Juan Badimon, PhD, is a professor of medicine and the director of the Atherothrombosis Research Unit at the Cardiovascular Institute of the Icahn School of Medicine at Mount Sinai.

SOTA-P-CARDIA: Sotagliflozin Exhibits Antithrombotic Effects in Patients with HFpEF, With Juan Badimon, PhD

Sotagliflozin treatment resulted in a statistically significant improvement in left ventricular mass, diastolic function, capacity for the 6-minute walk test, and Kansas City Cardiomyopathy Questionnaire (KCCQ) measurements in patients with 

heart failure with preserved ejection fraction (HFpEF)

 without diabetes, according to results from the SOTA-P-CARDIA study.

American Heart Association’s Scientific Sessions 2025

 in New Orleans, Louisiana, by Juan Badimon, PhD, professor of medicine and director of the atherothrombosis research unit at the Cardiovascular Institute at the Icahn School of Medicine at Mount Sinai. Although the trial reached statistical significance in several measures, it failed to achieve significance in peak VO2 improvement, despite producing a notable improvement after sotagliflozin treatment.

Sotagliflozin is an oral combination SGLT2 and SGLT1 inhibitor, which simultaneously monitors glucose and sodium reabsorption in the kidney and the gastrointestinal tract. It has been studied in patients with HF, diabetes, and 

, and is currently under investigation for 

The previous SOLOIST and SCORED trials investigated sotagliflozin’s efficacy in patients with 

 hospitalized for worsening HF and patients with T2DM and chronic kidney disease, respectively. Both trials achieved their endpoints and saw effects on HF irrespective of left ventricular ejection fraction. However, despite these outcomes, neither trial established sotagliflozin’s mechanism of action.

 sat down with Badimon to discuss the implications of these data and next steps for SGLT2 inhibitor research in patients with HF.

“One of the things to take into account is that the SOLOIST and the SCORED trials enrolled exclusively diabetic patients,” Badimon told 

. “So, one of the objectives that we wanted to investigate is whether we could expand the benefits seen in the SOLOIST and SCORED trials to a non-diabetic HFpEF population.”

For enrollment in the SOTA-P-CARDIA study, patients were required to be ambulatory, exhibit no diabetes as confirmed by HbA1c <6.5%, fasting serum glucose <126 mg/dL, and review of concomitant medications and medical history, as well as having a diagnosis of heart failure (HF), LVEF >50%, and being on medical therapy for HF for ≥4 weeks prior to screening. Patients with 

and 2 diabetes, acute coronary syndrome or cardiac surgery within the last week, acute decompensated HF or hospitalized HF within 1 month, or who had been receiving SGLT inhibitors 3 months prior to randomization were excluded.

A total of 88 patients were included, with notable racial diversity and of whom 70% were female. Patients were randomly assigned in blocks of 4 to either sotagliflozin or placebo, administered daily over 6 months. The primary outcome was change in left ventricular mass at 6 months compared to baseline, while secondary endpoints included changes in left ventricular end-systolic volume (LVESV) at 6 months, changes in left ventricular end-diastolic volume (LVEDV) at 6 months, changes in extracellular volume at 6 months, changes in peak oxygen consumption at 6 months, changes in 6-minute walk test results at 6 months, and changes in KCCQ results at 6 months, among other factors.

Ultimately, investigators found that 6-month satagliflozin administration resulted in improvements in left ventricular mass, diastolic function, 6-minute walk test, and KCCQ measurements. Badimon spoke with 

 on the results of the trial, as well as the next steps for sotagliflozin research in patients with HFpEF.

“I think we need to start getting familiar with the dual SGLT-2/SGLT-1 inhibitors because they have similar effects to the specific SGLT-2 inhibitor; they have this effect on reducing atherothrombotic events,” Badimon said. “Theoretically, inhibiting SGL-1 and -2 seems to offer the better choice. But again, we need to be patient; we have more data coming.”

DeFrancesco L. Clinical Data Demonstrating Efficacy of Sotagliflozin in Preserved Ejection Fraction Heart Failure (HFpEF) without Diabetes Presented at American Heart Association (AHA) Annual Scientific Sessions 2025. Lexicon Pharmaceuticals. November 8, 2025. Accessed November 18, 2025. 

https://investors.lexpharma.com/news-releases/news-release-details/clinical-data-demonstrating-efficacy-sotagliflozin-preserved

Badimon J. Sotagliflozin in Heart Failure with Preserved Ejection Fraction (HFpEF) Patients. ClinicalTrials.gov Identifier: NCT05562063. Updated July 18, 2025. Accessed November 18, 2025. 

https://www.clinicaltrials.gov/study/NCT05562063

Badimon J, Requena JA, Santos-Gallego C, et al. SOTA-P-CARDIA Trial (ATRU-V): A Randomized Trial of Sotagliflozin in HFpEF patients without diabetes. Abstract presented at the American Heart Association’s Scientific Sessions 2025. New Orleans, Louisiana. November 8-10, 2025.

Videos

Badimon explains the impact of sotagliflozin’s improvements in left ventricular mass, diastolic function, and 6-minute walk test results in patients without diabetes.

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Cardiology condition center page is a comprehensive resource for clinical news and insights on cardiovascular and cardiometabolic diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for heart disease and cardiovascular events, as well as associated diabetes, renal failure, and more...

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The HCPLive heart failure page is a resource for medical news and expert insights on HF. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for heart disease, reduced and preserved ejection fraction, and more.

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Alex Hillenbrand is an assistant editor for 

. She earned her BA in English from Lafayette College in 2023 and went on to write for pop culture, entertainment, and sports media outlets before joining MJH Life Sciences in 2025. In her free time, Alex enjoys cooking, going on walks, and meeting new people. Contact her at mjhlifesciences.com.

Credit: International Symposium of IgA Nephropathy

New research shows RemeGen’s telitacicept exhibited efficacy and a favorable safety profile in adults with 

A 39-week phase 3 multicenter, randomized, double-blind, 2-part study examined telitacicept’s impact on urine protein creatinine ratio (UPCR), CD19+ B-cell count, immunoglobulin levels (IgG, IgA, and IgM), and estimated glomerular filtration rate (eGFR).

A novel fusion protein and B-cell modulating biologic, telitacicept, dually targets and neutralizes B-lymphocyte stimulator (BLyS) and A proliferation-inducing ligand (APRIL), 2 immune-system signalling proteins implicated in the production of pathogenic galactose-deficient IgA1.

“Telitacicept delivered statistically significant deep, sustained, and clinically meaningful reductions in proteinuria with stabilization of kidney function and a favorable safety profile. An objective endpoint like 24h-UPCR validates the therapeutic effect of dual BAFF/APRIL inhibition,” said Jean-Paul Kress, MD, chief executive officer and chairman of the board at Vor Bio in a statement from the company. “With this Phase 3 success in IgAN, telitacicept has provided additional clinical evidence supporting its mechanism in yet another indication, reinforcing our confidence in its potential as a foundational therapy for B-cell mediated diseases.”

In stage A, patients were randomly assigned in a 1:1 ratio to receive subcutaneous telitacicept 240mg or placebo once weekly for 39 weeks, with a primary endpoint of change from baseline in 24-hour UPCR. Other endpoints assessed were kidney function, measured by eGFR, resolution of hematuria, changes in B-cell counts, and serum immunoglobulins.

Investigators reported telitacicept achieved the primary endpoint of reducing proteinuria, with a -58.9% change in 24-hour urine protein-to-creatinine ratio (24h-UPCR) compared with -8.8% for placebo (

Telitacicept also demonstrated substantial proteinuria improvements across additional measures. At week 39, the treatment group showed a 55% reduction in 24h-UPCR. A greater proportion of patients receiving telitacicept achieved thresholds associated with lower progression risk: 61% vs 19.5% achieved 24h-UPCR <0.8 g/g, 42.1% vs 7.5% achieved <0.5 g/g, and 24.5% vs 0.6% achieved <0.3 g/g.

Across secondary endpoints, kidney function remained stable with telitacicept. Investigators reported a stabilized eGFR (-0.010 mL/min/1.73 m²) in the telitacicept group, compared with a decline (-0.77 mL/min/1.73 m²) in the placebo group. The risk of ≥30% eGFR decline was lower among patients receiving telitacicept than in the placebo group (27.0%).

Investigators noted a favorable safety profile. Although treatment-emergent adverse events occurred more frequently with telitacicept (89.3%) than placebo (78.6%), most were mild or moderate. Serious adverse events occurred less often with telitacicept (2.5%) than placebo (8.2%).

The investigational recombinant fusion protein enters a 

rapidly evolving therapeutic landscape in IgAN

, where multiple B-cell–, BAFF-, and APRIL-targeted approaches are under active clinical investigation. These include 

, which is designed to interrupt the upstream biology that drives Gd-IgA1 generation in IgAN and anti-PLA2R autoantibody production in pMN, and 

, which has continued to demonstrate reductions in galactose-deficient immunoglobulin A1 along with a favorable safety profile.

Jicheng L, Liu LJ, Wang W. Efficacy and Safety of Telitacicept in Patients with IgAN: Results from Stage A of a Phase 3 Clinical Study. 

Journal of the American Society of Nephrology

Telitacicept Demonstrates Clinically Meaningful and Statistically Significant Impact on ESSDAI Compared to Placebo in Late-Breaking China Phase 3 Results in Primary Sjögren’s Disease at ACR 2025 | Vor Bio. Vor Bio. Published 2025. Accessed November 18, 2025. 

https://ir.vorbio.com/news-releases/news-release-details/telitacicept-demonstrates-clinically-meaningful-and

Telitacicept Achieved Primary Endpoint of Reducing Proteinuria in Stage A of a Phase 3 Clinical Study for IgA Nephropathy in China | Vor Bio. Vor Bio. Published 2025. Accessed November 18, 2025. 

https://ir.vorbio.com/news-releases/news-release-details/telitacicept-achieved-primary-endpoint-reducing-proteinuria

Articles

Telitacicept, a novel fusion protein, has shown efficacy and a favorable safety profile in a Phase 3 study for IgA nephropathy (IgAN). The study demonstrated significant reductions in proteinuria and stabilization of kidney function, with a notable decrease in the 24-hour urine protein-to-creatinine ratio. Telitacicept targets B-lymphocyte stimulator (BLyS) and A proliferation-inducing ligand (APRIL), crucial in IgAN pathogenesis. Despite a higher incidence of mild to moderate adverse events, serious adverse events were less frequent compared to placebo, reinforcing telitacicept's potential as a foundational therapy for B-cell mediated diseases.

Dual BLyS/APRIL inhibition with telitacicept led to significant 24h-UPCR reductions, lower progression-risk thresholds, and stable eGFR compared with placebo.


Nephrology

The HCPLive nephrology page is a resource for medical news and expert insights on kidney disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in nephrology, and more.

IgA Nephropathy

The HCPLive Berger disease page is a resource for medical news and expert insights on IgA nephropathy. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments in Berger disease, and more.

Telitacicept Achieves Primary Endpoint in IgA Nephropathy Phase 3 Study

Kayla Taylor, MD, is a dermatologist with Atrium Health Dermatology.

Skin of Color Savvy: The Art and Science of Treating Patients of Color

Skin of Color Savvy: Hair-Care Challenges in Dermatology With Amy McMichael, MD, and Kayla Taylor, MD

, Amy McMichael, MD, a professor in the Department of Dermatology at Wake Forest School of Medicine

sits down with guest dermatologist Kayla Taylor, MD, of Atrium Health Dermatology for an in-depth discussion on scarring alopecia, hair loss differentials, and hair-care–related challenges facing patients with skin of color. 

The conversation begins with Taylor’s background and her early research experience with McMichael, which sparked her long-term clinical and academic focus on hair loss disorders—especially scarring alopecias that disproportionately affect patients of African descent.

The episode opens with McMichael highlighting Taylor’s recent presentation at the Southeastern Consortium of Dermatology, where she addressed under-recognized forms of hair loss in men of color. Taylor expands on the topic, noting that while male-pattern hair loss (androgenetic alopecia) remains common, clinicians must stay alert for scarring conditions—such as lichen planopilaris, central centrifugal cicatricial alopecia (CCCA), folliculitis decalvans, and dissecting cellulitis—that may mimic or coexist with pattern loss.

She emphasizes the diagnostic importance of identifying symptoms such as scalp tenderness, pruritus, erythema, and perifollicular scaling, which should prompt dermoscopy and, when necessary, biopsy. The dermatologists discuss therapeutic approaches, with Taylor outlining how anti-inflammatory regimens—including topical corticosteroids, intralesional steroids, doxycycline, and occasionally dapsone—are layered onto traditional treatments like finasteride and minoxidil.

McMichael and Taylor also examine the role of isotretinoin, particularly in patients who present with severe acne alongside scalp disease. Their shared experience underscores that early intervention is critical to preventing irreversible follicular destruction.

The conversation then shifts to surgical decision-making in advanced cases, with Taylor describing referrals for excision in acne keloidalis nuchae once medical therapy has stabilized inflammation. Both dermatologists note that procedural approaches—including intralesional corticosteroids combined with cryotherapy—can significantly improve outcomes when properly timed and supported by realistic patient counseling.

A major portion of the episode addresses hair-care practices among patients of color, including the impact of locs, braiding, high-tension styles, and the cultural pressure to maintain “laid” hairstyles. Taylor highlights the misconception that locs are a “safe” alternative for those with hair loss. She emphasizes the cumulative tension from retwisting, styling, and infrequent washing—factors that can accelerate or exacerbate CCCA and traction alopecia. The pair underscore how dermoscopic imaging can be used to demonstrate subclinical inflammation to patients, helping reframe their understanding of “pain-free” styling.

The episode concludes with guidance on patient education around hair washing frequency, the risks of gels and heavy pomades, and the pitfalls of applying oils directly to the scalp. Both dermatologists emphasize the need for broader outreach to hairstylists and trichologists, noting that culturally aligned community education is crucial for meaningful change in hair health outcomes for patients of color.

This engaging Savvy Conversations episode offers clinicians nuanced, practice-ready insights into diagnosing and managing complex hair disorders in patients with skin of color—while highlighting the cultural considerations that must accompany effective dermatologic care.

To learn more about SOCS’s mentorship programs and initiatives, visit 

Editor’s note: This episode was written with the help of artificial intelligence tools.

This November 18 episode explores early detection, diagnosis, and management of scarring alopecias and hair-care–related hair loss in patients of color.

Hosted by Skin of Color Society and produced by HCPLive, 

 delves into the latest research, clinical insights, and culturally intelligent care practices in dermatology with leading experts. 

Whether it’s groundbreaking research, practice-changing insights, or highlights from the SOCS community, this twice-monthly program provides dermatologists and care providers with expert perspectives on treating patients with skin of color.

Dermatology

The HCPLive dermatology page is a resource for medical news and expert insights on skin disease. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for dermatologic conditions, and more.

Podcasts

podcasts page features a feed of medical news and interview podcast series, including DocTalk, Lungcast, Derm Discussions, and Heart Trials.

Roflumilast Efficacy and Safety in Pediatric AD

Panelists discuss how recent research has evaluated nonsteroidal topical agents for mild to moderate pediatric atopic dermatitis (AD), showing encouraging results for safety, tolerability, and durability. These findings suggest that effective inflammation control can be achieved with minimal irritation or adverse effects.

They highlight the importance of meaningful measures—such as itch reduction, body surface area improvement, and quality-of-life scores—to guide treatment decisions. These patient-centered outcomes help clinicians tailor therapies to what matters most for families.

Panelists emphasize that as research continues, these data-driven insights will refine treatment approaches and support individualized care for every child.

Panelists discuss how evidence from clinical studies supports the safety and effectiveness of new nonsteroidal treatments for children with AD.

Video Series

Peer Exchange

HCPLive® Peer Exchange panel discussions feature authoritative insights, opinions, and perspectives on important issues facing today's care professionals.

Linda Stein Gold, MD, is a dermatologist at Henry Ford Health. 

The experts analyze new patient and clinician survey data, revealing gaps between treatment satisfaction and practice realities.

Factoring Comorbidities into Diagnostic Workup for Psoriasis Patients 

, despite the expanding therapeutic landscape. Linda Stein Gold, MD, and her colleagues analyze patient- and provider-reported data from the 

 surveys, revealing that many patients remain dissatisfied with current therapies and that oral agents are overwhelmingly preferred over injectables. The experts discuss how patient lifestyle, comorbidities, and psychosocial burden influence shared decision-making and treatment adherence. They also interpret the 

International Psoriasis Council’s (IPC)

 and explore its implications for reducing “topical churn” and advancing systemic therapy earlier in the disease course.

 and its potential to close current gaps in care. The panel provides an in-depth review of the 

 clinical development program, summarizing the 

 trials, which demonstrated superior efficacy versus deucravacitinib at both 16 and 24 weeks, with favorable safety and tolerability. They also discuss new 

 showing sustained clearance and no new safety signals in adults and adolescents. The faculty reflect on ICO’s implications for adolescent psoriasis and how early, aggressive oral intervention may help prevent progression to psoriatic arthritis, marking a significant milestone in the evolution of oral IL-23–targeted therapy.

The final portion of the series shifts focus to 

managing active psoriatic arthritis (PsA)

. The experts discuss new findings from the 

 demonstrated the first clear evidence of IL-23–mediated inhibition of structural joint damage, reinforcing the rationale for early biologic use in high-risk patients. They compare APEX to prior IL-23 studies, discuss implications for therapy sequencing, and highlight other emerging data from 

 studies. In closing, Stein Gold and colleagues emphasize a forward-looking approach that integrates personalized therapy selection, early detection of PsA, and cross-specialty collaboration to elevate standards of psoriasis care

Discussion on how patient goals, treatment experiences, and preference for oral agents shape individualized therapy plans.

Expert Perspectives on When to Discuss Psoriatic Arthritis With Patients 

Panelists discuss how low systemic absorption and simple dosing schedules improve safety, adherence, and caregiver confidence in pediatric AD care.

Systemic Absorption and Dosing in Pediatric AD

Professor of Rheumatology, Northwestern Feinberg School of Medicine

Ramsey-Goldman emphasized the importance of QoL in lupus, looking beyond disease scores.

Lupus

Rheumatology

Rheumatology condition center page is a comprehensive resource for clinical news and insights on rheumatologic disease. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for arthritis, gout, nr-AxSpA, and more.

Fatigue, Pain, Daily Function: DZP’s Patient-Centered Impact in SLE, with Rosalind Ramsey-Goldman, MD

Ramsey-Goldman discussed the potential of NAC for treating systemic lupus erythematosus.

Proof of Concept: Targeting Mitochondrial Dysfunction in SLE With NAC, with Rosalind Ramsey-Goldman, MD

Nicholas Marston, MD, is a cardiologist and an assistant professor of medicine at Brigham and Women's Hospital.

Marston discusses the CORE and CORE2 trials, highlighting olezarsen’s success in lowering fasting triglyceride.

Dyslipidemia

Olezarsen Proves Efficacy in Severe Hypertriglyceridemia, With Nicholas Marston, MD

Vinay Mehta, MD: Board-certified allergist/immunologist with Allergy & Asthma Associates of Southern California

A phase 3b study in patients with skin of color found lebrikizumab provides reliable efficacy and safety for treating moderate-to-severe AD.


Atopic Dermatitis

Atopic Dermatitis condition center page, audiences can find a variety of coverage mediums for medical news and updates, including articles, video interviews, podcasts, and breaking news on dermatitis research, treatment, and drug development.

Lebrikizumab Effectively Treats AD in Patients with Skin of Color, With Vinay Mehta, MD

Panelists examine how these emerging therapies compare with existing options and consider what their advances mean for clinicians and patients in everyday practice.

Current Standard of Care and Treatment Options in Psoriasis

Cytokine Pathways and Their Impact on Plaque Psoriasis

New ACAAI 2025 data show lebrikizumab improves disease control, quality of life, and work productivity in patients of skin of color with moderate to severe atopic dermatitis.


Lebrikizumab Benefits AD Patients With Skin of Color, With Vinay Mehta, MD

Michael Schilsky, MD, is a professor of medicine and medical director of adult liver transplant at Yale-New Haven Transplantation Center.

Data presented at AASLD 2025 show patients without severe neurologic involvement can achieve cognitive improvement with early detection and therapy.


Hepatology

Neurology

Neurology condition center page is a comprehensive resource for clinical news and insights on nervous system disorders. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for Alzheimer's disease, brain injury, PTSD, and more.

Latest News

SOTA-P-CARDIA: Sotagliflozin Exhibits Antithrombotic Effects in Patients with HFpEF, With Juan Badimon, PhD

Telitacicept Achieves Primary Endpoint in IgA Nephropathy Phase 3 Study

Skin of Color Savvy: Hair-Care Challenges in Dermatology With Amy McMichael, MD, and Kayla Taylor, MD

Roflumilast Efficacy and Safety in Pediatric AD

Factoring Comorbidities into Diagnostic Workup for Psoriasis Patients