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SGLT2 Inhibitor
Sotagliflozin for Hypertrophic Cardiomyopathy (SONATA-HCM Trial)
Phase 3
Recruiting
Research Sponsored by Lexicon Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
For obstructive hypertrophic cardiomyopathy (oHCM), left ventricular outflow tract (LVOT) peak gradient ≥ 30 millimetre of mercury (mm Hg) during screening as assessed by echocardiography at rest or during a valsalva maneuver
NYHA functional class II or III
Must not have
History of stroke or myocardial infarction within 6 months prior to screening
Current use of thiazolidinediones or digoxin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 26
Awards & highlights
Pivotal Trial
Summary
"This trial aims to see how symptoms and functional limitations in people with symptomatic hypertrophic cardiomyopathy change when treated with sotagliflozin compared to a placebo."
Who is the study for?
This trial is for individuals with symptomatic hypertrophic cardiomyopathy (HCM), which is a condition where the heart muscle becomes abnormally thick. Participants should have symptoms and limitations due to HCM but specific inclusion and exclusion criteria details are not provided.
What is being tested?
The study aims to see if sotagliflozin, a medication, can improve symptoms and physical limitations in people with HCM compared to a placebo (a substance with no active drug).
What are the potential side effects?
While specific side effects of sotagliflozin are not listed here, common ones may include dehydration, low blood pressure, kidney problems, diabetic ketoacidosis in diabetics, genital yeast infections, urinary tract infections, and increased cholesterol.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart condition causes a significant blockage in blood flow.
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I have mild to moderate heart condition symptoms.
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I have been diagnosed with HCM without any other heart or systemic disease.
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My heart condition does not block blood flow and my heart's output is normal during tests.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have not had a stroke or heart attack in the last 6 months.
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I am currently taking thiazolidinediones or digoxin.
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I am not currently in, nor have I been in an experimental drug trial within the last 45 days.
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I have a condition like Fabry, amyloidosis, or Noonan syndrome that causes heart thickening.
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I have never taken sotagliflozin before.
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I have taken SGLT2 inhibitor medication in the last 8 weeks.
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I haven't had major heart surgery or device implantation in the last 3 months and don't plan to during the study.
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I have not been hospitalized for heart failure or arrhythmia in the last 4 weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 26
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 26
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from Baseline to Week 26 in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS)
Secondary study objectives
Change from Baseline to Week 26 in KCCQ Total Symptom Score (TSS).
Percentage of Participants at Week 26 with a New York Heart Association (NYHA) Functional Class Improvement ≥ 1 Category
Side effects data
From 2019 Phase 3 trial • 277 Patients • NCT0324201811%
Glomerular filtration rate decreased
11%
Urinary tract infection
10%
Hyperkalaemia
10%
Vitamin D deficiency
9%
Nasopharyngitis
5%
Diarrhoea
5%
Renal impairment
5%
Influenza
3%
Arthralgia
2%
Hypoglycaemia
2%
End stage renal disease
2%
Renal failure
2%
Hyperuricaemia
1%
Peripheral sensorimotor neuropathy
1%
Pneumonia bacterial
1%
Acute kidney injury
1%
Pulmonary hypertension
1%
Haemorrhoids
1%
Atrial fibrillation
1%
Cardiac failure chronic
1%
Inguinal hernia
1%
Obstructive pancreatitis
1%
Cellulitis
1%
Metatarsalgia
1%
Alanine aminotransferase increased
1%
Cardiac failure
1%
Acute myocardial infarction
1%
Bronchitis
1%
Osteomyelitis
1%
Atrioventricular block complete
1%
Gangrene
1%
Acute respiratory failure
1%
Pancreatic carcinoma
1%
Post procedural haemorrhage
1%
Plasma cell myeloma
1%
Femoral neck fracture
1%
Hypertension
1%
Peripheral ischaemia
1%
Asthenia
1%
Renal colic
1%
Cholangitis
1%
Cholelithiasis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Sotagliflozin 200 mg
Sotagliflozin 400 mg
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SotagliflozinExperimental Treatment1 Intervention
Following a 2-week screening period, sotagliflozin 400 milligrams (mg) tablets will be administered as two 200 mg tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Group II: PlaceboPlacebo Group1 Intervention
Following a 2-week screening period, sotagliflozin-matching placebo 400 mg tablets will be administered as two 200 mg tablets, once daily, before the first meal of the day in the double-blind treatment period for up to 26 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sotagliflozin
2013
Completed Phase 3
~5700
Find a Location
Who is running the clinical trial?
Lexicon PharmaceuticalsLead Sponsor
66 Previous Clinical Trials
23,934 Total Patients Enrolled