary syndrome or coronary intervention within the past 2 months
- Primary pulmonary artery hypertension (WHO Group 1 Pulmonary Arterial Hypertension)
- Clinically significant lung disease as defined by: Chronic Obstructive Pulmonary Disease meeting Stage III or greater GOLD criteria (FEV1<50% predicted), treatment with oral steroids within the past 6 months for an exacerbation of obstructive lung disease, or current use of supplemental oxygen aside from nocturnal oxygen for the treatment of obstructive sleep apnea.
- Clinically-significant ischemia, as per investigator's judgement, on stress testing without either (1) subsequent revascularization, (2) an angiogram demonstrating the absence of clinically significant epicardial coronary artery disease, as per investigator judgment; (3) a follow-up 'negative' stress test, particularly when using a more specific technique (i.e., a negative perfusion imaging test following a 'positive' ECG stress test)
- Symptomatic bradycardia or second- or third-degree heart block, in the absence of a pacemaker
- Significant liver disease impacting synthetic function or volume control (ALT/AST > 3x ULN, Albumin < 3.0 g/dL)
- Severe right ventricular dysfunction on baseline echocardiogram
- Orthostatic blood pressure response to the transition from supine to standing (>20 mmHg reduction in systolic blood pressure 2-3 minutes after standing)
- Active participation in another study that utilizes an investigational agent (observational studies/registries allowed)
- Any condition that, in the opinion of the investigator, will interfere with the completion of the study. This may include comorbid or psychiatric conditions that may impede successful completion of the protocol, or logistical concerns (e.g. inability to travel to the exercise unit).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Sharlene Day, MD, 734 548 0394, sharlene.day@pennmedicine.upenn.edu
Lindsey Behlman, lindsey.behlman@pennmedicine.upenn.edu
About this study
The goal of this clinical trial is to learn if sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, works to treat symptomatic, nonobstructive hypertrophic cardiomyopathy (noHCM) in adult patients. It will also learn about the safety of sotagliflozin in this patient population. The main questions it aims to answer are:
- Will sotagliflozin be well tolerated in patients with nonobstructive HCM?
- Will sotaglifozin improve exercise capacity, diastolic dysfunction and/or physical functioning in patients with nonobstructive HCM?
- Will sotagliflozin improve circulating markers of cardiac metabolism in patients with nonobstructive HCM?
Read more
Researchers will compare sotagliflozin to a placebo (a look-alike substance that contains no drug) to see if sotagliflozin is effective at treating hypertrophic cardiomyopathy (HCM).
Participants will:
Take sotagliflozin or a placebo every day for 12 weeks. They will then cross-over (or switch) to taking placebo or sotagliflozin (whichever one they did not take initially) for an additional 12 weeks.
Visit the clinic once every 4-12 weeks for checkups, surveys, and tests including a stress test and echocardiogram.
- Being tested
- Sotagliflozin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SotagliflozinDrug
Also called Inpefa
Sotagliflozin or placebo will be administered to each participant in a cross over study design. Each participant will receive active drug and placebo with randomization of the order in which they receive them.
| Study group | Role | What they receive |
|---|---|---|
| Placebo first phase, Sotagliflozin second phase | Placebo comparator | Matching placebo once daily will be administered in the first phase, Sotagliflozin 400 mg once daily will be administered in the second phase Receives: Drug: Sotagliflozin |
| Sotagliflozin first phase, Placebo second phase | Active comparator | Sotagliflozin 400 mg once daily will be administered in the first phase, matching placebo once daily will be administered in the second phase Receives: Drug: Sotagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events
Adverse event reporting
Measured: Through study completion, 28 weeks
Intracavitary obstruction
Intracavitary left ventricular pressure gradient in mmHg
Measured: Through study completion, 28 weeks
Cardiac rhythm
New occurrence of cardiac arrhythmia measured by ambulatory monitoring
Measured: Through study completion, 28 weeks
Maximal exercise capacity
Peak oxygen consumption in mL/min
Measured: Through study completion, 28 weeks
Submaximal exercise capacity
Stroke volume augmentation at exercise steady state in mL/min
Measured: Through study completion, 28 weeks
Secondary outcomes (9)
Systolic function
Left ventricular ejection fraction in % measured by echocardiography
Measured: Through study completion, 28 weeks
Contractility
Global longitudinal strain in % measured by echocardiography
Measured: Through study completion, 28 weeks
Diastolic function
E/E' ratio measured by echocardiography
Measured: Through study completion, 28 weeks
Left ventricular hypertrophy
Maximal left ventricular wall thickness in mm by echocardiography
Measured: Through study completion, 28 weeks
Symptom scores
Kansas City Living with Heart Failure (KCCQ) Clinical Summary Score, scale 0-100 with lower scores being worse
Measured: Through study completion, 28 weeks
Symptom scores and quality of life
Kansas City Living with Heart Failure (KCCQ) Overall Summary Score, score 0-100 with lower scores being worse
Measured: Through study completion, 28 weeks
Biomarkers
Serum levels of N-terminal-proBNP
Measured: Through study completion, 28 weeks
Circulating metabolites
Concentration of serum metabolites
Measured: Through study completion, 28 weeks
Measurement of periods of activity and rest
Daily step counts by actigraphy
Measured: Through study completion, 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start17 Dec 2024
- Primary completionApr 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic Cardiomyopathy Without ObstructionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Sharlene Day, University of Pennsylvania
- Investigators
- Sharlene Day, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06433050
- Sponsor's protocol ID
- 855065
- Other IDs
- R61HL164376
- Acronym
- SOTA-CROSS HCM
- Status last verified
- Feb 2026
- First submitted
- 13 May 2024
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sodium Glucose Co-transporter (SGLT) Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy
- ClinicalTrials.gov ID
- NCT06433050
- Acronym / sponsor ID
- SOTA-CROSS HCM / 855065
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 17 Dec 2024 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 29 May 2024 (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 goal of this clinical trial is to learn if sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, works to treat symptomatic, nonobstructive hypertrophic cardiomyopathy (noHCM) in adult patients. It will also learn about the safety of sotagliflozin in this patient population. The main questions it aims to answer are:
- Will sotagliflozin be well tolerated in patients with nonobstructive HCM?
- Will sotaglifozin improve exercise capacity, diastolic dysfunction and/or physical functioning in patients with nonobstructive HCM?
- Will sotagliflozin improve circulating markers of cardiac metabolism in patients with nonobstructive HCM?
Researchers will compare sotagliflozin to a placebo (a look-alike substance that contains no drug) to see if sotagliflozin is effective at treating hypertrophic cardiomyopathy (HCM).
Participants will:
Take sotagliflozin or a placebo every day for 12 weeks. They will then cross-over (or switch) to taking placebo or sotagliflozin (whichever one they did not take initially) for an additional 12 weeks.
Visit the clinic once every 4-12 weeks for checkups, surveys, and tests including a stress test and echocardiogram.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo first phase, Sotagliflozin second phase | Placebo comparator | Drug: SotagliflozinMatching placebo once daily will be administered in the first phase, Sotagliflozin 400 mg once daily will be administered in the second phase |
| Sotagliflozin first phase, Placebo second phase | Active comparator | Drug: SotagliflozinSotagliflozin 400 mg once daily will be administered in the first phase, matching placebo once daily will be administered in the second phase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age at least 18 years, both sexes
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Ability to take oral medication and be willing to adhere to the study intervention.
- For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 2 weeks after the end of administration of study drug.
Key exclusion criteria (25 listed)
- Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrollment or previous intolerance of an SGLT2 inhibitor
- Type 1 diabetes mellitus
- Age <18 years old
- Pregnant or lactating women: Women of childbearing potential will undergo a urine pregnancy test during the screening visit.
- Uncontrolled atrial fibrillation, as defined by a resting heart rate > 100 beats per minute at the time of the baseline assessment
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 |
|---|---|---|
| SotagliflozinAlso: InpefaSotagliflozin or placebo will be administered to each participant in a cross over study design. Each participant will receive active drug and placebo with randomization of the order in which they receive them. | Drug | Placebo first phase, Sotagliflozin second phase, Sotagliflozin first phase, Placebo second phase |
Primary outcome
Number of participants with treatment-related adverse events
Time frame: Through study completion, 28 weeks
Adverse event reporting
Intracavitary obstruction
Time frame: Through study completion, 28 weeks
Intracavitary left ventricular pressure gradient in mmHg
Cardiac rhythm
Time frame: Through study completion, 28 weeks
New occurrence of cardiac arrhythmia measured by ambulatory monitoring
Maximal exercise capacity
Time frame: Through study completion, 28 weeks
Peak oxygen consumption in mL/min
Submaximal exercise capacity
Time frame: Through study completion, 28 weeks
Stroke volume augmentation at exercise steady state in mL/min
9 secondary outcomes
Systolic function
Time frame: Through study completion, 28 weeks
Contractility
Time frame: Through study completion, 28 weeks
Diastolic function
Time frame: Through study completion, 28 weeks
Left ventricular hypertrophy
Time frame: Through study completion, 28 weeks
Symptom scores
Time frame: Through study completion, 28 weeks
Symptom scores and quality of life
Time frame: Through study completion, 28 weeks
Biomarkers
Time frame: Through study completion, 28 weeks
Circulating metabolites
Time frame: Through study completion, 28 weeks
Measurement of periods of activity and rest
Time frame: Through study completion, 28 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
- Individual participant dataSharing planned: No. No individual participant data will be available to other researchers
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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.
Sharlene Day, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sotagliflozin in people with Hypertrophic Cardiomyopathy Without Obstruction, run by University of Pennsylvania at 1 site in United States.
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 9 inclusion and 25 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: looking for participants now, as of the sponsor's last update on 11 Feb 2026. 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 States. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sharlene Day, MD (734-548-0394, sharlene.day@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events (time frame: Through study completion, 28 weeks). The study lists 5 primary outcomes in all. 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 11 Feb 2026.