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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 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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 26

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

Nasopharyngitis

Diarrhoea

Renal impairment

Influenza

Arthralgia

Hypoglycaemia

End stage renal disease

Renal failure

Hyperuricaemia

Peripheral sensorimotor neuropathy

Pulmonary hypertension

Acute respiratory failure

Haemorrhoids

Acute kidney injury

Atrial fibrillation

Cardiac failure chronic

Pancreatic carcinoma

Inguinal hernia

Obstructive pancreatitis

Cellulitis

Hypertension

Metatarsalgia

Alanine aminotransferase increased

Cardiac failure

Pneumonia bacterial

Acute myocardial infarction

Bronchitis

Osteomyelitis

Atrioventricular block complete

Post procedural haemorrhage

Gangrene

Plasma cell myeloma

Femoral neck fracture

Peripheral ischaemia

Asthenia

Renal colic

Cholangitis

Cholelithiasis

100%

80%

60%

40%

20%

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

0 / 12Eligibility criteria met