A Multi-centre, Prospective, Open-label, Single-arm, Non-interventional, Regulatory Post Marketing Surveillance (rPMS) Study of Ozempic Solution for Injection 1.34mg/ml (Semaglutide) to Evaluate Safety and Effectiveness in Patients With Type 2 Diabetes Mellitus in Routine Clinical Practice in Korea

The aim of this study is to assess the safety and effectiveness of Ozempic initiated according to label in adults with Type 2 Diabetes Mellitus (T2DM) under routine clinical practice conditions. Participants will get Ozempic as prescribed by study doctor. The study will last for about 26 weeks.

Start Date31 Mar 2025

Sponsor / Collaborator

Novo Nordisk A/S

NCT05646199 / Not yet recruitingPhase 2/3IIT

The Effect of Semaglutide Compared to Metformin in Obese Women With Polycystic Ovary Syndrome (PCOS): a Randomised Controlled Study (Semaglutide-PCOS Trial).

The goal of this clinical trial is to compare the effect of Semaglutide and metformin on weight loss in obese women with Polycystic Ovarian Syndrome (PCOS) over a 28-week treatment period.
The main question it aims to answer is:
• Which of the 2 drugs, metformin or Semaglutide causes more weight loss when used over a 28 week treatment period in obese women with PCOS?
Participants will be divided into 2 groups by chance. In the first group, participants will be asked to take metformin orally. In the second group, participants will take Semaglutide by injection under the skin weekly.
The maximum duration of participation for the patients in the trial is 32 weeks.
Researchers will compare the weight reduction, quality of life and individuals' wellbeing between the two groups.

Start Date01 Mar 2025

Sponsor / Collaborator

The University of Hull

NCT06639464 / Not yet recruitingPhase 2IIT

Semaglutide for the Treatment of Opioid Use Disorder: a Pilot Randomized Controlled Trial

The is a pilot, 12-week, double-blind, placebo-controlled, randomized trial of individuals with opioid use disorder (OUD) newly initiating buprenorphine to receive either weekly injections of semaglutide (n=23) or matching placebo (n=23). The primary aim is to determine the effects of semaglutide on cue-reactivity among individuals with OUD. The secondary aim is to assess the preliminary efficacy, safety, and tolerability of semaglutide for OUD

Start Date01 Feb 2025

Sponsor / Collaborator

The Brigham & Women's Hospital, Inc.

100 Clinical Results associated with Semaglutide (Novo Nordisk)

100 Translational Medicine associated with Semaglutide (Novo Nordisk)

100 Patents (Medical) associated with Semaglutide (Novo Nordisk)

1,430

Literatures (Medical) associated with Semaglutide (Novo Nordisk)

01 Jan 2025·BRAIN RESEARCH

Principal components analysis on genes related to inflammasome complex and microglial activation in the hypothalamus of obese mice treated with semaglutide (GLP-1 analog)

Article

Author: Marinho, Thatiany S ; Mandarim-de-Lacerda, Carlos A. ; Marinho, Thatiany S. ; Aguila, Marcia B ; Fabiano, Matheus M ; Mandarim-de-Lacerda, Carlos A ; Fabiano, Matheus M. ; Aguila, Marcia B.

We studied the effect of semaglutide (glucagon-like peptide type 1 agonist) on hypothalamic pro-inflammatory genes in diet-induced obese mice. Male C57BL/6J mice were fed a control (C) or high-fat (HF) diet for 16 weeks, then divided into six groups and maintained for an additional four-week study: C, C+semaglutide (CS), C pair-feeding (CP), HF, HF+semaglutide (HFS), and HF pair-feeding (HFP).Weight gain (WG), food efficiency (FE), and plasmatic biochemistry were determined. The hypothalamus was removed and prepared for molecular analysis. Semaglutide reduced WG and FE in the HF group. High cytokines levels (tumor necrosis factor alpha, TNF alpha, monocyte chemoattractant protein 1, MCP1, and Resistin) in HF mice were reduced in HFS mice. High pro-inflammatory gene expressions were seen in HF (toll-like receptor 4, Tlr4; Mcp1; interleukin 6, Il6; Tnfa), inflammasome complex (Pirina domain-containing receptor 3, Nlrp3; Caspase 1, Il1b, Il18), and microglial activation (ionized calcium-binding adapter molecule 1, Iba1; cluster differentiation 68, Cd68; argirase 1, Arg1) but mitigated in HFS. The principal components analysis (PCA) based on these markers in a PC1 x PC2 scatterplot put HF and HFP together but far away from a cluster formed by C and HFS, indicating little significance of weight loss (HFP) but decisive action of semaglutide (HFS) in the results. In conclusion, semaglutide benefits hypothalamic pro-inflammatory genes, inflammasome complex, and microglial activation independent of the weight loss effect. Since GLP-1 receptor agonists such as semaglutide are already indicated to treat obesity and diabetes, the potential translational effects on neuroinflammation should be considered.

01 Jan 2025·JOURNAL OF AFFECTIVE DISORDERS

Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) and suicidality: A replication study using reports to the World Health Organization pharmacovigilance database (VigiBase®)

Article

Author: Le, Gia Han ; Mansur, Rodrigo B. ; Rhee, Taeho Greg ; Rosenblat, Joshua D. ; McIntyre, Roger S ; Ho, Roger ; McIntyre, Roger S. ; Rosenblat, Joshua D ; Kwan, Angela T.H. ; Teopiz, Kayla M ; Wong, Sabrina ; Cao, Bing ; Kwan, Angela T H ; Teopiz, Kayla ; Mansur, Rodrigo B

INTRODUCTION:

Reports of suicidality associated with glucagon-like peptide 1 receptor agonists (GLP-1 RAs) have been reported to the European Medicines Agency (EMA) and the United States Food and Drug Administration (FDA). We previously reported an increased reporting odds ratio (ROR) of some measures of suicidality with semaglutide and liraglutide using the FDA Adverse Event Reporting System (FAERS). Notwithstanding the increased ROR, causality between GLP-1 RAs exposure and any aspect of suicidality is not established.

RESEARCH DESIGN AND METHODS:

The analysis herein aims to extend a previous analysis of the FAERS by evaluating the ROR for suicidality reported to the World Health Organization (WHO) Pharmacovigilance Database (VigiBase). We aimed to characterize the ROR of suicidality associated with GLP-1 RAs, as extrapolated from spontaneous reports. As per our previous report, the ROR was considered significant when the lower limit of the 95 % confidence (CI) was >1.0.

RESULTS:

We searched VigiBase reports from inception to January 2024. The RORs for suicidal ideation were significantly increased for semaglutide (5.82), liraglutide (4.03) and tirzepatide (2.25). For "depression/suicidal", the ROR was significantly increased for semaglutide (14.74) and liraglutide (5.86); and for suicidal behaviour, the ROR was significantly increased for semaglutide (6.52) and liraglutide (3.90). However, for suicide attempts, the ROR was significantly decreased for semaglutide (0.11), dulaglutide (0.075), exenatide (0.047) and liraglutide (0.15). For completed suicide, the ROR was also significantly decreased for semaglutide (0.01), dulaglutide (0.003), exenatide (0.002) and liraglutide (0.008).

CONCLUSION:

Unlike our previous report with FAERS, a mixed pattern of ROR emerged in the WHO VigiBase with respect to suicidality and exposure to select GLP-RAs. Causation between GLP-1 RA exposure and suicidality (either increased or decreased) cannot be ascertained from ROR data.

31 Dec 2024·Journal of medical economics

Budget impact analysis for three glucagon-like peptide-1 receptor agonist-based therapies for type 2 diabetes mellitus management in Saudi Arabia

Article

Author: Al-Omar, Hussain A ; Almodaimegh, Hind S ; Al-Harbi, Ibtisam ; Hassan, Mohamed ; Alzubaidi, Lamya M ; Al-Harbi, Bandar ; Akhtar, Omar ; Omaer, Abubker

BACKGROUND AND OBJECTIVES:

This study presents a budget impact analysis (BIA) conducted in Saudi Arabia, evaluating the cost implications of adopting semaglutide, tirzepatide, or dulaglutide in the management of type 2 diabetes mellitus (T2DM) patients. The analysis aims to assess the individual budgetary impact of these treatment options on healthcare budgets and provide insights for decision-makers.

METHODS:

A prevalence-based BIA was developed using real-world and clinical trials data. The model considered disease epidemiology, medication prices, diabetes management expenses, cardiovascular (CV) complications costs, and weight reduction savings over a 5-year time horizon. One-way and probabilistic sensitivity analyses (OWSA, PSA) were performed to assess the robustness of the results.

RESULTS:

Over a 5-year period, the cumulative budget impact for semaglutide, tirzepatide, and dulaglutide were 85,923,089 USD, 169,790,195 USD, and 94,558,356 USD, respectively. Hypothetical scenarios considering price parity between semaglutide and tirzepatide are associated with financial impacts of 85,923,091 USD and 86,475,335 USD, respectively. In the public sector, semaglutide showed the lowest incidence of 3-point major adverse CV events (3P-MACE), with tirzepatide leading in weight loss and HbA1c reduction, and dulaglutide presenting the highest 3P-MACE rates and least improvements in HbA1c and weight. A breakeven analysis suggested that tirzepatide's list price would need to be $199.91 lower than its current list price to achieve budget impact parity with semaglutide based on currently available evidence. Results from the OWSA suggested that risk reductions for CV events were key drivers of budget impact. PSA results were confirmatory of base-case analyses.

CONCLUSIONS:

CV cost-offsets and drug acquisition considerations may make semaglutide a favorable use of resources for Saudi budget planners and decision-makers. These results were robust to assumptions regarding the list price of tirzepatide.

1,411

News (Medical) associated with Semaglutide (Novo Nordisk)

22 hours ago

·www.prnewswire.com

Ro selected to present new research at The Obesity Society's ObesityWeek 2024

Research advances knowledge about the role telehealth can play in supporting obesity care NEW YORK, Nov. 4, 2024 /PRNewswire/ -- Ro, the leading direct-to-patient healthcare company, is set to present new research at The Obesity Society's ObesityWeek 2024 conference in San Antonio, TX. All six of Ro's abstracts, authored by leaders from across the company's clinical, research, and data teams as well as several of Ro's renowned obesity advisors and other obesity thought leaders, were selected for poster presentation. The research sheds light on key issues in obesity medicine today, including: how telehealth can bridge access to weight management care for patients living in rural areas or care deserts; patients' diverse motivations for weight loss and their relationship to quality of life; the role technology plays in monitoring and managing side effects among patients treated with GLP-1s, and more. "Ro's vertically integrated platform gives us the unique ability to collect and analyze diverse, structured data throughout our patients' journeys – from the moment they start a visit to the time they celebrate reaching a health goal. These research capabilities are critical to Ro's ability to deliver the best possible patient experience and highest quality of care," said Zachariah Reitano, Co-founder and CEO of Ro. "Our findings presented at ObesityWeek demonstrate Ro's dedication to uncovering, applying, and sharing insights that enable us and others to improve care for the millions of patients with overweight and obesity." The following abstracts were selected and will be presented in the Poster Hall (Exhibit Hall 4): Improving semaglutide adverse event management using a structured severity classification system Poster–189 | Nov 3 at 7:30PM Authors: Lauren Broffman, PhD, Kerry Quolliotine, BSN, MHA, Laurey Lou, DPT, Linda Pietzman, MD, Sydney Getzin, Raoul Manalac, MD, Melynda Barnes, MD Using data from Ro's comprehensive adverse event reporting and classification system, this study assessed the differences between how patients perceive the severity of GLP-1 related adverse events vs a clinical definition of severity. From a random sample of 10,000 patients on Ro's platform, it was found that patient reported severity exceeded clinical severity in 17.2% of cases, while clinical severity exceeded patient reported in 24.3% of cases. In either scenario, a structured adverse events reporting and classification system can help prompt timely intervention that supports quality of care and treatment adherence. Findings from an online surveillance tool for GLP-1 RA supply issues and availability Poster–341 | Nov 4 at 2:30PM Authors: Lauren Broffman, PhD, Benjamin Gershuny, Zachariah Reitano, Nicholas Samonas The GLP-1 medication shortages have been a persistent challenge for patients seeking weight management pharmacotherapy. While the FDA monitors supply, there is little data available on demand. Ro launched an online tool that allows anyone in the United States to report GLP-1 supply or availability. Users can also opt-in to receive localized updates about GLP-1 supply as well as changes to the status of GLP-1s on the FDA's drug shortage list. An analysis of data collected through the tool showed that more than 40,000 supply issues were reported by more than 20,000 unique users in a little more than a month (May 24 - July 3, 2024). With some deviations, the reports generally aligned with the FDA shortage list, and the uptake of the tool suggests that offering availability notifications may incentivize reporting. The role of telehealth in mitigating access gaps for weight management care Poster–597 | Nov 5 at 2:30PM Authors: Raoul Manalac, MD, Nick Hardy, Lauren Broffman, PhD Access to weight management care can be challenging for patients that live in rural areas and/or care deserts. Ro conducted a study to assess whether patients residing in rural or designated Primary Care Health Provider Shortage Area (HPSAs) are seeking weight management care via telehealth, and if this population possesses unique characteristics. The study found that a substantial portion of those seeking weight management care via Ro's platform live in rural or HSPAs and that rural-residing patients were more likely to suffer from more advanced disease. The findings suggest that telehealth can help bridge gaps for patients with geographic access challenges and may present opportunities to improve access for undertreated populations in these groups. Intrusive food thoughts are common when seeking weight loss treatment irrespective of obesity class Poster–340 | Nov 4 at 2:30PM Authors: Raoul Manalac, MD, Lauren Broffman, PhD, Lee Robinson, Erika Schmidt, David B. Allison, PhD* The increasing use of GLP-1 medications for overweight and obesity has led to anecdotal reports of a reduction in 'food noise.' This study looked at a random sample of 12,000 patients who answered a prospective question, "how often do you find yourself thinking about food even when you're not hungry?" while being assessed for weight management treatment on Ro's platform. Experiencing intrusive thoughts about food when not hungry was common among patients with overweight and obesity seeking pharmacotherapy, indicating that more research on 'food noise' is needed to further define and understand it. Understanding diverse motivations for weight loss and their relationship to quality of life Poster–596 | Nov 5 at 2:30PM Authors: Lee Robinson, Lauren Broffman, PhD, Max Kerwick, Beverly Tchang, MD The discourse around anti-obesity medications, including GLP-1s, emphasizes their health benefits while trying to avoid perceptions of the treatments as 'vanity drugs'. This study conducted qualitative interviews with patients with overweight or obesity who were actively undergoing treatment with GLP-1 medications about their personal goals and definitions of success. The study found that patients with overweight and obesity seek pharmacotherapy due to diverse medical, psychological, functional, and social motivations that contribute to their overall quality of life. It also found that dismissing some motivations as vanity overlooks the potential impact that these goals have on patients' sense of identity or quality of life. Who is seeking telehealth care following bariatric surgery? Poster–188 | Nov 3 at 7:30PM Authors: Raoul Manalac, MD, Lauren Broffman, PhD, Laura Boyer, FNP-C, Philip Schauer, MD, FACS, FASMBS Ro partnered with researchers at a leading academic bariatric surgery and research center to better understand the journeys of patients who underwent metabolic and bariatric surgery (MBS) and have experienced weight regain. Using a random sample of 5,000 patients who previously underwent MBS and sought pharmacotherapy via Ro, the study revealed that most patients still lived with severe obesity, had at least one comorbidity that indicated impaired metabolic homeostasis, and had previously attempted lifestyle modifications. "The breadth of our findings highlights the value of real-world data collected in conjunction with high-quality obesity care and pharmacotherapy delivered at scale via a telehealth platform. With this data, we can address a wide range of scientific questions, driving advancements in knowledge that enhance access to and quality of care," Lauren Broffman, PhD, Director of Real World Evidence. About Ro Ro is a direct-to-patient healthcare company with a mission of helping patients achieve their health goals by delivering the easiest, most effective care possible. Ro is the only company to offer nationwide telehealth, labs, and pharmacy services. This is enabled by Ro's vertically integrated platform that helps patients achieve their goals through a convenient, end-to-end healthcare experience spanning from diagnosis, to delivery of medication, to ongoing care. Since 2017, Ro has helped millions of patients in nearly every single county in the United States, including 98% of primary care deserts. Visit Ro.co for more information. *Dr. Allison is a distinguished professor and dean at Indiana University-Bloomington and is acting as an independent consultant to Ro and his views do not necessarily represent those of Indiana University-Bloomington or any other organization. Contact: [email protected] SOURCE Ro WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

04 Nov 2024

·endpts.com

Is there room for MASH drugs in a GLP-1 world?

For years, drug developers working to treat an advanced form of fatty liver disease known as MASH were chasing wide-open terrain. There were no products on the market, millions of potential patients and a high bar on the science to get a successful drug. Then, in June, Eli Lilly reported that its blockbuster weight loss drug tirzepatide might be an effective treatment for the condition. Last week, Novo Nordisk released a study showing that its weight loss drug semaglutide also improved MASH in patients . It’s planning to apply for an FDA approval next year. MASH (metabolic dysfunction-associated steatohepatitis) is often associated with obesity, and the apparent success of the widely available (and cheaper) GLP-1 drugs has raised the question about how much room there will be for MASH-targeting drugs. The answer, however, appears to be that there’s still an opportunity. Last week, the first company to bring a MASH drug to market reported third-quarter sales of $62.2 million, well above Wall Street expectations. It’s a fraction of what the weight loss products are selling, but it was enough to send the company’s stock up by almost half. On a call with investors Thursday, Madrigal Pharmaceuticals executives said many of their patients are also on weight loss drugs, and they don’t expect patients to have to try a GLP-1 before moving to a MASH therapy. “We’ve had ongoing dialogue with payers now for well over a year,” Madrigal CEO Bill Sibold said. “They understand the profile of the product and what it can offer.” At the same time, biotechs developing the MASH drugs have begun to tweak their development strategies to prove that their liver-targeting candidates work in conjunction with the weight loss drugs, especially as more patients show up in trials already on the therapies. And early batches of data released by biotechs in the space suggest there are benefits to combining the treatments. Sagimet Biosciences, for example, has a once-daily, oral MASH drug named denifanstat that’s set to enter Phase 3 before the end of the year . In the company’s Phase 2b study that read out this year, about 10% of patients were on a GLP-1 receptor agonist. CEO David Happel estimates that rate could jump to as much as 50% in a Phase 3 trial, and a survey of clinicians published by Cantor Fitzgerald in late June found that about a third of patients with advanced MASH are already on GLP-1s. “We were able to show a highly statistically significant improvement in fibrosis in those patients that frankly exceeded what either molecule alone could achieve,” Happel said in an interview with Endpoints News . None of the four patients on a GLP-1 who were given placebo demonstrated an improvement in either resolution of MASH without worsening of fibrosis or improvement in fibrosis without worsening of MASH. Five of 12 patients that were given the study drug showed MASH resolution and fibrosis improvement, respectively, though the MASH resolution results weren’t statistically significant. Those sorts of data are just beginning to emerge, now that companies developing MASH drugs are starting to study what happens when patients are on GLP-1s — and whether some patients might benefit more than others. “Until now, we have put all these patients in one population to examine, so there is little granularity in the treatment of the patients so far,” said Frank Tacke, director of hepatology at Charité – Universitätsmedizin Berlin, who’s consulted for numerous pharmas, including Novo Nordisk and Madrigal. “If we want to position whatever drug we would like to develop in patients with MASH, it will be in an environment where GLP-1s are one of the main drugs to treat the comorbidities,” Tacke said. Akero Therapeutics has performed similar analyses as Sagimet with its experimental MASH drug efruxifermin, currently in Phase 3. The drug is an analogue of fibroblast growth factor 21 (FGF21), a protein which fights against fat-induced toxicity and its effect on cellular distress. In a Phase 2 trial cohort, Akero studied 31 people on GLP-1s who had type 2 diabetes and MASH, adding either efruxifermin or a placebo. In the group, the majority of patients who added efruxifermin saw significant improvement to key markers of the disease. “The two in combination are really making substantial differences to the liver,” Akero chief development officer Kitty Yale said of the effect of the weight loss drugs and Akero’s experimental medicine. Other results, presented earlier this year, found that efruxifermin improved patients’ fibrosis across two dose levels at the 96-week mark compared to placebo. One reassurance for the companies developing MASH drugs is that the weight loss treatments, while effective in treating obesity, don’t appear to be a cure for the liver disease. Data from Eli Lilly at this year’s European Association for the Study of the Liver annual meeting showed that tirzepatide met the primary endpoint of wiping out fat cells in the liver compared to placebo. The company said the drug demonstrated the potential to be “clinically meaningful” at improving fibrosis, but that the study was not powered for the endpoint. And in a 2021 trial, Novo Nordisk failed to show a significant difference between semaglutide and placebo. “While these medications can be very helpful for the treatment of MASH, they’re not a complete panacea,” said Sidney Barritt, director of hepatology at the University of North Carolina’s liver center. Lilly is still mulling whether to launch a pivotal trial of tirzepatide in MASH, or wait to test a successor weight loss drug — if the better bet is retatrutide — in the disease. A spokesperson for the company said it “plans to continue conversations with the FDA on the next steps for tirzepatide for the treatment of MASH.” As for Novo, investors described the new data as roughly in line with expectations. Analysts at Leerink Partners said the GLP-1s don’t appear to be a ‘silver bullet’ for MASH and believe that combination use will be the standard of care. “For NASH stocks — we believe this outcome removes a potential overhang / worst-case scenario where [semaglutide] showed ‘game-changing’ fibrosis improvement,” the analysts wrote. Investors agreed and Madrigal’s stock climbed after the readout. There could be a handful of reasons for why the obesity drugs don’t solve MASH, Barritt explained, including that GLP-1 receptors aren’t located in the liver. The benefits are indirect, with improvements in weight through decreased appetite that naturally improve MASH — to a point. It’s also possible that a 52-week endpoint that some MASH trials implement may be a bit too soon for GLP-1s to show a full effect. Other trials have a longer, 72-week endpoint. “I think there’s going to be a market for these combination therapies in the future,” said Brian Ting, a transplant surgeon and gastroenterology specialist at the Tulane Transplant Institute. Reynald Castañeda contributed reporting.

Clinical ResultPhase 2Phase 3

04 Nov 2024

·www.globenewswire.com

Biomea Fusion Presents Preclinical Data Showing Icovamenib (BMF-219) Enhanced Effectiveness of GLP-1-Based Therapies and Introduces BMF-650, a Next-Generation, Oral Small-Molecule GLP-1 Receptor Agonist Candidate

Preclinical data from ex vivo human islet experiments showed that icovamenib (BMF-219) was able to enhance the activity of glucagon-like peptide-1 (GLP-1)-based therapies, potentially leading to increased insulin secretion and improved glycemic control in patients with diabetes Phase II study (COVALENT-211), combining icovamenib with a GLP-1-based therapy, planned to begin in 2025 BMF-650, an investigational next-generation, oral small-molecule GLP-1 receptor agonist (GLP-1 RA), demonstrated positive early preclinical activity, including improved glucose-stimulated insulin secretion, reduction in blood glucose concentration, and appetite suppression in cynomolgus monkeys Oct. 30, 2024 -- Biomea Fusion, Inc. (“Biomea” or “the Company”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to improve the lives of patients with diabetes, obesity, and genetically defined cancers, today presented preclinical data showing icovamenib enhanced the activity of GLP-1-based therapies, along with early preclinical efficacy and pharmacokinetic data for BMF-650, a next-generation, oral small-molecule GLP-1 RA candidate. “Menin plays a central role in the pancreas, not only impacting the proliferation of beta cells but also the expression of GLP-1 receptors. We observed that icovamenib, when combined with either of the two most commonly used GLP-1-based therapies, tirzepatide or semaglutide, enhanced the responsiveness of human islets to the GLP-1-based therapy, leading to substantial insulin secretion under hyperglycemic conditions. The dose-dependent improvements, where glucose-stimulated insulin secretion more than doubled, are highly promising,” stated Juan Pablo Frias, MD, Biomea Fusion’s Chief Medical Officer. “Additionally, we believe the results we’ve seen with our own GLP-1 RA product candidate, BMF-650, highlight a strong potential as a next-generation, oral GLP-1 RA for both diabetes and obesity. We believe these findings open exciting new avenues for treatment.” Icovamenib (BMF-219) in Combination with a GLP-1-Based Therapy Key Highlights: Preclinical studies evaluated insulin secretion by GLP-1-based therapies (tirzepatide and semaglutide) using human islets cultured ex vivo under hyperglycemic conditions, with and without icovamenib treatment. We hypothesized that menin inhibition would enhance the effectiveness of GLP-1-based therapies and showcased functional data, indicating stronger insulin responses with both tirzepatide and semaglutide when combined with icovamenib treatment. Further studies with orforglipron also indicated that icovamenib pretreatment improved insulin secretion, approximately doubling the effect-size depending on the dose. Additionally, BMF-650, Biomea’s next-generation, oral small molecule GLP-1 RA product candidate, used alone or in combination with icovamenib, yielded even further improved results supporting the potential for therapeutic benefits. The initiation of a Phase II study, COVALENT-211, to evaluate the combination of icovamenib with a GLP-1-based therapy, is planned for 2025. In addition, the Company announced additional details about its investigational, next-generation, oral small-molecule GLP-1 RA candidate, BMF-650. BMF-650 - an Investigational, Next-Generation, Oral Small Molecule GLP-1 Receptor Agonist - Key Highlights: We conducted preclinical studies to evaluate the properties of BMF-650 in comparison to a leading oral GLP-1 RA. BMF-650 exhibited higher bioavailability and a less variable pharmacokinetic profile, which may translate to improved tolerability and support successful dose escalation in patients. The estimated human dose will be approximately 100 mg once daily. In human donor islet studies, BMF-650 significantly enhanced glucose-stimulated insulin secretion. In cynomolgus monkey studies, BMF-650 showed significant improvements in glucose stimulated insulin secretion, in line with findings from the human donor islet experiments. BMF-650 also demonstrated superior glucose control. Appetite suppression studies revealed that daily oral BMF-650 dosing significantly reduced food intake during peak drug concentration, with sustained effects throughout the day for a six-day study period. These findings highlight BMF-650’s potential as an oral treatment for diabetes and obesity. “Our preclinical findings about the inhibition of menin in the GLP-1 pathway, announced today, may support the profile of icovamenib as a potential combination agent for GLP-1-based therapies. With the combination of icovamenib, less GLP-1 RA dosing may be required, which may support the overall benefits of these therapeutics. We believe, icovamenib may contribute to improved efficacy, tolerability and adherence, which ultimately will lead to more patients having longer benefits from these agents. We plan to clinically evaluate icovamenib as an adjunct to GLP-1-based therapies,” stated Thomas Butler, Biomea Fusion’s Chief Executive Officer and Chairman of the Board. “We are equally excited with the early results of our newest asset, BMF-650, which demonstrated clear advantages, including when compared to a leading GLP-1 RA in our preclinical studies. BMF-650 has shown superior insulin secretion, better glucose control, a smoother pharmacokinetic profile and higher bioavailability; all of which point to the potential for a greater therapeutic window and support our plans to evaluate BMF-650 as a next-generation oral treatment for diabetes. The appetite suppression results were particularly exciting, as they signal a new and impactful profile which we believe may support an impact on obesity.” Obesity is a chronic disease necessitating long-term management, associated with diminished life expectancy and a spectrum of severe health complications. These include metabolic disorders such as type 2 diabetes and non-alcoholic fatty liver disease; cardiovascular diseases like heart attack, stroke, and hypertension; and increased risks of chronic kidney disease, certain cancers, and chronic inflammation. The CDC estimates that over 40% of adults in the U.S. are considered obese, contributing to a significant burden on public health and healthcare systems. Globally, over 650 million adults are living with obesity, and these numbers are steadily rising. Glucagon-like peptide-1 (GLP-1) is a naturally occurring incretin hormone that plays a vital role in glucose homeostasis and appetite regulation. GLP-1 receptor agonists (GLP-1 RAs) are a class of medications that bind to and activate GLP-1 receptors, mimicking the effects of native GLP-1. These agents have demonstrated robust clinical efficacy in improving glycemic control, promoting weight loss, and enhancing insulin sensitivity in individuals with type 2 diabetes and obesity. Biomea Fusion is a clinical-stage biopharmaceutical company focused on the discovery and development of oral covalent small molecules to improve the lives of patients with diabetes, obesity, and genetically defined cancers. A covalent small molecule is a synthetic compound that forms a permanent bond to its target protein and offers a number of potential advantages over conventional non-covalent drugs, including greater target selectivity, lower drug exposure, and the ability to drive a deeper, more durable response. We are utilizing our proprietary FUSION™ System to discover, design and develop a pipeline of next-generation covalent-binding small-molecule medicines designed to maximize clinical benefit for patients. We aim to have an outsized impact on the treatment of disease for the patients we serve. We aim to cure. The content above comes from the network. if any infringement, please contact us to modify.

Clinical Result

100 Deals associated with Semaglutide (Novo Nordisk)

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KEGG	Wiki	ATC	Drug Bank
D10025	Semaglutide (Novo Nordisk)	A10BJ06	DB13928

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Obesity	US	Novo Nordisk, Inc.	04 Jun 2021
Overweight	US	Novo Nordisk, Inc.	04 Jun 2021
Diabetes Mellitus, Type 2	US	Novo Nordisk, Inc.	05 Dec 2017

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Chronic Kidney Diseases	NDA/BLA	CN	Novo Nordisk A/S	26 Aug 2024
Albuminuria	Phase 3	CA	Novo Nordisk A/S	14 Mar 2022
Albuminuria	Phase 3	DE	Novo Nordisk A/S	14 Mar 2022
Albuminuria	Phase 3	NL	Novo Nordisk A/S	14 Mar 2022
Albuminuria	Phase 3	ES	Novo Nordisk A/S	14 Mar 2022
Diabetes Mellitus	Phase 3	CA	Novo Nordisk A/S	14 Mar 2022
Diabetes Mellitus	Phase 3	DE	Novo Nordisk A/S	14 Mar 2022
Diabetes Mellitus	Phase 3	NL	Novo Nordisk A/S	14 Mar 2022
Diabetes Mellitus	Phase 3	ES	Novo Nordisk A/S	14 Mar 2022
Osteoarthritis, Knee	Phase 3	US	Novo Nordisk A/S	01 Oct 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05064735 (STEP 9, Pubmed) Manual	Phase 3	Obesity \| Osteoarthritis, Knee	407	Semaglutide 2.4 mg	xmhgnzassb(mkjivpwxtn) = ljtiosbysm lipissnigq (bfkiqnmyjr ) View more	Positive	31 Oct 2024
				Placebo	xmhgnzassb(mkjivpwxtn) = axyqqpcysu lipissnigq (bfkiqnmyjr ) View more
NCT05040971 (STEP 10, CTgov)	Phase 3	Prediabetic State \| Obesity	207	Semaglutide (Semaglutide 2.4 mg)	kthwzjvqmr(arsxamrlvc) = jredzklvfc epckrkpgen (ytuoedaawg, kthqhtqsnl - kxamdcczzr) View more	-	28 Oct 2024
				Semaglutide+placebo (Placebo)	kthwzjvqmr(arsxamrlvc) = ldbrkhlpro epckrkpgen (ytuoedaawg, ykdywpauqu - ulyvxxrkxq) View more
Pubmed Manual	Not Applicable	Alzheimer Disease \| Diabetes Mellitus, Type 2	-	Semaglutide	lrxwkqmnlb(iibysqqdwh): HR = 0.33 (95% CI, 0.21 - 0.51), P-Value = 0.33	Positive	24 Oct 2024
				Insulin
NCT03914326 (SOUL, Corporate Publications) Manual	Phase 3	Diabetes Mellitus, Type 2	9,650	semaglutide	omzeynafpg(dnlnfpkvsx): Difference (%) = -14 Met	Positive	21 Oct 2024
				Placebo
PRNewswire Manual	Not Applicable	Diabetes Mellitus, Type 2	14	ReCET procedure + semaglutide	rlxdtjmfdw(jwmrivfndp) = qbkuzieftb qwavgjxdva (tocferrpdv )	Positive	14 Oct 2024
NCT05478252 (CTgov)	Phase 3	Diabetes Mellitus, Type 2	388	Semaglutide J (Semaglutide J)	pcnzzvpdri(bdjgkzljpj) = fnnzuhaxnp tptkojlgag (dazjeusvbe, yivonplwlw - amlzrbkmqo) View more	-	09 Oct 2024
				Semaglutide B (Semaglutide B)	pcnzzvpdri(bdjgkzljpj) = lmyvktcjcy tptkojlgag (dazjeusvbe, svgxyxxznv - lwkztjxbbv) View more
PRNewswire Manual	Not Applicable	Obesity \| Hidradenitis Suppurativa	30	司美格鲁肽	ggmsoaipkj(klzjvvhpyx) = otnfvwogbg onvdnhwluo (lvldtmncem ) View more	Positive	25 Sep 2024
Drugs Manual	Not Applicable	Diabetes Mellitus, Type 1	100	Ozempic	brprcmtafj(fvrairhfun) = tildhntzsm qpabwadshr (vzubjyyiac ) View more	Positive	13 Sep 2024
				Mounjaro	brprcmtafj(fvrairhfun) = ncmcbqyhvu qpabwadshr (vzubjyyiac ) View more
Drugs Manual	Not Applicable	Diabetes Mellitus \| Obesity	-	Ozempic (obesity)	sohadxkzpl(mnjbfrvaff) = optztcsfyv csmlkvxfnc (aajlnaccsg )	Positive	13 Sep 2024
				Saxenda (obesity)	sohadxkzpl(mnjbfrvaff) = tpzoagzngw csmlkvxfnc (aajlnaccsg )
NEWS Manual	Not Applicable	Overweight \| Obesity	-	semaglutide	lfgwriohhh(gsktuxnifz) = avnqkdhamk yznfdcozxp (oikadsordn )	Positive	03 Sep 2024
				Placebo	lfgwriohhh(gsktuxnifz) = teeaqmnxvb yznfdcozxp (oikadsordn )

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