Actively Recruiting
A Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy
Led by Lexicon Pharmaceuticals · Updated on 2026-05-18
500
Participants Needed
108
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of sotagliflozin on symptoms and functional limitations in adults with symptomatic hypertrophic cardiomyopathy (HCM), including both obstructive and non-obstructive types. This phase 3 trial aims to compare sotagliflozin to a placebo to understand changes in symptom scores and heart function. Participants have HCM diagnosed according to established guidelines and experience moderate symptoms as classified by the New York Heart Association (NYHA). Participants will enter a screening period lasting up to 3 weeks. Those eligible will be randomly assigned to receive either sotagliflozin 400 mg daily (two 200 mg tablets) or a matching placebo once daily before their first meal. This double-blind treatment will continue for up to 26 weeks. The study includes careful monitoring to evaluate both groups over this period. During the study, participants will undergo regular assessments including symptom questionnaires like the Kansas City Cardiomyopathy Questionnaire (KCCQ) and NYHA functional class evaluations. Researchers will track changes in clinical summary scores and symptom severity from baseline to week 26. Safety and tolerability will be monitored throughout the trial. The total participant involvement may last around 29 weeks including screening and treatment.
CONDITIONS
Brief 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...
- Adults aged 18 years or older
- Diagnosed with hypertrophic cardiomyopathy (HCM) according to established guidelines
- KCCQ Clinical Summary Score less than 85
- NYHA functional class II or III
- For obstructive HCM, left ventricular outflow tract peak gradient of 30 mm Hg or higher
- For non-obstructive HCM, left ventricular outflow tract peak gradient less than 30 mm Hg
- Left ventricular ejection fraction 50% or higher (55% or higher if on cardiac myosin inhibitor)
- Stable dose of cardiac myosin inhibitor for at least 3 months prior to screening if applicable
- Stable doses of background heart medications for at least 1 month prior to screening
You will not qualify if you...
- Use of sodium glucose co-transporter 2 (SGLT2) inhibitors within 8 weeks before screening
- Previous intolerance or treatment with sotagliflozin
- Current use of thiazolidinediones or digoxin
- Participation in other interventional clinical trials within 45 days before screening
- Known storage or infiltrative disorders causing cardiac hypertrophy like Fabry disease or amyloidosis
- History of unexplained fainting within 6 months before screening
- Recent sustained ventricular tachyarrhythmia or defibrillator discharge within 6 months
- Atrial fibrillation not on anticoagulation or not adequately controlled
- Planned septal reduction therapy or recent cardiac surgery/device implantation within 3 months
- Presence of cardiac resynchronization therapy device
- Recent acute coronary syndrome, stroke, or heart attack within 2 to 6 months
- Hospitalization for heart failure or arrhythmia within 4 weeks before screening
- Moderate or severe aortic valve stenosis
- Current angina or significant coronary artery disease as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 3 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 26 weeks
Participants receive sotagliflozin or placebo tablets orally once daily before the first meal of the day during the double-blind treatment period.
Trial Site Locations
Total: 108 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 (4045)
Seattle, Washington, United States, 98101
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31
Lexicon Investigational Site (4010)
Seattle, Washington, United States, 98195
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32
Lexicon Investigational Site (4022)
Marshfield, Wisconsin, United States, 54449
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33
Lexicon Investigational Site (4040)
Milwaukee, Wisconsin, United States, 53215
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34
Lexicon Investigational Site (5016)
Santa Rosa, La Pampa Province, Argentina, L6304BWE
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35
Lexicon Investigational Site (5012)
Rosario, Santa Fe Province, Argentina, 2000
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36
Lexicon Investigational Site (5015)
Corrientes, Argentina, W3400CDS
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37
Lexicon Investigational Site (5010)
Córdoba, Argentina, 5002
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38
Lexicon Investigational Site (5013)
Córdoba, Argentina, X5000AAX
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39
Lexicon Investigational Site (5011)
Salta, Argentina, 4400
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40
Lexicon Investigational Site (5014)
Santa Fe, Argentina, 3000
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41
Lexicon Investigational Site (1012)
Genk, Belgium, 3600
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42
Lexicon Investigational Site (5114)
Salvador, Estado de Bahia, Brazil, 40170-130
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43
Lexicon Investigational Site (5110)
Campinas, São Paulo, Brazil, 13060-080
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44
Lexicon Investigational Site (5112)
Recife, Brazil, 52051-380
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45
Lexicon Investigational Site (5115)
São Paulo, Brazil, 04039-000
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46
Lexicon Investigational Site (1112)
Rousse, Bulgaria, 7013
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47
Lexicon Investigational Site (1111)
Sofia, Bulgaria, 1407
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48
Lexicon Investigational Site (1215)
Krapinske Toplice, Croatia, 49217
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49
Lexicon Investigational Site (1212)
Opatija, Croatia, 51410
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50
Lexicon Investigational Site (1210)
Rijeka, Croatia, 51000
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51
Lexicon Investigational Site (1213)
Zagreb, Croatia, 10000
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52
Lexicon Investigational Site (1311)
Brno, Czechia, 602 00
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53
Lexicon Investigational Site (1310)
Prague, Czechia, 128 08
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54
Lexicon Investigational Site (1312)
Ústí nad Labem, Czechia, 400 11
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55
Lexicon Investigational Site (1514)
Chambray-lès-Tours, France, 37170
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56
Lexicon Investigational Site (1511)
Marseille, France, 13005
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57
Lexicon Investigational Site (1513)
Paris, France, 75651
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58
Lexicon Investigational Site (1510)
Poitiers, France, 86021
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59
Lexicon Investigational Site (1512)
Rennes, France, 35033
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60
Lexicon Investigational Site (1515)
Toulouse, France, 31059
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61
Lexicon Investigational Site (1611)
Tbilisi, Georgia, 0112
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62
Lexicon Investigational Site (1610)
Tbilisi, Georgia, 0131
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63
Lexicon Investigational Site (1612)
Tbilisi, Georgia, 0144
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64
Lexicon Investigational Site (1613)
Tbilisi, Georgia, 0186
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65
Lexicon Investigational Site (2813)
Berlin, Germany, 13353
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66
Lexicon Investigational Site (2812)
Hamburg, Germany, 22041
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67
Lexicon Investigational Site (2811)
Leipzig, Germany, 04289
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68
Lexicon Investigational Site (2810)
München, Germany, 80336
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69
Lexicon Investigational Site (1710)
Budapest, Hungary, 1122
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70
Lexicon Investigational Site (1711)
Pécs, Hungary, 7624
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71
Lexicon Investigational Site (1712)
Szeged, Hungary, 6725
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72
Lexicon Investigational Site (1713)
Zalaegerszeg, Hungary, 8900
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73
Lexicon Investigational Site (7017)
Be’er Ya‘aqov, Israel, 7033001
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74
Lexicon Investigational Site (7013)
Haifa, Israel, 3109601
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75
Lexicon Investigational Site (7014)
Haifa, Israel, 3339419
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76
Lexicon Investigational Site (7015)
Holon, Israel, 5822012
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77
Lexicon Investigational Site (7011)
Jerusalem, Israel, 9112001
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78
Lexicon Investigational Site (7016)
Petah Tikva, Israel, 4941492
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79
Lexicon Investigational Site (7012)
Ramat Gan, Israel, 5265601
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80
Lexicon Investigational Site (7019)
Tel Aviv, Israel, 6423906
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81
Lexicon Investigational Site (1814)
Arezzo, Italy, 52100
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82
Lexicon Investigational Site (1811)
Brescia, Italy, 25123
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83
Lexicon Investigational Site (1813)
Naples, Italy, 80131
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84
Lexicon Investigational Site (2114)
Lodz, Poland, 91-347
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85
Lexicon Investigational Site (2113)
Lodz, Poland, 92-213
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86
Lexicon Investigational Site (2115)
Oświęcim, Poland, 32-600
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87
Lexicon Investigational Site (2110)
Wroclaw, Poland, 50-981
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88
Lexicon Investigational Site (2210)
Braga, Portugal, 4710-243
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89
Lexicon Investigational Site (2213)
Faro, Portugal, 8000-386
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90
Lexicon Investigational Site (2211)
Lisbon, Portugal, 1350-352
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91
Lexicon Investigational Site (2215)
Lisbon, Portugal, 1500-650
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92
Lexicon Investigational Site (2218)
Lisbon, Portugal, 1649-035
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93
Lexicon Investigational Site (2216)
Lisbon, Portugal, 1998-018
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94
Lexicon Investigational Site (2217)
Porto, Portugal, 4200-319
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95
Lexicon Investigational Site (2910)
Baloteşti, Romania, 077015
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96
Lexicon Investigational Site (2913)
Suceava, Romania, 720049
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97
Lexicon Investigational Site (2911)
Târgu Mureş, Romania, 540124
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98
Lexicon Investigational Site (2912)
Târgu Mureş, Romania, 540143
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99
Lexicon Investigational Site (2312)
Belgrade, Serbia, 11000
Actively Recruiting
100
Lexicon Investigational Site (2314)
Belgrade, Serbia, 11000
Actively Recruiting
101
Lexicon Investigational Site (2311)
Belgrade, Serbia, 11040
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102
Lexicon Investigational Site (2313)
Belgrade, Serbia, 11040
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103
Lexicon Investigational Site (2310)
Niš, Serbia, 18108
Actively Recruiting
104
Lexicon Investigational Site (2510)
Stockholm, Sweden, 17164
Actively Recruiting
105
Lexicon Investigational Site (2712)
Glasgow, United Kingdom, G51 4TF
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106
Lexicon Investigational Site (2713)
Leicester, United Kingdom, LE3 9QP
Actively Recruiting
107
Lexicon Investigational Site (2710)
Liverpool, United Kingdom, L14 3PE
Actively Recruiting
108
Lexicon Investigational Site (2711)
London, United Kingdom, EC1M 6BQ
Actively Recruiting
Research Team
T
Tracy Newbold
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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