Pooja Singhal, MD, is a gastroenterologist, hepatologist, and obesity medicine specialist at Oklahoma Gastro Health and Wellness.

Pooja Singhal, MD | Image Credit: Oklahoma Gastro Health and Wellness

 published a Commission establishing an official definition and diagnostic criteria for 

, aiming to alter the way the condition is approached in 

The central conceit of the Commission was the difference between clinical and preclinical obesity, which is described as the presence or absence of objective clinical manifestations. These primarily include altered organ function or the impairment of a patient’s ability to conduct daily activities. A lens this specific allows clinicians to account for patients who are technically obese but exhibit no comorbidities, outwardly appearing to be in good health.

Additionally, the Commission provided suggestions for altering the diagnostic process for obesity, encouraging the abandonment of the body mass index (BMI) as the sole indicator. Instead, the commissioners suggest the utilization of ≥2 individual anthropometric criteria, such as waist circumference, or direct fat measurement when possible. This should prevent the rampant overdiagnosis of obesity that was predicted by the Commission.

To address how the Commission’s decision has influenced endocrinology since its publication, the editorial team at 

 spoke with Pooja Singhal, MD, a gastroenterologist, hepatologist, and obesity medicine specialist at Oklahoma Gastro Health and Wellness, in the following Q&A:

: How has the move toward formally defining obesity as a disease shaped the landscape of obesity care?

: I think defining obesity as a disease was truly transformational. It helped establish a scientific and moral basis for treating obesity directly. You know, in the past, we used to treat the complications – sleep apnea, diabetes, hypertension, cardiovascular disease, MASLD. Now it has helped us to have a newer approach, which is that obesity itself is a disease, and we need to treat that and prevent complications. I think this reframing has been revolutionary and has really redefined how we approach obesity in general. It’s validated that obesity should be treated. It is a disease, and it should be treated before complications arise. It also helped reduce this kind of moral blame on patients by defining it as a true disease that exists on its own, in its own right. It has promoted earlier intervention proactiveness to seek help, and I also think it’s going to help and already has helped early intervention in pediatric obesity, because that’s what we have seen more and more of. I think the whole Commission’s work is helping us in all these ways.

: To what extent has defining obesity as a disease opened the door to broader acceptance of pharmacologic treatment, especially GLP-1s?

: I think GLP-1s have fit perfectly into this new narrative of biological disease. Because it’s really when people see results, when they see that a medication that works neurohormonally can lead to appetite curbing and lead to the weight loss that people were absolutely not able to achieve, no matter what they tried. It has changed that narrative and acceptance as a community, as a society, even globally, that obesity is truly a disease and regulation of appetite signaling has a big role in it. So, I think the timing of the GLP-1s and the results have also been very much a boon to this biologic narrative of obesity as a disease without that disease framing, where GLP-1s would not have been culturally accepted.

: What other details can you provide around clinicians’ views of obesity following the Commission?

: It’s also led to the clinician’s view of obesity has changed too. Before, it was kind of episodic treatment, if you will. Now there’s more willingness to view pharmacotherapy as a first-line option of obesity for many patients. In the past, it was all about diet and exercise and lifestyle changes. Now, more and more clinicians understand that obesity is a disease, and early prevention and treatment could lead to preventing some very serious complications. So I do also love the fact that it has informed clinician behavior as well and promoted chronic management approach rather than episodic weight loss attempts.

Rubino F, Cummings DE, Eckel RH, et al. Definition and diagnostic criteria of clinical obesity. 

Livingston R. The Lancet Commission on Obesity: Redefining Endocrinology’s Most Notorious Condition. 

. December 18, 2025. Accessed December 19, 2025. 

https://www.hcplive.com/view/the-lancet-commission-on-obesity-redefining-endocrinology-s-most-notorious-condition

Articles

The Lancet Diabetes & Endocrinology Commission has redefined obesity by distinguishing between clinical and preclinical obesity, focusing on objective clinical manifestations. This new definition encourages moving beyond BMI as the sole diagnostic tool, advocating for multiple anthropometric criteria. The reclassification of obesity as a disease has transformed its treatment, promoting early intervention and reducing patient stigma. It has also facilitated the acceptance of pharmacologic treatments like GLP-1s, shifting clinician perspectives towards chronic management rather than episodic interventions.

Singhal discusses the multi-pronged impact of the Commission’s definition of obesity and how it effects clinicians, patients, and the treatment structure itself.

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Impacts of the Lancet Commission on Obesity Treatment, With Pooja Singhal, MD

Hanny Al-Samkari, MD, is the Peggy S. Blitz Endowed Chair in hematology and oncology at the Massachusetts General Hospital and an associate professor of medicine at Harvard Medical School.

Systemic Bevacizumab Improves Chronic Bleeding from GI Lesions, With Hanny Al-Samkari, MD

Systemic bevacizumab has proven its safety and efficacy in treating 

 from gastrointestinal (GI) vascular lesions across a variety of non-hereditary hemorrhagic telangiectasia (HHT) etiologies – including idiopathic angiodysplasia, esophageal varices, and von Willebrand disease – among adult and elderly patients, according to data from a recent observational study.

Previous case studies have investigated systemic bevacizumab for various forms of GI bleeding. A patient with HHT and a massive transfusion dependence saw drastic improvement in required red blood cell (RBC) transfusions after 12 months of treatment with bevacizumab. Another patient, a 69-year-old man with severe 

 as a result of small bowel angioectasia bleeding, demonstrated improved hemoglobin levels after several months of bevacizumab treatment.

67th American Society of Hematology (ASH) Annual Meeting and Exposition

 in Orlando, Florida, by Hanny Al-Samkari, MD, the Peggy S. Blitz Endowed Chair in hematology and oncology at the Massachusetts General Hospital and associate professor of medicine at Harvard Medical School, these data may provide a more efficient and longer-lasting method of treating severe chronic bleeding compared to surgical interventions.

“Right now, the standard of care is to go in and do local ablation with argon plasma, coagulation, clipping, and things like this to the lesions,” Al-Samkari told 

. “But all these conditions have an underlying angiogenic dysregulation such that there’s excessive angiogenic signal. And the more tissue injury you do, the more lesions you provoke to grow. You go in, you cauterize, you do whatever you can, but then a few months later, the bleeding is back, and often worse than before.”

Al-Samkari and colleagues conducted an observational study of patients with non-HHT severe chronic bleeding from GI vascular lesions of any etiology refractory to standard therapies, who had been treated with off-label systemic bevacizumab. The primary endpoint was hematologic support requirements, such as RBC transfusions and intravenous (IV) iron infusions, measured in RBC unit equivalents (1 RBC unit equivalent = 1 RBC unit or 250 mg IV elemental iron). Secondary endpoints included hemoglobin, IV iron, and RBC transfusions measured independently, as well as safety.

A total of 23 patients with chronic, severe bleeding received bevacizumab. The median age was 78 years (range, 42-90), and all but 1 patient was ≥60 years. All patients began treatment at 5 mg/kg daily (77%) or 2.5 mm/kg daily (23%) and were infused every 2 weeks for 4 treatments, followed by 2.5-5 mg/kg daily every 4 weeks. Treatment lasted for up to 4.2 years.

Ultimately, hematologic support required substantially improved from 6 months pretreatment (median 14.2 RBC unit equivalents [interquartile range [IQR] 10-23.9]) during months 1-6 (4.1 [2-7.1] RBC unit equivalents; 

 = .0003) and further improved during months 7-12 (0.6 [0-3.5] RBC unit equivalents; 

 >.001). These improvements coincided with improvements in median (IQR) hemoglobin, measured at 8.2 (7.7-9.4) g/dL at baseline, 10.1 (8.6-12.9) g/dL at month 3, 12.2 (9.6-13) g/dL at month 6, 10.6 (8.8-13.1) g/dL at month 9, and 10.4 (8.9-13.3) g/dL at month 12 of bevacizumab treatment (

Additionally, patients in the cohort required 60 emergency department visits or hospital admissions specifically for GI vascular lesion bleeding in the 12 months prior to initiation, compared to 21 in the 12 months after the initiation. The median number of visits and admissions per patient improved from 3.5 (IQR, 1-5) to 1 (0-1.25) (

 – .0049). Proteinuria was the most common treatment-emergent adverse event (TEAE), occurring in 7 patients (30%), followed by hypertension in 6 (26%) and fatigue in 3 (13%). No venous or arterial thromboembolic events occurred, and no fatal TEAEs were noted. Ultimately, 3 patients discontinued for TEAEs, all of which were grade 3 proteinuria, and 5 discontinued for inadequate treatment effect.

“Not only did bevacizumab trigger a dramatic improvement in Hematologic Support Score, it reduced hospitalizations and emergency department visits, specifically due to vascular GI bleeding in these patients, by >50% in the year after versus the year before starting bevacizumab,” Al-Samkari said. “And it did it pretty safely; most patients were able to deal with the side effects and stay out of the hospital with monthly to every 2-month low-dose bevacizumab infusions.”

Editor’s Note: Al-Samkari reports disclosures with Pharmacosmos, Agios, Amgen, Vaderis, Novartis, Sobi, and others.

Ayad N, Al-Samkari H. Long-term safety and effectiveness of systemic bevacizumab for chronic severe bleeding in idiopathic gastrointestinal angiodysplasia, esophageal varices, and angiodysplasia of von Willebrand disease and acquired von Willebrand syndrome. Abstract presented at the 67th American Society of Hematology Annual Meeting. Orlando, FL. December 6-9, 2025.

Ou G, Galorport C, Enns R. Bevacizumab and gastrointestinal bleeding in hereditary hemorrhagic telangiectasia. World J Gastrointest Surg. 2016;8(12):792-795. 

Compare D, Sgamato C, Rocco A, et al. Long-term bevacizumab is safe and effective in managing small bowel angioectasias bleeding refractory to conventional treatments: a case report. Gastroenterol Rep (Oxf). 2024;12:goae070. Published 2024 Jul 6. 

Videos

Al-Samkari discusses a potentially novel use for bevacizumab in improving outcomes for patients with lesions from non-HHT etiologies.

Hematology

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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.

The US Food and Drug Administration has approved Boehringer Ingelheim’s nerandomilast (Jascayd) tablets for the treatment of progressive pulmonary fibrosis (PPF) in adults.

According to a December 19, 2025, release from the Company, the decision makes nerandomilast the first and only preferential phosphodiesterase 4B (PDE4B) inhibitor with immunomodulatory and antifibrotic effects approved in this indication and was based on results from the phase 3 FIBRONEERTM-ILD clinical trial, the largest clinical trial program in PPF to date.

“Progressive pulmonary fibrosis is linked to underlying clinical ILD diagnoses including autoimmune ILDs – which can be caused by disorders like rheumatoid arthritis or systemic sclerosis – as well as hypersensitivity pneumonitis, among other conditions,” Shervin Assassi, MD, Director of Rheumatology, McGovern Medical School, UTHealth Houston, said in a press release.

“These underlying conditions often lead to the lungs being overlooked, yet lung scarring may lead to debilitating and irreversible impact on lung function. This can have a detrimental effect on patients’ lives and highlights the need for new treatment options that can help reduce the decline in lung function, as has been observed with [nerandomilast].”

Nerandomilast is an oral, preferential inhibitor of PDE4B. It was approved by the FDA as an oral treatment option for idiopathic pulmonary fibrosis (IPF) in adult patients on September 10, 2025.

Its use in PPF was explored in the FIBRONEERTM-ILD trial. The primary endpoint was the absolute change from baseline in Forced Vital Capacity (FVC), a measure of lung function, in mL at week 52. Results showed nerandomilast demonstrated a significantly smaller reduction in FVC decline from baseline compared to placebo.

The adjusted mean decline in absolute change from baseline in FVC in patients receiving nerandomilast 18 mg or 9 mg was -86 mL and -69 mL, respectively, versus -152 mL in the placebo group. The respective treatment difference compared with the placebo group was 65 mL (95% CI, 30-101) and 83 mL (95% CI, 48-118).

The most common adverse reactions in patients with PPF treated with nerandomilast were generally consistent with those observed in patients with IPF.

The key secondary composite endpoint was the time to the first occurrence of any of the components of the composite endpoint over the blinded duration of the trial, up to 109 weeks, including acute ILD exacerbation, hospitalization for respiratory cause, or death. Overall, there was no statistically significant treatment difference in the hazard ratio (HR) for the nerandomilast 18 mg or 9 mg groups compared to placebo for the key secondary composite endpoint (nerandomilast 18 mg or 9 mg groups, respectively, compared to placebo: HR, 0.77; 95% CI, 0.59-1.01 and HR, 0.88; 95% CI, 0.68-1.14).

In further exploratory analyses, nerandomilast 18 mg showed a nominally significant reduction in the risk of acute ILD exacerbations over the blinded trial duration compared to placebo (HR, 0.60; 95% CI, 0.38-0.94). It also showed a numerical reduction in the risk of hospitalization for respiratory cause over the blinded trial duration compared to placebo (HR, 0.82; 95% CI, 0.61-1.11).

Additionally, a prespecified analysis of overall survival at the end of the FIBRONEERTM-ILD trial showed a trend in favor of nerandomilast. The HRs for all-cause mortality until the end of the trial, up to 114 weeks, for nerandomilast 18 mg and 9 mg compared to placebo were 0.51 (95% CI, 0.34-0.78) and 0.51 (95% CI, 0.34-0.78), respectively, although these results were not prespecified for multiplicity control.

In the trial, nerandomilast was well-tolerated in patients with PPF. In patients taking background nintedanib, diarrhea occurred 49%, 50%, and 37% of patients treated with nerandomilast 18 mg twice daily, nerandomilast 9 mg twice daily, and placebo, respectively. In patients without concomitant use of background nintedanib, diarrhea occurred in 27%, 16%, and 16% of patients using nerandomilast 18 mg twice daily, nerandomilast 9 mg twice daily, and placebo, respectively.

Diarrhea was the most common adverse reaction associated with treatment discontinuation and occurred most frequently in patients treated with nerandomilast 18 mg (4%) or nerandomilast 9 mg (3%) with background antifibrotic therapy, versus patients receiving placebo (1%) and background antifibrotic therapy. Of note, in patients not receiving concomitant nintedanib, diarrhea led to treatment discontinuation in 1% of patients treated with nerandomilast 18 mg and in no patients receiving nerandomilast 9 mg or placebo.

“People living with progressive pulmonary fibrosis often carry a heavy burden that others don’t always see,” said Scott Staszak, President and CEO of the Pulmonary Fibrosis Foundation.

 “A progressive disease condition process like PPF can worsen lung function quickly, and patients have been eagerly awaiting additional treatment options. The FDA approval of [nerandomilast] for PPF is a welcomed milestone for the community.”

Boehringer Ingelheim. U.S. FDA approves JASCAYD® (nerandomilast) tablets for the treatment of progressive pulmonary fibrosis in adults. December 19, 2025. Accessed December 19, 2025. 

https://www.boehringer-ingelheim.com/us/human-health/lung-diseases/pulmonary-fibrosis/fda-approves-new-treatment-option-adults-ppf

Boehringer Ingelheim. U.S. FDA approves Boehringer’s JASCAYD® (nerandomilast tablets) as first new treatment option for adults with IPF in over a decade. September 10, 2025. Accessed December 19, 2025. 

https://www.boehringer-ingelheim.com/human-health/lung-diseases/pulmonary-fibrosis/fda-approves-jascayd-nerandomilast-first-new-treatment-ipf-over-decade

The FDA has approved Boehringer Ingelheim's nerandomilast tablets for treating progressive pulmonary fibrosis (PPF) in adults, marking it as the first PDE4B inhibitor with immunomodulatory and antifibrotic effects for this indication. The approval was based on the FIBRONEERTM-ILD trial, which demonstrated a significant reduction in lung function decline compared to placebo. While nerandomilast was well-tolerated, diarrhea was the most common adverse reaction. The trial also indicated a trend towards improved overall survival, although not statistically significant for multiplicity control.

The decision makes nerandomilast the first and only PDE4B inhibitor with immunomodulatory and antifibrotic effects approved in this indication.

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Infectious Disease condition center page is a comprehensive resource for clinical news and insights on respiratory health. This page consists of interviews, articles, podcasts, and videos on the research, treatment and development of therapies for asthma, COPD, interstitial lung disease, COVID-19, and more.

FDA News

FDA Approves Nerandomilast (Jascayd) Tablets for Progressive Pulmonary Fibrosis

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.

A new study reported that kinesiophobia and central sensitization frequently occur in patients with 

 and were linked to increased pain intensity and decreased quality of life, mental health, functionality, and physical activity.

Kinesiophobia, defined as an excessive fear of physical movement often following a traumatic injury, can significantly impair patients’ quality of life.

 Efforts to avoid movement to prevent pain may paradoxically lead to worsening pain. Kinesiophobia leads to a loss of physical mobility, physical fitness, inactivity, functional decline, and psychological issues with the belief that movement will increase pain. Research has shown that kinesiophobia has contributed to increased levels of disability and pain intensity.

A study published in January 2025 reported that 48.3% of 424 patients with a musculoskeletal disorder had kinesiophobia (95% confidence interval [CI], 43.3 to 53.3).

 Factors included being overweight or obese (adjusted odds ratio [aOR], 3.98), having a moderate pain level (aOR, 3.31), having a severe pain level (aOR, 9.29), physical inactivity (aOR, 3.00), anxiety (aOR, 2.57), and depression (aOR, 8.21).

Another study published in February 2025 identified the prevalence of kinesiophobia in patients with chronic diseases between 42.85% to 93%, depending on the condition.

 However, this study did not include participants with gout, instead focusing on cardiovascular diseases, cancers, diabetes, and chronic respiratory diseases.

In this recent cross-sectional analysis, Kübra Tuncer, from the department of physical medicine and rehabilitation at Cukurova University in Türkiye, and colleagues sought to assess the prevalence of kinesiophobia and central sensitization among patients with gout and age- and gender-matched controls. The team also assessed the association between these factors and clinical gout outcomes.

Investigators assessed kinesiophobia and central sensitization in patients using the Tampa Scale of Kinesiophobia (TSK) and Central Sensitization Inventory (CSI), respectively. They measured clinical outcomes via the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36), Hospital Anxiety and Depression Scale (HADS), International Physical Activity Questionnaire-Short Form (IPAQ-SF), Gout Activity Score (GAS), and Health Assessment Questionnaire-Disability Index (HAQ-DI).

The study reported a 62.3% and 33.8% prevalence of kinesiophobia and central sensitization in patients with gout, respectively. Patients with gout had greater scores for Tampa Scale of Kinesiophobia, Central Sensitization Inventory, and Hospital Anxiety and Depression Scale compared to controls, but lower scores of SF-36 and International Physical Activity Questionnaire-Short Form.

Moreover, patients with kinesiophobia displayed statistically greater scores of Gout Activity Score, Central Sensitization Inventory, Hospital Anxiety and Depression Scale, and Health Assessment Questionnaire-Disability Index. These individuals also had lower sub-scores of SF-36, excluding the emotional role, and total International Physical Activity Questionnaire-Short Form scores than those without kinesiophobia.

Additionally, patients with central sensitization had greater scores in the Gout Activity Score, Tampa Scale of Kinesiophobia, Hospital Anxiety and Depression Scale, and Health Assessment Questionnaire-Disability, as well as lower scores in the SF-36 and total International Physical Activity Questionnaire-Short Form.

The analysis revealed that scores in the Tampa Scale of Kinesiophobia and Central Sensitization Inventory had significant positive correlations with each other and with pain, Gout Activity Score, Hospital Anxiety and Depression Scale, and Health Assessment Questionnaire-Disability Index. The regression analyses showed that the Central Sensitization Inventory score appeared to determine kinesiophobia severity.

Overall, this study suggests that mental health plays a large role in influencing central sensitization in gout. The research showed that central sensitization was independently associated with kinesiophobia.

“These close associations lead to challenges in optimizing management, functionality, physical activity level, and quality of life in gout,” investigators wrote.

Tuncer K, Kozanoğlu E, Sariyildiz A, Yetişir A. Evaluation of kinesiophobia, central sensitization, and related factors in patients with gout: a cross-sectional study. 

Mekonnen Y, Gashaw M, Abich Y, Takele MD, Chanie ST, Wayessa DI, Deme S, Kibret AK. Kinesiophobia and associated factors among people with musculoskeletal disorders in Ethiopia: a multicenter cross-sectional study. BMC Musculoskelet Disord. 2025 Jan 15;26(1):55. 

doi: 10.1186/s12891-025-08306-7. PMID: 39815219; PMCID: PMC11734341.

Wlazło M, Szlacheta P, Grajek M, Staśkiewicz-Bartecka W, Rozmiarek M, Malchrowicz-Mośko E, Korzonek-Szlacheta I. The Impact of Kinesiophobia on Physical Activity and Quality of Life in Patients with Chronic Diseases: A Systematic Literature Review. 

Kinesiophobia and central sensitization are prevalent in gout patients, significantly impacting pain intensity, quality of life, mental health, and physical activity. A recent study found 62.3% of gout patients experienced kinesiophobia, while 33.8% had central sensitization. These conditions were linked to higher scores on the Gout Activity Score, Hospital Anxiety and Depression Scale, and Health Assessment Questionnaire-Disability Index. The study highlighted the strong correlation between kinesiophobia and central sensitization, emphasizing the role of mental health in managing these conditions and their impact on gout management.

Patients with gout frequently experience kinesiophobia and central sensitization, which were independently linked to greater pain intensity.

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On the HCPLive gout page, resources on the topics of medical news and expert insight into gouty arthritis can be found. Content includes articles, interviews, videos, podcasts, and breaking news on gout, and more.

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Fear of Movement, Central Sensitization May Worsen Outcomes in Gout

Altimmune has announced positive topline results from the phase 2b IMPACT trial of pemvidutide, a balanced 1:1 glucagon/GLP-1 dual receptor agonist, in patients with metabolic dysfunction-associated steatohepatitis (MASH) at 48 weeks.

As described in a December 19, 2025, press release from the Company, topline 48-week data showed treatment with pemvidutide achieved statistically significant improvements across treatment arms in key noninvasive tests (NITs), including Enhanced Liver Fibrosis (ELF) and Liver Stiffness Measurement (LSM), versus placebo. Of note, these data exhibited continued reductions from week 24 and provide evidence of continued improvement in antifibrotic activity with both treatment doses.

“The magnitude of response versus placebo on measures such as ELF and LSM at 48 weeks makes these data particularly compelling, as these noninvasive markers have been shown to correlate with histologic fibrosis stage. These results reinforce that pemvidutide may address both liver-specific and metabolic drivers of MASH without compromising tolerability – three critical elements of a potential effective treatment for this patient population,” Mazen Noureddin, MD, IMPACT trial principal investigator, professor of medicine at Houston Methodist Hospital and co-chairman of the Board for Summit and Pinnacle Clinical Research, said in a statement.

 “I am encouraged by the dose response observed and the performance of the 1.8 mg arm and I am eager to see this differentiated therapeutic candidate advance into Phase 3 evaluation.”

Additionally, Altimmune announced that it held a productive End-of-Phase 2 meeting with the US Food and Drug Administration (FDA) resulting in alignment on the parameters for a registrational phase 3 trial of pemvidutide for MASH patients with moderate to advanced liver fibrosis.

Pemvidutide is a novel, investigational peptide with balanced 1:1 glucagon/GLP-1 dual receptor agonist activity, in development for the treatment of MASH, alcohol use disorder (AUD) and alcohol-associated liver disease (ALD).

The randomized, placebo-controlled, double-blind IMPACT trial enrolled 212 participants with biopsy-confirmed MASH and fibrosis stages F2 or F3, with and without diabetes. Study participants were randomly assigned in a 1:2:2 ratio to receive weekly subcutaneous pemvidutide doses at either 1.2 mg, 1.8 mg or placebo for 48 weeks.

The primary efficacy endpoints, measured at 24 weeks, were MASH resolution without worsening of fibrosis, or fibrosis improvement without worsening of MASH. Secondary endpoints included non-invasive tests of fibrosis and weight loss measured at 24 and 48 weeks.

Results showed pemvidutide-treated participants achieved statistically significant reductions in primary non-invasive markers of fibrosis, including ELF and LSM:

ELF: 1.2 mg and 1.8 mg doses achieved a mean reduction from baseline of -0.49 and -0.58 respectively, versus +0.16 in placebo-treated patients (

LSM: 1.2 mg and 1.8 mg doses achieved a mean reduction from baseline of -3.04 (

<.001), respectively, versus -0.03 in placebo-treated participants

The proportion of participants receiving pemvidutide 1.2 mg and 1.8 mg who achieved both a ≥0.5 reduction in ELF and a 30% reduction in LSM were 27.8% (

<.0001) respectively, versus 3.2% in placebo-treated participants.

Further analysis revealed participants who received the pemvidutide 1.2 mg and 1.8 mg doses achieved a mean reduction in liver fat content from baseline of 45.2% and 54.7% respectively, compared to 8.2% in participants who received placebo (

<.0001). For ALT, 1.2 mg and 1.8 mg achieved a mean reduction from baseline of -37.8 IU/L and -37.4 IU/L respectively, versus -10.3 IU/L in placebo-treated participants (

<.0001, both doses). For cT1, 1.2 mg and 1.8 mg achieved a mean reduction from baseline of -124 and -140 milliseconds respectively, versus -21 milliseconds in placebo-treated participants (

Results additionally showed participants receiving pemvidutide 1.2 mg and 1.8 mg achieved weight loss of 4.5% and 7.5%, respectively, compared with 0.2% of placebo-treated participants (

<.0001, both doses). Of note, no plateauing at 48 weeks was observed with the 1.8 mg dose.

Adverse events leading to treatment discontinuation occurred in 0% and 1.2% of patients treated with pemvidutide 1.2 mg and 1.8 mg, respectively, versus 3.5% of participants on placebo. Investigators noted no serious or severe adverse events related to treatment were reported.

Altimmune and the FDA have aligned on the parameters for a registrational phase 3 trial of pemvidutide for MASH patients with moderate to advanced liver fibrosis. With the FDA’s recent qualification of AIM-MASH AI Assist, the Agency was open to the Company’s intent to integrate use of this AI tool into the phase 3 trial.

“With the benefit of FDA feedback and these 48-week data now in hand, we are greatly looking forward to progressing pemvidutide to a Phase 3 program which we intend to initiate in 2026. Strong evidence of antifibrotic improvements based upon non-invasive tests, combined with an attractive tolerability profile, highlight pemvidutide’s differentiation and potential to be a meaningful treatment option for the MASH patient community,” said Vipin Garg, PhD, Chief Executive Officer of Altimmune.

Altimmune. Altimmune Announces that Pemvidutide Achieved Key Measures of Success at 48 Weeks in IMPACT Phase 2b MASH Trial. December 19, 2025. Accessed December 19, 2025. 

https://www.globenewswire.com/news-release/2025/12/19/3208385/0/en/Altimmune-Announces-that-Pemvidutide-Achieved-Key-Measures-of-Success-at-48-Weeks-in-IMPACT-Phase-2b-MASH-Trial.html

US Food and Drug Administration. FDA Qualifies First AI Drug Development Tool, Will Be Used in 'MASH' Clinical Trials. December 8, 2025. Accessed December 19, 2025. 

https://www.fda.gov/drugs/drug-safety-and-availability/fda-qualifies-first-ai-drug-development-tool-will-be-used-mash-clinical-trials

Altimmune's phase 2b IMPACT trial of pemvidutide, a glucagon/GLP-1 dual receptor agonist, demonstrated significant improvements in metabolic dysfunction-associated steatohepatitis (MASH) patients over 48 weeks. The trial showed statistically significant reductions in non-invasive fibrosis markers, liver fat content, and weight loss compared to placebo. The trial's success led to alignment with the FDA on a phase 3 trial, incorporating AI tools. Pemvidutide's favorable tolerability and efficacy profile suggest its potential as a promising treatment for MASH, with phase 3 trials planned for 2026.

Positive topline results from the phase 2b IMPACT trial show statistically significant improvements in key noninvasive tests with pemvidutide.

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Pemvidutide Shows Continued Antifibrotic Activity for MASH, Progresses to Phase 3 Trial

Topical steroid withdrawal remains a controversial topic in the dermatology field, given the lack of necessary data. 

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This Year In Medicine

 Topical Steroid Withdrawal: Inside the Controversy Over TSW in Dermatology

Maria Hordinsky, MD, is an R.W. Goltz Professor of the Department of Dermatology at the University of Minnesota.

Cosmo Pharmaceuticals released pivotal phase 3 findings on clascoterone treatment, a potential first-in-class medication designed to target androgenetic alopecia.

Alopecia

Phase 3 SCALP Study on Clascoterone for Androgenetic Alopecia, With Maria Hordinsky, MD

In a new study, children exposed to gestational diabetes showed lower FEV1 and increased odds of current asthma at ages 8–9 years.

Type 1 Diabetes

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Gestational Diabetes Linked to Reduced Lung Function in Children

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.

A cross-sectional study indicates a link between urinary levels of measured metals and metalloids and the stages of cardiovascular-kidney-metabolic syndrome.


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.

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...

Chronic Kidney Disease

Metal Exposure Levels May Explain Cardiovascular-Kidney-Metabolic Stages

Al-Samkari discusses the slew of HHT-related complications, their frequency, and their severity, highlighting the need for more active intervention.

Patients with HHT Exhibit More Severe Complications Than Previously Believed, With Hanny Al-Samkari, MD

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.

Results from the ATTAIN-MAINTAIN phase 3 study have displayed orforglipron’s efficacy in maintaining weight loss without major safety concerns.

Orforglipron Maintains Weight Loss in Patients Switching from Semaglutide or Tirzepatide

A retrospective observational cohort study identifies an association between patients undergoing peritoneal dialysis and their physical activity level. 


Increased Physical Activity Linked to Reduced Mortality In Peritoneal Dialysis

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.

Investigators observed rapid, sustained clinical benefits after using vixarelimab in patients living with prurigo nodularis.

Vixarelimab Demonstrates Rapid, Sustained Clinical Benefits in Prurigo Nodularis

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

Debate on whether early IL-23–targeted therapy like ICO could delay or prevent PsA onset.

Video Series

Oral vs Biologic IL-23: Key Factors That Impact Treatment Decisions 

Sonalika Khachikian, MD, is an endocrinologist at Monument Health.

Thyroid eye disease (TED) is a common extrathyroidal manifestation of Graves disease, with growing clinical emphasis on early recognition, risk stratification, and routine screening. In this video series, Sonalika Khachikian, MD, an endocrinologist at Monument Health Hospital in South Dakota, notes that TED is not a new entity, but that recognition and interest have increased substantially over the past 5 years. The prevalence appears stable, approximately 1 in 2 patients with Graves disease may develop some degree of TED, but clinicians are becoming more attuned to subtle manifestations and more proactive about offering treatment. Autoimmune thyroid disease is more common in women, although men may experience more severe disease.

Khachikian emphasizes that TED and Graves hyperthyroidism are distinct but related disease processes, with the immune response directed at both the thyroid and orbital tissues. She describes her experience with euthyroid and hypothyroid TED, estimating that roughly 90% of her TED patients have hyperthyroidism, about 15% have hypothyroidism over the disease course, and fewer than 10% are euthyroid. For patients with classic ocular features and normal thyroid function, she often pursues antibody testing (eg, thyrotropin receptor antibodies) and reviews family history to uncover autoimmune thyroid disease.

Screening has been shaped by the American Thyroid Association (ATA) guideline update in November 2022, which recommends that all patients with thyroid disease be screened for TED. In her practice, Khachikian incorporates systematic questioning into every visit with a patient who has hyperthyroidism, asking about dryness, grittiness, tearing, pressure, and other nonvisual symptoms while simultaneously observing for overt changes such as lid retraction or proptosis. For patients with early or mild disease, she initiates education and supportive measures, including lubricating eye drops, elevation of the head of the bed, smoking cessation counseling, and aggressive normalization of thyroid function.

Latest News

Impacts of the Lancet Commission on Obesity Treatment, With Pooja Singhal, MD

Systemic Bevacizumab Improves Chronic Bleeding from GI Lesions, With Hanny Al-Samkari, MD

FDA Approves Nerandomilast (Jascayd) Tablets for Progressive Pulmonary Fibrosis

Fear of Movement, Central Sensitization May Worsen Outcomes in Gout

Pemvidutide Shows Continued Antifibrotic Activity for MASH, Progresses to Phase 3 Trial