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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

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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~week 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 26 for reporting.

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 • NCT03242018
11%
Glomerular filtration rate decreased
11%
Urinary tract infection
10%
Hyperkalaemia
10%
Vitamin D deficiency
9%
Nasopharyngitis
5%
Renal impairment
5%
Diarrhoea
5%
Influenza
3%
Arthralgia
2%
End stage renal disease
2%
Hypoglycaemia
2%
Renal failure
2%
Hyperuricaemia
1%
Cardiac failure
1%
Pneumonia bacterial
1%
Pulmonary hypertension
1%
Acute respiratory failure
1%
Alanine aminotransferase increased
1%
Gangrene
1%
Cellulitis
1%
Hypertension
1%
Inguinal hernia
1%
Peripheral sensorimotor neuropathy
1%
Pancreatic carcinoma
1%
Atrial fibrillation
1%
Cardiac failure chronic
1%
Plasma cell myeloma
1%
Obstructive pancreatitis
1%
Acute kidney injury
1%
Atrioventricular block complete
1%
Haemorrhoids
1%
Metatarsalgia
1%
Acute myocardial infarction
1%
Bronchitis
1%
Osteomyelitis
1%
Femoral neck fracture
1%
Post procedural haemorrhage
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

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
65 Previous Clinical Trials
23,910 Total Patients Enrolled
~333 spots leftby Jul 2026
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