57 completed, 4 terminated, 2 active not recruiting, 2 recruiting. 28 Phase 1, 20 Phase 2, 20 Phase 3, 1 Early Phase 1.
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| CKM For Safe Use of SGLT2i in Type 1 Diabetes Sotagliflozin Low Dose, Sotagliflozin High Dose, Dual Continuous Glucose and Ketone Monitor - Type 1 Diabetes (T1D) | Phase 3 | Not yet recruiting | University of California, San Diego | 52 | 2027-04-01 | 2026-11-04 |
| Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs 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 - Platelet Function and Reactivity Tests | Early Phase 1 | Completed | University of Michigan | 21 | 2025-09-02 | 2026-10-22 |
| Sotagliflozin in Patients With Heart Failure Symptoms and Type 1 Diabetes Sotagliflozin, Placebo - Type 1 Diabetes, Heart Failure | Phase 2 | Recruiting | University of Dundee | 320 | 2025-01-28 | 2026-04-06 |
| Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease Sotagliflozin, Placebo - Diabetic Nephropathies, Kidney Failure, Chronic | Phase 3 | Recruiting | Alessandro Doria | 150 | 2024-10-31 | 2026-03-24 |
| A Study to Evaluate the Efficacy and Safety of Sotagliflozin in Symptomatic Obstructive and Non-obstructive Hypertrophic Cardiomyopathy Sotagliflozin, Placebo - Obstructive Cardiomyopathy, Hypertrophic, Non-obstructive Hypertrophic Cardiomyopathy | Phase 3 | Active not recruiting | Lexicon Pharmaceuticals | 500 | 2024-09-24 | 2026-08-26 |
| Combination Adjunctive Therapy to Address Multiple Metabolic Imbalances in Type 1 Diabetes Sotagliflozin, Volagidemab - Type 1 Diabetes | Phase 1 / Phase 2 | Active not recruiting | University of California, San Diego | 24 | 2024-09-09 | 2026-06-15 |
| A Dose-ranging Study in Patients With Diabetic Peripheral Neuropathic Pain (DPNP) Placebo (blinded), LX9211 (blinded) - Diabetic Peripheral Neuropathic Pain | Phase 2 | Completed | Lexicon Pharmaceuticals | 496 | 2023-11-29 | 2025-10-10 |
| Efficacy and Safety of LX9211 in Participants With Postherpetic Neuralgia Placebo, LX9211 - Postherpetic Neuralgia | Phase 2 | Completed | Lexicon Pharmaceuticals | 79 | 2020-12-10 | 2026-02-13 |
| Open Label Study to Analyze the Effect of Telotristat Ethyl on Weight Regulation/Gain telotristat ethyl - Pancreatic Cancer, Neuroendocrine Tumors | Withdrawn | Andrew Hendifar, MD | 2020-10-01 | 2020-12-30 | ||
| Efficacy, Safety, and PK of LX9211 in Participants With Diabetic Peripheral Neuropathic Pain LX9211, LX9211 Matching Placebo - Diabetic Peripheral Neuropathy, Diabetes | Phase 2 | Completed | Lexicon Pharmaceuticals | 319 | 2020-09-03 | 2025-06-25 |
| Telotristat Ethyl to Promote Weight Stability in Patients With Advanced Stage Pancreatic Cancer Gemcitabine, Nab-paclitaxel, Telotristat Ethyl - Locally Advanced Unresectable Pancreatic Adenocarcinoma, Metastatic Pancreatic Adenocarcinoma | Phase 2 | Completed | Emory University | 23 | 2019-04-17 | 2025-12-16 |
| Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure (SOLOIST-WHF Trial) Sotagliflozin, Placebo - Heart Failure, Type 2 Diabetes Mellitus | Phase 3 | Terminated | Lexicon Pharmaceuticals | 1222 | 2018-06-15 | 2022-10-28 |
| Efficacy and Bone Safety of Sotagliflozin 400 and 200 mg Versus Placebo in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control Sotagliflozin, Placebo - Type 2 Diabetes Mellitus | Phase 3 | Terminated | Lexicon Pharmaceuticals | 376 | 2018-02-19 | 2021-06-25 |
| Effect of Sotagliflozin on Cardiovascular and Renal Events in Participants With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk Sotagliflozin, Placebo - Heart Failure, Type 2 Diabetes Mellitus | Phase 3 | Terminated | Lexicon Pharmaceuticals | 10584 | 2017-12-19 | 2022-10-28 |
| Safety, Tolerability and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Participants With Worsening Heart Failure Sotagliflozin, Placebo - Cardiac Failure Aggravated | Phase 2 | Terminated | Lexicon Pharmaceuticals | 32 | 2017-12-04 | 2021-05-11 |
| Efficacy and Safety of Sotagliflozin Versus Glimepiride and Placebo in Participants With Type 2 Diabetes Mellitus That Are Taking Metformin Monotherapy Sotagliflozin (SAR439954), Glimepiride, Metformin - Type 2 Diabetes Mellitus | Phase 3 | Completed | Lexicon Pharmaceuticals | 954 | 2017-12-01 | 2021-05-11 |
| Study to Evaluate the Pharmacokinetics of Telotristat Ethyl in Subjects With Severe Hepatic Impairment Telotristat Ethyl - Hepatic Impairment | Phase 1 | Completed | Lexicon Pharmaceuticals | 16 | 2017-11-28 | 2018-10-15 |
| Efficacy and Safety of Sotagliflozin Versus Placebo and Empagliflozin in Participants With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control While Taking a DPP4 Inhibitor Alone or With Metformin Sotagliflozin, Empagliflozin, Placebo - Type 2 Diabetes Mellitus | Phase 3 | Completed | Lexicon Pharmaceuticals | 770 | 2017-11-27 | 2021-05-11 |
| A Phase 1 Study to Evaluate the Effects of Omeprazole and Famotidine on the Absorption of Telotristat Ethyl in Healthy Subjects Omeprazole 40 MG, Famotidine 40 mg, Telotristat ethyl 250 mg - Drug-drug Interaction | Phase 1 | Completed | Lexicon Pharmaceuticals | 32 | 2017-09-21 | 2018-04-25 |
| 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 Sotagliflozin, Insulin glargine (HOE901), Placebo - Type 2 Diabetes Mellitus | Phase 3 | Completed | Lexicon Pharmaceuticals | 571 | 2017-09-15 | 2021-05-11 |
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Diabetes Mellitus, Type 2 (17) · Diabetes Mellitus, Type 1 (10) · Serotonin Syndrome (6) · Heart Failure (4) · Arthritis, Rheumatoid (3) · Irritable Bowel Syndrome (3) · Renal Insufficiency, Chronic (3) · Diabetes Mellitus (2) · Pancreatic Neoplasms (2) · Renal Insufficiency (2) · Cachexia (1) · Cardiomyopathy, Hypertrophic (1) · Cardiovascular Diseases (1) · Colitis, Ulcerative (1) · Diabetic Nephropathies (1)
(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol (38) · telotristat (12) · Metformin (4) · telotristat ethyl (4) · Moxifloxacin (2) · 130-nm albumin-bound paclitaxel (1) · 2-amino-3-(4-(2-amino-6-(2,2,2-trifluoro-1-(3'-methoxybiphenyl-4-yl)ethoxy)-pyrimidin-4-yl)phenyl)propionic acid (1) · Albumin-Bound Paclitaxel (1) · Canagliflozin (1) · Contraceptives, Oral (1) · Famotidine (1) · Fluid Therapy (1) · Gemcitabine (1) · Insulin Glargine (1) · LX-7101 (1)
United States (62) · Canada (15) · United Kingdom (14) · Hungary (12) · Germany (11) · Poland (11) · France (10) · Israel (10) · Italy (10) · Slovakia (10) · Spain (10) · Bulgaria (9) · Belgium (8) · Czechia (8) · Netherlands (8)
Suman Wason, MD (23) · Ikenna Ogbaa, MD (5) · Pablo Lapuerta, MD (4) · Joel P. Freiman, MD, MPH (3) · Sangeeta Sawhney, M.D. (3) · Doug Fleming, MD (2) · Paul Strumph, M.D. (2) · Suma Gopinathan, PhD (2) · Suman Wason (2) · Alessandro Doria, MD PhD MPH (1) · Andrew Hendifar, MD, MPH (1) · David Cherney, MD PhD (1) · Gehan Botrus, MD, PhD (1) · Ify Mordi, MBChB, MD (1)
PMID 38770818, PMID 22739142, PMID 30833371, PMID 31587812, PMID 32146619, PMID 32721228, PMID 32928957, PMID 34598813, PMID 35257579, PMID 23433601, PMID 23911260, PMID 25012985, PMID 25216510, PMID 25529979, PMID 25636046, PMID 26049551, PMID 27041406, PMID 28899222, PMID 28932269, PMID 29330194, PMID 29724499, PMID 29937430, PMID 29937431, PMID 30477789, PMID 30819210, PMID 31264767, PMID 31655936, PMID 31837264, PMID 32157590, PMID 32640846, PMID 33200891, PMID 33200892, PMID 33940581, PMID 34152828, PMID 34338408, PMID 36782093, PMID 38277468, PMID 38771012, PMID 38878007, PMID 39260929, PMID 39918875, PMID 39961315, PMID 42815751
2016 (8), 2017 (4), 2009 (1), 2014 (1), U01DK143381 (1)