Jonggi Choi, MD, PhD, is an associate professor at Asan Medical Center, University of Ulsan College of Medicine, and visiting scholar at Mass General Hospital.

Statins and Improved Long-Term Liver Outcomes in PBC, With Jonggi Choi, MD, PhD

Statins are widely recognized as cholesterol-lowering agents, but over the past decade, accumulating evidence has suggested their benefits may extend beyond lipid management.

 highlights a reduced risk of hepatic decompensation and major liver events in patients with primary biliary cholangitis (PBC) taking statins, supporting a potential protective effect in this population.

“Several large observational studies have suggested that statins may slow liver fibrosis, reduce complications related to portal hypertension, and even lower the risk of liver cancer,” Jonggi Choi, MD, PhD, an associate professor at Asan Medical Center, University of Ulsan College of Medicine, and visiting scholar at Mass General Hospital, told HCPLive. “About a year ago, our group also published a large case study in 

 showing that statin use was associated with improved outcomes in patients with overall chronic liver disease, which further raised interest in their potential liver protective effects. However, when it comes to PBC, the evidence has been much more limited.”

He noted that PBC is a rare autoimmune cholestatic liver disease characterized by chronic inflammation and progressive destruction of the small bile ducts, ultimately leading to cirrhosis if left untreated. Most prior studies in PBC, he explained, focused on short-term laboratory changes rather than clinically meaningful long-term outcomes like liver failure, transplantation, or cancer. As a result, whether statins influence the long-term course of PBC has remained unclear.

Because randomized controlled trials are particularly challenging in rare diseases like PBC, investigators used a target trial emulation approach with real-world data. As Choi described, this method structures observational data to closely mimic a randomized clinical trial, helping to minimize common biases such as immortal time bias.

Using 2 large, independent electronic health record databases from Mass General Brigham and Asan Medical Center, investigators identified statin initiation on a month-by-month basis. In each monthly trial, statin initiators were matched in a 1:2 ratio to non-users using propensity score matching.

The primary outcome was hepatic decompensation while the secondary outcome was a composite major adverse liver outcome (MALO), including decompensation, hepatocellular carcinoma, and liver transplantation.

Among 2889 eligible patients, 443 statin users were matched to 886 non-users. During a median follow-up of 3.8 years, hepatic decompensation occurred in 24 statin users (5.4%) and in 67 non-users (7.6%) (hazard ratio [HR], 0.61; 95% confidence interval [CI]: 0.38–0.97). Statin use was additionally associated with a reduced risk of MALO (HR, 0.58; 95% CI: 0.38–0.89).

Importantly, Choi noted sensitivity analyses stratified by data source (MGB, HR 0.65; AMC, HR 0.60) and cirrhosis status (HR 0.70 for cirrhosis; HR 0.57 for without) showed similar directional trends, indicating that results were consistent across different groups.

Editors’ Note: Choi reports relevant disclosures with Gilead.

Choi J, Xu J, Nguyen VH, et al. Association between statin use and hepatic decompensation in patients with primary biliary cholangitis: A target trial emulation study. 

Choi J, Nguyen VH, Przybyszewski E, et al. Statin Use and Risk of Hepatocellular Carcinoma and Liver Fibrosis in Chronic Liver Disease. 

 2025;185(5):522–530. doi:10.1001/jamainternmed.2025.0115

Videos

Choi describes existing evidence on statin use in patients with liver disease and reviews his new research about their potential utility in PBC.

News

news page, resources on the topics of disease- and specialty-specific medical news and expert insight can be found. Content includes articles, interviews, videos, podcasts, and breaking news on health care research, treatment, and drug development.

Clinical

clinical page is a resource for content on every specialty, disease, and topic available on our medical news site.

Hepatology

Cholangitis

cholangitis page, resources on the topics of medical news and expert insight into cholangitis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on research, treatment, and drug development in PBC, PSC, and more!

Tim Smith joined the MJH Life Sciences team in 2022 and is currently an associate editor for HCPLive. He is also the executive producer of two podcasts: Skin of Color Savvy and The Medical Sisterhood. Previously, he was the producer of the Lungcast podcast. He graduated from UC Berkeley and worked in multimedia journalism as a staff writer prior to joining MJH. You can contact him at tsmith@mjhlifesciences.com.

Positive results have been released from the 36-week blinded maintenance period of the 52-week REZOLVE-AD study of rezpegaldesleukin, a novel regulatory T-cell (Treg) biologic, in individuals with 

These data, announced on February 10 by Nektar Therapeutics, resulted from the global, phase 2b REZOLVE-AD study, involving 393 individuals with atopic dermatitis. Atopic dermatitis is known to impact around 30 million patients in the US. The 

 granted a Fast Track designation for rezpegaldesleukin for the treatment of adult and pediatric patients aged 12 years and older with atopic dermatitis.

"These data show that rezpegaldesleukin, as a broad-based Treg agonist, is emerging as one of the most important mechanisms in development to treat atopic dermatitis," Jonathan Silverberg, MD, PhD, MPH, professor of dermatology at The George Washington University School of Medicine and Health Sciences, said in a statement.

 "With both monthly and quarterly maintenance dosing, new and sustained responses were observed across the key endpoints of EASI-75, vIGA-0/1 and itch and with a large proportion of patients achieving complete clearance with EASI-100."

Investigators of the REZOLVE-AD study began in October 2023, conducting their research at roughly 110 sites around the world. Most of the participants involved in this analysis were treated in Europe (68%), followed by the US (16%), Canada (11%), and Australia (5%). Patients were required, in order to qualify for involvement, to have an Eczema Area and Severity Index (EASI) score of 16.0 at minimum, a validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of 3 or higher at both screening and randomization, and a level of body surface area involvement of 10% or greater.

There were 393 subjects involved in this global phase 2b study, with participants being randomized during the 16-week induction phase in a 3:3:3:2 ratio to be provided with 1 of 3 subcutaneous doses of rezpegaldesleukin or placebo. Rezpegaldesleukin-treated individuals who attained at least a 50% reduction in their 16-week EASI scores were re-randomized on a 1:1 basis to continue with the drug at their original induction dose administered either every 4 or every 12 weeks through Week 52 as part of a blinded maintenance period.

Those shown not to meet the EASI-50 threshold during induction entered a treatment escape arm that allowed up to 36 additional weeks of use. Both of the aforementioned maintenance schedules were linked with durable disease control. This was across multiple efficacy measures, including EASI-75, EASI-90, vIGA-AD response, and improvement on the Itch Numerical Rating Scale. The 24 µg/kg dose administered either monthly or quarterly demonstrated the strongest response maintenance by the 52-week mark.

Notably, continued treatment led to additional clinical gains, with a substantial number of patients achieving new EASI-75, EASI-90, itch, and vIGA-AD 0/1 responses by the end of the study, despite less frequent dosing. In the maintenance phase, the proportion of patients reaching complete skin clearance increased markedly. Among all re-randomized participants, EASI-100 response rates rose from 4% to 22% with Q4W dosing and from 9% to 18% with Q12W dosing between weeks 16 and 52.

Among those who already had an EASI-75 or vIGA-AD response at maintenance baseline, EASI-100 rates were found to have risen from 6% to 30% with monthly dosing and from 14% - 27% with quarterly dosing regimens. The team highlighted these rates as representing a 2- to 5-fold improvement in complete response rates for the 24 µg/kg regimens. The safety profile of rezpegaldesleukin during maintenance was consistent with earlier data from the induction period, with the investigators finding no new safety signals. Across all of those assessed, discontinuations resulting from AEs occurred in 3.5%.

Reports of treatment-emergent adverse events (TEAEs) were noted among 72% of re-randomized rezpegaldesleukin-treated individuals, 65% of placebo-treated patients in maintenance, and 83% of subjects in the escape cohort. Reactions at patients’ injection sites were the most often AEs reported, the majority of which were mild, occurred less frequently than during induction, and resulted in discontinuation of the drug in only .7% of those evaluated.

"These data highlight that rezpegaldesleukin offers a completely novel therapeutic modality for the potential treatment of atopic dermatitis with numerous advantages to existing classes," said David Rosmarin MC, the chair of the department of dermatology and associate professor of Dermatology at Indiana University School of Medicine, said in a statement.

New REZOLVE-AD Maintenance Data in Atopic Dermatitis Demonstrate Rezpegaldesleukin Resulted in Durable and New Responses Across Key Disease Measurements with Both Monthly and Quarterly Dosing. Nektar Therapeutics. February 10, 2026. 

https://ir.nektar.com/news-releases/news-release-details/new-rezolve-ad-maintenance-data-atopic-dermatitis-demonstrate

Smith T. FDA Grants Fast Track Designation to Rezpegaldesleukin for Atopic Dermatitis. HCPLive. February 10, 2025. Accessed February 10, 2026. 

https://www.hcplive.com/view/fda-grants-fast-track-designation-rezpegaldesleukin-atopic-dermatitis

Articles

Rezpegaldesleukin, a Treg agonist biologic, demonstrated durable and incremental efficacy through 52 weeks in moderate-to-severe atopic dermatitis following a 16-week induction and blinded maintenance period. Patients achieving EASI-50 at Week 16 maintained control with Q4W or Q12W dosing, with the 24 µg/kg regimen showing the strongest maintenance. Complete clearance improved substantially during maintenance, with EASI-100 rising from single digits at Week 16 to ~18%–22% by Week 52. Safety remained consistent, without new signals.

These data highlight the impact of rezpegaldesleukin therapy on adults with moderate-to-severe atopic dermatitis in the phase 2b REZOLVE-AD study.

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.

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.

REZOLVE-AD: Rezpegaldesleukin Improves Symptoms of Atopic Dermatitis

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.

Takeda announced on February 10, 2026, that the US Food & Drug Administration (FDA) accepted the New Drug Application (NDA) and granted Priority Review of oveporexton (TAK-861) for the treatment of 

Oveporexton, an investigational oral orexin receptor (OX2R)-selective agonist, addresses the underlying orexin deficiency that causes NT1 by restoring orexin signaling. The FDA assigned oveporexton a Prescription Drug User Fee Act (PDUFA) target date in the third quarter of 2026.

“The FDA’s acceptance of our NDA is a milestone for people living with narcolepsy type 1,” said Andy Plump, MD, PhD, president of R&D at Takeda, in a statement. “Considering the high unmet need, this community deserves a new and different treatment approach that aims to address the underlying orexin deficiency that causes NT1 by restoring orexin signaling.

Patients with NT1 experience a spectrum of physical, cognitive, and psychosocial effects. Despite available treatments, most patients with this rare neurological disease continue to live with these debilitating symptoms.

The NDA is supported by pivotal phase 3 data from FirstLight and (TAK-861-3001) and RadiantLight (TAK-861-3002). Takeda had presented this phase 3 data at World Sleep 2025 in Singapore on September 8, 2026. Both FirstLight and RadiantLight met all primary and secondary endpoints.

These trials demonstrated significant and clinically meaningful improvements in wakefulness, excessive daytime sleepiness, cataplexy, ability to maintain attention, overall quality of life, and daily functions by week 12 with either 1 mg or 2 mg of oveporexton taken twice daily (all 

 By the end of the trial, symptom levels were all near normal ranges.

The trial showed that most patients treated with oveporexton 2 mg twice a day achieved wakefulness within a normal range (≥ 20 minutes) on the Maintenance of Wakefulness Test, and nearly 85% of patients reached Epworth Sleepiness Scale scores that were comparable to healthy controls (≤ 10). Regarding cataplexy, participants had a median percent change from baseline of > 80%. Compared to placebo, the average cataplexy-free days improved from 0 days at baseline to 4 – 5 days per week at week 12.

Furthermore, oveporexton demonstrated statistically significant changes from baseline in the narcolepsy severity score compared to placebo. More than 70% of participants reported the lowest severity levels (0 – 14). Additionally, 97% of participants treated with oveporexton reported improvements, as reflected by the self-related Patient Global Impression of Change (PGI-C) scale.

Oveporexton significantly improved quality of life, as seen through the Short Form-36-item (SF-36) survey. Patients also experienced improvements in the EuroQol 5-Dimension 5-Level (EQ-5D-5L).

The treatment was generally well-tolerated; common adverse events included insomnia, urinary urgency, and urinary frequency. No serious treatment-related adverse events were reported.

The FDA had previously granted oveporexton Breakthrough Therapy designation for the treatment of excessive daytime sleepiness in NT1. Oveporexton had also received a Breakthrough Therapy designation from the Center for Drug Evaluation of China’s National Medical Products Administration, as well as a Sakigake designation from the Japanese Ministry of Health, Labor, and Welfare.

“We are one step closer to potentially transforming the current treatment paradigm and intend to deliver through our leading work in orexin science,” Plump continued.

U.S. Food and Drug Administration Accepts New Drug Application and Grants Priority Review for Takeda’s Oveporexton (TAK-861) as a Potential First-in-Class Therapy for Narcolepsy Type 1. Takeda. Published on February 10, 2026. Accessed on February 10, 2026. 

https://www.takeda.com/newsroom/newsreleases/2026/fda-accepts-nda-priority-review-oveporexton-narcolepsy-type-1/ 

Takeda Presents Orexin Data from Landmark Oveporexton (TAK-861) Phase 3 Program in Narcolepsy Type 1 at World Sleep 2025. Takeda. Published on September 8, 2025. Accessed on February 10, 2026. 

https://www.takeda.com/newsroom/newsreleases/2025/takeda-orexin-data-oveporexton-phase-3-narcolepsy-world-sleep-2025/

FDA grants Priority Review for Takeda’s oveporexton, an oral orexin agonist for narcolepsy type 1, showing near-normal symptom control in phase 3.

FDA News

Sleep

On the HCPLive sleep page, resources on the topics of medical news and expert insight into sleep medicine can be found. Content includes articles, interviews, videos, podcasts, and breaking news on sleep apnea, insomnia, narcolepsy, and more.

FDA Accepts NDA, Grants Priority Review for Oveporexton to Treat Narcolepsy Type 1

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.

Hengrui Pharma and Kailera Therapeutics have announced positive topline data from Hengrui’s phase 2 clinical trial of once-daily oral ribupatide (HRS9531 tablet; KAI-9531-T), a GLP-1/GIP receptor dual agonist peptide, in adults living with obesity in China.

As described in a February 10, 2026, press release, participants receiving oral ribupatide demonstrated a mean weight reduction from baseline of up to 12.1% at 26 weeks based on the efficacy estimand with no observed plateau in weight loss, and vomiting was reported in ≤ 11.4% of participants taking oral ribupatide.

“The Hengrui Phase 2 clinical trial results mark an important milestone in the expansion of our ribupatide franchise. We believe oral ribupatide could help to address the diverse needs of people living with obesity or overweight and meet patients wherever they are in their treatment journey,” Scott Wasserman, MD, Chief Medical Officer of Kailera, said in a statement. “These positive data suggest a potentially game-changing clinical profile for an oral obesity therapy, and we look forward to initiating a Phase 2 trial later this year. Concurrently, we intend to build upon the comprehensive injectable ribupatide data with the Phase 3 KaiNETIC program with the goal of rapidly and efficiently bringing more options to patients.”

Ribupatide is a GLP-1 receptor dual agonist peptide being developed as a once-weekly subcutaneous injection and as a once-daily oral tablet for the treatment of obesity and overweight. Once-weekly injectable ribupatide has been studied in > 2500 clinical trial participants who have been dosed with treatment out to 52 weeks, including in multiple late-stage clinical trials conducted by Hengrui in China. Hengrui submitted a marketing authorization application to the National Medical Products Administration in China for long-term weight management in adults.

In May 2024, Hengrui granted Kailera exclusive global rights outside Greater China to develop, manufacture, and commercialize its portfolio of innovative GLP‑1 therapeutics, including ribupatide. With these rights, Kailera is currently evaluating injectable ribupatide for the treatment of obesity in the KaiNETIC global phase 3 clinical program.

The HRS9531-T-201 clinical trial is a multi-center, randomized, double-blind, placebo-controlled Phase 2 clinical trial conducted by Hengrui in China to evaluate the efficacy and safety of oral ribupatide in adults ≥18 years of age living with obesity, defined as BMI ≥ 28 kg/m2, and without type 2 diabetes.

The study enrolled 166 participants who were randomly assigned in equal ratio to receive once-daily oral ribupatide 10 mg, 25 mg, 50 mg, or placebo. Participants followed a simple titration schedule, reaching the doses of 10 mg and 25 mg at week 4, and 50 mg at week 8. The primary objective was to evaluate the effect of oral ribupatide versus placebo on body weight at 26 weeks.

Based on the efficacy estimand at week 26, participants taking oral ribupatide achieved a mean weight loss of 6.9% (10 mg), 12.1% (25 mg), and 12.1% (50 mg) from baseline, with no observed plateau in weight loss, compared to 2.3% with placebo. Based on the treatment policy estimand at week 26, participants taking oral ribupatide achieved a mean weight loss of 6.7% (10 mg), 11.9% (25 mg), and 11.4% (50 mg) from baseline, with no observed plateau in weight loss, compared to 2.1% with placebo.

Additionally, at the 25 mg dose, 59.1% of participants achieved at least 10% weight loss, and 38.6% of participants achieved at least 15% weight loss at week 26. At the 50 mg dose, 52.5% of participants achieved at least 10% weight loss, and 37.5% of participants achieved at least 15% weight loss at week 26.

Results showed wral ribupatide demonstrated a favorable safety and tolerability profile, with most treatment-emergent adverse events (TEAEs) being mild to moderate and gastrointestinal (GI)-related. Rates of vomiting were 2.4% at 10 mg, 11.4% at 25 mg, and 7.5% at 50 mg while nausea was 11.9% at 10 mg, 22.7% at 25 mg, and 20.0% at 50 mg, consistent with the results of the trials previously conducted by Hengrui in China. No permanent treatment discontinuations or down-titrations due to nausea, vomiting, diarrhea, or constipation were reported in participants taking oral ribupatide.

“We are pleased to share these positive topline Phase 2 results for oral ribupatide. These data highlight the potential to deliver a differentiated oral medication for the treatment of obesity," Zi Ye, Senior Medical Director, Metabolic Diseases, Clinical Development, Hengrui Pharma, said in a statement. “We plan to rapidly advance to a Phase 3 clinical trial in China, bringing us a step closer to a potential new oral treatment option for people living with obesity.”

In addition to Hengrui’s plans to advance oral ribupatide to a phase 3 clinical trial for the treatment of obesity in China, Kailera plans to initiate a global phase 2 clinical trial in 2026. Hengrui additionally described intentions to share the full oral ribupatide phase 2 clinical trial data at an upcoming scientific conference.

Kailera Therapeutics. Kailera Therapeutics and Hengrui Pharma Report Positive Topline Data from Phase 2 Obesity Trial of Oral Ribupatide. February 10, 2026. Accessed February 10, 2026. 

https://www.kailera.com/press-release/kailera-therapeutics-and-hengrui-pharma-report-positive-topline-data-from-phase-2-obesity-trial-of-oral-ribupatide/

Kailera Therapeutics Announces First Participants Randomized in KaiNETIC Global Phase 3 Clinical Program of GLP-1/GIP Receptor Dual Agonist Ribupatide (KAI-9531). January 12, 2026. Accessed February 10, 2026. 

https://www.kailera.com/press-release/kailera-therapeutics-announces-first-participants-randomized-in-kainetic-global-phase-3-clinical-program-of-glp-1-gip-receptor-dual-agonist-ribupatide-kai-9531/

Hengrui’s phase 2, randomized, double-blind, placebo-controlled trial in 166 Chinese adults with obesity (BMI ≥28 kg/m²) without type 2 diabetes showed once-daily oral ribupatide produced clinically meaningful weight loss at 26 weeks. Mean reductions reached 12.1% with 25 mg and 50 mg (efficacy estimand) versus ~2.3% with placebo, without an observed plateau. GI adverse events were mostly mild-to-moderate; vomiting occurred in ≤11.4% and no permanent discontinuations or down-titrations occurred due to GI toxicity. Phase 3 plans are advancing in China, with global development ongoing.

Positive topline data from Hengrui’s phase 2 clinical trial of once-daily oral ribupatide highlight weight loss of up to 12.1% with no observed plateau at 26 weeks.

Obesity Management

Obesity Management condition center page, resources on the topics of medical news and expert insight into clinical weight management can be found. Content includes articles, interviews, videos, podcasts, and breaking news on obesity research, treatment, and drug development.

Ribupatide, An Oral Dual GLP-1/GIP, Achieves Weight Loss in Phase 2 Obesity Trial

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.

Rob Myers, MD | Image Credit: Drug Discovery & Development

TLC-2716, an oral, liver-targeted liver X receptor (LXR) inverse agonist in development by OrsoBio, has met its primary efficacy endpoint in patients with 

metabolic dysfunction-associated steatotic liver disease (MASLD)

Announced on February 10, 2026, OrsoBio announced positive topline results from a phase 2a proof-of-concept study evaluating TLC-2716 in reducing fasting triglyceride and improving remnant cholesterol and hepatic fat. This was a randomized, double-blind, placebo-controlled study including once-daily oral doses of TLC-2716 6 mg or 12 mg for 4 weeks.

“These Phase 2a data provide compelling clinical validation of LXR inverse agonism as a differentiated therapeutic strategy for severe metabolic disorders,” Rob Myers, MD, chief medical officer and head of development for OrsoBio, said in a statement. “The substantial reductions in triglycerides, remnant cholesterol, and other atherogenic lipids – along with improvements in liver fat and a favorable safety profile – support the potential of TLC-2716 to become a meaningful therapeutic option for patients with diseases driven by excessive lipid production, including SHTG, [metabolic dysfunction-associated steatohepatitis (MASH)], and elevated remnant cholesterol.”

TLC-2716 is an oral, small-molecule, liver-targeted, inverse LXR agonist, designed to modulate key pathways connected to lipid homeostasis. The drug targets de novo lipogenesis, lipoprotein clearance, and intestinal lipid absorption. Liver X receptors are oxysterol-activated nuclear hormone receptors, typically modulating plasma triglycerides and cholesterol via several complementary mechanisms.

In total, the study included a 4-week screening period, a 4-week treatment period, and a 2-week follow-up period. Investigators included patients with a body mass index (BMI) ≥28 kg (61.7 lb)/m2 and a fasting triglyceride ≥350 mg/dL without diabetes or with diabetes and HbA1c <9.5% at screening. Additionally, patients were required to have a diagnosis of nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH) within 5 years of screening based on hepatic imaging and be normotensive or without uncontrolled hypertension, which was defined as systolic blood pressure >155 mmHg and/or diastolic blood pressure >90 mmHg at screening.

Patients were excluded if they had HbA1c ≥9.5% at screening, weight loss >5% during the 90 days before screening, a positive test for human immunodeficiency virus antibody, hepatitis B surface antigen, or hepatitis C antibody, or a medical history of liver disease other than NAFLD/NASH. Additionally, those with unstable cardiovascular disease, a history of intestinal resection or malabsorptive conditions, or the presence of severe peptic ulcer, gastroesophageal reflux disease, or other gastric acid hypersecretory conditions at screening, among other criteria.

A total of 30 adults with overweight and fasting triglycerides ≥350 mg/dL with evidence of MASLD via imaging or biopsy were enrolled. These patients were then randomly assigned to TLC-2716 6 mg, 12 mg, or matched placebo. The primary endpoints were the relative percent change in fasting triglycerides at week 4 and incidence of treatment-emergent adverse events. Both were measured up to day 28 of the study.

Ultimately, TLC-2716 demonstrated consistent improvements across total cholesterol, non-HDL cholesterol, and VLDL cholesterol. Investigators determined that these data support continued evaluation. These data follow a recent publication of first-in-human phase 1 clinical data, which demonstrated clinical and mechanistic validation of TLC-2716 across human genetics and organoid systems.

“We look forward to presenting a comprehensive dataset at a future scientific conference to provide a more detailed characterization of the therapeutic profile of TLC-2716,” Myers said. “These results support continued development of TLC-2716 across multiple severe metabolic disorders, which collectively affect millions of patients worldwide.”

OrsoBio, Inc. OrsoBio Announces Positive Topline Phase 2a Data for LXR Inverse Agonist TLC-2716 in Severe Hypertriglyceridemia and Metabolic Liver Disease. 

. February 10, 2026. Accessed February 10, 2026. 

https://www.businesswire.com/news/home/20260210425918/en/OrsoBio-Announces-Positive-Topline-Phase-2a-Data-for-LXR-Inverse-Agonist-TLC-2716-in-Severe-Hypertriglyceridemia-and-Metabolic-Liver-Disease

OrsoBio, Inc. Phase 2a Study of Safety, Tolerability, and Efficacy of TLC-2716 in Subjects With Hypertriglyceridemia and NAFLD. ClinicalTrials.gov Identifier: NCT06564584. Updated April 3, 2025. Accessed February 10, 2026. 

https://clinicaltrials.gov/study/NCT06564584

OrsoBio reported positive topline phase 2a proof-of-concept results for TLC-2716, an oral liver-targeted LXR inverse agonist, in severe hypertriglyceridemia with MASLD. Thirty overweight adults with fasting triglycerides ≥350 mg/dL received 6 mg, 12 mg, or placebo once daily for four weeks. Primary endpoints were percent change in fasting triglycerides at week 4 and treatment-emergent adverse events. Treatment produced substantial triglyceride and remnant cholesterol reductions, broader atherogenic lipid improvements, decreased hepatic fat, and a favorable safety profile, supporting continued development.

Patients with severe hypertriglyceridemia and MASLD saw reductions in fasting triglyceride and improvements in remnant cholesterol and hepatic fat.

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.

Cardiology

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

Dyslipidemia

TLC-2716 Achieves Primary Endpoints in Phase 2a Trial in Patients With SHTG and MASLD

An interview conducted at Maui Derm 2026 highlights a presentation by Raj Chovatiya, MD, PhD, on managing atopic dermatitis and itch in 2026.

Conference

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

Atopic Dermatitis and Pruritus Management Updates for 2026, With Raj Chovatiya, MD, PhD

Frank Gonzalez is an attending physician at Children’s Hospital Los Angeles and an assistant professor of clinical pediatrics at Keck School of Medicine of USC.

A retrospective study found an independent association between increased pain episodes in sickle cell disease and the cold in light of increasingly extreme weather.


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.

Extreme Cold Independently Associated with Pain Episodes in Pediatric Sickle Cell Disease

Nancy Reau, MD, is Professor of Internal Medicine, Richard B. Capps Chair of Hepatology, Associate Director of Solid Organ Transplantation, and Section Chief of Hepatology at Rush University Medical Center.

In this segment of a Liver Lineup episode, experts discuss where the new US Dietary Guidelines miss the mark for alcohol recommendations.

Why Alcohol Recommendations in the New Dietary Guidelines Fall Short

Lina Jia, MD, PhD, from Beth Israel Deaconess Medical Center, Harvard Medical School, and Xuanwu Hospital in China.

A prospective study finds adolescents with MDD show faster response, fewer cognitive effects, and better tolerability with magnetic seizure therapy than adults.


Psychiatry

Psychiatry condition center page is a comprehensive resource for clinical news and insights on mental illnesses. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for depression, schizophrenia, bipolar disorder, anxiety, and more.

Major Depressive Disorder

Major Depressive Disorder condition center page, resources on the topics of medical news and expert insight into depression can be found. Content includes articles, interviews, videos, podcasts, and breaking news on MDD research, treatment, and drug development.

MST Shows Age-Related Differences in MDD Outcomes, With Lina Jia, MD, PhD

Peter Friedmann, MD, MPH, is a professor of quantitative health sciences at UMass Chan Medical School.

Friedmann describes his research exploring the benefits of mobile telemedicine for HCV infection among persons who inject drugs in rural areas.

Hepatitis C

Hepatitis C page, resources on the topics of medical news and expert insight into HCV can be found. Content includes articles, interviews, videos, podcasts, and breaking news on hepatitis C virus research, treatment, and drug development.

Bringing Hepatitis C Care to Rural Communities Through Mobile Telemedicine, With Peter Friedmann, MD, MPH

Vlado Perkovic is Dean and Scientia Professor of Medicine at UNSW Sydney. He is also a Professorial Fellow at The George Institute and a Staff Specialist in Nephrology at the Royal North Shore Hospital in Sydney.

FLOW/SELECT suggest. GLP-1 receptor agonists may protect kidneys beyond glucose control

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.

Chronic Kidney Disease

Inflammation Emerges as Promising CKD Treatment Target, With Vlado Perkovic, MBBS, PhD

These positive results of Ameluz photodynamic therapy suggest the treatment is effective in actinic keratoses on the neck, trunk, and extremities.

New Phase 3 Findings Support Ameluz-PDT for Patients with Actinic Keratosis

Shakia Hardy, PhD, MPH, is an associate professor in the department of epidemiology at the University of North Carolina at Chapel Hill.

Hardy discussed the disparity between treatment access and usage, highlighting the fact that most patients are within 10 mmHg of guideline recommendations.

Hypertension

The HCPLive hypertension page is a resource for medical news and expert insights on high blood pressure. This page features expert-led coverage, articles, videos and research on the therapies and development of treatments for hypertension, and more.

Most US Adults With Uncontrolled Blood Pressure Not Taking Medication, With Shakia Hardy, PhD, MPH

In their closing remarks, Auchus and DeFronzo emphasize routine screening of high-risk patients, the persistent cardiovascular burden of hypercortisolism despite risk-factor treatment, and the necessity of targeting cortisol excess itself.

Video Series

Special Reports

Final Takeaways: Screening, Cardiovascular Risk, and Treating Cortisol as the Root Cause

Auchus and DeFronzo survey the broader pharmacologic armamentarium for Cushing syndrome and hypercortisolism, including metyrapone, osilodrostat, ketoconazole, levoketoconazole, pasireotide, and investigational agents such as relacorilant and ACTH receptor antagonists.

Latest News

Statins and Improved Long-Term Liver Outcomes in PBC, With Jonggi Choi, MD, PhD

REZOLVE-AD: Rezpegaldesleukin Improves Symptoms of Atopic Dermatitis

FDA Accepts NDA, Grants Priority Review for Oveporexton to Treat Narcolepsy Type 1

Ribupatide, An Oral Dual GLP-1/GIP, Achieves Weight Loss in Phase 2 Obesity Trial

TLC-2716 Achieves Primary Endpoints in Phase 2a Trial in Patients With SHTG and MASLD