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 Date01 Jan 2025

Sponsor / Collaborator

Icahn School of Medicine at Mount Sinai

NCT06435156 / Not yet recruitingPhase 2IIT

A Phase 2 Double-blind Randomised Controlled Trial Studying the Effect of Sotagliflozin Versus Placebo in Individuals with Heart Failure and Type 1 Diabetes.

People with type 1 diabetes sometimes develop heart failure which can cause symptoms like breathlessness, tiredness or ankle swelling, reduced quality of life and lead to being admitted to hospital or suffering potential fatal consequences. This trial is investigating if a tablet called sotagliflozin, can improve quality of life in people with type 1 diabetes and heart failure. In addition, this trial will also assess the safety and tolerability of sotagliflozin in this population.
In previous trials that included people with type 2 diabetes and heart failure sotagliflozin was shown to improve patients' symptoms of heart failure, quality of life and reduce the chance of people with heart failure being admitted to hospital or dying. However, people with type 1 diabetes and heart failure were not included in these trials meaning that it is not known if these benefits also apply to this population.
This trial aims to recruit 320 people with type 1 diabetes and heart failure symptoms in multiple sites in the United Kingdom (UK). This trial will compare the health and quality of life of participants who take sotagliflozin tablets with participants who take placebo tablets, which is a dummy tablet that looks the same as sotagliflozin. Participants will be randomly allocated to one of two groups (i.e. one taking sotagliflozin and the other the placebo) and both the medical team and participants will not know in which group each participant is until the end of the study. Participants will be in the trial for approximately 6 months and will be given sotagliflozin or placebo tablets to take 1 per day for 4 months. The trial is expected to run for a total of 26 months.

Start Date01 Jan 2025

Sponsor / Collaborator

University Of Dundee

[+2]

NCT06510894 / RecruitingNot ApplicableIIT

Diagnostic Utility of SGLT1/2 Inhibition to Facilitate Myocardial Glucose Suppression During Evaluation of Cardiac Inflammation on FDG-PET

This is a pilot mechanistic study of the diagnostic utility of sodium-glucose cotransporter-1/2 inhibition (SGLT1/2) on myocardial glucose suppression on FDG PET/CT. The investigators will test whether the addition of a SGLT1/2 inhibitor (SGLT1/2i) plus the standard dietary modification (ketogenic diet) will provide enhanced myocardial glucose suppression. The primary objective is to assess rates of complete myocardial glucose suppression (MGS) with 7 days of sotagliflozin 400 mg QD among healthy volunteers on a background of 1 day (N=20) or 3 days (N=20) of the KD. The secondary goal is to investigate the relationship between sotagliflozin, targeted metabolite levels, and myocardial glucose utilization on FDG-PET.
Participants will be asked to:
* undergo a screening visit that includes blood tests, vitals, and questions regarding health history/medications
* take the provided sotagliflozin as instructed for 7 days leading up to the scan
* follow a ketogenic diet as instructed for 1 or 3 days leading up to the scan
* undergo an FDG PET/CT scan, which includes vitals and blood draws

Start Date20 Nov 2024

Sponsor / Collaborator

University of Pennsylvania

[+1]

100 Clinical Results associated with Sotagliflozin

100 Translational Medicine associated with Sotagliflozin

100 Patents (Medical) associated with Sotagliflozin

192

Literatures (Medical) associated with Sotagliflozin

01 Jan 2025·DIABETOLOGIA

Molecular mechanisms underlying glucose-dependent insulinotropic polypeptide secretion in human duodenal organoids

Article

Author: Smith, Christopher A ; Santos-Hernández, Marta ; Guccio, Nunzio ; Davison, Adam ; Bany Bakar, Rula ; Miedzybrodzka, Emily L ; Kay, Richard G ; Alcaino, Constanza ; Gribble, Fiona M ; Reimann, Frank

Abstract:

Aims/hypothesis:

Glucose-dependent insulinotropic polypeptide (GIP) is an incretin hormone secreted by enteroendocrine K cells in the proximal small intestine. This study aimed to explore the function of human K cells at the molecular and cellular levels.

Methods:

CRISPR-Cas9 homology-directed repair was used to insert transgenes encoding a yellow fluorescent protein (Venus) or an Epac-based cAMP sensor (Epac-S-H187) in the GIP locus in human duodenal-derived organoids. Fluorescently labelled K cells were purified by FACS for RNA-seq and peptidomic analysis. GIP reporter organoids were employed for GIP secretion assays, live-cell imaging of Ca2+ using Fura-2 and cAMP using Epac-S-H187, and basic electrophysiological characterisation. The G protein-coupled receptor genes GPR142 and CASR were knocked out to evaluate roles in amino acid sensing.

Results:

RNA-seq of human duodenal K cells revealed enrichment of several G protein-coupled receptors involved in nutrient sensing, including FFAR1, GPBAR1, GPR119, CASR and GPR142. Glucose induced action potential firing and cytosolic Ca2+ elevation and caused a 1.8-fold increase in GIP secretion, which was inhibited by the sodium glucose co-transporter 1/2 (SGLT1/2) blocker sotagliflozin. Activation of the long-chain fatty acid receptor free fatty acid receptor 1 (FFAR1) induced a 2.7-fold increase in GIP secretion, while tryptophan and phenylalanine stimulated secretion by 2.8- and 2.1-fold, respectively. While CASR knockout blunted intracellular Ca2+ responses, a CASR/GPR142 double knockout was needed to reduce GIP secretory responses to aromatic amino acids.

Conclusions/interpretation:

The newly generated human organoid K cell model enables transcriptomic and functional characterisation of nutrient-sensing pathways involved in human GIP secretion. Both calcium-sensing receptor (CASR) and G protein-coupled receptor 142 (GPR142) contribute to protein-stimulated GIP secretion. This model will be further used to identify potential targets for modulation of native GIP secretion in diabetes and obesity.

Graphical Abstract:

01 Sep 2024·NEUROBIOLOGY OF DISEASE

Sotagliflozin attenuates cardiac dysfunction and depression-like behaviors in mice with myocardial infarction through the gut-heart-brain axis

Article

Author: Dai, Guangming ; Liao, Lei ; Feng, Ling ; Zhang, Lu ; Chang, Lijia ; Peng, Chendong ; Yang, Chengying ; Wei, Yan ; Wang, Tong ; Long, Yang ; Fan, Xinrong

Myocardial infarction (MI) and depression are leading causes of mortality and morbidity globally, and these conditions are increasing recognized as being fundamentally interconnected. The recently recognized gut-heart-brain axis offers insights into depression following MI, but effective treatments for this comorbidity remain lacking. To address this medical need, we employed an animal model of MI to investigate the potential repurposing of sotagliflozin (SOTA), an approved sodium-glucose cotransporter 1 and 2 (SGLT1/2) inhibitor for diabetes, for managing depression following MI and identifying potential SOTA-associated microbial mechanisms. SOTA treatment improved cardiac dysfunction and alleviated depression-like behaviors induced by MI, accompanied by alterations in gut microbiota composition, such as changes in the Prevotellaceae NK3B31 group, Alloprevotella, and Prevotellaceae UCG-001. Moreover, fecal microbiota transplantation (FMT) using fecal samples from SOTA-treated MI mice demonstrated that gut microbiota contributed to the beneficial effects of SOTA on cardiac dysfunction and depression-like behaviors in MI mice. Intriguingly, FMT-based intervention and concordance analysis of gut microbiota before and after FMT suggested that Prevotellaceae NK3B31 group, Alloprevotella, and Prevotellaceae UCG-001 were associated with the beneficial effects of SOTA. Furthermore, functional prediction of gut microbiota and correlation analysis support the significance of these dynamic microbial communities. In conclusion, these findings suggest that SOTA could serve as a potential drug to ameliorate cardiac dysfunction and depressive symptoms in MI patients via through the gut-heart-brain axis.

01 Sep 2024·JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

Effects of Sotagliflozin on Health Status in Patients With Worsening Heart Failure

Article

Author: Bhatt, Ankeet S. ; Riddle, Matthew C ; Szarek, Michael ; Davies, Michael ; Wilcox, Christopher S ; Steg, Ph Gabriel ; Cannon, Christopher P. ; Kosiborod, Mikhail N ; Testani, Jeffrey M. ; Pitt, Bertram ; McGuire, Darren K ; Wilcox, Christopher S. ; Testani, Jeffrey M ; Leiter, Lawrence A. ; Bhatt, Deepak L ; Leiter, Lawrence A ; Bhatt, Ankeet S ; Cannon, Christopher P ; Voors, Adriaan A ; Lund, Lars H ; Voors, Adriaan A. ; Lund, Lars H. ; Bhatt, Deepak L. ; Lewis, Julia B. ; McGuire, Darren K. ; Kosiborod, Mikhail N. ; Lewis, Julia B ; Metra, Marco ; Riddle, Matthew C.

BACKGROUND:

Sodium-glucose cotransporter 2 (SGLT2) inhibitors improve health status in heart failure (HF) across the left ejection fraction ejection spectrum. However, the effects of SGLT1 and SGLT2 inhibition on health status are unknown.

OBJECTIVES:

These prespecified analyses of the SOLOIST-WHF (Effect of Sotagliflozin on Cardiovascular Events in Patients with Type 2 Diabetes Post Worsening Heart Failure) trial examined the effects of sotagliflozin vs placebo on HF-related health status.

METHODS:

SOLOIST-WHF randomized patients hospitalized or recently discharged after a worsening HF episode to receive sotagliflozin or placebo. The primary endpoint was total number of HF hospitalizations, urgent HF visits, and cardiovascular death. Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) score was a prespecified secondary endpoint. This analysis evaluated change in the KCCQ-12 score from baseline to month 4.

RESULTS:

Of 1,222 patients randomized, 1,113 (91%) had complete KCCQ-12 data at baseline and 4 months. 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. Sotagliflozin vs placebo reduced the risk of the primary endpoint consistently across KCCQ-12 tertiles (P_trend = 0.54). Sotagliflozin-treated patients vs those receiving placebo experienced modest improvement in KCCQ-12 at 4 months (adjusted mean change: 4.1 points; 95% CI: 1.3-7.0 points; P = 0.005). KCCQ-12 improvements were consistent across prespecified subgroups, including left ventricular ejection fraction <50% or ≥50%. More patients receiving sotagliflozin vs those receiving placebo had at least small (≥5 points) improvements in KCCQ-12 at 4 months (OR: 1.38; 95% CI: 1.06-1.80; P = 0.017).

CONCLUSIONS:

Sotagliflozin improved symptoms, physical limitations, and quality of life within 4 months after worsening HF, with consistent benefits across baseline demographic and clinical characteristics. (Effect of Sotagliflozin on Cardiovascular Events in Participants With Type 2 Diabetes Post Worsening Heart Failure [SOLOIST-WHF]; NCT03521934).

143

News (Medical) associated with Sotagliflozin

20 Dec 2024

·www.globenewswire.com

Lexicon Announces Receipt of Complete Response Letter for Zynquista™ (sotagliflozin)

Confirms Previously Disclosed and Anticipated FDA DecisionTHE WOODLANDS, Texas, Dec. 20, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced it has received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD). This expected communication from the FDA aligns with the company’s previously disclosed strategic decision to discontinue launch preparations for Zynquista and focus solely on its clinical development pipeline. "We are sincerely grateful to the patients and physicians who participated in our Zynquista™ clinical trials, and the broader diabetes community who strongly advocated for Zynquista’s approval," said Mike Exton, Ph.D., chief executive officer and director of Lexicon. “Although this was not our desired outcome for sotagliflozin in this indication, we remain steadfast in our commitment to advancing our clinical pipeline, including our near-term focus on LX9211 for diabetic neuropathic pain (DPNP) with top line data from our PROGRESS Phase 2b study anticipated in Q1 2025, and pursuing innovations that we believe can profoundly benefit patients." About Lexicon Pharmaceuticals Lexicon 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 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 sotagliflozin, LX9211, LX9851 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, 2023 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. Investor ContactLisa DeFrancescoLexicon Pharmaceuticals, Inc.lexinvest@lexpharma.com Media ContactSheryl SeapyReal Chemistrycorpcomm@lexpharma.com

Phase 2NDA

22 Nov 2024

·www.globenewswire.com

Lexicon to Reposition as Clinical Development-Focused Company Following Regulatory Update From FDA

Implementing Strategic Restructuring to Eliminate Commercial Organization and Rationalize Operations Across All Functions Prioritizing Strong R&D Pipeline Including Ongoing Studies in DPNP, HCM and Obesity Efforts Expected to Reduce 2025 Operating Costs by $100 Million Conference Call and Webcast at 9:00 am ET THE WOODLANDS, Texas, Nov. 22, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that the company has made the strategic decision to eliminate its commercial operations and rationalize resources across all functions in order to preserve cash and focus its resources on advancing its promising clinical development pipeline. This prioritization of investment is designed to advance the research and development programs that have the greatest potential for value creation and patient impact. This decision follows the receipt of a “deficiencies preclude discussion” letter from the U.S. Food and Drug Administration (FDA) regarding the Company’s New Drug Application (NDA) for Zynquista™ (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and chronic kidney disease (CKD). The letter noted deficiencies with the application that preclude discussion of labeling and/or post-marketing requirements and commitments at this time. "While this decision was not made lightly, it reflects our commitment to make prudent business decisions that enhance value across our portfolio and deliver on our Lead to Succeed strategy," said Mike Exton, Ph.D., Lexicon’s chief executive officer and director. "We see significant potential in our strong pipeline of R&D opportunities, and we will focus our resources on programs with the potential for the greatest impact. We are confident that by carefully selecting therapeutic areas where we are the first and only therapy in class, and focusing our R&D efforts where there are significant needs, we can deliver innovations that will meaningfully benefit patients while simultaneously positioning Lexicon to fully realize future growth opportunities." Details of the Strategic Restructuring Complete elimination of the Company’s commercial field team and reduction in size of other functions across the organization, including the elimination of all promotional efforts for INPEFA® and all planned commercial activities for ZYNQUISTA.A total reduction of approximately 60 percent of employees, effective for most affected employees by December 31st.INPEFA to continue to be manufactured and made available to patients and existing prescribers.An expected reduction of 2025 full year operating costs by $100 million. This amount is in addition to the $40 million in expected 2025 cost savings announced in August as part of a realignment of resources. Reemerging as a Clinical Development-Focused Company Lexicon will concentrate its resources on the continued research and development of its strong pipeline, including: The Phase 2b PROGRESS study evaluating LX9211 in diabetic peripheral neuropathic pain (DPNP), with topline data anticipated in Q1 2025.The pivotal Phase 3 SONATA HCM study evaluating sotagliflozin in hypertrophic cardiomyopathy (HCM), with enrollment underway.IND-enabling studies of LX9851, a novel, non-incretin oral development candidate in obesity and associated cardiometabolic disorders.Advancing earlier stage opportunities for LX9211 and LX9851 in additional indications.Exploring strategic partnerships to advance and accelerate the value of our pipeline. Conference Call and Webcast InformationLexicon management will hold a live conference call and webcast today at 9:00 am ET / 8:00 am CT to review the details of this announcement. Participants can access the conference call live via webcast on the Events page of the Company’s website at https://www.lexpharma.com/media-center/events. Participants who wish to ask a question may register here to receive dial-in numbers and a unique pin to join the call. An archived version of the webcast will be available on the website for 14 days. About Lexicon Pharmaceuticals Lexicon 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, metabolism and other therapeutic areas. For additional information, please visit www.lexpharma.com. 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 sotagliflozin, LX9211, LX9851 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, 2023 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. Investor ContactLisa DeFrancescoLexicon Pharmaceuticals, Inc.lexinvest@lexpharma.com Media ContactMolly DevlinReal Chemistrycorpcomm@lexpharma.com

NDAPhase 2Phase 3

22 Nov 2024

·endpts.com

Lexicon ends commercial work to focus on R&D

Lexicon Pharmaceuticals is reverting to a clinical development company after facing repeated setbacks at the FDA for its type 1 diabetes and chronic kidney disease drug. The Texas biotech is slashing its commercial force and laying off about 60% of its employees as it switches its focus to R&D, the company said Friday morning. It’s the second round of cuts under recently appointed CEO Mike Exton. In August, the company said it was cutting about half of its sales and commercial teams, or about 75 people. Together, the two rounds of cuts are expected to slash operating costs by $140 million in 2025, Lexicon said. “While this decision was not made lightly, it reflects our commitment to make prudent business decisions that enhance value across our portfolio and deliver on our Lead to Succeed strategy,” Exton said in a press release. Lexicon said the move was made after receiving a “deficiencies preclude discussion” letter from the FDA with regard to the company’s new drug application for Zynquista (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes and CKD. Undisclosed deficiencies with the application “preclude discussion of labeling and/or post-marketing requirements and commitments at this time,” the company said. Last month, an FDA advisory committee voted against endorsing the benefit-risk profile of Lexicon’s SGLT2 inhibitor. It was the second such thumbs-down in five years. The company said while it’s eliminating its entire commercial field team, its drug Inpefa will still be manufactured and made available. Now, it will focus on R&D, with a Phase 2b readout in diabetic peripheral neuropathic pain expected in the first quarter of next year. It also has a Phase 3 testing sotagliflozin in hypertrophic cardiomyopathy. A non-incretin, oral obesity drug candidate is in IND-enabling studies. Exton previously led the cardiovascular and metabolic disease work at Novartis. The company said it is also looking at potential strategic partnerships for its pipeline. Lexicon had $258.4 million in cash and investments at the end of September. It recently inked a licensing deal with the generics company Viatris, which gets rights to sotagliflozin in all global regions outside the US and Europe. Viatris paid $25 million upfront and could dish out another $197 million in regulatory and sales milestones. The company also recently added former Eisai Alzheimer’s chief Ivan Cheung to its board.

Phase 2License out/inExecutive ChangePhase 3

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	US	Lexicon Pharmaceuticals, Inc.	26 May 2023
Diabetes Mellitus, Type 1	EU	NCI Healthcare LLC	26 Apr 2019
Diabetes Mellitus, Type 1	IS	NCI Healthcare LLC	26 Apr 2019
Diabetes Mellitus, Type 1	LI	NCI Healthcare LLC	26 Apr 2019
Diabetes Mellitus, Type 1	NO	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	US	Lexicon Pharmaceuticals, Inc.	21 Jun 2024
Hypertrophic Cardiomyopathy without Obstruction	Phase 3	US	Lexicon Pharmaceuticals, Inc.	24 Sep 2024
Hypertrophic obstructive cardiomyopathy	Phase 3	US	Lexicon Pharmaceuticals, Inc.	24 Sep 2024
Diabetes Mellitus, Type 2	Phase 3	US	Lexicon Pharmaceuticals, Inc.	01 Nov 2016
Diabetes Mellitus, Type 2	Phase 3	US	Sanofi	01 Nov 2016
Diabetes Mellitus, Type 2	Phase 3	CA	Sanofi	01 Nov 2016
Diabetes Mellitus, Type 2	Phase 3	CA	Lexicon Pharmaceuticals, Inc.	01 Nov 2016
Diabetes Mellitus, Type 2	Phase 3	HU	Lexicon Pharmaceuticals, Inc.	01 Nov 2016
Diabetes Mellitus, Type 2	Phase 3	SK	Lexicon Pharmaceuticals, Inc.	01 Nov 2016
Hyperglycemia	Phase 3	US	Sanofi	01 Sep 2015

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Pubmed Manual	Not Applicable	Diabetes Mellitus, Type 1 \| Chronic Kidney Diseases	-	Sotagliflozin 200mg (CKD)	iczwkczhxh(zqhppvhhpn) = orerluvcwq emytxzxoso (fehcepbufu ) View more	Positive	01 Nov 2024
				Sotagliflozin 400mg (CKD)	iczwkczhxh(zqhppvhhpn) = uxocfbvnah emytxzxoso (fehcepbufu ) View more
NCT03285594 (SOTA-INS, GlobeNewswire) Manual	Phase 3	Diabetes Mellitus, Type 2	-	Sotagliflozin 400 mg	ewaywrxmgj(ztlkrsfetr) = ptcdfguvgc uhvmsiakmd (zmttztdkce )	Positive	10 Sep 2024
				Sotagliflozin 200 mg	ewaywrxmgj(ztlkrsfetr) = vvawdumbvz uhvmsiakmd (zmttztdkce )
NCT03521934 (SOLOIST-WHF, Pubmed \| J Am Coll Cardiol)	Phase 3	Diabetes Mellitus, Type 2 \| Heart Failure	-	Sotagliflozin	usloknaqwo(mfoprsaxni) = 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 dykgfnrmjk (bisrxbaviv )	Positive	01 Sep 2024
				Placebo
ESC2024	Not Applicable	Diabetes Mellitus	-	Sotagliflozin	mziirfhruf(ovrurayjcv) = tnkxtxvzer jmohjgvysh (niawpydbmo ) View more	-	30 Aug 2024
				Placebo	mziirfhruf(ovrurayjcv) = oggepreaxh jmohjgvysh (niawpydbmo ) View more
924-P (ADA2024)	Phase 3	Diabetes Mellitus, Type 2 Add-on	570	Sotagliflozin 400 mg	slxcxotdjd(tmbiljmysa) = tlbkrptaje gxtzpvnbch (dlzjsutltf )	Positive	14 Jun 2024
				Sotagliflozin 200 mg	slxcxotdjd(tmbiljmysa) = jpcpkjtjhy gxtzpvnbch (dlzjsutltf )
917-P (ADA2024)	Phase 3	Diabetes Mellitus, Type 2	770	Sotagliflozin 400 mg	ejtyuserpi(ydfxbiktgz) = Other adverse events in the SOTA group aligned with expectations associated with SGLTi therapy ovpkcigtud (idwbuuzdmg ) View more	Positive	14 Jun 2024
				Empagliflozin 25 mg
SCORED (GlobeNewswire) Manual	Phase 3	Heart Failure	1,932	INPEFA® (sotagliflozin)	xeraqxycrh(arrjiiulsy) = atfqeruwwk ozcheotmfn (zgqsuaexya )	Positive	14 May 2024
SOLOIST-WHF and SCORED (ESC2024)	Not Applicable	obesity \| type 2 diabetes (T2D)	-	Sotagliflozin	tpvletdggi(bsdclzahbt) = luivtzenkv fnnpvxpxay (avyhpexjlb )	Positive	14 May 2024
NCT03315143 (SCORED, ACC2024) Manual	Phase 3	Cardiovascular Diseases \| Diabetes Mellitus, Type 2 \| Chronic Kidney Diseases	10,584	Sotagliflozin	xogzgawqzl(bqeuigbvlf) = duhcmbitbm gjchpydold (knvlbiucup ) View more	Positive	25 Mar 2024
				Placebo	xogzgawqzl(bqeuigbvlf) = bouwbertob gjchpydold (knvlbiucup ) View more
SCORED (GlobeNewswire) Manual	Not Applicable	Heart Failure	-	INPEFA	eanlvciwrb(skomurdmny) = ucdthypzuj csdtdqidsw (sfirhegdso ) View more	Positive	12 Nov 2023
				placebo	-

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