Actively Recruiting
A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy
Led by Lexicon Pharmaceuticals · Updated on 2026-02-27
500
Participants Needed
107
Research Sites
96 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The main purpose of the study is to determine the changes in symptoms and functional limitations in participants with symptomatic hypertrophic cardiomyopathy (HCM) treated with sotagliflozin as compared to placebo.
CONDITIONS
Official Title
A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ CSS) less than 85.
- New York Heart Association (NYHA) functional class II or III.
- Diagnosed hypertrophic cardiomyopathy (HCM) with left ventricular wall thickness ≥ 15 mm, or ≥ 13 mm with family history.
- For obstructive HCM, left ventricular outflow tract peak gradient ≥ 30 mm Hg at rest or with Valsalva.
- For nonobstructive HCM, left ventricular outflow tract peak gradient less than 30 mm Hg at rest and with Valsalva.
- Left ventricular ejection fraction (LVEF) ≥ 50%, or ≥ 55% if on cardiac myosin inhibitor.
- Stable cardiac myosin inhibitor dose for at least 3 months before screening, with no planned dose increase during the trial.
- Stable background heart medication (beta-blockers, calcium channel blockers, ACE inhibitors, ARBs, diuretics) for at least 1 month before screening.
You will not qualify if you...
- Received any sodium glucose co-transporter 2 (SGLT2) inhibitor treatment within 8 weeks before screening.
- Previous intolerance to any SGLT2 inhibitor.
- Any prior treatment with sotagliflozin.
- Current use of thiazolidinediones or digoxin.
- Current or planned participation in another interventional clinical trial, or participation in one within 45 days before screening.
- Known cardiac storage or infiltrative diseases like Fabry disease, amyloidosis, or Noonan syndrome with left ventricular hypertrophy.
- History of unexplained fainting (syncope) within 6 months before screening.
- History of sustained ventricular tachyarrhythmia lasting more than 30 seconds or appropriate ICD discharge within 6 months before screening.
- Atrial fibrillation not anticoagulated for at least 4 weeks before screening or not adequately rate controlled within 3 months before screening.
- Planned septal reduction therapy during the study or septal reduction therapy completed less than 3 months before screening.
- Cardiac surgery, coronary intervention, or cardiac device implantation within 3 months before screening or planned during the study.
- Presence of cardiac resynchronization therapy device.
- Acute coronary syndrome within 2 months before screening.
- Stroke or heart attack within 6 months before screening.
- Hospitalization for heart failure or arrhythmia within 4 weeks before screening.
- Moderate or severe aortic valve stenosis at screening.
- Current angina or significant ischemia from unstable coronary disease as judged by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 107 locations
1
Lexicon Investigational Site (4041)
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Lexicon Investigational Site (4037)
Scottsdale, Arizona, United States, 85260
Actively Recruiting
3
Lexicon Investigational Site (4012)
Los Angeles, California, United States, 90048
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4
Lexicon Investigational Site (4035)
Pomona, California, United States, 91767
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5
Lexicon Investigational Site (4044)
San Francisco, California, United States, 94143
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6
Lexicon Investigational Site (4046)
Jacksonville, Florida, United States, 32224
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7
Lexicon Investigational Site (4034)
Orlando, Florida, United States, 32804
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8
Lexicon Investigational Site (4018)
Atlanta, Georgia, United States, 30322
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9
Lexicon Investigational Site (4033)
Evanston, Illinois, United States, 60208
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10
Lexicon Investigational Site (4036)
Merrillville, Indiana, United States, 46410
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11
Lexicon Investigational Site (4021)
Baltimore, Maryland, United States, 21218
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12
Lexicon Investigational Site (4016)
Boston, Massachusetts, United States, 02115
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13
Lexicon Investigational Site (4042)
Boston, Massachusetts, United States, 02118
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14
Lexicon Investigational Site (4028)
Ann Arbor, Michigan, United States, 48109
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15
Lexicon Investigational Site (4038)
Grand Rapids, Michigan, United States, 49525
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16
Lexicon Investigational Site (4027)
Rochester, Minnesota, United States, 55905
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17
Lexicon Investigational Site (4013)
St Louis, Missouri, United States, 63110
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18
Lexicon Investigational Site (4029)
Morristown, New Jersey, United States, 07960
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19
Lexicon Investigational Site (4039)
Manhasset, New York, United States, 11030
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20
Lexicon Investigational Site (4043)
New York, New York, United States, 10016
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21
Lexicon Investigational Site (4026)
Morrisville, North Carolina, United States, 27560
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22
Lexicon Investigational Site (4031)
Cincinnati, Ohio, United States, 45219
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23
Lexicon Investigational Site (4017)
Cleveland, Ohio, United States, 44195
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24
Lexicon Investigational Site (4024)
Tulsa, Oklahoma, United States, 74104
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25
Lexicon Investigational Site (4015)
Portland, Oregon, United States, 97239
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26
Lexicon Investigational Site (4011)
Philadelphia, Pennsylvania, United States, 19104
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27
Lexicon Investigational Site (4019)
Germantown, Tennessee, United States, 38138
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28
Lexicon Investigational Stie (4014)
Houston, Texas, United States, 77030
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29
Lexicon Investigational Site (4032)
Charlottesville, Virginia, United States, 22908
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30
Lexicon Investigational Site (4010)
Seattle, Washington, United States, 98195
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31
Lexicon Investigational Site (4022)
Marshfield, Wisconsin, United States, 54449
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32
Lexicon Investigational Site (4040)
Milwaukee, Wisconsin, United States, 53215
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33
Lexicon Investigational Site (5016)
Santa Rosa, La Pampa Province, Argentina, L6304BWE
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34
Lexicon Investigational Site (5012)
Rosario, Santa Fe Province, Argentina, 2000
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35
Lexicon Investigational Site (5015)
Corrientes, Argentina, W3400CDS
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36
Lexicon Investigational Site (5010)
Córdoba, Argentina, 5002
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37
Lexicon Investigational Site (5013)
Córdoba, Argentina, X5000AAX
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38
Lexicon Investigational Site (5011)
Salta, Argentina, 4400
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39
Lexicon Investigational Site (5014)
Santa Fe, Argentina, 3000
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40
Lexicon Investigational Site (1012)
Genk, Belgium, 3600
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41
Lexicon Investigational Site (5114)
Salvador, Estado de Bahia, Brazil, 40170-130
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42
Lexicon Investigational Site (5110)
Campinas, São Paulo, Brazil, 13060-080
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43
Lexicon Investigational Site (5112)
Recife, Brazil, 52051-380
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44
Lexicon Investigational Site (5115)
São Paulo, Brazil, 04039-000
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45
Lexicon Investigational Site (1112)
Rousse, Bulgaria, 7013
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46
Lexicon Investigational Site (1111)
Sofia, Bulgaria, 1407
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47
Lexicon Investigational Site (1215)
Krapinske Toplice, Croatia, 49217
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48
Lexicon Investigational Site (1212)
Opatija, Croatia, 51410
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49
Lexicon Investigational Site (1210)
Rijeka, Croatia, 51000
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50
Lexicon Investigational Site (1213)
Zagreb, Croatia, 10000
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51
Lexicon Investigational Site (1311)
Brno, Czechia, 602 00
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52
Lexicon Investigational Site (1310)
Prague, Czechia, 128 08
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53
Lexicon Investigational Site (1312)
Ústí nad Labem, Czechia, 400 11
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54
Lexicon Investigational Site (1514)
Chambray-lès-Tours, France, 37170
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55
Lexicon Investigational Site (1511)
Marseille, France, 13005
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56
Lexicon Investigational Site (1513)
Paris, France, 75651
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57
Lexicon Investigational Site (1510)
Poitiers, France, 86021
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58
Lexicon Investigational Site (1512)
Rennes, France, 35033
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59
Lexicon Investigational Site (1515)
Toulouse, France, 31059
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60
Lexicon Investigational Site (1611)
Tbilisi, Georgia, 0112
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61
Lexicon Investigational Site (1610)
Tbilisi, Georgia, 0131
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62
Lexicon Investigational Site (1612)
Tbilisi, Georgia, 0144
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63
Lexicon Investigational Site (1613)
Tbilisi, Georgia, 0186
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64
Lexicon Investigational Site (2813)
Berlin, Germany, 13353
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65
Lexicon Investigational Site (2812)
Hamburg, Germany, 22041
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66
Lexicon Investigational Site (2811)
Leipzig, Germany, 04289
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67
Lexicon Investigational Site (2810)
München, Germany, 80336
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68
Lexicon Investigational Site (1710)
Budapest, Hungary, 1122
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69
Lexicon Investigational Site (1711)
Pécs, Hungary, 7624
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70
Lexicon Investigational Site (1712)
Szeged, Hungary, 6725
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71
Lexicon Investigational Site (1713)
Zalaegerszeg, Hungary, 8900
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72
Lexicon Investigational Site (7017)
Be’er Ya‘aqov, Israel, 7033001
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73
Lexicon Investigational Site (7013)
Haifa, Israel, 3109601
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74
Lexicon Investigational Site (7014)
Haifa, Israel, 3339419
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75
Lexicon Investigational Site (7015)
Holon, Israel, 5822012
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76
Lexicon Investigational Site (7011)
Jerusalem, Israel, 9112001
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77
Lexicon Investigational Site (7016)
Petah Tikva, Israel, 4941492
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78
Lexicon Investigational Site (7012)
Ramat Gan, Israel, 5265601
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79
Lexicon Investigational Site (7019)
Tel Aviv, Israel, 6423906
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80
Lexicon Investigational Site (1814)
Arezzo, Italy, 52100
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81
Lexicon Investigational Site (1811)
Brescia, Italy, 25123
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82
Lexicon Investigational Site (1813)
Naples, Italy, 80131
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83
Lexicon Investigational Site (2114)
Lodz, Poland, 91-347
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84
Lexicon Investigational Site (2113)
Lodz, Poland, 92-213
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85
Lexicon Investigational Site (2115)
Oświęcim, Poland, 32-600
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86
Lexicon Investigational Site (2110)
Wroclaw, Poland, 50-981
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87
Lexicon Investigational Site (2210)
Braga, Portugal, 4710-243
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88
Lexicon Investigational Site (2213)
Faro, Portugal, 8000-386
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89
Lexicon Investigational Site (2211)
Lisbon, Portugal, 1350-352
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90
Lexicon Investigational Site (2215)
Lisbon, Portugal, 1500-650
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91
Lexicon Investigational Site (2218)
Lisbon, Portugal, 1649-035
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92
Lexicon Investigational Site (2216)
Lisbon, Portugal, 1998-018
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93
Lexicon Investigational Site (2217)
Porto, Portugal, 4200-319
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94
Lexicon Investigational Site (2910)
Baloteşti, Romania, 077015
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95
Lexicon Investigational Site (2913)
Suceava, Romania, 720049
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96
Lexicon Investigational Site (2911)
Târgu Mureş, Romania, 540124
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97
Lexicon Investigational Site (2912)
Târgu Mureş, Romania, 540143
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98
Lexicon Investigational Site (2312)
Belgrade, Serbia, 11000
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99
Lexicon Investigational Site (2314)
Belgrade, Serbia, 11000
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100
Lexicon Investigational Site (2311)
Belgrade, Serbia, 11040
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101
Lexicon Investigational Site (2313)
Belgrade, Serbia, 11040
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102
Lexicon Investigational Site (2310)
Niš, Serbia, 18108
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103
Lexicon Investigational Site (2510)
Stockholm, Sweden, 17164
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104
Lexicon Investigational Site (2712)
Glasgow, United Kingdom, G51 4TF
Actively Recruiting
105
Lexicon Investigational Site (2713)
Leicester, United Kingdom, LE3 9QP
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106
Lexicon Investigational Site (2710)
Liverpool, United Kingdom, L14 3PE
Actively Recruiting
107
Lexicon Investigational Site (2711)
London, United Kingdom, EC1M 6BQ
Actively Recruiting
Research Team
T
Tracy Newbold
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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