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Eli Lilly Nails Oral GLP-1 Trial—Here's What It Means for LLY
MarketBeat· 2025-04-23 11:33
Eli Lilly and Company TodayLLYEli Lilly and Company$827.87 +9.85 (+1.20%) 52-Week Range$677.09▼$972.53Dividend Yield0.72%P/E Ratio70.70Price Target$1,017.00Add to WatchlistThe world’s largest pharmaceutical stock, Eli Lilly and Company NYSE: LLY, is back in the green in 2025 as of the Apr. 21 close. Shares were down moderately in 2025 through mid-April. However, huge news came out regarding one of the company’s experimental drugs, causing shares to spike by over 14%. That drug is orforglipron, Eli Lilly’s ...
Ascletis Announces Positive Topline Results of U.S. Phase Ib Multiple Ascending Dose Study of Small Molecule Oral GLP-1R Agonist ASC30 and Submission of 13-week Phase IIa Study Protocol to FDA
Prnewswire· 2025-04-22 23:30
Core Insights - Ascletis Pharma Inc. announced positive topline results from its Phase Ib study of ASC30, an oral once-daily tablet for obesity treatment, demonstrating significant body weight reductions compared to placebo [3][10] - The study utilized three different weekly titration schemes, with the most effective showing a 6.5% placebo-adjusted mean body weight reduction after four weeks [4][5] Group 1: Study Design and Results - The Phase Ib study was randomized, double-blind, and placebo-controlled, conducted in the U.S. with participants having a BMI of 30-40 kg/m² [3] - Three dosing schemes were tested: - Scheme 1 (mid starting dose, slow titration) resulted in a 4.5% placebo-adjusted weight reduction - Scheme 2 (mid starting dose, normal titration) resulted in a 6.5% placebo-adjusted weight reduction - Scheme 3 (high starting dose, fast titration) resulted in a 5.0% placebo-adjusted weight reduction [4][5] - No serious adverse events were reported across all schemes, indicating a favorable safety profile [6] Group 2: Future Development Plans - Based on the Phase Ib results, the company plans to initiate a 13-week Phase IIa study with a "lower starting dose and slower titration" strategy, expected to begin in Q3 2025 [7] - The study protocol has been submitted to the U.S. FDA following preliminary consultations [7] Group 3: Product Information - ASC30 is a first and only investigational small molecule GLP-1 receptor biased agonist, designed for both oral and subcutaneous administration [8][11] - The compound has patent protection until 2044, highlighting its potential for long-term market exclusivity [11] Group 4: Company Overview - Ascletis Pharma Inc. is an innovative biotech company listed on the Hong Kong Stock Exchange, focusing on metabolic diseases and addressing unmet medical needs globally [12] - The company has multiple clinical-stage drug candidates in its pipeline, emphasizing its commitment to research and development [12]
MetaVia Reports Additional Positive Top-Line Results From the MAD Part 2 of Its Phase 1 Study of DA-1726, a Novel 3:1 Ratio GLP-1 and Glucagon Dual Receptor Agonist to Treat Obesity, Further Demonstrating Its Best-In-Class Potential
Prnewswire· 2025-04-22 12:31
Core Insights - MetaVia Inc. reported promising results from its Phase 1 clinical trial of DA-1726, indicating a dose-dependent response in body weight reduction, with significant differences in BMI and body weight compared to placebo [1][2][4] - DA-1726 demonstrated a maximum weight loss of -6.3% and a mean weight loss of -4.3% at the 32 mg dose, alongside notable reductions in fasting glucose and waist circumference [3][4] - The drug showed a favorable safety profile, with no significant cardiovascular effects observed, and a slight decrease in heart rate across most treatment groups [4][7] Company Overview - MetaVia Inc. is a clinical-stage biotechnology company focused on developing treatments for cardiometabolic diseases, particularly obesity [10] - The company is advancing DA-1726, a dual agonist targeting GLP-1 and glucagon receptors, which aims to improve weight loss outcomes compared to existing therapies [9][10] Clinical Trial Details - The Phase 1 trial was a randomized, double-blind, placebo-controlled study involving 36 subjects, assessing the safety, tolerability, pharmacokinetics, and pharmacodynamics of DA-1726 [6] - The trial's primary endpoint was to evaluate the safety and tolerability of DA-1726, while secondary endpoints included pharmacokinetic assessments and exploratory metabolic parameters [6] Future Directions - MetaVia plans to conduct a Phase 1 Part 3 study to evaluate DA-1726 in patients who discontinued other GLP-1 agonists, aiming to demonstrate improved tolerability and weight loss outcomes [5] - Additional cohorts will be added to determine the maximum tolerated dose of DA-1726, with expectations of enhanced efficacy at higher doses [5]
Eli Lilly: Cementing Its GLP-1 Empire With Orforglipron's Promising Phase 3 Results
Seeking Alpha· 2025-04-17 17:45
Core Insights - The article provides an overview of the investment landscape, emphasizing the importance of independent research and verification of information before making investment decisions [2][3]. Group 1 - The article highlights that past performance does not guarantee future results, indicating a need for caution among investors [3]. - It stresses that the opinions presented are based on probabilistic analysis rather than absolute certainty, which reflects the inherent volatility in stock investments [2][3]. - The content is intended for informational purposes and should not be interpreted as personalized investment advice, underscoring the necessity for investors to assess their own financial circumstances [2][3].
Lilly's oral GLP-1, orforglipron, demonstrated statistically significant efficacy results and a safety profile consistent with injectable GLP-1 medicines in successful Phase 3 trial
Prnewswire· 2025-04-17 10:45
Orforglipron is the first small molecule GLP-1 to successfully complete a Phase 3 trial, lowering A1C by an average of 1.3% to 1.6% across dosesThe investigational once-daily oral pill reduced weight by an average 16.0 lbs (7.9%) at the highest dose in a key secondary endpointThe overall safety and tolerability profile of orforglipron in ACHIEVE-1 was consistent with injectable GLP-1 therapies INDIANAPOLIS, April 17, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) today announced positive topline Ph ...
RedHill Biopharma's Positive Opaganib Weight Loss & Diabetes Data Published: Signals Potential $100B Market Disruption
Prnewswire· 2025-04-16 11:00
GLP-1 comparable efficacy: Opaganib's positive results, newly published in the journal Diabetes, Metabolic Syndrome and Obesity, demonstrated weight loss and improved metabolic markers on par with semaglutide in preclinical models--Novel mechanism of action, formulation and administration: Opaganib is a differentiated oral, non-peptide therapeutic that targets sphingosine kinase-2 (SPHK2), potentially avoiding common Glucagon-like peptide-1 (GLP-1) inhibitor side effects and administration burdens --Market ...
Lexaria Updates its Ongoing Human Study GLP-1-H24-4
Thenewswire· 2025-04-03 13:10
Registered Phase-1b 12-week study investigating safety, diabetes control, and weight loss Kelowna, British Columbia – April 3, 2025 – TheNewswire - Lexaria Bioscience Corp. (NASDAQ:LEXX) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms, is pleased to provide this progress update on its Phase 1b, 12-week chronic study GLP-1-H24-4 (the “Study”) underway in Australia. Enrollment of patients for all 5 Study arms has now been completed on schedule. Participation interest in the Stu ...
Fractyl Health Reports Positive Early Data Showing Revita® Has Potential to Prevent Weight Regain After GLP-1 Discontinuation
GlobeNewswire News Room· 2025-04-01 11:00
New REVEAL-1 study results show early signs of weight maintenance after GLP-1 discontinuation REMAIN-1 pivotal study now more than 50% enrolled; midpoint data analysis anticipated in Q3 2025 BURLINGTON, Mass., April 01, 2025 (GLOBE NEWSWIRE) -- Fractyl Health, Inc. (Nasdaq: GUTS) ("the Company"), a metabolic therapeutics company focused on pattern breaking approaches that treat root causes of obesity and type 2 diabetes (T2D), today announced positive early data from the open-label REVEAL-1 cohort of its on ...
The Vitamin Shoppe® Unveils First-of-its-Kind Supplement Line Formulated for GLP-1 Users
Prnewswire· 2025-03-31 12:35
The dietitian formulated, doctor-approved GLP-1 Support from Whole Health Rx™ by The Vitamin Shoppe® range of supplements delivers comprehensive nutritional solutions for individuals on GLP-1 weight- loss medications SECAUCUS, N.J., March 31, 2025 /PRNewswire/ -- The Vitamin Shoppe®, a leading omni-channel specialty retailer of nutritional products, today announced the launch of GLP-1 Support from Whole Health Rx™ by The Vitamin Shoppe®, an innovative line of dietary supplements designed to address the uniq ...
Beyond GLP-1 Drugs: This Opportunity at Eli Lilly Could Surprise Everyone in 2025
The Motley Fool· 2025-03-27 13:15
Mounjaro and Zepbound are Eli Lilly's largest sources of growth, but there is much more to the company.Over the last couple of years, the pharmaceutical sector has captivated investors thanks in large part to novel medications used to treat chronic weight management and diabetes.While you may be more familiar with brand names such as Ozempic or Wegovy, these drugs are known as glucagon-like peptide-1 (GLP-1) agonists in the medical world. Eli Lilly (LLY -2.98%) has emerged as one of the hottest stocks in th ...