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

Credit: National Alopecia Areata Foundation

New topline, phase 3 findings from the SCALP 1 and 2 studies have been released by Cosmo Pharmaceuticals suggesting clascoterone may be an effective medication for men living with 

Androgenetic alopecia, commonly referred to as male pattern hair loss, would have the first new therapeutic agent in over 3 decades if clascoterone were to receive approval by the 

 Clascoterone solution was formulated to target androgenetic alopecia via a novel biological pathway, selectively binding to androgen receptors in the skin and scalp.

Both SCALP 1 and SCALP 2 attained statistically significant endpoints in Target-Area Hair Count (TAHC) results.

 To discuss these new findings on clascoterone and androgenetic alopecia, the 

 editorial team spoke with Maria Hordinsky, MD, an RW Goltz Professor of Dermatology at the University of Minnesota, along with Diana Harbort of Cosmo Pharmaceuticals. Hordinsky and Harbort highlighted a variety of key points from the data:

Would you speak with us about the trial design itself and what these studies assessing clascoterone looked like?

 We here at the University of Minnesota were engaged in this particular clinical trial, and it was a trial where patients were applying the topical medication twice a day. The data that is out there is from the first 6 months. There is still another 6 months of data that is under review at present. We were blinded, like all the sites, as to whether or not a participant was receiving the actual drug or not. This is where I'm going to turn to Diana, because Diana can talk about the 2 studies [in depth]. There are 2 different studies examining the same clinical trial goals. Can you comment on that?

The phase 3 program for clascoterone solution contained 2 identical in design trials. These were multi-center, prospective, randomized, 2-to-1 vehicle-controlled studies with either the vehicle or the study drug being delivered BID. The study enrolled 1465 patients with mild to moderate AGA in 51 sites across the US and Europe. Scalp 1 is the pivotal part of the program, which is meant for just the first 6 months of treatment, and the goal is to evaluate the safety and efficacy of the drug versus the vehicle.

Scalp 2 is identical in design to the first 6 months to also evaluate the safety and efficacy. So part 1 is the pivotal part, and part 2 is the safety extension part, where patients roll over from scalp one or scalp to the responders' rollover into the second 6 months of the trial. The goal of that is to determine the long-term safety and durability of the treatment. In part one, the co-primary efficacy endpoints are the TAHC and the patient-reported outcomes.

Would either of you explain some of the most notable findings for the 6 months of treatment with clascoterone and androgenetic alopecia?

From an investigator's point of view, the findings are outstanding in that sense that the total number of hair counts in the areas that were mentioned increased greatly. I can tell, just in our own institution, and the patients who participated with us, again, didn't know what they were on, and neither did we. When you see improvement, you assume that the patient has been on the actual medication. Patients found the medication to be tolerable.

If you look at the safety data across the entire studies, both studies to date, the safety profile is very good, with minimal irritation to the skin from the use of the topical product and, most importantly, very few systemic or internal side effects. We're dealing here with a topical agent that targets testosterone and the receptor, so when you start to think about medications that might impact hormones, we're talking about something that really impacts hormones in the skin alone. Another very important point from this particular study is that there were very there were no significant sexual side effects related to the use of this topical medication twice a day.

In light of what you have said, what are some of the most notable concerns patients might have regarding some unmet needs related to existing treatments?

 I can speak from personal experience in the clinic. When a person comes in who's in their early twenties and is starting to develop early pattern alopecia, or androgenic alopecia, also known as male pattern baldness, then one has to think, ‘What can we do at that particular stage?’ At this time, we have 2 approved medications. We have topical minoxidil, or Rogaine in a liquid or foam preparation, and we have an oral medication called finasteride, which blocks the conversion of testosterone to dihydrotestosterone.

I just gave the example of someone in their early 20s taking a pill that, more recently, has risen to the top of social media in terms of having significant side effects. With topical minoxidil, it does work, but as has been pointed out, this medication was approved almost 30 years ago, so we have basically 2 medications that we can really talk about that are FDA-approved to that young person sitting there talking about how to prevent hair loss.

Our other options when we're in clinic we’ll be to talk about are devices like red light therapy, which you have to do a few times per week, or something like platelet-rich plasma. We don't talk about hair transplantation in those early stages, but we do talk about how, if you don't do anything, we really don't know how far this hair loss is going to extend…So that young patient in the clinic is getting a lot of information about a lot of different approaches to treating male pattern hair loss or androgenetic alopecia. That's why this new topical is so exciting, because it's a completely different mechanism of action. It's topical, and the 6-month data looks really, really good.

Cosmo announces breakthrough Phase III Topline results from Scalp 1 and Scalp 2 for Clascoterone 5% Solution in male hair loss, showing up to 539% relative improvement in Target-Area Hair Count vs placebo; US and EU submissions are underway. Cosmo Pharmaceuticals. December 3, 2025. Accessed: December 18, 2025. 

https://www.cosmopharma.com/news/cosmo-announces-breakthrough-phase-iii-topline-results-from-scalp-1-and-scalp-2-for-clascoterone-5-solution-in-male-hair-loss-showing-up-to-539-relative-improvement-in-target-area-hair-count-vs-place

Chen S, Li L, Zhou N, et al. Androgenetic alopecia: An update on pathogenesis and pharmacological treatment. Drug Des Devel Ther. 2025 Aug 25;19:7349-7363. 

Articles

Clascoterone, a novel topical solution, shows promise as a treatment for androgenetic alopecia, marking the first potential new therapy in over 30 years. Phase 3 trials, SCALP 1 and 2, demonstrated significant improvements in Target-Area Hair Count (TAHC) with minimal side effects. The trials involved 1465 patients across the US and Europe, focusing on safety and efficacy. Current treatments include minoxidil and finasteride, but clascoterone offers a new mechanism of action, targeting androgen receptors in the skin, with promising 6-month data.

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

Alopecia

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

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.

Credit: Vanderbilt University Medical Center

“[Gestational diabetes mellitus] was associated with a modest decrease in baseline FEV1 in children, and further research is needed to determine if this finding translates into early adulthood lung function deficits that have been associated with long-term respiratory decline,” wrote study investigator Margaret A. Adgent, PhD, MSPH, of Vanderbilt University Medical Center, and colleagues.

Lung development begins around 4 weeks’ gestation, with most structural growth occurring during fetal and early postnatal life. Low lung function early in life predicts reduced lung function in adulthood and is associated with adverse health outcomes, including an increased risk of persistent asthma in children.

Investigators recognized the need to characterize prenatal risk factors for low lung function and persistent lung disease.

 Prior research suggests that gestational diabetes mellitus may be a prenatal risk factor for respiratory disease in children due to hyperglycemia, placental inflammation, altered immune response, and oxidative stress during susceptible windows of fetal lung development.

In this study, investigators assessed the association between gestational diabetes mellitus and lung function, as well as current asthma and wheeze, in children aged 8 – 9 years. The study included 722 mother-child dyads from the Conditions Affecting Neurocognitive Development in Early Childhood (CANDLE) study, a socioeconomically and racially diverse prospective US pregnancy cohort based in Shelby County, Tennessee.

CANDLE enrolled women aged 16 – 40 years (mean, 26 years) during the second trimester of pregnancy who were pregnant with their first child, not considered medically low-risk (i.e., no chronic hypertension requiring medication, oligohydramnios, or type 1 diabetes), and planned to deliver at a study hospital. Births occurred between December 2006 and June 2011.

Among participants, 66% identified as Black or African American and 34% identified as non-Black (33% White, 0.5% Asian, and 0.5% other); 98% identified as non-Hispanic. More than half of the women had a high school education or less (56%), and 50% gave birth to male children.

Participants completed questionnaires and provided biospecimens during the second and third trimesters of pregnancy and at delivery, and attended follow-up visits at ages 1, 2, and 3 years, at approximately 4.5 years, and 8 – 9 years. This current analysis included participants with documented gestational diabetes mellitus status, gestational age at delivery of ≥ 32 weeks, acceptable function test data (determined by pulmonologist review), or a respiratory outcome questionnaire completed at ages 8 – 9 years.

Pulmonary function tests, conducted using the software Breezesuite, assessed forced expiratory volume in the first second (FEV1), forced vital capacity (FVC), the FEV1/FVC ratio, and forced expiratory flow between 25% and 75% of vital capacity (FEF25-75). Childhood respiratory outcomes were assessed using a questionnaire based on the International Study of Asthma and Allergies in Children (ISAAC).

Wheeze was defined as wheezing or whistling in the chest in the previous 12 months, despite no cold. Current asthma was defined as meeting ≥ 2 of the following: current wheeze, physician-diagnosed asthma or reactive airway disease, or reported asthma-specific medication use in the previous 12 months.

The analysis adjusted for many covariates, including age, race, ethnicity, prenatal smoking, pre-pregnancy weight and height, and education level.

Gestational diabetes mellitus was identified in 6% of pregnancies. Median pulmonary function z scores were −0.46 for FEV1, −0.41 for FVC, −0.08 for FEV1/FVC, and −0.34 for FEF25–75. After adjustment, children exposed to gestational diabetes had lower FEV1 (95% CI, −0.55 to −0.00) and FEF25–75 (95% CI, −0.76 to −0.10), as well as higher odds of current asthma (OR, 3.12; 95% CI, 1.55 to 6.28), compared with unexposed children. No differences were observed for other lung function measures.

“[Gestational diabetes mellitus] is already recognized as a risk factor for multiple pregnancy complications and childhood morbidities, such as obesity and type 2 diabetes. This study highlights a possible relationship between [gestational diabetes mellitus] and childhood lung function, which is a meaningful indicator for long-term health. However, as our study is based on [a] few [gestational diabetes mellitus] exposed pregnancies, continued investigation into the long-term impacts of [gestational diabetes mellitus] on offspring respiratory development and health outcomes in larger studies is needed.”

Adgent MA, Gebretsadik T, Moore PE, et al. Gestational diabetes and childhood lung function at age 8-9 years in a diverse US cohort. 

Sánchez-Solís M. Early Lung Function and Future Asthma. Front Pediatr. 2019 Jun 19;7:253.

 doi: 10.3389/fped.2019.00253. PMID: 31275912; PMCID: PMC6593473.

Gestational diabetes mellitus (GDM) may contribute to reduced lung function in children, potentially leading to long-term respiratory issues. A study involving 722 mother-child pairs from the CANDLE cohort found that children exposed to GDM had lower FEV1 and FEF25-75 scores and higher odds of current asthma compared to unexposed children. The study adjusted for various covariates and highlighted the need for further research to explore the long-term respiratory impacts of GDM. The findings suggest GDM as a prenatal risk factor for childhood respiratory health.

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.

Metal and metalloid exposure may be associated with an increased risk of developing 

 syndrome, highlighting a rising environmental concern, according to new research.

“As far as we know, no study to date has been published that comprehensively examines the combined effects of metal exposure on cardiovascular disease, 

, and metabolic-related diseases,” wrote study investigators Shuai Zhang, PhD the deputy director of the male reproductive department at Lianyungang Maternal and Child Health Hospital, and colleagues. “Most existing research focuses on the association between metal exposure and specific diseases.”

The National Health and Nutrition Examination Survey (NHANES) has monitored the general population of the United States for metal exposure, collected from urine sample analyses. Worldwide > 1,000,000 people are impacted by residual toxic metal particles from current and former mining operations.

The detrimental health impacts of these pollutants are a growing concern for ecological, nutritional, and environmental factors. The association between metal/metalloid levels and CKM syndrome is an area of unexplored research that could provide insight into health outcomes.

In a cross-sectional study leveraging data from NHANES, investigators examined relationships between metal mixtures and CKM syndrome stage, with CKM stage 0 as the reference group to compare differences in urinary metal concentrations.

Stage 0: No identified risk factors for CKM syndrome

Stage 1: Overweight, dysfunctional obesity, or prediabetes

Stage 2: The presence of ≥ 1 condition, such as hypertriglyceridemia, hypertension, diabetes, any component of MetS, or moderate to high-risk CKD

Stage 3: Chronic kidney disease with a very high risk or a predicted 10-year cardiovascular disease risk of ≥ 20%

Stage 4: Self-reported clinical CVD, including coronary artery disease, angina, myocardial infarction, heart failure, or stroke

To assess the specific metals driving these associations, investigators examined 9 metal and metalloid species, including barium, cadmium, cobalt, cesium, molybdenum, lead, antimony, thallium, and tungsten. Subgroup analyses were conducted by sex, age groups <60 years and ≥60 years, and race. Mediation analysis was conducted to explore how inflammation, oxidative stress, and aging might mediate the link between metal mixtures and CKM syndrome.

The study’s population included 6650 participants ≥ 20 years of age with complete data on CKM syndrome and metal exposure. There were 814 participants with stage 0 CKM (14.9%), 1122 in stage 1 (18.9%), 3731 in stage 2 (55.6%), and 982 ≥ in the stage 3 (10.6%).

As the stage of CKM syndrome increased, the average age of participants significantly increased, along with a notable increase in the proportion of males and non-Hispanic black individuals. In stage 1, metal levels of barium, cadmium, cesium, palladium, and titanium were increased. In participants ≥ stage 3, investigators saw increased levels of cobalt, molybdenum, antimony, and tungsten.

In weighted multinomial logistic regression analysis, increased levels of barium, cobalt, and molybdenum were significantly associated with increased odds of CKM stages ≥3. Participants in CKM stages ≥1 exhibited increased levels of metal exposure, although investigators observed an exception of palladium. They did not report any clear dose-dependent trend in urinary metal levels across different CKM syndrome stages.

Upon quantile gcomputation regression analysis, the exposure to metal mixtures was significantly associated with the prevalence of stage 1 (Odds Ratio [OR], 2.209; 95% Confidence Interval [CI], 1.78-2.74), and increased urinal metal mixture leveels were associated with increased odds of stage 2 and ≥ stage 3, respectively (OR, 2.242; 95% CI, 1.851-2.715 and OR, 3.401; 95% CI, 2.63-4.399). For every quartile increase, participants in the upper quartiles of urinary metal mixtures had a 2.207-fold increased odds of CKM syndrome (95% CI, 1.835-2.654).

In the subgroup analysis based on age, participants <60 years of age exhibited increased statistical associations between metal exposure and CKM syndrome, and all metals, except for palladium, were significantly associated with CKM syndrome.

In mediation analyses, inflammation, measured by serum albumin and alkaline phosphatase, and biological aging, defined by the Klemera-Doubal method (KDM) residuals, partially explained the associations between metal mixture exposure and CKM syndrome across disease stages and overall.

Stage 1: serum albumin (12.09%) and KDM residuals (9.15%) explained the association.

Stage 2: alkaline phosphatase (8.87%), serum albumin (9.14%), and KDM residuals (35.79%) explained the association.

≥ stage 3: alkaline phosphatase (8.64%), serum albumin (11.46%), and KDM residuals (23.2%) explained the association.

“These results improve our understanding of CKM syndrome by suggesting that environmental metal exposure may be associated with CKM stages,” concluded investigators. “However, as NHANES reflects exposure patterns in the U.S. general population, the results are most applicable to community-level environmental exposures and should not be directly extrapolated to high-exposure occupational groups. Further validation through prospective cohort studies and mechanistic research is warranted.”

Zhang S, Tang H, Pan L, Zhou M. Association of metal and metalloid exposure with cardiovascular-kidney-metabolic syndrome: mediation by inflammation, oxidative stress, and aging. 

. Published online December 12, 2025. doi:

https://doi.org/10.1186/s12889-025-25894-0

Jomova K, Alomar SY, Nepovimova E, Kuca K, Valko M. Heavy metals: toxicity and human health effects. 

https://doi.org/10.1007/s00204-024-03903-2

New research suggests a link between metal and metalloid exposure and increased risk of cardiovascular-kidney-metabolic (CKM) syndrome, raising environmental health concerns. The study utilized data from the National Health and Nutrition Examination Survey (NHANES) to explore the relationship between metal mixtures and CKM syndrome stages. Findings indicate that increased levels of certain metals are associated with higher CKM stages, with inflammation, oxidative stress, and aging partially mediating these associations. The study emphasizes the need for further research to validate these findings and explore underlying mechanisms.

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


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Chronic Kidney Disease

Metal Exposure Levels May Explain Cardiovascular-Kidney-Metabolic Stages

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.

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

Hereditary hemorrhagic telangiectasia (HHT)

 can result in substantially more frequent and significantly more severe complications than previously thought, according to an analysis of the Comprehensive HHT Outcomes Registry of the United States (CHORUS).

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.

HHT is the second most common inherited bleeding disorder and is associated with the development of malformed blood vessels. These may be small and cutaneous or mucosal with frequent complications of bleeding, or large and visceral with additional risks that can lead to significant morbidity and mortality. HHT is also notoriously difficult to recognize, particularly in younger patients without a family history of disease or epistaxis.

“For every man with hemophilia, there is ≥1 man and 1 woman with HHT – it’s twice as common as hemophilia, at least,” Al-Samkari told 

 in an exclusive interview. “There are no approved therapies for it. It’s been largely neglected in the hemostasis community – for the longest time, it was really just managed with procedures to treat bleeding, which is not the way to adequately address this disease, as we now know.”

CHORUS is a prospective, multicenter, longitudinal registry enrolling unselected patients with HHT. It contains >2400 data elements, which were collected by trained research coordinators at enrollment and follow-up visits via medical records and direct participant interviews for the purpose of Al-Samkari’s and colleagues’ study.

Investigators included a total of 600 participants with either genetically- or Curacao-criteria-confirmed HHT from November 2023 to April 2025, across 15 HHT centers in the US. Median age was 53 years (range, 0-88), and 60% of patients were female. Most diagnoses were made during mid-to-late adulthood, despite most patients typically displaying manifestations of HHT by age 13.

A total of 568 patients (95%) developed recurrent spontaneous epistaxis, with 339 (60%) developing recurrent epistaxis before age 13. 43% had ≥1 nasal surgery/procedure and 22% had ≥1 medical therapy for epistaxis, such as antifibrinolytic or antiangiogenic. 180 (30%) had a known diagnosis of chronic GI bleeding. Among post-menarche female patients, 124 (34%) had been diagnosed with heavy menstrual bleeding. 247 (41%) reported other clinically significant mucocutaneous oral or skin bleeding.

454 patients (76%) had developed moderate-to-severe HHT-associated mucocutaneous bleeding, which was defined as an Epistaxis Severity Score >4, bleeding requiring targeted pharmaceutical or surgical intervention, intravenous iron, and/or red cell transfusion. This included 334 (56%) with moderate-to-severe HHT-associated epistaxis.

Additionally, 408 patients (68%) had been diagnosed with 

 (n = 351; 59%) or iron deficiency (n = 381; 64%). Of these, 247 (61%) and 150 (37%) required intravenous iron and red blood cell transfusion, respectively. Venous and arterial thromboembolism occurred in 44 (7%) and 38 (6%) patients, respectively, including 34 (6%) with ischemic stroke.

Solid organ AVMs, including brain, pulmonary, and liver, were diagnosed in 81 (15%), 268 (45%), and 128 (21%) patients, respectively. Only 30 with brain AVMs (37%) were diagnosed by age 25. Finally, 16 patients (3%) suffered ≥1 intracranial hemorrhage, with 10 (63%) suffering a first intracranial hemorrhage by age 25. 13 (2%) suffered ≥1 pulmonary hemorrhage.

 in 44 (7%), chronic liver disease in 17 (2.8%), epilepsy in 24 (4%), severe bacterial/deep-seated tissue infection in 35 (6%), and brain abscess in 15 (3%). Serious manifestations occurred in 128 (21%) of patients, and 241 (40%) required emergency room visits and/or hospital admissions for HHT complications.

“These very concerning manifestations, particularly intracranial hemorrhage, can affect people while they’re young,” Al-Samkari said. “Most intracranial hemorrhages in HHT occur before age 25, and the average age of diagnosis was about 37 years. It’s a very concerning diagnostic delay, which we knew was present in HHT, but this study really raised the stakes of just how problematic that delay is.”

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

Al-Samkari H, Friday C, Kasthuri R, et al. Clinical spectrum of hereditary hemorrhagic telangiectasia (HHT): Data from the comprehensive HHT outcomes registry of the United States (CHORUS). Abstract presented at the 67th American Society of Hematology Annual Meeting. Orlando, FL. December 6-9.

Hammill AM, Wusik K, Kasthuri RS. Hereditary hemorrhagic telangiectasia (HHT): a practical guide to management. Hematology Am Soc Hematol Educ Program. 2021;2021(1):469-477. 

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

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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.

Kenneth Custer, PhD | Image Credit: Eli Lilly

Orforglipron has met the primary and all key secondary endpoints in the phase 3 ATTAIN-MAINTAIN trial by providing superior 

 compared to placebo in patients enrolled from the phase 3 SURMOUNT-5 trial, as announced by parent company Eli Lilly on December 18, 2025.

Orforglipron is an investigational, once-daily small molecule oral glucagon-like peptide-1 (GLP-1) receptor agonist, made to be taken at any time of the day without restrictions on food or water intake. Lilly is currently running phase 3 studies to investigate orforglipron in 

, for weight management in adults with obesity and overweight with ≥1 weight-related medical issue, for 

, and for knee osteoarthritis in adults with obesity, as well as stress urinary incontinence and cardiovascular and renal outcomes.

“Obesity is a chronic, progressive disease, and sustaining weight loss remains a significant challenge for many,” Kenneth Custer, PhD, executive vice president and president of Lilly Cardiometabolic Health, said in a statement. “ATTAIN-MAINTAIN showed that orforglipron, a once-daily oral GLP-1, helped people maintain the weight they worked hard to lose.”

SURMOUNT-5 was a phase 3b, open-label, controlled trial, including adult participants with obesity but without type 2 diabetes. Patients were randomly assigned in a 1:1 ratio to either the maximum tolerated dose of tirzepatide – 10mg or 15 mg - or the maximum tolerated dose of semaglutide – 1.7 mg or 2.4 mg – subcutaneously once weekly for 72 weeks.

A total of 751 participants were included in SURMOUNT-5 – least-squares mean percent change in weight at week 72 was -20.2% (95% CI, -21.4 to -19.1) with tirzepatide and -13.7% (95% CI, -14.9 to -12.6) with semaglutide (

 <.001). The least-squares mean change in waist circumference was -18.4 cm (95% CI, -19.6 to -17.2) with tirzepatide and -13 cm (95% CI, -14.3 to -11.7) with semaglutide (

 <.001). Additionally, participants in the tirzepatide group were more likely than those in the semaglutide group to have weight reductions of ≥10%, 15%, 20%, and 25%.

The ATTAIN-MAINTAIN trial was a 52-week, randomized, double-blind, placebo-controlled trial. Adult patients with obesity or overweight and weight-related comorbidities who previously completed SURMOUNT-5 were enrolled in the trial – a total of 376 participants were enrolled and randomly assigned in a 3:2 ratio to either orforglipron maximum tolerated dose (24 mg or 36 mg) or placebo, as an adjunct to healthy diet and physical activity. ATTAIN-MAINTAIN’s primary endpoint was to demonstrate superiority in body weight maintenance in patients who had achieved plateau with either semaglutide or tirzepatide.

A total of 376 participants were randomized into the trial. Patients were initially given a 12 mg dose of once-daily oral orforglipron or matching placebo, which was then increased every 4 weeks until the randomized maintenance dose of 36 mg or maximum tolerated dose was reached. All participants who regained ≥50% of their body weight from SURMOUNT-5 were treated with rescue orforglipron therapy.

Ultimately, patients who switched to orforglipron from semaglutide maintained previously achieved weight loss, with an average difference of 0.9 kg. Those who switched from tirzepatide also maintained their achieved weight loss, with an average difference of 5 kg, using the efficacy estimand. In post-hoc analyses at 24 weeks, the change in body weight from ATTAIN-MAINTAIN baseline for patients switching from semaglutide was -0.1 kg vs 9.4 kg for placebo. Similarly, patients switching from tirzepatide saw a change from baseline of 2.6 kg vs 9.1 kg for placebo.

The safety and tolerability profile of orforglipron was also consistent with previous orforglipron phase 3 studies. The most common adverse events were gastrointestinal and generally mild to moderate in severity. Discontinuation rates due to adverse events were 4.8% (orforglipron from semaglutide), 7.6% (placebo from semaglutide), 7.2% (orforglipron from tirzepatide), and 6.3% (placebo from tirzepatide).

“Participants in this study were able to switch directly from the highest tolerated doses of available injectable therapies onto oral doses of orforglipron,” Custer said. “If approved for the treatment of obesity, orforglipron could provide a convenient alternative for the millions of individuals living with obesity around the globe to continue their long-term health journey.”

Lilly has submitted a New Drug Application to the US Food and Drug Administration (FDA) for orforglipron for the treatment of obesity or overweight in adults. Orforglipron has been granted a Commissioner’s National Priority Voucher from the FDA.

Biro N. Lilly’s orforglipron helped people maintain weight loss after switching from injectable incretins to oral GLP-1 therapy in first-of-its-kind Phase 3 trial. Eli Lilly. December 18, 2025. Accessed December 18, 2025. 

https://investor.lilly.com/news-releases/news-release-details/lillys-orforglipron-helped-people-maintain-weight-loss-after

Aronne LJ, Horn DB, le Roux CW, et al. Tirzepatide as compared with semaglutide for the treatment of obesity. New England Journal of Medicine. 2025;393(1):26-36. 

Orforglipron, an oral GLP-1 receptor agonist, demonstrated superior weight maintenance compared to placebo in the ATTAIN-MAINTAIN trial, following the SURMOUNT-5 trial. This investigational drug, taken without food or water restrictions, is being studied for various conditions, including obesity, type 2 diabetes, and hypertension. The trial showed that patients switching from injectable therapies to orforglipron maintained weight loss effectively. The safety profile was consistent with previous studies, with mild to moderate gastrointestinal adverse events. Eli Lilly has submitted a New Drug Application to the FDA for orforglipron.

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

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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 

Examination of unique challenges and the importance of early, effective therapy in younger patients.

Expert Perspectives on First-In-Class IL-23 Oral Peptide 

Registry data show worse asthma control, more exacerbations, and higher healthcare utilization in patients with severe asthma and a comorbid sleep disorder.

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.

Sleep Disorders Linked to Poorer Symptom Control in Severe Asthma

Shyam Joshi, MD, reviews clinical and mechanistic data on remibrutinib in chronic spontaneous urticaria, as presented at ACAAI 2025 and EADV 2025.


Updates in Remibrutinib from ACAAI 2025

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 highly selective oral TYK2 inhibitor met coprimary endpoints for sPGA 0/1 and PASI 75 at week 16 versus placebo in the phase 3 Latitude studies.

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.

Once-Daily Oral Zasocitinib Delivers Strong Phase 3 Efficacy in Plaque Psoriasis

Experts redefine obesity, distinguishing between preclinical and clinical forms, aiming to improve diagnosis and treatment strategies for better health outcomes.

This Year In Medicine

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

A retrospective cohort study developed and validated a predictive model for IgA nephropathy, using routinely available variables. 


IgA Nephropathy

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

IgA Nephropathy Prediction Model Aids 5-Year Survival Estimation

In this episode, a panel of dermatologists join to discuss the impact of the Boards University educational initiative for residents and early-career physicians.

The Medical Sisterhood, with Mona Shahriari, MD

The Medical Sisterhood, hosted by Mona Shahriari, MD, is a podcast dedicated to empowering female physicians by providing a platform for shared experiences, mentorship, and support. 

Each episode delves into the unique challenges women in medicine face, including work-life balance, leadership roles, and overcoming gender biases. Shahriari aims to inspire women to lead fulfilling professional and personal lives on their own terms through candid discussions and expert interviews. 

e as we foster a community where women can uplift and support each other in achieving their goals!

Podcasts

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

Latest News

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

Gestational Diabetes Linked to Reduced Lung Function in Children

Metal Exposure Levels May Explain Cardiovascular-Kidney-Metabolic Stages

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

Orforglipron Maintains Weight Loss in Patients Switching from Semaglutide or Tirzepatide