Ann Marie Navar, MD, PhD, is an associate professor of cardiology at the University of Texas Southwestern Medical Center.

Ann Marie Navar, MD, PhD | Image Credit: UT Southwestern

On July 16, 2026, enlicitide (Lipfendra) received approval from the US Food and Drug Administration (FDA) to lower LDL-C in patients with hypercholesterolemia or heterozygous familial hypercholesterolemia (HeFH). The 20 mg tablet, administered once daily as an adjunct to diet and exercise, substantially reduced LDL-C in the CORALreef Lipids and CORALreef HeFH trials compared to placebo.

Now, with the drug expected to be accessible in a few weeks, parent company Merck will continue to investigate the drug’s safety and efficacy in lowering the risk of major adverse cardiovascular events through LDL-C lowering.

Ann Marie Navar, MD, PhD, associate professor of medicine in the Division of Cardiology at UT Southwestern Medical Center and a lead investigator throughout enlicitide’s investigational pathway, spoke with

 to discuss the drug’s potential impact on this condition, which affects a disproportionate percentage of the US population.


Q&A: Enlicitide’s FDA Approval for LDL-C Reduction and the CORALreef Outcomes Trial

How significant is this approval for preventive cardiology? Can it meaningfully change clinical practice?

I think this is really big. We now have an oral option that lowers LDL cholesterol by ≤60% on top of high intensity statins and other background therapies. That's huge in terms of getting more patients to goal. The approval, though, is just the first step. Now we actually have to get it into the hands of our clinician prescribers, and then ultimately into our patients. So, it's going to come down to: are people going to use it, and are we going to be able to get payers and insurers to cover it for the patients that need it?

What barriers did the field encounter with injectable PCSK9 inhibitors, and how might an oral version overcome them?

Well, some of the early barriers to uptake were the high sticker price, which led to really high copays and high rates of insurance company refusals, so we just couldn't get patients approved for the drug. That's actually gotten a lot better. The sticker price has come way down. The directed patient price for Repatha is <$250 a month, and a lot of PBMs have actually even dropped a prior authorization. So, approval rates are really high. The challenge is that not all of my colleagues are using them. We looked a couple of years ago, and 40% of cardiologists had never prescribed an injectable PCSK9. Over 90% of primary care doctors hadn't prescribed one. So, these drugs just haven't made it into the armamentarium of all of the clinicians that are seeing the patients who need further cholesterol lowering. This is where I'm hopeful for Lipfendra, enlicitide’s new brand name, that we'll be able to have more clinicians actually using this as an add-on after statins if people are not at LDL goal, and while the injections are really well tolerated and they work really well, I think it just takes a little bit more time to prescribe it in clinic than it does to prescribe a pill. And I think for some patients, it just sort of psychologically feels like a much bigger deal to add on a shot versus adding on a pill. I'm really hopeful that the availability of an oral PCSK9 actually broadens the number of people who are using these therapies. Maybe even use more injectables as well.

How do you interpret the 56-59% LDL-C reduction from CORALreef in the context of currently available lipid-lowering therapies?

Well, if you look at the LDL lowering, the non-HDL lowering, the ApoB, and the Lp(a) lowering, the efficacy of enlicitide looked almost identical numerically to what we saw with alirocumab and evolocumab. Now, all three of them have a little bit greater relative reductions in atherogenic lipoproteins than in glycerin, though even in glycerin is getting you well over 50%, so we know that inhibiting PCSK9 is a really powerful way to lower LDL cholesterol. This is just basically evolocumab or Repatha in a pill.

Which patients do you expect to benefit most from enlicitide initially?

Well, I would anticipate that probably the payers are going to make it easiest for us to get this drug for people with established ASCVD. That's certainly been the experience with the injectable PCSK9s, and that's also where we have cardiovascular outcomes data for at least the injectable class. So probably those with established ASCVD who are not reaching LDL goals, there's certainly a subgroup of patients, including those with FeFH, who just really do not want an injection and are waiting for more oral options, or on statin ezetimibe, and they're not at goal. I think this is going to be a great option for them now if they can get access to it to be able to increase their therapy and get to that goal of <55.

How do you weigh the convenience of oral medications against the adherence advantages of therapies administered every few months, like injectables?

Well, the CORALreef Lipids trial was a clinical trial, but it also was conducted in the real world. The participants in the trial lived their normal lives for a year, and we saw that the durability of the efficacy of enlicitide was sustained for the entire year that patients were on therapy. So, we've seen in thousands of patients that people are able to get on drug and stay on it. The administration requirements for Lipfendra are that you have to take it first thing in the morning on an empty stomach, but you can take it with your other medicines. So, you could take your statin and ezetimibe at the same time. I actually think for those patients, it was actually helpful to give them very explicit instructions on when to take it because we were able to make a habit out of it. People woke up, took their meds in the morning, and they continued on. And it really just is not that big of a deal. We also have had some data since then that a cup of black coffee or black tea does not affect the exposure to drug, so you can't eat food with it because that impacts the absorption. But if you're like me and don't want to talk to anybody without a cup of coffee, you can have a cup of black coffee before that 30 minute window is up.

What further questions are you hoping that the ongoing CORALreef Outcomes trial will answer?

Well, that trial is going to be really important to show us, you know, adherence data and LDL data for longer than a year. It will be also important to add to the continued body of evidence that lowers better not only in secondary prevention, but high-risk primary prevention. We saw data from the Vesalius trial recently that in high-risk individuals who have not had a prior cardiovascular event, PCSK9 inhibition, lowering LDL cholesterol well below 55, reduced cardiovascular events, and that was in people with high-risk diabetes or coronary calcium scores >100. CORALreef Outcomes is also including a high-risk primary prevention group, and so that's a group I'm really excited to continue to have more data on because I think the more evidence we have that lower is better in primary prevention, we'll be able to make even more aggressive recommendations to try to prevent the heart attacks before they happen, instead of waiting until they've already had an event to try to drive the cholesterol down.

Editors’ Note: This transcript has been edited for grammar and clarity using artificial intelligence tools.

Livingston R. Enlicitide Receives FDA Approval for Hypercholesterolemia Following CORALreef Trials. 

. July 17, 2026. Accessed July 22, 2026. 

https://www.hcplive.com/view/enlicitide-receives-fda-approval-for-hypercholesterolemia-following-coralreef-trials

Merck Clinical Trials. CORALreef Outcomes. Accessed July 22, 2026. 

https://www.merckclinicaltrials.com/trial/nct06008756/

Articles

FDA approval of oral enlicitide (Lipfendra) adds a once-daily PCSK9 inhibitor that reduced LDL-C ~56–59% in hypercholesterolemia and HeFH as adjunct to diet/exercise and background therapy. Efficacy across LDL-C, non–HDL-C, ApoB, and Lp(a) appears numerically comparable to alirocumab/evolocumab, potentially improving goal attainment, especially when injections are a barrier. Real‑world–conducted trial data suggest yearlong durability with fasting morning dosing. Access and payer coverage will likely determine uptake, while CORALreef Outcomes will test longer-term adherence and MACE reduction, including high-risk primary prevention.

Ann Marie Navar, MD, PhD, highlights enlicitide’s FDA approval for hypercholesterolemia and its potential to fundamentally change therapy.

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Dyslipidemia

FDA News

Enlicitide’s FDA Approval for LDL-C Reduction and the CORALreef Outcomes Trial

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.

Monopar Therapeutics Inc. has initiated the rolling submission of a New Drug Application (NDA) to the 

for ALXN1840 (bis-choline tetrathiomolybdate; TMC) in Wilson disease.

If approved, ALXN1840 would become the first FDA-approved Wilson disease therapy with a novel mechanism of action in decades. Current treatment options for Wilson disease have focused primarily on reducing copper accumulation through chelation or limiting intestinal copper absorption.

Wilson Disease Treatment Landscape Remains Focused on Copper Reduction

Wilson disease is a rare autosomal recessive disorder caused by pathogenic variants in the ATP7B gene, which impair biliary copper excretion and result in toxic copper accumulation in tissues, particularly the liver and brain. Patients may develop a range of manifestations, including liver disease and neurological or psychiatric symptoms such as personality changes, tremors, and difficulty with movement, swallowing, or speech.

Current FDA-approved therapies include copper chelators such as penicillamine and trientine, which increase urinary copper excretion, as well as zinc acetate, which reduces intestinal copper absorption.

“Wilson disease is a serious, lifelong condition, and patients and their families have waited a long time for a new treatment option,” said Chandler Robinson, MD, chief executive officer of Monopar, in a statement. “Initiating the rolling NDA submission marks an important milestone in our efforts to bring this novel copper-sequestering therapy to patients.”

ALXN1840 Designed to Promote Copper Mobilization

ALXN1840 (bis-choline tetrathiomolybdate) is an investigational once-daily oral therapy designed to bind and remove excess copper from tissues and blood through a novel mechanism of action. The therapy has received orphan drug designation from the FDA and orphan designation from the European Medicines Agency for Wilson disease.

The therapy is designed to address copper dysregulation by promoting copper mobilization and facilitating removal from the body. Unlike existing Wilson disease therapies that primarily rely on copper chelation or reducing absorption, ALXN1840 is intended to target copper stored in tissues and circulating in the blood.

Phase 3 FoCus Trial Supports NDA Submission

The regulatory submission is supported by findings from the pivotal phase 3 FoCus trial, a randomized, rater-blinded, multicenter study evaluating ALXN1840 compared with standard of care in patients with Wilson disease ≥ 12 years of age.

The trial enrolled 214 patients across 2 cohorts. The treatment-experienced cohort included patients who had received standard of care for more than 28 days, while the second cohort included patients who were treatment-naïve or had received standard of care for 28 days or less. Patients were randomized to receive ALXN1840 or standard of care.

The primary endpoint assessed copper mobilization over 48 weeks using the daily mean area under the effect curve (AUEC) for directly measured non-ceruloplasmin-bound copper (dNCC). ALXN1840 met the primary endpoint, demonstrating significantly greater copper mobilization compared with standard of care over 48 weeks.

According to Monopar, ALXN1840 demonstrated approximately three-times greater copper mobilization compared with standard of care (least squares mean difference, 2.18 µmol/L; 

 < .0001). Copper mobilization was observed within 4 weeks and sustained through the 48-week treatment period.

ALXN1840 Safety Profile Reported in Clinical Development Program

Across the ALXN1840 clinical development program, Monopar reported 645 patient-years of follow-up across 266 patients. In the FoCus trial, ALXN1840 was generally well tolerated, with most adverse events considered mild to moderate. The most frequently reported adverse event in the ALXN1840 treatment group was a reversible increase in transaminase levels.

The rolling NDA submission allows Monopar to submit completed sections of the application to the FDA for review as they become available. The FDA will determine whether the completed application is accepted for review following submission of all required components.

Monopar Therapeutics Inc. Monopar Initiates Rolling NDA Submission for ALXN1840 in Wilson Disease. GlobeNewswire News Room. Published July 22, 2026. Accessed July 22, 2026. 

https://www.globenewswire.com/news-release/2026/07/22/3331283/0/en/monopar-initiates-rolling-nda-submission-for-alxn1840-in-wilson-disease.html

ALXN1840.; 2025. Accessed July 22, 2026. 

https://www.monopartx.com/pipeline/alxn1840

Monopar Therapeutics has begun a rolling NDA submission to the FDA for ALXN1840 (bis-choline tetrathiomolybdate) for Wilson disease, positioning it as a potential first-in-decades therapy with a distinct copper-sequestering mechanism. Wilson disease results from ATP7B variants causing impaired biliary copper excretion with hepatic and neuropsychiatric toxicity. In the phase 3 FoCus trial (n=214; ≥12 years), ALXN1840 achieved significantly greater copper mobilization versus standard of care over 48 weeks, with early onset and durability. Safety was generally favorable; reversible transaminase elevations were most common.

Monopar initiated a rolling NDA submission for ALXN1840, an investigational therapy for Wilson disease targeting copper dysregulation.

Hepatology

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Monopar Files Rolling NDA for ALXN1840 in Wilson Disease

Victoria Johnson joined MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and is now an assistant managing editor for HCPLive and RheumatologyLive. She doesn’t have enough time for her numerous hobbies. You can reach her at vjohnson@mjhlifesciences.com.

 affects up to 20% of children and approximately 10% of adults in the United States, ranking first among cutaneous diseases as measured by disability-adjusted life-years and carrying a systemic burden that extends well beyond the skin to encompass sleep disruption, impaired school and work performance, anxiety, and depression — particularly in adolescents.¹ 

Where Does the Atopic Dermatitis Treatment Landscape Stand?

The pathophysiology involves a dual defect in skin barrier function and type 2 immune dysregulation, driven primarily by IL-4 and IL-13 with downstream IgE class switching, eosinophil tissue infiltration, and increasingly recognized neuroimmunologic contributions through mast cell–nerve interactions.² Topical corticosteroids (TCS) and calcineurin inhibitors have anchored atopic dermatitis treatment for decades, and the 2023 AAAAI/ACAAI Joint Task Force (JTF) guidelines reinforced their primacy — awarding strong recommendations with high certainty for both in patients aged 3 months and older across all severity levels.³ Three additional topical drug classes have since received FDA approval for AD: the JAK1/JAK2 inhibitor ruxolitinib cream (Opzelura; Pfizer/Incyte), the aryl hydrocarbon receptor agonist tapinarof cream 1% (Vtama; Dermavant), and the PDE4 inhibitor roflumilast cream (Zoryve; Arcutis) — expanding the non-biologic armamentarium for patients who remain insufficiently controlled on older agents but are not yet candidates for systemic therapy.⁴⁻⁶

 convened a panel of allergist-immunologists and advanced practice providers from the Chicago metropolitan area for an interactive roundtable focused on topical therapy decision-making, guideline integration, and real-world barriers to prescribing newer agents in AD. The forum was moderated by Nicole Chase, MD, an allergist-immunologist in private practice in Minneapolis–St. Paul and associate professor of medicine at the University of Minnesota, and included peers representing Endeavor Health, private multi-site allergy practices in the Chicago suburbs, and a solo community allergy practice in Muncie, Indiana, allowing the discussion to surface both the clinical and structural factors governing topical agent selection in settings where patients frequently arrive after having already navigated primary care, urgent care, and dermatology without adequate control.

Where Do New Therapies Fit in the Allergist's Atopic Derm Algorithm?

The discussion surfaced a near-universal pattern in the panel's prescribing: TCS first, then calcineurin inhibitors, then dupilumab — with the 3 newer topicals rarely filling the gap. Several panelists described prescribing calcineurin inhibitors or crisaborole not with clinical intent but to satisfy insurance step-therapy documentation requirements before dupilumab prior authorization, a routine workaround described candidly across the group. 

Among the 3 agents, topical ruxolitinib generated the most clinical confidence. Trial data from TRuE-AD1 and TRuE-AD2 demonstrated an IGA treatment success rate (clear or almost clear, ≥2-point improvement from baseline) of approximately 53% with 1.5% ruxolitinib cream at week 8 versus approximately 15% with vehicle, alongside a mean 2-point reduction in peak pruritus NRS score within 12 hours of first application — a rapid itch-relief finding confirmed anecdotally in at least one panelist's practice within 15 to 20 minutes.⁴ The 20% body surface area label restriction was the most commonly cited practical barrier, given that patients presenting to allergists disproportionately exceed this threshold after failing primary care management. 

Topical tapinarof was the most novel and theoretically appealing agent: ADORING 1 and 2 demonstrated IGA success in approximately 46% to 50% of patients, and the ADORING 3 open-label extension found a mean treatment-free interval of 79.8 days (standard deviation 81.4) after achieving complete clearance — a feature the panel identified as potentially compelling to steroid-phobic or maintenance-resistant patients.⁵,⁷ Tapinarof's worm-derived natural origin was also discussed as a possible persuasion tool for patients seeking non-pharmaceutical alternatives to TCS. Roflumilast drew the most skepticism: its IGA success rate of approximately 30% at week 4 against a vehicle response rate of approximately 15% yielded the narrowest drug-vehicle separation of the three agents, and its week-4 primary endpoint was viewed as a less meaningful benchmark than the week-8 data available for the other agents.⁶ Its freedom from the stinging and burning that limits crisaborole was, however, specifically noted as an advantage in younger pediatric patients.

Steroid Phobia, Social Media, and the Real Barriers to Guideline Implementation

The panel devoted significant discussion to a parallel set of barriers operating at the patient level. Panelists described a clinical environment in which TikTok-driven narratives around topical corticosteroid withdrawal syndrome are actively undermining adherence to first-line therapy, while alternative topical products such as beef tallow are gaining traction among steroid-phobic patients and their parents. 

Adolescents were identified as the patient group most affected by this dynamic, with 1 panelist noting the challenge of simultaneously managing TCS phobia and FDA black-box warning anxiety around calcineurin inhibitors in the same appointment. The panel discussed practical patient communication strategies: framing biologics as "an injectable medication for asthma" rather than a biologic for health-literacy-sensitive patients; asking patients to identify the activities their atopic dermatitis prevents before introducing a treatment plan; and using what 1 panelist termed a fire analogy to explain maintenance therapy — "You have to get it out and prevent the embers from burning," she described her approach to dosing consistency. 

Most panelists apply gestalt severity assessment in practice and described response to therapy itself as the most practical surrogate for severity classification — a clinically elegant observation the moderator surfaced explicitly: patients who do not respond to appropriately applied TCS and calcineurin inhibitors are, by that definition, at least moderate. Structural barriers mirrored the clinical ones: insurance prior authorization was the primary hurdle for all 3 focal agents, with at least 1 panelist abandoning tapinarof entirely after a single denial. Health system–employed clinicians lack access to non-biologic samples under institutional conflict-of-interest policies, creating a de facto prescribing disadvantage relative to private practice. Multiple panelists noted they had never been visited by pharmaceutical representatives for these topical agents — a striking gap given allergy's substantial atopic dermatitis volume — and several are now using AI to draft prior authorization letters and generate cross-trial comparisons in the absence of head-to-head evidence. As Thompson noted: "If I don't know how well it will work, am I going to want to put in the effort for something that may not work?" The panel's collective wish list for industry included streamlined specialty pharmacy routing with built-in prior authorization support, more consistent representative access to allergist practices, patient education materials with greater skin-of-color representation, and clearer step-therapy documentation guidance.

Chan KR, Keddie S, Tsoi LC. Prevalence of atopic dermatitis in the United States from 2021 to 2024: data from the National Health Interview Survey. 

 Published online October 6, 2025. doi:10.1016/j.jaad.2025.09.043

 2008;358(14):1483–1494. doi:10.1056/NEJMra074081

AAAAI/ACAAI JTF Atopic Dermatitis Guideline Panel; Chu DK, Schneider L, Asiniwasis RN, et al. Atopic dermatitis (eczema) guidelines: 2023 American Academy of Allergy, Asthma and Immunology/American College of Allergy, Asthma and Immunology Joint Task Force on Practice Parameters GRADE– and Institute of Medicine–based recommendations. 

 2024;132(3):274–312. doi:10.1016/j.anai.2023.11.009

Kim BS, Sun K, Papp K, Venturanza M, Nasir A, Kuligowski ME. Effects of ruxolitinib cream on pruritus and quality of life in atopic dermatitis: results from a phase 2, randomized, dose-ranging, vehicle- and active-controlled study. 

 2020;82(6):1305–1313. doi:10.1016/j.jaad.2020.02.009 [For TRuE-AD primary publication: Papp K, Bhalla B, Torres T, et al. Ruxolitinib cream 1.5% for atopic dermatitis in adolescents and adults (TRuE-AD1 and TRuE-AD2): two phase 3, randomised, double-blind, vehicle-controlled trials. 

 2021;397(10290):2160–2173. doi:10.1016/S0140-6736(21)00586-1]

Silverberg JI, Eichenfield LF, Hebert AA, et al. Tapinarof cream 1% once daily: significant efficacy in the treatment of moderate to severe atopic dermatitis in adults and children down to 2 years of age in the pivotal phase 3 ADORING trials. 

 2024;91(3):457–465. doi:10.1016/j.jaad.2024.05.023

Eichenfield LF, Ahluwalia J, Waldman A, Borok J, Udkoff J, Boguniewicz M. Current guidelines for the evaluation and management of atopic dermatitis: a comparison of the Joint Task Force Practice Parameter and American Academy of Dermatology guidelines. 

 2017;139(4S):S49–S57. DOI: 10.1016/j.jaci.2017.01.009

Bissonnette R, Simpson EL, Eichenfield LF, et al. Skin clearance, duration of treatment-free interval, and safety of tapinarof cream 1% once daily: results from ADORING 3, a 48-week phase 3 open-label extension trial in adults and children down to 2 years of age with atopic dermatitis. 

 2025;93(3):707–714. doi:10.1016/j.jaad.2025.05.1391

Atopic dermatitis remains highly prevalent and systemically burdensome, driven by barrier dysfunction and type 2 inflammation dominated by IL-4/IL-13. Contemporary guidance strongly endorses topical corticosteroids and calcineurin inhibitors across severities, while newer non-biologic options—topical ruxolitinib, tapinarof, and roflumilast—expand choices for patients not controlled on legacy agents. In allergy practices, real-world use of these newer topicals is constrained by label limits, modest perceived incremental benefit, steroid phobia amplified by social media, and pervasive payer and health-system access barriers.

Experts unpack where new eczema creams fit, and why insurance hurdles and steroid fear keep patients from faster itch relief.

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.

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New Topicals in Atopic Dermatitis: Evidence, Barriers, and Real-World Perspectives 

, Jason Hawkes, MD, associate professor of Dermatology at the University of California Davis in Sacramento, reflected on the evolution of 

 treatment, noted clinicians initially had only 1 single targeted biologic available for those with type 2 inflammation.

New targeted therapies are helping clinicians better understand atopic dermatitis biology.

Different inflammatory pathways may explain why patients respond differently to treatment.

Advances in precision medicine could improve individualized therapy selection for patients with atopic dermatitis.

Since then, however, Hawkes described the therapeutic landscape as having broadened notably, with the introduction of increasingly selective biologics targeting individual cytokines such as interleukin (IL)-13 and IL-31, alongside Janus kinase (JAK) inhibitors impacting multiple inflammatory pathways. He discussed these in his session at the 

2026 Revolutionizing Atopic Dermatitis (RAD) Conference

 and highlighted them in this on-site interview.

How Are New Biologics Changing Atopic Dermatitis Treatment?

According to Hawkes, this notable increase in the diversity of treatment mechanisms has allowed dermatology clinicians to have new and valuable opportunities to compare therapeutic responses across patients and disease states.

How Targeted Therapies Are Revealing Differences Between Patients

He described such advances as having extended beyond simply expanding treatment choices. As more targeted drugs have entered clinical practice, researchers have gained greater insight into why certain inflammatory pathways appear to drive some diseases but not others. Comparing responses among individuals living with atopic dermatitis, chronic spontaneous urticaria (CSU), nasal polyps, and other type 2 inflammatory disorders has begun to reveal meaningful biologic differences that were previously difficult to appreciate.

Hawkes emphasized that clinicians are now witnessing these distinctions in real-world patient care rather than relying solely on laboratory or animal models. Observing which patients respond to specific cytokine blockade, as well as identifying situations in which treatment improves inflammation without fully addressing itch, or vice versa, is helping investigators better characterize the heterogeneous nature of atopic dermatitis.

Why Personalized Medicine May Represent the Future of Atopic Dermatitis Care

Rather than viewing atopic dermatitis as a single disease entity, Hawkes suggested the condition is increasingly being understood as a collection of biologically distinct subgroups. The expanding therapeutic armamentarium is allowing clinicians to identify these differences while generating new insights into disease mechanisms and treatment response.

Ultimately, Hawkes described this shift as an important step toward precision medicine in dermatology. By continuing to define the unique inflammatory pathways driving disease in individual patients, clinicians may eventually be able to better match therapies to specific disease phenotypes, improving outcomes while further refining the management of atopic dermatitis and related inflammatory conditions.

Disclosures: Hawkes has served as a consultant, advisory board member, investigator, and speaker for multiple pharmaceutical companies involved in dermatology, including AbbVie, Arcutis, Blueprint Medicines, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Regeneron, Sanofi, Sun Pharma, Takeda, and UCB, among others. He has also received research funding and reports stock ownership in Regeneron.

Hawkes J, Lieberman J. Session 2: Connecting AD to Other Dermatologic Disorders and Related Comorbidities. Session presented at: 2026 Revolutionizing Atopic Dermatitis Conference; June 17-19, 2026; Nashville, TN.


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Newly published 12-week phase 2 data suggest zabopegdutide (DD01) produced rapid improvements in liver fat, liver stiffness, and fibrosis biomarkers in patients with metabolic dysfunction-associated steatotic liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH), with many benefits occurring before clinically meaningful weight loss.

The findings provide additional context for the company's recently announced positive 48-week phase 2 biopsy results, in which zabopegdutide achieved statistically significant improvements in both MASH resolution and fibrosis improvement among patients with biopsy-confirmed MASH and fibrosis stages F1-F3.

“Our recently announced 48-week biopsy results established that zabopegdutide produces clinically meaningful histological improvements in patients with MASH,” said Seulki Lee, PhD, President and CEO of D&D Pharmatech, in a statement. “The publication in 

 demonstrates that these outcomes were foreshadowed by rapid and substantial improvements in liver health within the first 12 weeks of treatment. Importantly, many of these benefits occurred before meaningful weight loss, suggesting that zabopegdutide provides direct therapeutic effects on the liver beyond weight reduction. Together, these findings highlight the differentiated profile of zabopegdutide and support its potential to become a best-in-class therapy for MASH.”

Early Improvements in Liver Fat and Fibrosis Biomarkers

Zabopegdutide is an investigational once-weekly dual glucagon-like peptide-1 (GLP-1) and glucagon receptor agonist designed to reduce hepatic steatosis while promoting weight loss and improving metabolic parameters. According to investigators, activation of the glucagon receptor is intended to enhance lipid mobilization from the liver, complementing the metabolic effects of GLP-1 receptor agonism.

The randomized, double-blind, placebo-controlled phase 2 DD01-DN-02 trial (NCT06410924) enrolled 67 adults who were overweight or obese with MASLD/MASH. The participants received a 2-week dose escalation to a maintenance dose of 40 mg once weekly or placebo.

At 12 weeks, 75.8% of patients receiving zabopegdutide achieved at least a 30% reduction in liver fat, while 72.7% experienced > 50% reductions. Additionally, 48.5% achieved normalization of liver fat, defined as less than 5% by MRI-proton density fat fraction (MRI-PDFF).

Investigators also reported significant reductions in liver stiffness measured by magnetic resonance elastography (MRE) as well as decreases in fibrosis biomarkers, including enhanced liver fibrosis (ELF) score and procollagen type III N-terminal peptide (PRO-C3). Improvements were also observed in liver enzymes, glycemic control, lipid parameters, and body weight, with mean weight reductions of 3.8% at week 12 and 6.4% at week 24.

Liver Benefits Observed Before Clinically Meaningful Weight Loss

A key finding from the analysis was the observation that improvements in liver health occurred even among participants who had not yet achieved clinically meaningful weight loss.

Among patients with less than 5% weight loss by week 12, treatment with zabopegdutide was associated with a 37.4% reduction in liver fat measured by MRI-PDFF and a 19.2% reduction in liver stiffness by MRE. Investigators noted patients who achieved at least 5% weight loss experienced even greater reductions in liver fat, suggesting both weight-dependent and potentially weight-independent effects may contribute to treatment response.

The investigators suggested these findings support the possibility that zabopegdutide exerts direct hepatic effects in addition to improvements associated with weight reduction. They further noted that the previously reported 48-week biopsy analysis demonstrated statistically significant improvements in MASH resolution and fibrosis among patients who experienced relatively modest weight loss, although additional studies are needed to further characterize the relationship between weight loss and histologic response.

Findings Provide Context for Positive 48-Week Biopsy Results

Although liver biopsy remains the reference standard for evaluating treatment response in MASH, noninvasive imaging and serum fibrosis biomarkers are increasingly used to monitor disease activity during clinical trials.

Investigators noted the current analysis suggests improvements in liver fat, liver stiffness, and fibrosis biomarkers may emerge within the first 12 weeks of treatment and precede the histologic improvements observed after 48 weeks. If confirmed in future studies, these findings could help inform earlier assessment of treatment response using noninvasive measures.

Zabopegdutide was generally well tolerated in the study and reached its target maintenance dose following a 2-week dose-escalation period.

D&D Pharmatech Announces The Lancet Gastroenterology & Hepatology Publication of Phase 2 Data Demonstrating Rapid, Weight-Independent Activity of Zabopegdutide (DD01) in MASLD/MASH

https://www.businesswire.com/news/home/20260721648937/en/DD-Pharmatech-Announces-The-Lancet-Gastroenterology-Hepatology-Publication-of-Phase-2-Data-Demonstrating-Rapid-Weight-Independent-Activity-of-Zabopegdutide-DD01-in-MASLDMASH

D&D Pharmatech Announces Positive 48-Week Histology Results for Zabopegdutide (DD01), Demonstrating Statistically Significant Fibrosis Improvement and MASH Resolution

https://www.businesswire.com/news/home/20260526295057/en/DD-Pharmatech-Announces-Positive-48-Week-Histology-Results-for-Zabopegdutide-DD01-Demonstrating-Statistically-Significant-Fibrosis-Improvement-and-MASH-Resolution

Once-weekly zabopegdutide (DD01), a dual GLP-1/glucagon receptor agonist, demonstrated rapid, noninvasive improvements in hepatic steatosis, liver stiffness, and fibrosis-associated biomarkers over 12 weeks in overweight/obese adults with MASLD/MASH. Most treated patients achieved ≥30% liver fat reduction, with nearly half normalizing liver fat by MRI-PDFF. Reductions in MRE-assessed stiffness and serum fibrosis markers (ELF, PRO-C3) were accompanied by improved liver enzymes and cardiometabolic parameters. Notably, meaningful liver benefits occurred even before ≥5% weight loss, aligning with later 48-week histologic improvements.

Phase 2 data suggest zabopegdutide improved liver fat, stiffness, and fibrosis biomarkers within 12 weeks in adults with MASH.

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.

Phase 2 Data Show Early Liver Benefits With Zabopegdutide in MASH

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

Most newer nonsteroidal topical options are now approved for children as young as 2 years. Linda Stein Gold, MD, discusses adherence and misconceptions of pediatric AD.

Treatment Selection, Adherence, and Misconceptions in Pediatric Atopic Dermatitis

Ryan Livingston joined the MJH Life Sciences team in March of 2025, shortly after graduating from TCNJ with a bachelor’s degree in English. He enjoys creative writing, reading, and scuba diving. He can be reached at rlivingston@mjhlifesciences.com.

If approved, encaleret will be the first treatment specifically indicated for this underrepresented patient population.

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 page also hosts content previously published by EndocrinologyNetwork. 


Hormonal Disorders

FDA Accepts NDA for Encaleret for Autosomal Dominant Hypocalcemia Type 1

Abigail Brooks is a strategic content lead overseeing 

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.

Plozasiran cut triglycerides up to 81% and reduced acute pancreatitis events in phase 3 SHASTA-3, SHASTA-4 trials for severe hypertriglyceridemia.

Plozasiran Meets Primary Endpoint in SHASTA-3, SHASTA-4 sHTG Trials

In the final episode of the series, the discussion turns to therapies currently in development for CSU.

Video Series

Emerging Therapies on the Horizon for CSU

In this episode titled “Building Therapeutic Alliance and Addressing Access Barriers in CSU,” the panel focuses on practical strategies for empowering both patients and clinicians earlier in the CSU care journey.

Building Therapeutic Alliance and Addressing Access Barriers in CSU

This Q&A highlights the significance of the FDA approval of risankizumab (Skyrizi) for psoriasis and psoriatic arthritis in pediatric patients.

Plaque Psoriasis

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

Q&A: How Is Risankizumab’s FDA Approval Changing the Psoriatic Disease Landscape?

New topical mechanisms introduce more ways to control pediatric AD without the sting, burn, or long-term steroid concerns that limit adherence, Linda Stein Gold, MD, says.

New Nonsteroidal Options Are Reshaping Pediatric Atopic Dermatitis Care

Amy Paller, MD, highlights takeaways from the recent FDA approval of risankizumab-rzaa (Skyrizi) for children with psoriasis and PsA.

How Does the FDA Approval of Risankizumab Impact Pediatric Psoriasis and PsA? With Amy Paller, MD

Ron Blankstein, MD, is the associate director of the cardiovascular imaging program, director of cardiac computed tomography, and co-director of the cardiovascular imaging training program at Brigham and Women’s Hospital, as well as a professor of medicine at Harvard Medical School.

Ron Blankstein, MD, discusses a recent study confirming the replicability of CCTA results with AI-CPA in patients with coronary plaque at risk of cardiovascular disease.

Atherosclerotic Cardiovascular Disease

AI-CPA Plaque Assessment Results Consistent, Reproducible Among Observers

Medical director, pediatric hematology/oncology, Sarah Cannon Pediatric Transplant and Cellular Therapy Program, TriStar Centennial, and investigator, Sarah Cannon Research Institute

Exa-cel requires careful counseling on treatment timelines, chemotherapy conditioning, fertility risks, and the gene therapy journey.

Hematology

Sickle Cell

Sickle Cell condition center page, resources on the topics of medical news and expert insight into sickle cell disease can be found. Content includes articles, interviews, videos, podcasts, and breaking news on sickle cell research, treatment, and drug development.

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Enlicitide’s FDA Approval for LDL-C Reduction and the CORALreef Outcomes Trial

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Phase 2 Data Show Early Liver Benefits With Zabopegdutide in MASH