Kathryn Berlacher, MD, MS, is the clinical & strategic director of cardiology at UPMC and the chair of ACC 2026.

Kristen Campbell, PharmD, is a senior research associate in electrophysiology at Duke University Hospital.

ACC 2026 Conference Preview With Kathryn Berlacher, MD, MS, and Kristen Campbell, PharmD

 Scientific Sessions 2026 are set to begin in New Orleans, Louisiana, on March 28th, 2026, spotlighting some of the most impactful developments in cardiovascular care so far this year. With 60 late-breaking presentations and hundreds of discussions scheduled over the 4-day period, keeping up with all of these trial results and treatment advances can be difficult.

 spoke with Kathryn Berlacher, MD, MS, clinical and strategic director of cardiology at UPMC and the chair of ACC 2026, and Kristen Campbell, PharmD, senior research associate in electrophysiology at Duke University Hospital and cardiovascular team lead for ACC 2026, to discuss their top trials to watch during the conference.

Additionally, they covered key updates from ACC itself to be discussed at the meeting, including dyslipidemia and pulmonary embolism guidelines, a crowdsourced session on concierge medicine, and artificial intelligence in cardiovascular medicine.


1. Ultrasound-facilitated Catheter-directed Thrombolysis Vs Anticoagulation Alone for Acute Intermediate-High-Risk Pulmonary Embolism: Primary Results of the HI-PEITHO Randomized Clinical Trial

: The Higher-Risk Pulmonary Embolism Thrombolysis (HI-PEITHO) study, a multicenter randomized controlled parallel-group comparison trial, compared acute pulmonary embolism (PE) treatment with ultrasound-facilitated catheter-directed thrombolysis plus anticoagulation to anticoagulation alone. Investigators sought to establish a first-line treatment in intermediate to high-risk patients with PE with imminent hemodynamic collapse, and expected the results to set the standard for catheter-directed reperfusion options for the future.

2. Reliability Of CAC=0 to Exclude Coronary Plaque in Diverse Global Cohorts: A Global Probability Study of Coronary Artery Disease (GPS-CAD) Analysis

: Coronary artery calcium (CAC) scores are guideline-recommended to evaluate coronary artery disease (CAD); however, different populations have different coronary artery phenotypes, potentially limiting the generalizability of CAC and other pre-test probability strategies. GPS-CAD, which investigated multiple international cohorts of patients referred for noninvasive coronary CTA testing, aimed to determine the accuracy of CAC, among other minimal risk tools, to de-risk cardiovascular diseases in various populations.

3. A Prospective Multicenter Registry to Define Coronary Vasomotor Disorders in Ischemia With Nonobstructive Coronary Arteries: Primary Results of Discover Inoca

: DISCOVER INOCA is a multi-center registry aiming to identify specific phenotypes of ischemia with no obstructive coronary artery disease (INOCA) via an anatomic evaluation and physiological assessment. Investigators used coronary angiography, intravascular imaging, and the Abbott Coroventis Coroflow Cardiovascular System, monitoring long-term outcomes to characterize the burden of 

epicardial coronary artery atherosclerosis

 and myocardial bridging, among other outcomes of patients with INOCA.

4. Outcomes in Patients With Atrial Fibrillation Randomized to Receive Left Atrial Appendage Closure or Oral Anticoagulation: Primary results of the CHAMPION-AF Clinical Trial

: This prospective, randomized, multi-center global investigation aimed to determine if left atrial appendage closure (LAAC) with the WATCHMAN FLX device is a functional and efficacious alternative to standard, non-vitamin K oral anticoagulants in patients with non-valvular atrial fibrillation. These data could provide an alternative to medication in this patient population.

5. Discontinuation Of Beta-Blocker Therapy in Stabilized Patients After Acute Myocardial Infarction

: The SMart Angioplasty Research Team: DEcision on Medical Therapy in patients with Coronary Artery Disease or Structural Heart Disease Undergoing InterventiON (SMART-DECISION) trial is a multicenter, prospective, randomized, open-label, non-inferiority trial comparing discontinuation of beta-blocker therapy after ≥1 year of maintenance in patients after acute myocardial infarction (AMI) to non-discontinuation. Investigators cited a lack of evidence to support the effectiveness of prolonged beta-blocker therapy after stabilization of patients with AMI without 

 or left ventricular systolic dysfunction.

6. NOTIFY-HF: A Randomized Pilot Trial of Patient-Facing Heartlogic Alerts in Heart Failure Patients

: NOTIFY-HF examined HeartLogic, a multiparameter algorithm using physiological sensors in Boston Scientific implantable electronic devices to predict heart failure deterioration with a 34-day median lead time. Investigators integrated the algorithm with a mobile health solution, providing weekly feedback and patient-directed alerts in an attempt to enhance patient self-management of heart failure and assess the feasibility of this approach.

Klok FA, Piazza G, Sharp ASP, et al. Ultrasound-facilitated, catheter-directed thrombolysis vs anticoagulation alone for acute intermediate-high-risk pulmonary embolism: Rationale and design of the HI-PEITHO study. Am Heart J. 2022;251:43-53. 

National Heart Centre Singapore. Global Pretest Probability Study of Coronary Artery Disease (GPS-CAD). ClinicalTrials.gov Identifier: NCT05722145. Updated December 4, 2025. Accessed March 16, 2026. 

https://clinicaltrials.gov/study/NCT05722145

Yale University. The DISCOVER INOCA Prospective Multi-center Registry (DISCOVER INOCA). ClinicalTrials.gov Identifier: NCT05288361. Updated December 18, 2025. Accessed March 16, 2026. 

https://clinicaltrials.gov/study/NCT05288361

Boston Scientific Corporation. CHAMPION-AF Clinical Trial (CHAMPION-AF). ClinicalTrials.gov Identifier: NCT04394546. Updated March 12, 2026. Accessed March 16, 2026. 

https://clinicaltrials.gov/study/NCT04394546

Choi KH, Kim J, Kang D, et al. Discontinuation of β-blocker therapy in stabilised patients after acute myocardial infarction (SMART-DECISION): rationale and design of the randomised controlled trial. BMJ Open. 2024;14(8):e086971. Published 2024 Aug 31. 

Assad J, Lac C, Briggs N, Femia G, Leung DY, Dimitri HR. Early results from a pilot RCT of a heartlogic-driven mHealth pathway (notify-HF) for early heart failure intervention. European Heart Journal. 2025;46(Supplement_1). 

Videos

This conference preview with Kathryn Berlacher, MD, MS, and Kristen Campbell, PharmD, highlights the top 6 trials to watch at ACC 2026.

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Atherosclerotic Cardiovascular Disease

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Conference Preview: American College of Cardiology Scientific Sessions 2026, With Kathryn Berlacher, MD, MS, and Kristen Campbell, PharmD

Introductory episode for ABCs in Dermatology. A new expert-led show in dermatology from HCPLive.

 Introducing ABCs in Dermatology!

In the inaugural episode, co-hosts Lindsay Ackerman, MD, of US Dermatology Partners, and Chris Bunick, MD, PhD, of Yale School of Medicine, introduced the podcast and the philosophy behind it. 

Ackerman-Bunick Conversations in Dermatology, 

 for short, aims to translate complex and rapidly evolving clinical and scientific developments into practical insights for practicing clinicians. New episodes will be released monthly, with video available on HCPLive and audio distributed through Spotify and Apple Podcasts.

The conversation began with each host reflecting on their path into dermatology. Ackerman described early exposure to cutaneous oncology research at the University of Pennsylvania, where she was drawn to the field’s range. Dermatology, she noted, uniquely spans infectious disease, malignancy, genetic disorders, and chronic inflammatory conditions. That breadth, combined with the opportunity to build long-term relationships with patients, helped shape her decision to pursue the specialty.

Bunick traced his interest back to doctoral research in nucleotide excision repair, where his work on the XPC protein introduced him to the biology of non-melanoma skin cancers. A later clinical rotation, along with mentorship from a program director at Vanderbilt University School of Medicine, reinforced his decision to move from laboratory science into dermatology.

A central theme of the episode was the growing importance of molecular literacy in everyday clinical practice. As therapeutic options expand, Bunick emphasized, clinicians increasingly need to understand and communicate the mechanisms behind treatment choices. Explaining the “why” behind a therapy, he noted, helps patients and families feel more confident and engaged in care. He also discussed ongoing work in his structural biology laboratory, including research into keratin biology that has extended beyond dermatology into potential therapeutic applications in triple-negative breast cancer. The work highlights how discoveries rooted in dermatology can inform treatment approaches across other disease areas.

Ackerman discussed her focus on advancing medical dermatology, particularly through clinical trials involving rare or underserved diseases. Her work includes research in congenital ichthyosis, hidradenitis suppurativa, and other conditions that currently lack FDA-approved therapies. Both hosts described the current moment as one of rapid therapeutic progress, with biologic and targeted treatments reshaping outcomes for diseases that historically had limited options.

The episode also addressed the doctor-patient relationship. Ackerman and Bunick stressed the value of genuine human connection in clinical care, noting that trust and clear communication can reduce patient isolation and improve engagement with treatment plans.

Looking ahead, the hosts previewed upcoming topics for the series, including genodermatoses, women’s health in dermatology, and controversial or underexplored clinical questions. The next episode, a preview of the American Academy of Dermatology Annual Meeting, is scheduled for release on March 23.

Podcasts

Experts unpack biologics, molecular know-how, and patient trust—plus key previews for the upcoming AAD Annual Meeting.

Dermatology

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

ABCs in Dermatology

Welcome to ABC’s in Dermatology, HCPLive’s newest dermatology podcast, hosted by a pair of the field’s leading minds in Lindsay Ackerman, MD, and Chris Bunick, MD, PhD.

Created by the same team behind The Medical Sisterhood and Skin of Color Savvy, ABCs in Dermatology is a monthly podcast designed to deliver candid conversations, clinical insight, and forward-looking perspectives from the voices shaping dermatology today.

Introducing ABCs in Dermatology, with Lindsay Ackerman, MD, and Chris Bunick, MD, PhD

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.

 has granted Fast Track designation to BW-20805, an investigational small interfering RNA (siRNA) therapy, for the treatment of 

. Argo Biopharmaceutical announced the news on March 16, 2026. 1

“Receiving FTD from the FDA highlights the significant unmet medical need for patients living with HAE and underscores the potential of BW-20805 as a novel therapeutic option," said Dongxu Shu, co-founder and chief executive officer of Argo Biopharma, in a statement.

The therapy is currently being evaluated in an ongoing global phase 2 open-label trial in adults with HAE, with primary study completion anticipated in the second half of 2026. Early clinical findings presented at the 2026 American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting in Philadelphia suggested that BW-20805 led to substantial pharmacodynamic suppression of prekallikrein and reductions in HAE attack frequency among treated participants.

“The drug BW-20805 is doing what we expect to do, reducing the plasma kallikrein activity and reducing it by more than 90% in a very stable way,” 

said investigator Markus Magerl, MD, from Charité-Universitätsmedizin Berlin, in an interview with HCPLive

The trial continues to evaluate adults with HAE type 1 or 2 across 3 dosing regimens: 600 mg every 24 weeks, 300 mg every 24 weeks, and 300 mg every 12 weeks. As of February 2026, 80% of participants (n = 14; 10 with post-dose efficacy data) remained completely attack-free during the observation period. The 600 mg cohort experienced a 100% reduction in time-normalized HAE attack rates, compared to 89% and 97% reductions in the 300 mg every 24 weeks and every 12 weeks arms, respectively. Depending on the dosing regimen, prekallikrein levels declined by approximately 90% to 97% within the first month of administration and remained stable throughout follow-up.

BW-20805 uses RNA interference to silence messenger RNA encoding hepatic prekallikrein, the precursor of plasma kallikrein. By suppressing prekallikrein production in hepatocytes, the therapy is designed to reduce downstream activation of the kallikrein–kinin cascade and limit bradykinin formation, a key mediator of HAE attacks. The approach reflects a broader therapeutic strategy in HAE focused on inhibiting the kallikrein pathway, which has been validated by currently approved prophylactic agents such as the monoclonal antibody lanadelumab.3

Although these early findings suggest the potential for sustained suppression of the kallikrein pathway, investigators emphasized that the data remain preliminary. The phase 2 study has a relatively small sample size and an open-label design, which may introduce bias in reporting attack outcomes.2 Longer follow-up will be necessary to determine the durability of pharmacologic suppression and to assess long-term safety.

The phase 2 trial of BW-20805 is expected to reach primary completion later in 2026. Following completion of this study, Argo Biopharma has indicated plans to initiate a global phase 3 trial.

“We look forward to advancing the clinical development of BW-20805 and bringing a potentially long-acting treatment option to patients as effectively as possible,” Shu said.

PR Newswire. Argo Biopharma Receives FDA Fast Track Designation for BW-20805, an Investigational siRNA Therapy for the Treatment of HAE. Prnewswire.com. Published March 16, 2026. Accessed March 16, 2026. 

https://www.prnewswire.com/news-releases/argo-biopharma-receives-fda-fast-track-designation-for-bw-20805-an-investigational-sirna-therapy-for-the-treatment-of-hae-302714159.html

Magerl M. BW-20805 Reduces HAE Attacks in Phase 2 Trial, With Markus Magerl, MD. HCPLive. Published on March 10, 2026. Accessed on March 16, 2026. 

https://www.hcplive.com/view/bw-20805-reduces-hae-attacks-phase-2-trial-markus-magerl-md

FDA Approves Lanadelumab for Hereditary Angioedema. Hcplive.com. Published August 24, 2018. Accessed March 16, 2026. 

https://www.hcplive.com/view/fda-approves-lanadelumab-for-hereditary-angioedema

Articles

FDA Fast Track designation was granted to BW-20805, an investigational siRNA prophylactic for hereditary angioedema targeting hepatic prekallikrein. In an ongoing global phase 2 open-label study in adults with HAE types 1/2, dosing every 12–24 weeks produced ~90–97% prekallikrein suppression within one month with sustained effect. As of February 2026, 80% of participants with efficacy data were attack-free; time-normalized attack rates fell 89–100% across cohorts. Limitations include small, open-label data; longer safety and durability follow-up is needed before phase 3.

Investigational RNA interference therapy targeting prekallikrein enters accelerated regulatory pathway as phase 2 trial evaluates long-acting prophylaxis for HAE.

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.

FDA News

FDA Grants Fast Track Designation to BW-20805 siRNA Therapy for HAE

Victoria Johnson joined the MJH Life Sciences in 2020 and has written for NeurologyLive, CGTLive, and now HCPLive. You can reach her at vjohnson@mjhlifesciences.com

announced March 16 that the United States Food and Drug Administration (US FDA) has accepted its new drug application (NDA) for bezuclastinib in adults with non-advanced systemic 

 (NonAdvSM) and set a PDUFA target action date of December 30, 2026.

 The agency communicated that it does not plan to hold an advisory committee meeting and has not identified any potential review issues. The acceptance marks the first potential therapy specifically targeting the KIT D816V mutation in this population.

The NDA is supported by results from the pivotal SUMMIT trial (NCT05186753), in which bezuclastinib met its primary endpoint and all key secondary endpoints with statistical significance.

 Extended 48-week data presented at the 2026 American Academy of Allergy, Asthma & Immunology (AAAAI) annual meeting show continued deepening of benefit across all symptom domains and across biomarker endpoints.

Systemic mastocytosis encompasses a spectrum of subtypes defined by neoplastic mast cell infiltration of tissues and pathologic mast cell mediator release. Non-advanced subtypes — indolent SM (ISM), smoldering SM (SSM), and bone marrow mastocytosis (BMM) — are the most prevalent forms and are distinguished from advanced SM by the absence of an associated hematologic neoplasm or mast cell leukemia.

The gain-of-function somatic KIT p.D816V mutation drives pathology in up to 95% of SM patients and is the primary therapeutic target for kinase inhibitor development in this space. Bezuclastinib (CGT9486) is an oral, potent, selective type 1 tyrosine kinase inhibitor with activity specifically against KIT D816V. Its type 1 binding conformation targets the active kinase state, differentiating it mechanistically from avapritinib, the only currently approved KIT D816V inhibitor, which is indicated for advanced SM only.

Despite its substantial symptom burden — which can include flushing, urticaria pigmentosa, anaphylaxis, bone pain, and gastrointestinal and neurocognitive manifestations — NonAdvSM has no approved therapy targeting the underlying mutation.

SUMMIT is a multicenter, randomized, double-blind, placebo-controlled phase 2 trial in adults with NonAdvSM and inadequate symptom control on best supportive care (BSC).

 Patients were randomized 2:1 to bezuclastinib 100 mg once daily plus BSC or placebo plus BSC, with the dose established from SUMMIT Part 1. As of the May 22, 2025 data cutoff, 179 patients were enrolled: 119 to bezuclastinib and 60 to placebo.

The primary endpoint was 24-week mean change from baseline in the Mastocytosis Symptom Severity Daily Diary (MS2D2) total symptom score (TSS; range 0–110), a fit-for-purpose patient-reported outcome tool. Key secondary endpoints included proportions achieving ≥50% reductions in serum tryptase, KIT p.D816V variant allele frequency (VAF), bone marrow mast cell burden, and MS2D2 TSS, as well as ≥30% TSS reduction.

The enrolled population was representative of the real-world NonAdvSM population: median age 51 years (range, 23–78); 65.9% female; mean baseline MS2D2 TSS 55.6. By subtype, 82% had ISM, 11% BMM, and 7% SSM. Median baseline serum tryptase was 40 ng/mL.

Bezuclastinib demonstrated statistically significant superiority over placebo on the primary endpoint and all key secondary endpoints.

LS mean –24.3 points (95% CI, –27.6 to –21.1) with bezuclastinib vs –15.4 points (95% CI, –19.6 to –11.2) with placebo; placebo-adjusted difference of –8.9 points (

87.4% of bezuclastinib patients vs 0% placebo (

KIT D816V VAF ≥50% reduction, bone marrow mast cell ≥50% reduction, MS2D2 TSS ≥50% and ≥30% reductions: 

All significantly favored bezuclastinib vs placebo (

 <.0001 for VAF, tryptase, and BM burden; 

Extended data presented at AAAAI 2026 demonstrate continued and deepening improvement through 48 weeks across all 13 MS2D2 symptom domains, with mean changes from the baseline score of 8.1 observed for itching (–5.2), flushing (–5.1), skin papules (–5.2), fatigue (–6.0), cognitive concentration (–7.3), memory (–5.7), nausea (–5.5), abdominal pain (–3.3), headache (–4.3), bone pain (–4.0), diarrhea (–5.6), brain fog (–3.0), and dizziness (–3.4) — each representing further improvement beyond the 24-week timepoint.

By week 48, 86% of bezuclastinib-treated patients (81/94) achieved a ≥30% reduction in MS2D2 TSS, and 56.4% (53/94) achieved ≥50% reduction.

Biomarker deepening was also pronounced. Serum tryptase ≥50% reduction was achieved in 98.9% of bezuclastinib patients (88/89) at week 48. Among patients who had crossed over from placebo, 96.1% (49/51) achieved the same threshold, with median serum tryptase of 5.8 ng/mL. In the bezuclastinib arm, median tryptase fell to 4.7 ng/mL; 91.7% (66/72) fell below 20 ng/mL and 83.3% (70/84) fell below 11.4 ng/mL. KIT p.D816V VAF in peripheral blood fell to a median of 0.04% in bezuclastinib-treated patients vs 0.07% in placebo crossovers, with 98.4% (61/62) of the ITT population achieving ≥50% VAF reduction.

"These interviews were conducted before they were enrolled in the trial, and they focused on different domains, like skin, gastrointestinal, neurocognitive domains and there are some sentences taken directly from the patient interview that kind of tells you the impact of these patients are experiencing. And some of them are really very severe. And I think for somebody who is new to the field, it is absolutely eye opening to recognize what the patient's going through,” investigator Cem Akin, MD, Professor of Medicine, University of Michigan Division of Allergy and Immunology, told 

The 24-week safety profile was consistent with KIT inhibitor class effects, with 70% of TEAEs grade 1.

 TEAEs occurring in ≥10% of bezuclastinib patients and at greater frequency than placebo included hair color changes (69.5% vs 5.0%), altered taste (23.7% vs 0%), nausea (22.0% vs 13.3%), ALT/AST elevation (22.0% vs 6.6%), headache (17.8% vs 11.7%), alopecia (11.9% vs 3.3%), and ALP elevation (10.2% vs 3.3%).

Grade ≥3 ALT/AST elevations occurred in 5.9% of bezuclastinib patients. All hepatic adverse events were transient laboratory abnormalities; none required hospitalization. Dose reductions due to treatment-related adverse events occurred in 11% of bezuclastinib patients. All discontinuations due to treatment-related adverse events (5.9%) were attributable to transaminase elevations, all of which fully resolved.

Through 48 weeks, the tolerability profile remained favorable: serious TEAEs occurred in just 1.7% of bezuclastinib-treated patients, and discontinuations due to TEAEs were 9.2% (11/119) during the double-blind period.

Cogent Biosciences also noted that a separate NDA submission for advanced SM (AdvSM) that remains on track for the first half of 2026.

Cogent Biosciences. FDA accepts NDA for bezuclastinib in NonAdvSM and assigns PDUFA date of December 30, 2026 [press release]. March 16, 2026.

2. Rein L, Boggs N, Bose P, et al. Efficacy and safety results from the primary analysis of the pivotal SUMMIT trial: bezuclastinib in adults with non-advanced systemic mastocytosis. 

2025;146(Suppl 1):80. doi:10.1182/blood-2025-80

3. Boggs NA, Rein L, Bose P, et al. Expanded Results From the Phase 2 Summit Trial: Bezuclastinib in Adults With Nonadvanced Systemic Mastocytosis. Presented at: AAAAI 2026 Annual Meeting, February 27-March 2, Philadelphia, Pennsylvania. Abstract #519

US FDA accepted the NDA for bezuclastinib for adults with non-advanced systemic mastocytosis and set a PDUFA date of December 30, 2026, without plans for an advisory committee or flagged review issues. The selective type 1 KIT D816V inhibitor produced statistically significant improvements in symptom burden and disease biomarkers in the randomized, placebo-controlled SUMMIT trial on best supportive care. Follow-up to 48 weeks showed deepening, broad-based symptom relief and further reductions in tryptase and KIT VAF, with manageable, largely low-grade toxicities.

The FDA has set a PDUFA date of December 30, 2026.

FDA Accepts NDA for Bezuclastinib in Non-Advanced Systemic Mastocytosis

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.

Raymond Stevens, PhD | Image Credit: Structure Therapeutics

On March 16, 2026, Structure Therapeutics reported positive topline results from the ACCESS clinical program, investigating aleniglipron for patients with 

The ACCESS program includes 44-week data from the phase 2 ACCESS II study and interim data from an ongoing body composition study, as well as the ACCESS open-label extension study. The former was a randomized, double-blind, placebo-controlled study investigating the safety and tolerability of increasing optimal doses of aleniglipron in patients with obesity or overweight with ≥1 weight-related comorbidity.

“The totality of efficacy and tolerability data across the Phase 2 program continue to demonstrate clear differentiation of aleniglipron, with the highest weight loss observed for an oral GLP-1RA to date and a safety profile appropriate for chronic use in a disease that impacts millions of people,” Raymond Stevens, PhD, chief executive officer of Structure Therapeutics, said in a statement. “The consistent weight loss observed across multiple studies to date reaffirms aleniglipron’s potential to be a best-in-class oral GLP-1, with injectable-like efficacy that could become a backbone oral small molecule therapy for obesity.”

Aleniglipron is an investigational, oral, once-daily small-molecule GLP-1 receptor agonist designed as a biased G Protein-Coupled Receptor (GPCR) agonist, which selectively activates the G-protein signaling pathway. The drug has demonstrated a consistent tolerability profile with the GLP-1 RA class, as well as a solid safety profile with no off-target events.

In ACCESS II, patients were eligible for inclusion if they had a body mass index (BMI) ≥30 kg/m2, or a BMI ≥27 kg/m2 and previous or current diagnosis of ≥1 obesity-related comorbidity. Patients were excluded if they had a previous diagnosis of 

 mellitus, a self-reported change in body weight >5% within 3 months before screening, a prior or planned surgical treatment for obesity, or were using medications intended to promote weight loss within 6 months prior to screening.

A total of 85 patients were enrolled in the ACCESS II trial and were assigned evenly to aleniglipron or placebo, starting at 5 mg and titrating up to 120 mg, 180 mg, and 240 mg over 4 weeks. By 44 weeks, patients receiving 120 mg of aleniglipron saw a mean body weight change of -13.6%, while the 180 mg arm saw -15.3% and the 240 mg arm saw -15%, compared to +1.1% in placebo (

 <.0001). Additionally, the most common adverse events were gastrointestinal-related, with the 2 most common being nausea and vomiting.

The ACCESS open-label extension is an ongoing investigation following the 36-week phase 2b ACCESS study, after which patients were given the option to continue into the extension and receive aleniglipron for another 36 weeks. Patients were then titrated up to a maximum dose of 120mg during the extension, achieving weight loss ≤16.2% from baseline to 56 weeks.

The body composition study, an ongoing randomized, placebo-controlled body composition study including 71 patients, aimed to assess the effect of aleniglipron ≤120 mg on body fat loss over a 40-week evaluation period. Participants start at a 2.5 mg dose and titrate monthly to a target dose of 120 mg. After 20 weeks, investigators conducted an interim analysis, highlighting that beginning at a lower dose for the first 4 weeks showed a manageable tolerability profile and 6.8% weight loss.

“The weight-lowering data from these ACCESS studies, without apparent plateau by Week 56, are encouraging—particularly the weight loss from baseline of up to -15.3% vs +1.1% at 180mg in ACCESS II that hopefully will be confirmed in larger, longer-term studies,” Julio Rosenstock, MD, chair of the ACCESS program Steering Committee and clinical professor of medicine at the University of Texas, Southwestern Medical Center, said in a statement. “In addition, the tolerability profile of starting at a low dose of 2.5 mg and the slow titration positions the program ready for Phase 3 studies.”

Structure Therapeutics. Structure Therapeutics Reports Positive Topline Data from Phase 2 ACCESS II Trial with Once-Daily Oral Small Molecule GLP-1 Receptor Agonist, Aleniglipron. March 16, 2026. Accessed March 16, 2026. 

https://ir.structuretx.com/news-releases/news-release-details/structure-therapeutics-reports-positive-topline-data-phase-2

Gasherbrum Bio. A Dose-Range Study of Aleniglipron (GSBR-1290) in Participants Living With Obesity or Overweight With at Least One Weight-related Comorbidity (ACCESS II). ClinicalTrials.gov Identifier: NCT06703021. Updated September 15, 2025. Accessed March 16, 2026. 

https://clinicaltrials.gov/study/NCT06703021

Topline phase 2 ACCESS program data for once-daily oral small-molecule GLP-1RA aleniglipron showed substantial, dose-related weight loss in adults with obesity/overweight plus comorbidity. In ACCESS II (n=85), 44-week mean body-weight change reached −13.6% (120 mg), −15.3% (180 mg), and −15.0% (240 mg) versus +1.1% with placebo (P<.0001), with primarily GI adverse events. Extension data suggested continued loss to 56 weeks without clear plateau. Mechanistically, biased GPCR agonism favors G-protein signaling; no off-target safety signals were reported.

Data from the ACCESS II trial, ACCESS extension study, and a body composition study provide an early look at efficacy and safety data of a new investigational oral GLP-1.

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.

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Interim Results from ACCESS Program of Aleniglipron Shows Weight Loss Efficacy

This interview highlights key points regarding new data on roflumilast cream 0.05% in children aged 2 to 5 years with atopic dermatitis.

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.

On New Roflumilast Cream Data for Atopic Dermatitis in Children, With Lawrence Eichenfield, MD

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

Psoriasis severity goes beyond BSA: IGA, DLQI and high-impact areas redefine “moderate,” guiding when to move from topicals to systemic therapy.

Video Series

Identifying and Managing Patients with Moderate Psoriasis

Martinez and Harper discuss the limits of current therapies, the role of septal reduction procedures versus cardiac myosin inhibitors, and the complexities of managing younger and childbearing-age patients with oHCM.

Choosing Between Septal Reduction and Myosin Inhibitors in oHCM Patients

Dermatology experts share how IL‑23 therapies and comparative data boost clearance, cut switching, and improve psoriasis quality of life

Challenges in Managing Plaque Psoriasis”

Patrick Campbell is the editorial director of HCPLive. Patrick has spent years spearheading coverage surrounding cardiometabolic health and rheumatic disease for MJH Life Sciences. Before joining MJH Life Sciences in 2019, he spent time as a beat reporter and/or multimedia specialist with the Pocono Record, Star News Group, and NJ Advance Media. He is the executive producer for multiple HCPLive podcasts, including Diabetes Dialogue, Don't Miss a Beat, Kidney Compass, Medical Ethics Unpacked, The Medical Sisterhood, and Skin of Color Savvy. 


Follow him on Twitter @RealPatCampbell or reach him via email at PCampbell@mjhlifesciences.com.

Phase 3 FIND-CKD shows finerenone slows non-diabetic CKD decline by improving eGFR slope; Bayer prepares FDA filing for expanded use.

Chronic Kidney Disease

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.

Finerenone Proves CKD Benefit Extends Beyond Diabetes in FIND-CKD

Lebrikizumab posts strong Phase 3 gains in infants to teens with atopic dermatitis, supporting FDA label expansion and itch relief.

Phase 3 Trial Supports Lebrikizumab in Pediatric Atopic Dermatitis

An audio recap of the top 5 stories in healthcare news from the week of 03/02-03/08.

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.

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.

Hepatology

HCPLive 5 Stories in Under 5: Week of 03/08

Nicole Negbenebor, MD, is a clinical assistant professor of dermatology and the director of the Skin of Color Clinic for the University of Iowa, as well as a Skin of Color Society (SOCS) member.

Nicole Negbenebor, MD, discusses how writing and collaboration help advance dermatologic research and patient advocacy.

Using Writing to Advocate for Patients in Dermatology, With Nicole Negbenebor, MD

Anna Nowak-Wegrzyn, MD, PhD, of NYU Grossman School of Medicine.

At AAAAI 2026, Anna Nowak-Wegrzyn, MD, discussed the use of ondansetron, home management strategies, and guidance on the gradual reintroduction of foods in FPIES.

Best Practices for Managing FPIES Reactions, With Anna Nowak-Wegrzyn, MD, PhD

Stay updated with the latest healthcare breakthroughs, including FDA actions and new trial data, in this week’s essential news roundup.

Latest News

Conference Preview: American College of Cardiology Scientific Sessions 2026, With Kathryn Berlacher, MD, MS, and Kristen Campbell, PharmD

Introducing ABCs in Dermatology, with Lindsay Ackerman, MD, and Chris Bunick, MD, PhD

FDA Grants Fast Track Designation to BW-20805 siRNA Therapy for HAE

FDA Accepts NDA for Bezuclastinib in Non-Advanced Systemic Mastocytosis

Interim Results from ACCESS Program of Aleniglipron Shows Weight Loss Efficacy