Diana Isaacs, PharmD, is an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and codirector of Endocrine Disorders in Pregnancy at the Cleveland Clinic.

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives!

Diabetes Dialogue: Celebrating 2025 as The Year of the Incretin Therapy

The rise of GLP-1 receptor agonists across a multitude of specialties and into the public consciousness has been meteoric and while many specialties now marvel at the effects of the class, endocrinology has been bearing witness to this ascent for years.

In 2025, several regulatory decisions and clinical trials have been nothing short of practice-changing, emphasizing the broad applicability of this medication across diabetes, obesity, chronic kidney disease, heart failure, and a variety of other conditions. Additionally, key approvals from the US Food and Drug Administration have positioned GLP-1 agents as critical components in the ongoing effort to lastingly and effectively treat obesity.

In this special edition of Diabetes Dialogue recorded for HCPLive’s 

, cohosts Diana Isaacs, PharmD, an endocrine clinical pharmacist, director of Education and Training in Diabetes Technology, and co-director of Endocrine Disorders in Pregnancy at the Cleveland Clinic, and Natalie Bellini, DNP, program director of Diabetes Technology at University Hospitals Diabetes and Metabolic Care Center, review an unprecedented year of advances in incretin-based therapies in 2025.

Isaacs and Bellini open this episode by highlighting a landmark milestone from January 2025: the FDA’s approval of semaglutide for patients with type 2 diabetes and CKD, based on the FLOW trial. Bellini emphasizes how FLOW reshaped treatment algorithms by definitively establishing renal protection as a primary, not incidental, benefit of semaglutide. With clear evidence that GLP-1 receptor agonists can slow progression to advanced CKD—even when SGLT2 inhibitors are not tolerated—the hosts note this represents a genuine paradigm shift toward confident combination therapy.

February: FDA Ends the Semaglutide Shortage

Isaacs and Bellini also highlighted the end of the global semaglutide shortage in February 2025. During the shortage, clinicians were often forced to switch patients between multiple medications to achieve similar treatment with a limited supply. Oftentimes, as Bellini notes, patients using a 2 mg dose were moved to 1 mg when the former ran out, and then to an 0.5 mg dose when the 1 mg dose ran out. Novo Nordisk’s ultimate decision to ramp up production of semaglutide significantly alleviated the pressures of the shortage, and since then, the field has seen a substantial decrease in usage of compounding pharmacies.

March: STRIDE and Semaglutide in Peripheral Artery Disease

Conversation turns to March and the STRIDE trial, where semaglutide significantly improved pain-free walking distance in patients with peripheral artery disease. Isaacs and Bellini underscore how this data reinforces GLP-1 agents as cardiometabolic therapies with broad vascular relevance, particularly given the accessibility of walking as a functional endpoint. Additionally, the trial highlighted the cardiovascular aspect of diabetes, as it substantially increases heart attack and stroke risk – making diabetes the ideal crosspoint for adopting GLP-1 agents into cardiovascular care.

June: The American Diabetes Association Scientific Sessions

June’s ADA Scientific Sessions brought an “explosive” volume of incretin data. They spotlight the monthly GLP-1 candidate MariTide, producing ~16% weight loss in early studies; the oral GLP-1 orforglipron, which delivered strong A1c and weight reductions without dosing-timing constraints; and the dual amylin/GLP-1 combination Cagri-Sema (semaglutide and cagrilintide) in the REDEFINE program, with weight-loss results surpassing 20% in people without diabetes and nearly 14% in those with type 2 diabetes. They also discuss STEP UP, where a higher 7.2-mg semaglutide dose achieved a 21% weight reduction with acceptable tolerability, and the SLIMMER trial’s glucagon/GLP-1 dual-agonist ecnoglutide, which delivered more than 13% mean weight loss. The hosts emphasize that, taken together, these studies signal a future defined by combination incretin pharmacology and diversified receptor targeting.

July: SURPASS-CVOT and Tirzepatide in Cardiovascular Disease

The July discussion centers on the SURPASS-CVOT top-line results. Although tirzepatide did not demonstrate superiority over dulaglutide, it achieved cardiovascular noninferiority, reinforcing clinical comfort in using tirzepatide for patients with elevated CV risk. They highlight the pre-specified indirect comparison suggesting a potential 28% reduction in three-point MACE and 39% reduction in all-cause mortality relative to a putative placebo. Additional analyses indicating slowed eGFR decline in high-risk CKD populations further broaden the therapeutic rationale.

August: Semaglutide in MASH and Orforglipron in Obesity

August delivered another milestone with semaglutide gaining FDA approval for metabolic dysfunction–associated steatohepatitis (MASH), becoming only the second therapy approved for this increasingly recognized condition. The hosts describe how this approval is already changing clinical workflows—with broader screening, routine incorporation of FIB-4 scoring, and stronger justification for GLP-1–based therapy in metabolic liver disease. In parallel, orforglipron produced 12% weight loss in obesity trials, signaling likely future broad utility.

By October, oral semaglutide achieved its own cardiovascular-risk-reduction indication via the SOUL trial, alleviating long-standing concerns about the CV efficacy of oral formulations. This new data also opened a new potential treatment pathway for patients unwilling or unable to receive injectable agents. Semaglutide is now the only oral GLP-1 receptor agonist currently available, but the promising results of SOUL promise more to come.

November: Semaglutide in Alzheimer’s Disease

Isaacs and Bellini review November’s disappointing termination of Novo Nordisk’s oral semaglutide Alzheimer’s disease trial, in which the GLP-1 agent was unable to prevent disease progression to a statistically significant degree. While progression was not slowed, the hosts point to expert commentary suggesting the possibility that therapy must begin earlier or use injectable formulations to meaningfully influence neurodegenerative pathways, leaving the door open for future investigation.

December: SURMOUNT-4 and Weight Gain After Withdrawal from Tirzepatide

The episode concludes with new post-hoc findings from SURMOUNT-4, showing that more than 80% of individuals withdrawing from tirzepatide regained at least 25% of their prior weight loss, accompanied by reversal of cardiometabolic improvements. Isaacs and Bellini stress the core message: obesity is a chronic disease requiring chronic treatment, and the accumulating benefits of incretin-based therapies—in renal protection, cardiovascular risk reduction, liver disease, and weight management—reinforce the importance of long-term continuity.

Novo Nordisk. FDA approves Ozempic® (semaglutide) as the only GLP-1 RA to reduce the risk of worsening kidney disease and cardiovascular death in adults with type 2 diabetes and chronic kidney disease. January 28, 2025. Accessed January 28, 2025. 

https://www.novonordisk-us.com/media/news-archive/news-details.html?id=915253

Novo Nordisk. FDA declares Wegovy® and Ozempic® shortage is over and that Novo Nordisk is fully meeting or exceeding nationwide demand for all doses. PR Newswire: press release distribution, targeting, monitoring and marketing. February 21, 2025. Accessed February 21, 2025. 

https://www.prnewswire.com/news-releases/fda-declares-wegovy-and-ozempic-shortage-is-over-and-that-novo-nordisk-is-fully-meeting-or-exceeding-nationwide-demand-for-all-doses-302382370.html

Bonaca MP, Catarig A, Houlind K. Semaglutide and walking capacity in people with symptomatic peripheral artery disease and type 2 diabetes (STRIDE): a phase 3b, double-blind, randomised, placebo-controlled trial. 

Johnson V. ADA 2025 Recap: 5 Studies on Obesity to Know. Hcplive.com. Published June 25, 2025. Accessed December 3, 2025. 

https://www.hcplive.com/view/ada-2025-recap-5-studies-on-obesity-to-know

Eli Lilly and Company. Lilly's Mounjaro (tirzepatide), a GIP/GLP-1 dual agonist, demonstrated cardiovascular protection in landmark head-to-head trial, reinforcing its benefit in patients with type 2 diabetes and heart disease. July 31, 2025. Accessed July 31, 2025. 

https://investor.lilly.com/news-releases/news-release-details/lillys-mounjaro-tirzepatide-gipglp-1-dual-agonist-demonstrated

Novo Nordisk. Wegovy® approved by FDA for the treatment of adults with noncirrhotic MASH with moderate to advanced liver fibrosis. August 15, 2025. Accessed August 15, 2025. 

https://www.novonordisk-us.com/media/news-archive/news-details.html?id=916417

Eli Lilly and Company. Lilly's oral GLP-1, orforglipron, delivers weight loss of up to an average of 27.3 lbs in first of two pivotal Phase 3 trials in adults with obesity. August 7, 2025. Accessed August 7, 2025. 

https://investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-delivers-weight-loss-average-273

Novo Nordisk, Inc. FDA approves Novo Nordisk’s oral semaglutide for cardiovascular (CV) risk reduction in adults with type 2 diabetes who are at high risk, including those who have not had a prior CV event. PR Newswire. October 17, 2025. Accessed October 20, 2025. 

https://www.prnewswire.com/news-releases/fda-approves-novo-nordisks-oral-semaglutide-for-cardiovascular-cv-risk-reduction-in-adults-with-type-2-diabetes-who-are-at-high-risk-including-those-who-have-not-had-a-prior-cv-event-302588005.html

Novo Nordisk. Novo Nordisk A/S: Evoke phase 3 trials did not demonstrate a statistically significant reduction in Alzheimer’s disease progression. November 24, 2025. Accessed November 24, 2025. 

https://www.novonordisk.com/content/nncorp/global/en/news-and-media/news-and-ir-materials/news-details.html?id=916462

Horn DB, Linetzky B, Davies MJ, et al. Cardiometabolic Parameter Change by Weight Regain on Tirzepatide Withdrawal in Adults With Obesity: A Post Hoc Analysis of the SURMOUNT-4 Trial. 

 Published online November 24, 2025. doi:10.1001/jamainternmed.2025.6112

Podcasts

This special edition episode explores the advancements in incretin therapies that defined 2025.

News

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Type 1 Diabetes

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Diabetes Dialogue

Diabetes Dialogue: Technology, Therapeutics, & Real-World Perspectives is a monthly podcast hosted by Diana Isaacs, PharmD, and Natalie Bellini, DNP, aimed at providing a regular roundup of the latest clinically applicable insights across diabetes and metabolic diseases, with a focus on leveraging technology to improve care.

Endocrinology

The HCPLive endocrinology page is a comprehensive resource for clinical news and insights on endocrine system conditions. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for diabetes, hormonal disease, and more.

This Year In Medicine

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

Tim Smith joined the MJH Life Sciences team as an assistant editor for HCPLive in August 2022. He graduated from UC Berkeley with a degree in political science, working in multimedia journalism as a staff writer prior to joining MJH. In his spare time, he enjoys reading, watching TV, listening to podcasts, and rock climbing. You can contact him at 

Society of Dermatology Physician Associates (SDPA) Fall Conference

 in San Antonio, Texas, a session was presented by Rosemary Son, MPAS, PA-C, RDN, who spoke in this talk about current information and updates on the cutaneous microbiome, drawing mainly on recent publications published within the 

Journal of the American Academy of Dermatology 

In this session, Son highlighted the rapidly-changing nature of research in this space and noted the available evidence remains largely associative rather than causal. In her talk, Son provided an overview of microbiome composition, links with dermatologic conditions, determinants of microbial variation, and recent insights related to host–microbe interactions.

"[The microbiome] encompasses all of the organisms that live in and on us, and that includes your bacteria, fungi, mites, viruses that inhabit both the outer surface and some of your inner surfaces," Son explained.

 "...Every nook or cranny that you have has things living in it. And how we define the skin microbiome is the community of all of the genes of all of those things. I think the broad way that micro the microbiome is whether or not [the microbes on us] are friendly, neutral, or actively not nice to us."

One of the activities done by the body's commensal organisms is the production compounds that defend themselves and protect the human body from such invaders as bacterial toxins from staph infections. They also help stimulate certain immune responses, Son noted.

Son went on to describe humans as “planets” with distinct ecological niches; oily, dry, and moist areas of the body are included in her list. These areas support characteristic microbial communities, she added. Sebaceous areas are known to be enriched with Cutibacterium acnes, moist regions host higher proportions of Staphylococcus as well as Corynebacterium, and the feet exhibit greater fungal diversity relative to other bodily regions.

"There's still a lot we don't know, and that's why it's so interesting and titillating," Son said.

 "We're just kind of beginning to scratch the surface of what this actually means. The interesting thing is that there's a lot of variability on body sites, both between an individual, but even on their own body areas."

Intrinsic and extrinsic factors are believed to shape these microbial populations, Son highlighted. She noted extrinsic influences include environmental exposures, such as swimming, fabric type, and even pandemic-related mask use. She went on to discuss antibiotics' role in inducing lasting shifts in the body's skin microbiome. Prolonged dermatologic antibiotic therapy is, consequently, a concern.

Intrinsic influences covered by Son in her presentation include puberty-linked hormonal shifts, mode of birth, sex distinctions in the creation of sebum, and age-related shifts in one's level of fungal diversity. Son noted research indicating microbial signatures may predict human age within several years. She also commented on the markedly similar microbial profiles of twins.

"It turns out that twins not only have a lot of their genes in common, like their clones, but their microbiomes are very more closely related [compared to] unrelated folks," she explained.

 "Certainly, the way that you were made has an influence on what kind of creatures want to live there."

The pilosebaceous unit was described by Son as a central hub for microbe–host interactions. This lipid-rich, low-oxygen microenvironment is supportive to C acnes and numerous other organisms, Son said, and it serves as the origin for several dermatologic conditions. Microbial changes, such as C acnes ribotype switching, were described by Son as converting commensal organisms into pathogenic ones, contributing to acne and other follicular issues on patients' skin.

Throughout her talk, Son reviewed the multifaceted role of the microbiome in maintaining cutaneous barrier integrity. The highlighted commensal organisms, describing them metaphorically as protective “guard dogs." This is due to their production of antimicrobial peptides known to inhibit certain pathogens.  Additionally, disease-specific information was addressed with emphasis on atopic dermatitis, a skin disease consistently linked to diminished microbial diversity and overrepresentation of specific S aureus strains. Son implemented an analogy contrasting the healthy microbiome to a diverse national park and the atopic dermatitis microbiome was described as an overrun monoculture lacking ecological balance.

Son's talk concluded with acknowledgment of major knowledge gaps and the need for longitudinal human research, standardized methods, and translational work to develop microbiome-based treatments for patients. While topical emollients and barrier-supportive care continue to be foundational, impacrting patients' microbial health, targeted microbiome interventions were described as not yet widely available or reliably effective.

Son R. We Contain Multitudes: The microbiome and skin disease. Presented at the 

Whiting C, Abdel Azim S, Friedman A. The Skin Microbiome and its Significance for Dermatologists. Am J Clin Dermatol. 2024 Mar;25(2):169-177. 

Articles

Rosemary Son's presentation at the SDPA Fall Conference focused on the cutaneous microbiome, emphasizing its complex and rapidly evolving research landscape. She discussed the microbiome's composition, its role in dermatologic conditions, and the factors influencing microbial variation. Son highlighted the protective functions of commensal organisms and the impact of intrinsic and extrinsic factors on microbial populations. She also addressed the microbiome's role in maintaining skin barrier integrity and its implications for conditions like atopic dermatitis. The session concluded with a call for further research to develop effective microbiome-based treatments.

This summary of an SDPA Fall session highlights data on the skin microbiome and its impact on dermatologic diseases such as atopic dermatitis.

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.

Conference

 conference coverage page features articles, videos, and expert-led live coverage from major medical meetings throughout the year.

Session on the Skin Microbiome and Atopic Dermatitis Presented at 2025 SDPA Fall Conference

Chelsie Derman is an associate editor for 

who covers psychiatry, sleep medicine, geriatrics, migraine, and allergy. She joined MJH Life Sciences in September 2023 after graduating from The College of New Jersey with a bachelor’s degree in journalism and professional writing. In her free time, she enjoys creative writing and reading.

Obstetric physicians rarely refer pregnant patients to 

specialists, a recent cross-sectional survey revealed.

“Pregnancy can change how a woman’s immune system reacts to allergies or asthma,” said lead author Miriam Al-Saedy, MD, internal medicine resident at Virginia Mason Franciscan Health, in a statement. “An allergist can help confirm true allergies, guide safe medication use, and create a care plan that supports both maternal and fetal health.”

Al-Saedy presented the poster, “Barriers to Allergy and Immunology Referral in Pregnancy: A Survey of Obstetric Physicians,” at the 2025 American College of Allergy, Asthma, & Immunology (ACAAI) Annual Scientific Meeting between November 6 – 10. The survey revealed that 23.1% of physicians at the University of Washington never referred their pregnant patients to an allergist or immunologist.

Many women during pregnancy face allergic and immunologic conditions, such as drug allergies, asthma, and urticaria, which can lead to implications for both maternal and fetal outcomes. For instance, food allergy reactions in the first 9 months of pregnancy can result in miscarriages, premature births, or birth defects. Allergies during pregnancy also increase the risk of the child getting sick after birth.

To reduce the risk of food-related complications during pregnancy, experts advise that women should avoid foods that have previously caused reactions, along with raw or undercooked items and easily spoiled leftovers.

 Staying well hydrated, exercising, and limiting spicy or bitter foods can also support overall well-being.

However, along with these dos and don’ts, the American College of Allergy, Asthma, and Immunology (ACAAI) notes that antihistamines can be appropriate during pregnancy for allergic rhinitis, conjunctivitis, urticaria, and as adjunctive treatment for anaphylaxis. Except for life-threatening anaphylaxis, clinicians should ensure that the benefits outweigh fetal risks.

 Chlorpheniramine and diphenhydramine have long safety histories, though chlorpheniramine is preferred despite its sedating effects. Newer, less sedating options such as loratadine and cetirizine have reassuring human and animal data and are recommended when indicated.

For decongestants, oxymetazoline is considered the safest due to minimal systemic absorption, while other topical agents may worsen congestion.4 Pseudoephedrine has been widely used but may be associated with a small increase in abdominal wall defects. Pregnant patients with persistent, mild allergic nasal symptoms may safely use corticosteroid nasal sprays, particularly budesonide. Allergen immunotherapy can continue during pregnancy, but should not be initiated.

Although pregnant patients can safely use certain allergy medications, referrals to allergy and immunology specialists remain low. Al-Saedy and colleagues conducted a 20-question cross-sectional survey to assess referral practices and barriers among obstetric physicians managing pregnant patients at a large academic center. The survey evaluated physician experience, comfort managing allergic conditions, referral frequency, perceived barriers to Allergy/Immunology consultation, and educational needs.

Among the 27 respondents, 59.3% were attending physicians with > 10 years of experience. In total, 92.6% practiced in both inpatient and outpatient settings, 23.1% never referred pregnant patients to Allergy/Immunology consultation, and 42.3% referred once per year. Physicians referred patients due to drug allergy (83.3%), urticaria (38.9%), and asthma (33.3%). Slightly more than half (51.8%) reported feeling completely or mostly comfortable at managing drug allergies.

Cited barriers to referring patients to allergy or immunology specialists included limited awareness of referral indications (55.6%) and long appointment wait times (44.4%). Respondents requested several educational interventions, including institutional guidelines (76%), provider resources (72%), and workshops (64%).

“Allergy and immunology care in pregnancy is safe and can make a real difference in how women feel,” Al-Saedy said. “Don’t hesitate to ask for a referral if you think you need one.”

Pregnant women often miss out on specialist allergy care. EurekAlert! November 6, 2025. 

https://www.eurekalert.org/news-releases/1103523

Saedy M and Colas K. Barriers to Allergy and Immunology Referral in Pregnancy: A Survey of Obstetric Physicians. 

Poster presented at ACAAI 2025 in Orlando, Florida, on November 6 – 10.

Food allergies during pregnancy: When is it dangerous? Vinmec International Hospital. Published 2025. Accessed December 4, 2025. 

https://www.vinmec.com/eng/blog/food-allergies-during-pregnancy-when-is-it-dangerous-en

Pregnancy and Allergies | Symptoms & Treatment. ACAAI Public Website. 

https://acaai.org/allergies/allergies-101/who-gets-allergies/pregnancy-and-allergy/

A recent survey highlights the infrequent referral of pregnant patients to allergy or immunology specialists by obstetric physicians. Allergic and immunologic conditions during pregnancy can impact maternal and fetal health, yet only 23.1% of surveyed physicians never referred patients to specialists. Barriers include limited awareness of referral indications and long wait times. Safe allergy medication options exist, such as certain antihistamines and nasal sprays. Physicians expressed a need for educational resources to improve referral practices. Addressing these barriers could enhance care for pregnant women with allergic conditions.

A survey found many obstetric physicians rarely refer pregnant patients for allergy or immunology care, citing knowledge gaps and long wait times.

Allergy

Allergy condition center page is a comprehensive resource for clinical news and insights on allergic and inflammatory diseases. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for food and seasonal allergies, as well as allergic asthma and related conditions.

Obstetric Physicians Rarely Refer Pregnant Patients to Allergists

Abigail Brooks is an assistant managing editor for 

She joined MJH Life Sciences in August 2023 shortly after graduating from Monmouth University where she earned her BA in Communication with a concentration in Public Relations/Journalism and later an MA in Interactive Digital Media. She enjoys traveling, running, and reading books. She can be reached at abrooks@mjhlifesciences.com.

November brought a series of impactful developments in hepatology, underscoring both therapeutic momentum and ongoing challenges across liver disease. The American Association for the Study of Liver Diseases (AASLD) opened the month with updated practice guidance on semaglutide for 

metabolic dysfunction-associated steatohepatitis (MASH)

, marking the first major revision since the organization’s 2023 NAFLD guidance and reflecting rapid evolution in MASLD/MASH care. New investigational data also signaled a shift in long-held assumptions about cirrhosis, with early findings from the phase 2 WAYFIND trial exploring combination therapy with semaglutide, cilofexor, and firsocostat in patients with compensated MASH cirrhosis.

, attention turned to a transformed cholestatic liver disease landscape following the withdrawal of obeticholic acid. Real-world data added clarity on seladelpar’s role in PBC management, particularly for patients transitioning from obeticholic acid. Complementary long-term findings from the ELATIVE extension study reinforced elafibranor’s durability and safety as a second-line therapy. Meanwhile, the ALTUS study introduced promising evidence that a new multi-target blood test could outperform abdominal ultrasound for early hepatocellular carcinoma (HCC) detection.

Rounding out the month, new research illuminated disparities across liver disease, including heightened fibrosis risk among women who binge drink and the strong association between socioeconomic and environmental disadvantage and pediatric MASLD, emphasizing the continued need for equity-focused approaches in hepatology.

Check out this November 2025 hepatology month in review for a recap of 

’s coverage of the top hepatic news and research from the past few weeks:

AASLD Releases Updated Practice Guidance on Semaglutide (Wegovy) for MASH

On November 7, 2025, the AASLD released an updated practice guidance on semaglutide (Wegovy) therapy for MASH. The document was published in 

 and serves as an update to the 2023 AASLD practice guidance on the clinical assessment and management of nonalcoholic fatty liver disease (NAFLD), now known as MASLD.

WAYFIND: Exploring Combination Therapy for MASH Cirrhosis, With Naim Alkhouri, MD

Despite historical perceptions of cirrhosis as an irreversible stage of chronic liver disease, emerging data from pharmacologic trials are challenging that notion. Among these, the phase 2 WAYFIND trial has drawn considerable attention for testing a novel combination approach of semaglutide alone and in fixed-dose combination with cilofexor and firsocostat in patients with biopsy-proven compensated cirrhosis due to MASH.

Headlines From AASLD The Liver Meeting 2025

Seladelpar’s Role in the Post-Obeticholic Acid PBC Treatment Landscape, With Christopher Bowlus, MD

The September 2025 voluntary withdrawal of obeticholic acid from the US market created a large therapeutic gap for PBC, removing what was once the sole second-line treatment option for patients who did not respond to or could not tolerate first-line ursodeoxycholic acid. With obeticholic acid no longer an option, clinical uncertainties have emerged regarding the safety and efficacy of switching these patients to the newly available second-line therapies elafibranor and seladelpar.

At AASLD The Liver Meeting 2025, Christopher Bowlus, MD, the Lena Valente Professor and Chief of the division of gastroenterology and hepatology at the University of California Davis School of Medicine, presented late-breaking, real-world data supporting the use of seladelpar in patients with PBC, including those who switched from obeticholic acid.

Defining Elafibranor’s Role in a New Era of PBC Management, With Cynthia Levy, MD

Since its accelerated approval and the subsequent removal of obeticholic acid from the US market, elafibranor has played a pivotal role in second-line treatment for PBC. Now, new > 3-year data from the ongoing ELATIVE open-label extension presented at AASLD The Liver Meeting 2025 demonstrate continued rapid, sustained, and reproducible responses in clinically relevant biomarkers of cholestasis as well as positive effects on cholestasis, sustained improvement in pruritus and fatigue, stabilization of markers of fibrosis, and a consistent safety profile.

ALTUS: Multi-Target Blood Outperforms Ultrasound for HCC, With Binu John, MD, MPH

Findings from the prospective multicenter ALTUS study suggest Exact Sciences’ Oncoguard® Liver blood test, a new multi-target blood test, delivers superior early-stage and overall sensitivity for hepatocellular carcinoma (HCC) compared to standard of care abdominal ultrasound.

Women Face Higher Risk of Advanced Fibrosis Due to Binge Drinking Than Men

New research sheds light on sex-based differences in the association between the frequency of binge drinking and advanced fibrosis, highlighting a heightened risk of liver injury among women even at low binge frequencies. Study findings pose important implications for the accuracy of current metabolic dysfunction-associated alcohol-related liver disease (MetALD) and alcohol-associated liver disease (ALD) definitions.

Socioeconomic, Environmental Disadvantage Linked to Pediatric MASLD Risk

Recent research suggests the presence of a significant association between social determinants of health (SDH) and MASLD in children with 

. In the study, children with MASLD were more likely to live in neighborhoods with greater socioeconomic and environmental disadvantage than their peers with overweight or obesity but without MASLD. Specifically, they were more likely to reside in neighborhoods with lower socioeconomic advantage, reduced access to education and economic resources, poorer housing conditions, and greater environmental risks, including higher air pollution exposure.

Brooks A. AASLD Releases Updated Practice Guidance on Semaglutide (Wegovy) for MASH. HCPLive. November 7, 2025. Accessed December 4, 2025. 

https://www.hcplive.com/view/aasld-releases-updated-practice-guidance-semaglutide-wegovy-mash

Alkhouri N. WAYFIND: Exploring Combination Therapy for MASH Cirrhosis, With Naim Alkhouri, MD. HCPLive. November 18, 2025. Accessed December 4, 2025. 

https://www.hcplive.com/view/wayfind-exploring-combination-therapy-for-mash-cirrhosis-with-naim-alkhouri-md

Bowlus C. Seladelpar’s Role in the Post-Obeticholic Acid PBC Treatment Landscape, With Christopher Bowlus, MD. HCPLive. November 9, 2025. Accessed December 4, 2025. 

https://www.hcplive.com/view/seladelpar-role-post-obeticholic-acid-pbc-treatment-landscape-with-christopher-bowlus-md

Levy C. Defining Elafibranor’s Role in a New Era of PBC Management, With Cynthia Levy, MD. HCPLive. November 13, 2025. Accessed December 4, 2025. 

https://www.hcplive.com/view/defining-elafibranor-role-new-era-pbc-management-with-cynthia-levy-md

John B. ALTUS: Multi-Target Blood Outperforms Ultrasound for HCC, With Binu John, MD, MPH. HCPLiveNovember 11, 2025. Accessed December 4, 2025. 

https://www.hcplive.com/view/altus-multi-target-blood-outperforms-ultrasound-hcc-john-binu-md-mpd

Brooks A. Women Face Higher Risk of Advanced Fibrosis Due to Binge Drinking Than Men. HCPLive. November 7, 2025. Accessed December 4, 2025. 

https://www.hcplive.com/view/women-face-higher-risk-advanced-fibrosis-due-binge-drinking-than-men

Brooks A. Socioeconomic, Environmental Disadvantage Linked to Pediatric MASLD Risk. HCPLive. November 24, 2025. Accessed December 4, 2025. 

https://www.hcplive.com/view/socioeconomic-environmental-disadvantage-linked-pediatric-masld-risk

November saw significant advancements in hepatology, with updates in MASH care and new insights into liver disease management. The AASLD released updated guidance on semaglutide for MASH, reflecting rapid changes in MASLD/MASH treatment. The WAYFIND trial explored combination therapy for MASH cirrhosis, challenging traditional views on cirrhosis. The withdrawal of obeticholic acid shifted the PBC treatment landscape, highlighting seladelpar and elafibranor's roles. The ALTUS study showed a new blood test's superiority over ultrasound for early HCC detection. Research also highlighted disparities in liver disease risk factors.

Catch up on new AASLD MASH guidelines on semaglutide, key research from The Liver Meeting 2025, and more.

Hepatology

MASH / MASLD

The HCPLive MASH & MASLD page is a comprehensive resource for clinical news and insights on metabolic dysfunction-associated steatotic liver disease and steatohepatitis. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for fatty liver disease, steatohepatitis, and more.

Cholangitis

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7 Hepatology Headlines You Missed in November 2025

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.

New research suggests recurrent urinary tract infections (rUTIs) are common in 

 and pose significant implications for morbidity and adverse quality of life.

These findings highlight the importance of proactively approaching risk factors, optimizing graft function, and implementing infection control measures to minimize the burden of rUTIs on kidney transplant recipients, specifically the disproportionate impact on the female patient population.1

“We believe that our paper is the first to measure the psychosocial burden of rUTIs in KTRs. We found a substantial negative impact on all five aspects assessed in the Recurrent UTI Impact Questionnaire (RUTIIQ) survey,” wrote study investigator Saima Aslam, MD, an infectious disease specialist and, a professor of medicine at the UC San Diego School of Medicine, and colleagues. “High levels of anxiety related to social interactions and impact on sex life were found, along with significant impairment of work and daily activities, highlighting the broader socioeconomic implications of rUTIs on patients' lives.”

To assess this psychosocial burden, investigators conducted a single-center, retrospective chart review and patient survey of adult kidney transplant recipients ≥ 18 years of age with rUTI at the University of California San Diego Health System. Aslam and colleagues defined rUTI as the ≥ 2 symptomatic UTI in 6 consecutive months or ≥ 3 symptomatic UTI in a year, and multidrug-resistant organisms (MDRO) as organisms with resistance to ≥3 antibiotic classes.

They adopted the RUTIIQ, a 30-item comprehensive, patient-centred questionnaire used to quantify psychosocial challenges associated with rUTI, with a scoring system across 5 domains: patient satisfaction, work and activity interference, social well-being, personal well-being, and sexual well-being. Participants used a 10-point Likert scale ranging from 1 (“strongly disagree”) to 10 (“strongly agree”) to rate their level of agreement with each question.

Investigators identified a cohort of 46 kidney transplant recipients with a median age of 59.5 years, highlighting that 82.6% of impacted patients were women. Of the population, 84.8% had undergone a single kidney transplant, with 73.9% from deceased donors. The median time since the patient’s most recent transplantation was 50.1 months, and a majority were receiving medication for maintenance immunosuppression.

The median number of UTIs during the study period was 3 (interquartile range [IQR], 2-5), and 54.3% of predominant uropathogens were E. coli, 43.5% were K. pneumoniae, while 37% of patients had MDROs. Investigators noted an increased rate of hospital admissions and intravenous antibiotics among these patients. Specifically, 65% of patients (n = 30) required hospital admission for UTI management within the 1-year study period, and 69.6% received IV antibiotics (n = 32).

Evaluating allograft function in 42 eligible patients, 57.1% had >1 episode of acute kidney injury (n = 24) at the time of the UTI event. For the whole cohort, 60.9% of patients had chronic kidney disease. Median tacrolimus trough level was 8.55 ng/mL (IQR 6.6–9.2), positive donor-specific antigen was present in 16.3% of 43 patients, and BK viremia was detected in 13.7% of 44 patients.

The quality of life survey was answered by 58.7% of participants (n = 27), with median scores showcasing significant personal and social impacts caused by rUTI. Psychological distress was recorded by scores of 7 for “increased anxiety” and 5 for “disrupted sleep” in respondents. In terms of social detriments, patients reported scores of 5 for “avoiding social interactions” and 4 for “feeling embarrassed in social situations”. Notably, patients answered a score of 9 for “regularly missing work or home responsibilities due to UTI” and 8.5 for “significant anxiety about the impact of UTI on their sex life”.

Investigators called attention to patients’ responses to healthcare-centered satisfaction. While patients reported median scores of 9 for “high satisfaction with the content of medical care”, they also reported a lower score of 4 for “feeling listened to by healthcare providers” and 3 for “ease of access to medical specialists”. According to study investigators, these findings underscore this patient population's desire for psychosocial healthcare integration.

“In conclusion, we note that rUTI significantly impacts KTRs with a high degree of morbidity and adverse QOL, with female recipients bearing a disproportionate burden,” investigators concluded. “Future research efforts focused on elucidating the underlying mechanisms of rUTI pathogenesis, conducting rigorous therapeutic clinical trials, and developing personalized preventive strategies are essential for improving outcomes in this vulnerable patient population.”

Jung S, Chen K, Kazim M, Shah M, Brubaker AL, Aslam S. Pilot Study to Assess the Impact of UTI Recurrence on Quality of Life and Medical Utilization in Kidney Transplant Recipients. 

. Published online November 25, 2025. doi:

Emil. RUTIIQ | The Recurrent Urinary Tract Infection Impact Questionnaire. PARED Insights. Published June 11, 2024. Accessed December 4, 2025. 

https://paredinsights.org/assessment-tools/rutiiq/

Recurrent urinary tract infections (rUTIs) are prevalent among kidney transplant recipients, significantly affecting morbidity and quality of life, particularly in women. A study using the Recurrent UTI Impact Questionnaire (RUTIIQ) revealed substantial psychosocial burdens, including anxiety, social interaction issues, and work disruptions. The research involved a retrospective review and survey of kidney transplant recipients, identifying a high incidence of multidrug-resistant organisms and hospital admissions. The findings emphasize the need for personalized preventive strategies and psychosocial healthcare integration to improve outcomes for this vulnerable patient population.

A single-center retrospective survey urges clinicians to address recurrent urinary tract infections in kidney transplant recipients. 


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Recurrent UTIs Linked to QOL Burden in Kidney Transplant Recipients

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Recurrent UTIs Linked to QOL Burden in Kidney Transplant Recipients