Individual and Combined Endothelin Receptor and SGLT1/2 Antagonism in Adults With Type 1 Diabetes Mellitus and Chronic Kidney Disease: a Phase 2, Multicenter, Open-label Randomized Cross-over Trial

The aim of this study is to test the hypothesis that sotagliflozin (SGLT1/2 inhibitor) and ambrisentan (ERA) combination therapy augments nephroprotection and mitigates fluid retention and ketogenesis in people with T1D through complementary and synergistic mechanisms of actions.

Start Date01 Sep 2025

Sponsor / Collaborator

University Medical Center Groningen

[+2]

NCT06933056

/ Not yet recruitingEarly Phase 1IIT

Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs: an Interventional Study

This study will identify the potential benefits of regulating platelet activation with sotagliflozin compared to other FDA-approved drugs known to limit platelet activation.

Start Date01 Jun 2025

Sponsor / Collaborator

University of Michigan

[+1]

NCT06618976

/ RecruitingPhase 4IIT

SOTA-THROMBOSIS: Antithrombotic Activities of Sotagliflozin vs. Empagliflozin

The availability of Sodium-glucose cotransporter-2 inhibitors (SGLT2-i) has dramatically altered the management of heart failure (HF) patients, independently of their ejection fraction and glycemic status. A meta-analysis of 57 studies comparing SGLT2-I monotherapy vs. placebo or active comparator showed reductions in major cardiovascular events, but no impact on atherothrombotic events. In fact, a non-significant increase in the risk for non-fatal stroke was observed. Similar trend observed in multiple trials indicate a SGLT2-i class effect. Sotagliflozin is the first dual SGLT1/2 receptor inhibitor, that was shown to significantly reduce atherothrombotic events compared with placebo in diabetic HF patients, suggesting that dual SGLT1/2 inhibitor may have additional properties vs. SGLT2-i. The hypothesis of this study is that dual SGLT1/2 inhibition by sotagliflozin improves thrombogenic profile (i.e. reduces thrombus formation), which could make it a safer and more effective treatment option for cardiovascular (CV) patients than SGLT2-i. To test the hypothesis, the researchers will compare the antithrombotic activity of sotagliflozin vs. empagliflozin in healthy volunteers using a randomized, cross-over study design, where each participant will receive both study treatments (sotagliflozin and empagliflozin) separated by a washout period. Treatment effects will be assessed by measuring ex vivo thrombus formation using the Badimon Perfusion chamber, platelet aggregation using Multiplate Analyzer, and Thromboelastometry using RoTEM Gamma. Study assessments will be performed before initiating (baseline/pre-treatment) and after completion of each treatment.

Start Date25 Feb 2025

Sponsor / Collaborator

Icahn School of Medicine at Mount Sinai

100 Clinical Results associated with Sotagliflozin

100 Translational Medicine associated with Sotagliflozin

100 Patents (Medical) associated with Sotagliflozin

327

Literatures (Medical) associated with Sotagliflozin

01 Jun 2025·DIABETES RESEARCH AND CLINICAL PRACTICE

Comparative efficacy and safety of SGLT2 inhibitor class members in patients with heart failure and type 2 diabetes: A systematic review and network meta-analysis of randomized controlled trials

Review

Author: Su, Angela Y ; Valenzuela, German V ; Pasupuleti, Vinay ; Hernandez, Adrian V ; Csere, Molly M ; Shan, Ryan

We conducted a systematic review with pairwise (PMA) and network meta-analyses (NMA) to evaluate sodium-glucose transport protein 2 inhibitor (SGLT2i) effects in patients with both heart failure (HF) and type 2 diabetes mellitus (T2DM). Five databases were searched up to April 15, 2025. Primary outcomes were all-cause mortality (ACM), cardiovascular death (CVD), all-cause hospitalization (ACH), and hospitalization for heart failure (HHF). SGLT2i class effects versus control were assessed via PMA and individual SGLT2i comparative efficacy via NMA plus ranking using p-scores. Seventeen randomized controlled trials (n = 17,809) were included. Arms included canagliflozin (n = 2), dapagliflozin (n = 6), empagliflozin (n = 6), ertugliflozin (n = 1), ipragliflozin (n = 1), sotagliflozin (n = 1), placebo (n = 13), and standard of care (n = 4). Compared to control, SGLT2i significantly reduced ACM (HR 0.87, 95 %CI 0.78 to 0.98, low quality of evidence [QoE]), ACH (HR 0.74, 95 %CI 0.62 to 0.88, high QoE), and HHF (HR 0.70, 95 %CI 0.63 to 0.77, low QoE); but not CVD (HR 0.87, 95 %CI 0.76 to 1.00, very low QoE). Canagliflozin ranked highest in decreasing ACM (p-score = 0.86), CVD (p-score = 0.82), and HHF (p-score = 0.88). In patients with HF and T2DM, SGLT2i class effects include ACM, ACH, and HHF reduction. Among SGLT2i, canagliflozin showed greatest ACM, CVD, and HHF benefit.

01 Jun 2025·Drug Research

Therapeutic Potential of Sotagliflozin in Animal Models of Non-alcoholic Fatty Liver Disease with and without Diabetes

Article

Author: Deshmukh, Nitin J. ; Patil, Mohan ; Kalshetti, M. S. ; Nandanwar, Manohar ; Sangle, Ganesh V.

Abstract:

Sotagliflozin, a dual SGLT1/2 inhibitor, enhances glucagon like peptide-1 (GLP-1) levels and GLP-1 receptor agonists are used to manage non-alcoholic fatty liver disease (NAFLD). Study investigates the effects of sotagliflozin on NAFLD, alone and combined with linagliptin, comparing outcomes in normoglycemic and hyperglycemic animal models.Obese fatty liver disease (FLD) model was induced by high-fat diet (HFD) feeding, while a diabetic non-alcoholic steatohepatitis (NASH) model was developed by administering a single dose of streptozotocin to neonatal mice, followed by HFD feeding post-weaning. At termination of the study, parameters including biochemical markers, inflammatory cytokines, hepatic lipid content, and histopathology were assessed.In NASH mice, sotagliflozin and linagliptin reduced hepatic triglycerides by 60% and 44%, respectively, and cholesterol by 46% and 49%. Their combination further decreased triglycerides by 68.5% and cholesterol by 83.9%. In FLD mice, sotagliflozin and linagliptin reduced triglycerides by 33% and 17%, respectively, and cholesterol by 46% and 21%. Combination treatment offered no benefit, reducing triglycerides by 38% and cholesterol by 27%. Both the treatments improved plasma fibroblast growth factor 21, hepatic interlukin-6, glucose tolerance, steatosis and mitigated fat pad weight, but their combination did not show additional benefit. However, combination treatment demonstrated added benefit in modulating NAFLD activity score, liver enzymes, glycogenated hepatic nuclei, plasma glucose and active GLP-1 levels.Study underscores sotagliflozinʼs potential to mitigate NAFLD and highlights the benefit of combining it with linagliptin in hyperglycemic NASH model, which showed limited efficacy in normoglycemic FLD mice.

01 Jun 2025·Biochemistry and Biophysics Reports

Type 2 diabetes mellitus – conventional therapies and future perspectives in innovative treatment

Review

Author: Sroka-Bartnicka, Anna ; Gieroba, Barbara ; Kryska, Adrianna

Type 2 Diabetes Mellitus (T2DM) is a chronic metabolic disorder characterized by insulin resistance and dysfunction of the pancreatic beta cells, which leads to elevated blood glucose levels. Conventional therapies, including metformin, sulfonylureas, and insulin, have long served as the cornerstone of treatment. However, they often face limitations, such as adverse effects, reduced efficacy over time, and difficulties in achieving optimal glycemic control. This has sparked considerable interest in developing novel and experimental therapeutic strategies to enhance treatment outcomes. Recent advances in diabetes management feature dual incretin receptor agonists, like tirzepatide, which combine GLP-1 and GIP receptor agonism, resulting in increased insulin secretion, decreased glucagon release, and significant weight loss. Additionally, dual SGLT1/2 inhibitors, such as sotagliflozin, show promise for more significant blood glucose reduction and improved weight loss by targeting glucose regulation in both the gut and kidneys. Other promising methods include glucagon receptor antagonists, GPR119 agonists, and FGF21 analogs, which strive to enhance insulin sensitivity and improve glucose metabolism through innovative pathways. Gene editing technologies, including CRISPR-Cas9 and AMPK activators, are also being investigated to tackle the underlying pathophysiology of T2DM more effectively. While these experimental therapies show promise, their long-term safety and efficacy remain under research. This article reviews the conventional therapies currently in use. It investigates future perspectives on innovative treatments for T2DM, emphasizing the potential of these new therapies to transform diabetes care and enhance patient outcomes.

173

News (Medical) associated with Sotagliflozin

19 May 2025

·www.globenewswire.com

SONATA-HCM Study Design Presented at Heart Failure 2025, the Annual Congress of the Heart Failure Association of the European Society of Cardiology

Lexicon is evaluating the safety and efficacy of sotagliflozin in patients with both obstructive and non-obstructive hypertrophic cardiomyopathy (HCM) Pivotal Phase 3 clinical trial is actively enrolling patients in 20 countries, with all sites expected to be operational by Q3 2025 THE WOODLANDS, Texas, May 19, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced details of its “SOtaglifloziN in Patients with SymptomATic obstructive And non-obstructive Hypertrophic CardioMyopathy (SONATA-HCM)” study were presented on Saturday, May 17. The study design was disclosed in Belgrade, Serbia at one of the premier international heart failure meetings: Heart Failure 2025, the Annual Congress of the Heart Failure Association of the European Society of Cardiology. Enrollment is underway in SONATA-HCM, with all study sites in 20 countries expected to be operational by September 2025. Lexicon believes there is potential for the study results to support a supplemental new drug application (sNDA) for sotagliflozin for both obstructive and non-obstructive HCM. SONATA-HCM is the only ongoing Phase 3 study in both obstructive and non-obstructive HCM. It is a randomized, double-blind, placebo-controlled multicenter trial that will evaluate the efficacy of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, on symptoms, function, and other patient-reported outcomes, as well as safety in patients with symptomatic HCM. The study is designed to enroll 500 patients worldwide, 250 with obstructive HCM and 250 with non-obstructive HCM. The primary efficacy endpoint is improvement in symptoms, as measured by change from baseline to week 26, in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ) CSS survey. "There is a huge unmet need for people suffering from HCM, with no approved or effective therapies for non-obstructive HCM," said Sharlene M. Day, M.D., co-principal investigator for SONATA-HCM and Presidential Professor and Director of Translational Research in the Division of Cardiovascular Medicine and the Cardiovascular Institute at the University of Pennsylvania Perelman School of Medicine. "I'm very excited to be testing the potential for sotagliflozin to improve symptoms in a broad number of patients across the spectrum of HCM, as has previously been demonstrated in patients with heart failure with reduced and preserved ejection fraction. Sotagliflozin’s tolerability profile and immediate benefits observed in patients with heart failure could potentially make it a very appealing option for patients with HCM if the benefits do indeed extend to this population." As a chronic, progressive disease, HCM can worsen over time and lead to other complications, including heart failure and stroke. Sotagliflozin is a proven drug for the treatment of heart failure, with an established safety record and significant use in clinical practice. A growing body of evidence suggests that sotagliflozin’s dual inhibition of SGLT1 and SGLT2 reduces the risk of major adverse cardiovascular events (MACE), including heart attack and stroke, as most recently published in The Lancet in February 2025. “SONATA-HCM is an important study with the potential to support a broad label to enhance the care of patients with both obstructive and non-obstructive HCM,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. For more information on the study, visit the SONATA-HCM page on ClinicalTrials.gov. About SotagliflozinDiscovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients. About Lexicon PharmaceuticalsLexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, hypertrophic cardiomyopathy (HCM), obesity, metabolism and other indications. For additional information, please visit www.lexpharma.com. Safe Harbor StatementThis press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of its other drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its approved products and other drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. For Investor and Media Inquiries:Lisa DeFrancescoLexicon Pharmaceuticals, Inc.lexinvest@lexpharma.com

Phase 3

28 Mar 2025

·www.globenewswire.com

Lexicon Pharmaceuticals Announces Exclusive License Agreement with Novo Nordisk for LX9851

Lexicon eligible to receive up to $1 billion in upfront and development, regulatory and sales milestone payments, including $75 million in upfront and near-term milestone paymentsTHE WOODLANDS, Texas, March 28, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that it has entered into an exclusive license agreement with Novo Nordisk A/S for LX9851, a first-in-class, oral non-incretin development candidate in obesity and associated metabolic disorders. Under the terms of the agreement, Novo Nordisk obtains an exclusive, worldwide license to develop, manufacture and commercialize LX9851 in all indications. Lexicon will be responsible for completing agreed upon Investigational New Drug (IND) application-enabling activities for LX9851. Novo Nordisk will be responsible for filing the IND, all further development, manufacturing and commercialization of LX9851. Lexicon is eligible to receive upfront and near-term milestone payments of up to $75 million. In total, Lexicon will be eligible to receive $1 billion in upfront and potential development, regulatory and sales milestone payments. Lexicon is also entitled to tiered royalties on net sales of LX9851. LX9851, discovered and developed by Lexicon, is a potent and selective oral small molecule inhibitor of Acyl-CoA Synthetase 5 (ACSL5). ACSL5 plays a key role in the metabolic pathway which regulates fat accumulation and energy balance. Additionally, LX9851 may activate the ileal brake mechanism leading to increased satiety by delaying gastric emptying and suppressing appetite. Preclinical in vivo efficacy data presented at Obesity Week 2024 show that LX9851, when combined with semaglutide, significantly reduced weight, food intake and fat mass compared to semaglutide alone. Separately, LX9851 mitigated weight regain and had positive effects on liver steatosis when introduced after semaglutide discontinuation. "We are thrilled that Novo Nordisk, a global leader in diabetes care and obesity management, has recognized the potential of LX9851," said Mike Exton, Ph.D., chief executive officer and director of Lexicon. "This arrangement decisively strengthens our financial position, providing optionality as we further invest and accelerate our R&D portfolio.” “Novo Nordisk is committed to serving the diverse needs of people living with obesity and other metabolic diseases and to build a pipeline of differentiated drug candidates in this space,” Jacob Sten Petersen, Senior Vice President, Diabetes, Obesity and MASH therapeutic area at Novo Nordisk. “We are pleased to enter this agreement with Lexicon as it will allow us to explore a novel biology and potential treatment paradigm further, and we look forward to building on the great work Lexicon has already done with the development of LX9851.” About LX9851LX9851 is an orally delivered small molecule drug candidate for the treatment of obesity and associated cardiometabolic disorders. Lexicon is investigating the pharmacology of LX9851 as a stand-alone therapy and in combination with GLP-1 agonists such as semaglutide. Lexicon scientists identified the function of ACSL5, the target of LX9851, based on their discovery that knockout mice lacking the target enzyme exhibited favorable phenotypes across multiple measures of metabolic syndrome in preclinical models, including resistance to diet-induced obesity and improved body composition. About Lexicon PharmaceuticalsLexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has a pipeline of promising drug candidates in discovery and clinical and preclinical development in cardiology, neuropathic pain, metabolism and other indications. For additional information, please visit www.lexpharma.com. About Novo Nordisk Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Safe Harbor Statement This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, conduct preclinical and clinical development and obtain necessary regulatory approvals of pilavapadin (LX9211), LX9851, sotagliflozin and its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2024 and other subsequent disclosure documents filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise. For Investor and Media Inquiries:Lisa DeFrancesco Lexicon Pharmaceuticals, Inc.lexinvest@lexpharma.com

License out/in

03 Mar 2025

·endpts.com

Lexicon plots Phase 3 trial for diabetic pain drug despite mid-stage flop

Lexicon Pharmaceuticals’ non-opioid drug has failed a mid-stage test in a chronic pain indication — but the company says there’s still a path forward and even potential partnership opportunities for the lower dose. The biotech’s AAK1 inhibitor, dubbed pilavapadin, did not meet the primary endpoint of change from baseline in average daily pain score (ADPS) at eight weeks in the Phase 2b PROGRESS trial in moderate to severe diabetic peripheral neuropathic pain (DPNP). The condition develops when high blood sugar levels damage nerves throughout the body, causing pain and numbness. The primary endpoint miss was driven by a “lack of separation” between the 20 mg dose and placebo, according to a Monday release. The 10 mg pilavapadin dose, meanwhile, demonstrated “early and clinically meaningful separation from placebo” in ADPS, which was maintained throughout the trial, Lexicon said. But the trial technically still failed because its primary endpoint was designed to detect a “dose-response signal” that assumed separation from placebo across all treatment cohorts. Detailed results from PROGRESS will be presented at an upcoming medical meeting. Lexicon’s share price $LXRX plummeted around 29% premarket Monday. The Texas biotech still plans to advance the 10 mg dose into Phase 3 based on PROGRESS as well as a previous mid-stage study called RELIEF-DPN-1. The RELIEF-DPN-1 trial tested 10 mg and 20 mg of pilavapadin given after initial loading doses of 100 mg and 200 mg, respectively. By contrast, the PROGRESS trial did not feature a loading dose. In RELIEF-DPN-1, the 10 mg arm met the ADPS primary endpoint at six weeks versus placebo but the 20 mg arm “narrowly missed statistical significance.” In RELIEF-DPN-1, both treatment arms were also negatively impacted by tolerability issues due to the high-loading doses. But in PROGRESS, the 10 mg dose was well tolerated with most side effects being mild or moderate. “The enormous potential of [pilavapadin] has generated significant interest from potential partners, and we intend to accelerate these discussions while we plan for Phase 3 development,” Lexicon CEO Mike Exton said in the Monday release. He added that the neuropathic pain market represents a “multibillion dollar opportunity.” Pilavapadin took center stage for Lexicon in November when the company got rid of its commercial team and switched tack to focus on clinical development. That decision came on the heels of regulatory setbacks for its type 1 diabetes and chronic kidney disease drug sotagliflozin, which faced two rejections from the FDA in the span of five years. In 2022, pilavapadin failed a Phase 2 study in patients with postherpetic neuralgia, a rare side effect of shingles. Editor’s Note: This article was updated to add information about Lexicon’s share price.

Phase 2Phase 3Clinical Result

100 Deals associated with Sotagliflozin

External Link

KEGG	Wiki	ATC	Drug Bank
D10669	Sotagliflozin	A10BK06	DB12713

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Heart Failure	United States	Lexicon Pharmaceuticals, Inc.	26 May 2023
Diabetes Mellitus, Type 1	European Union	NCI Healthcare LLC	26 Apr 2019
Diabetes Mellitus, Type 1	Iceland	NCI Healthcare LLC	26 Apr 2019
Diabetes Mellitus, Type 1	Liechtenstein	NCI Healthcare LLC	26 Apr 2019
Diabetes Mellitus, Type 1	Norway	NCI Healthcare LLC	26 Apr 2019

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Chronic Kidney Diseases	NDA/BLA	United States	Lexicon Pharmaceuticals, Inc.	21 Jun 2024
Diabetic Nephropathies	Phase 3	United States	Lexicon Pharmaceuticals, Inc.	31 Oct 2024
Diabetic Nephropathies	Phase 3	Canada	Lexicon Pharmaceuticals, Inc.	31 Oct 2024
Kidney Failure, Chronic	Phase 3	United States	Lexicon Pharmaceuticals, Inc.	31 Oct 2024
Kidney Failure, Chronic	Phase 3	Canada	Lexicon Pharmaceuticals, Inc.	31 Oct 2024
Hypertrophic Cardiomyopathy without Obstruction	Phase 3	United States	Lexicon Pharmaceuticals, Inc.	24 Sep 2024
Hypertrophic Cardiomyopathy without Obstruction	Phase 3	Argentina	Lexicon Pharmaceuticals, Inc.	24 Sep 2024
Hypertrophic Cardiomyopathy without Obstruction	Phase 3	Belgium	Lexicon Pharmaceuticals, Inc.	24 Sep 2024
Hypertrophic Cardiomyopathy without Obstruction	Phase 3	Brazil	Lexicon Pharmaceuticals, Inc.	24 Sep 2024
Hypertrophic Cardiomyopathy without Obstruction	Phase 3	Georgia	Lexicon Pharmaceuticals, Inc.	24 Sep 2024

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03315143 (SCORED, Lancet) Manual	Phase 3	Ischemia	10,584	Sotagliflozin	qepauajlgr(kokpbzyarz) = tsmqzlkehl baahmtpbtz (bvuxvjuxjm ) View more	Positive	14 Feb 2025
				Placebo	qepauajlgr(kokpbzyarz) = mtzunoiwbs baahmtpbtz (bvuxvjuxjm ) View more
NCT02531035 \| NCT02384941 \| NCT02421510 (Pubmed) Manual	Not Applicable	Diabetes Mellitus, Type 1 \| Chronic Kidney Diseases	-	Sotagliflozin 200mg (CKD)	qjazqykddh(hwluytziop) = pvgsiejuiz aqqzryzzxf (wenvtmrulw ) View more	Positive	01 Nov 2024
				Sotagliflozin 400mg (CKD)	qjazqykddh(hwluytziop) = xtfvyykzmp aqqzryzzxf (wenvtmrulw ) View more
NCT03285594 (SOTA-INS, GlobeNewswire) Manual	Phase 3	Diabetes Mellitus, Type 2	-	Sotagliflozin 400 mg	dkqykxbgrd(czbgnuhece) = epzxkqpzra jygttjlzko (uzmrjelrqy )	Positive	10 Sep 2024
				Sotagliflozin 200 mg	dkqykxbgrd(czbgnuhece) = jprfyzgyzm jygttjlzko (uzmrjelrqy )
NCT03521934 (SOLOIST-WHF, Pubmed \| J Am Coll Cardiol)	Phase 3	Diabetes Mellitus, Type 2 \| Heart Failure	-	Sotagliflozin	tedjzsxvns(opjgfffyql) = The baseline KCCQ-12 score was low overall (median: 41.7; Q1-Q3: 27.1-58.3) and improved by 4 months in both groups wcxitclrfx (xelcmfdrzg )	Positive	01 Sep 2024
				Placebo
ESC2024	Not Applicable	Diabetes Mellitus	-	Sotagliflozin	yvgiaolpat(ogtorgcdev) = okbcwcwyol srbrnzjdkz (dkmbnyptpy ) View more	-	30 Aug 2024
				Placebo	yvgiaolpat(ogtorgcdev) = szgdynqmok srbrnzjdkz (dkmbnyptpy ) View more
924-P (ADA2024)	Phase 3	Diabetes Mellitus, Type 2 Add-on	570	Sotagliflozin 400 mg	ardcyygnga(xqcvliidrv) = eqekfovxuj nfcvknftkf (niflbhpwcb )	Positive	14 Jun 2024
				Sotagliflozin 200 mg	ardcyygnga(xqcvliidrv) = hfjvlremrm nfcvknftkf (niflbhpwcb )
917-P (ADA2024)	Phase 3	Diabetes Mellitus, Type 2	770	Sotagliflozin 400 mg	fhvaytlvux(yuzzligils) = Other adverse events in the SOTA group aligned with expectations associated with SGLTi therapy amtoxnwvvy (wokltfmxss ) View more	Positive	14 Jun 2024
				Empagliflozin 25 mg
NCT03315143 (SCORED, GlobeNewswire) Manual	Phase 3	Heart Failure	1,932	INPEFA® (sotagliflozin)	avbefsqyuk(wisoxzfzpm) = ogxddkdjaz zpcarupkev (heimffqtpb )	Positive	14 May 2024
SOLOIST-WHF and SCORED (ESC2024)	Not Applicable	obesity \| type 2 diabetes (T2D)	-	Sotagliflozin	wcepiuybin(xvdfqanyiq) = vsoksprbow ixjpzycbnq (tayxnkujcp )	Positive	14 May 2024
NCT03315143 (SCORED, ACC2024) Manual	Phase 3	Cardiovascular Diseases \| Diabetes Mellitus, Type 2 \| Chronic Kidney Diseases	10,584	Sotagliflozin	phglmwiqlj(yoappqqudf) = nttolxlxaf ajjvhthgfr (rahzdhouru ) View more	Positive	25 Mar 2024
				Placebo	phglmwiqlj(yoappqqudf) = ijblcdxrje ajjvhthgfr (rahzdhouru ) View more

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