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Showing 1–24 of 40 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: sotagliflozin Clear all
Completed Phase 1 Interventional Accepts healthy volunteers

A Drug to Drug Interaction Study of Sotagliflozin With Hydrochlorothiazide

NCT03387657
View directory record Official record
Conditions
Type 2 Diabetes Mellitus
Interventions
Sotagliflozin (SAR439954), Hydrochlorothiazide
Drug
Lead sponsor
Sanofi
Industry
Eligibility
18 Years to 55 Years
Enrollment
16 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2018
U.S. locations
1
States / cities
Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Apr 24, 2022 · Synced Sep 11, 2026, 1:13 PM EDT
Not yet recruiting Phase 3 Interventional

CKM For Safe Use of SGLT2i in Type 1 Diabetes

NCT07211802
View directory record Official record
Conditions
Type 1 Diabetes (T1D)
Interventions
Sotagliflozin Low Dose, Sotagliflozin High Dose, Dual Continuous Glucose and Ketone Monitor
Drug · Device
Lead sponsor
University of California, San Diego
Other
Eligibility
18 Years and older
Enrollment
52 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2030
U.S. locations
1
States / cities
La Jolla, California
Source: ClinicalTrials.gov public record
Updated Oct 7, 2025 · Synced Sep 11, 2026, 1:13 PM EDT
Completed Phase 2 Interventional Results available

Dose-ranging Study in Patients With Type 1 Diabetes Mellitus

NCT02459899
View directory record Official record
Conditions
Type 1 Diabetes Mellitus
Interventions
Placebo, Sotagliflozin
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
141 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
17
States / cities
Concord, California • Ventura, California • Denver, Colorado + 14 more
Source: ClinicalTrials.gov public record
Updated Feb 11, 2020 · Synced Sep 11, 2026, 1:13 PM EDT
Completed Phase 2 Interventional Results available

Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C

NCT02383940
View directory record Official record
Conditions
Type 1 Diabetes Mellitus
Interventions
Sotagliflozin, Placebo
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years to 30 Years
Enrollment
87 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
15
States / cities
Tustin, California • Aurora, Colorado • New Haven, Connecticut + 12 more
Source: ClinicalTrials.gov public record
Updated Feb 11, 2020 · Synced Sep 11, 2026, 1:13 PM EDT
Completed Phase 3 Interventional Results available

Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus on Background of Sulfonylurea Alone or With Metformin

NCT03066830
View directory record Official record
Conditions
Type 2 Diabetes Mellitus
Interventions
Sotagliflozin (SAR439954), Placebo, Metformin, Sulfonylurea
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
507 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
28
States / cities
Litchfield Park, Arizona • Peoria, Arizona • Greenbrae, California + 25 more
Source: ClinicalTrials.gov public record
Updated May 10, 2021 · Synced Sep 11, 2026, 1:13 PM EDT
Completed Phase 3 Interventional Results available

A Study to Evaluate Safety and Effects of Sotagliflozin 400 and 200 mg on Glucose Control in Participants With Type 2 Diabetes, Severe Impairment of Kidney Function and Inadequate Blood Sugar Control

NCT03242018
View directory record Official record
Conditions
Type 2 Diabetes Mellitus, Chronic Kidney Disease Stage 4
Interventions
Placebo, Sotagliflozin
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
277 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
34
States / cities
Guntersville, Alabama • Phoenix, Arizona • Little Rock, Arkansas + 29 more
Source: ClinicalTrials.gov public record
Updated Jun 24, 2021 · Synced Sep 11, 2026, 1:13 PM EDT
Recruiting Phase 3 Interventional

Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease

NCT06217302
View directory record Official record
Conditions
Diabetic Nephropathies, Kidney Failure, Chronic, Diabetes Mellitus Type 1, Heart Failure
Interventions
Sotagliflozin, Placebo
Drug
Lead sponsor
Alessandro Doria
Other
Eligibility
18 Years to 75 Years
Enrollment
150 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2029
U.S. locations
13
States / cities
Stanford, California • Aurora, Colorado • Orlando, Florida + 10 more
Source: ClinicalTrials.gov public record
Updated Mar 23, 2026 · Synced Sep 11, 2026, 1:13 PM EDT
Completed Phase 3 Interventional Results available

Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy

NCT02384941
View directory record Official record
Conditions
Type 1 Diabetes Mellitus
Interventions
Placebo, Sotagliflozin
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
793 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
63
States / cities
Birmingham, Alabama • Little Rock, Arkansas • Escondido, California + 55 more
Source: ClinicalTrials.gov public record
Updated Feb 11, 2020 · Synced Sep 11, 2026, 1:13 PM EDT
Recruiting No phase listed Observational Accepts healthy volunteers

Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression

NCT06510894
View directory record Official record
Conditions
Cardiac Sarcoidosis
Interventions
Sotagliflozin
Drug
Lead sponsor
University of Pennsylvania
Other
Eligibility
Not listed
Enrollment
40 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2024 – 2027
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Jan 6, 2026 · Synced Sep 11, 2026, 1:13 PM EDT
Not listed Phase 1 Interventional Accepts healthy volunteers

Oral Contraceptive DDI Study

NCT02494609
View directory record Official record
Conditions
Healthy
Interventions
sotagliflozin, oral contraceptive, oral contraceptive + sotagliflozin
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years to 45 Years · Female only
Enrollment
30 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
Started 2015
U.S. locations
2
States / cities
Evansville, Indiana • Dallas, Texas
Source: ClinicalTrials.gov public record
Updated Mar 1, 2016 · Synced Sep 11, 2026, 1:13 PM EDT
Active, not recruiting Phase 1Phase 2 Interventional

Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes

NCT05696366
View directory record Official record
Conditions
Type 1 Diabetes
Interventions
Sotagliflozin, Volagidemab
Drug
Lead sponsor
University of California, San Diego
Other
Eligibility
18 Years to 70 Years
Enrollment
24 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2028
U.S. locations
1
States / cities
La Jolla, California
Source: ClinicalTrials.gov public record
Updated Jun 14, 2026 · Synced Sep 11, 2026, 1:13 PM EDT
Active, not recruiting Phase 3 Interventional

A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy

NCT06481891
View directory record Official record
Conditions
Obstructive Cardiomyopathy, Hypertrophic, Non-obstructive Hypertrophic Cardiomyopathy
Interventions
Sotagliflozin, Placebo
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
500 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
33
States / cities
Phoenix, Arizona • Scottsdale, Arizona • Los Angeles, California + 28 more
Source: ClinicalTrials.gov public record
Updated Aug 25, 2026 · Synced Sep 11, 2026, 1:13 PM EDT
Terminated Phase 3 Interventional Results available

Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial)

NCT03521934
View directory record Official record
Conditions
Heart Failure, Type 2 Diabetes Mellitus
Interventions
Sotagliflozin, Placebo
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years to 85 Years
Enrollment
1,222 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2018 – 2020
U.S. locations
94
States / cities
Alexander City, Alabama • Cottonwood, Arizona • Little Rock, Arkansas + 83 more
Source: ClinicalTrials.gov public record
Updated Oct 27, 2022 · Synced Sep 11, 2026, 1:13 PM EDT
Recruiting Early Phase 1 Interventional

Sodium Glucose Co-transporter (SGLT) Inhibitors in Nonobstructive Hypertrophic Cardiomyopathy

NCT06433050
View directory record Official record
Conditions
Hypertrophic Cardiomyopathy Without Obstruction
Interventions
Sotagliflozin
Drug
Lead sponsor
University of Pennsylvania
Other
Eligibility
18 Years and older
Enrollment
26 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2024 – 2027
U.S. locations
1
States / cities
Philadelphia, Pennsylvania
Source: ClinicalTrials.gov public record
Updated Feb 10, 2026 · Synced Sep 11, 2026, 1:13 PM EDT
Not yet recruiting Phase 4 Interventional

Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)

NCT07547878
View directory record Official record
Conditions
Chronic Kidney Disease, Type 2 Diabetes
Interventions
Finerenone, Semaglutide, Lotensin, Capoten, Enalapril, Monopril, Lisinopril, Univasc, Aceon, Accupril, Altace, Mavik, Edarbi, Atacand, Avapro, Cozaar, Benicar, Micardis, Diovan, Invokana, Farxiga, Jardiance, Ertugliflozin, Brenzavvy, Sotagliflozin
Drug
Lead sponsor
Baylor Research Institute
Other
Eligibility
18 Years to 84 Years
Enrollment
64 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2026 – 2029
U.S. locations
1
States / cities
Temple, Texas
Source: ClinicalTrials.gov public record
Updated May 7, 2026 · Synced Sep 11, 2026, 1:13 PM EDT
Completed Phase 3 Interventional Results available

Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control

NCT03242252
View directory record Official record
Conditions
Type 2 Diabetes Mellitus, Chronic Kidney Disease Stage 3
Interventions
Placebo, Sotagliflozin
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
787 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
51
States / cities
Birmingham, Alabama • Guntersville, Alabama • Phoenix, Arizona + 42 more
Source: ClinicalTrials.gov public record
Updated Jun 24, 2021 · Synced Sep 11, 2026, 1:13 PM EDT
Completed Phase 3 Interventional Results available

Efficacy and Safety of Sotagliflozin Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking Insulin Alone or With Other Oral Antidiabetic Agents

NCT03285594
View directory record Official record
Conditions
Type 2 Diabetes Mellitus
Interventions
Sotagliflozin, Insulin glargine (HOE901), Placebo, Oral Antidiabetes Drugs (OADs)
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
571 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
50
States / cities
Mesa, Arizona • Phoenix, Arizona • Huntington Park, California + 42 more
Source: ClinicalTrials.gov public record
Updated May 10, 2021 · Synced Sep 11, 2026, 1:13 PM EDT
Completed Phase 3 Interventional Results available

A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone

NCT02531035
View directory record Official record
Conditions
Type 1 Diabetes Mellitus (T1DM), High Level of Sugar (Glucose) in the Blood
Interventions
Sotagliflozin, Placebo
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
1,405 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
33
States / cities
Concord, California • Escondido, California • La Jolla, California + 30 more
Source: ClinicalTrials.gov public record
Updated Feb 11, 2020 · Synced Sep 11, 2026, 1:13 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

Study to Evaluate Sotagliflozin in Subjects With Varying Degrees of Renal Function

NCT02647918
View directory record Official record
Conditions
Renal Impairment, Healthy
Interventions
Sotagliflozin
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years to 75 Years
Enrollment
50 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2015 – 2017
U.S. locations
4
States / cities
Miami, Florida • Orlando, Florida • Minneapolis, Minnesota + 1 more
Source: ClinicalTrials.gov public record
Updated Feb 25, 2019 · Synced Sep 11, 2026, 1:13 PM EDT
Terminated Phase 2 Interventional Results available

Safety, Tolerability and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Participants With Worsening Heart Failure

NCT03292653
View directory record Official record
Conditions
Cardiac Failure Aggravated
Interventions
Sotagliflozin, Placebo
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years and older
Enrollment
32 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2017 – 2019
U.S. locations
4
States / cities
La Jolla, California • New Haven, Connecticut • Rochester, Minnesota + 1 more
Source: ClinicalTrials.gov public record
Updated May 10, 2021 · Synced Sep 11, 2026, 1:13 PM EDT
Recruiting Early Phase 1 Interventional Accepts healthy volunteers

Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs

NCT06933056
View directory record Official record
Conditions
Platelet Function and Reactivity Tests
Interventions
Sotagliflozin (SOTA) followed by 3 drugs in a random order, Aspirin followed by 3 drugs in a random order, Clopidogrel followed by 3 drugs in a random order, Eliquis followed by 3 drugs in a random order
Drug
Lead sponsor
University of Michigan
Other
Eligibility
18 Years to 79 Years
Enrollment
20 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025 – 2026
U.S. locations
1
States / cities
Ann Arbor, Michigan
Source: ClinicalTrials.gov public record
Updated Sep 14, 2025 · Synced Sep 11, 2026, 1:13 PM EDT
Completed Phase 1 Interventional Accepts healthy volunteers

PK Study of Sotagliflozin in Subjects With Hepatic Impairment

NCT02471274
View directory record Official record
Conditions
Hepatic Impairment, Healthy
Interventions
sotagliflozin
Drug
Lead sponsor
Lexicon Pharmaceuticals
Industry
Eligibility
18 Years to 70 Years
Enrollment
32 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
Started 2015
U.S. locations
4
States / cities
Lakewood, Colorado • Miami, Florida • Orlando, Florida + 1 more
Source: ClinicalTrials.gov public record
Updated Nov 16, 2016 · Synced Sep 11, 2026, 1:13 PM EDT
Active, not recruiting No phase listed Observational

Using Secondary Data to Evaluate Sex-based Heterogeneity of GLP-1 Agonists and SGLT2 Inhibitors on Cardiovascular-Kidney-Metabolic Health (CKMH) Outcomes in Real-world Settings (DASH-CKMH)

NCT07188545
View directory record Official record
Conditions
Cardiovascular Kidney Metabolic Syndrome
Interventions
Intervention, Active Comparator
Drug
Lead sponsor
Ohio State University
Other
Eligibility
18 Years and older
Enrollment
23,280,000 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2025 – 2029
U.S. locations
1
States / cities
Columbus, Ohio
Source: ClinicalTrials.gov public record
Updated Sep 22, 2025 · Synced Sep 11, 2026, 1:13 PM EDT
Completed Phase 4 Interventional Accepts healthy volunteers

Antithrombotic Activities of Sotagliflozin vs. Empagliflozin

NCT06618976
View directory record Official record
Conditions
Thrombosis
Interventions
Sotagliflozin, Empagliflozin
Drug
Lead sponsor
Icahn School of Medicine at Mount Sinai
Other
Eligibility
18 Years and older
Enrollment
17 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2025 – 2026
U.S. locations
1
States / cities
New York, New York
Source: ClinicalTrials.gov public record
Updated Apr 29, 2026 · Synced Sep 11, 2026, 1:13 PM EDT