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Preclinical, Journal: Semaglutide ameliorated autism-like behaviors and DNA repair efficiency in male BTBR mice by recovering DNA repair gene expression. (Pubmed Central) - Sep 15, 2024 Furthermore, we elucidated the underlying mechanism(s) responsible for the ameliorative effects of semaglutide against behavioral problems and DNA repair deficiency in BTBR mice...Semaglutide restored the disrupted DNA damage/repair pathways in the BTBR mice by reducing Gadd45a expression and increasing Ogg1 and Xrcc1 expression at both the mRNA and protein levels. This suggests that semaglutide holds great potential as a novel therapeutic candidate for treating ASD traits.
- |||||||||| Rybelsus (semaglutide oral) / Novo Nordisk, Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Journal: Subcutaneous Semaglutide during Breastfeeding: Infant Safety Regarding Drug Transfer into Human Milk. (Pubmed Central) - Sep 14, 2024 While questions about long-term infant outcomes, the safety of maternal nutrient intake, and the nutrient content of breast milk remain, our findings suggest that semaglutide concentrations in human milk are unlikely to pose clinical concerns for breastfed infants. These results support healthcare providers in making informed decisions regarding postpartum therapeutic interventions.
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Preclinical, Journal: Semaglutide Improves Myocardial Perfusion and Performance in a Large Animal Model of Coronary Artery Disease. (Pubmed Central) - Sep 1, 2024 These changes were associated with increased activation of the endothelial-protective AMPK pathway (p=0.005), coupled with downstream increases in endothelial nitric oxide synthase (p=0.014). This study is the first to reveal the capacity of oral semaglutide to augment cardiac function in the chronically ischemic heart in a highly translational large animal model, likely through AMPK-mediated improvement in endothelial function and perfusion to the ischemic myocardium.
- |||||||||| Rybelsus (semaglutide oral) / Novo Nordisk, Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Journal: The first report of leukocytoclastic vasculitis induced by once-weekly subcutaneous semaglutide. (Pubmed Central) - Aug 31, 2024 Herein, we describe the first case of skin-limited LCV induced by once-weekly subcutaneous semaglutide in a 73-year-old man with T2DM, who experienced the complete resolution of the skin lesions shortly after the discontinuation of semaglutide therapy. Future prospective studies, adverse event reporting and post-marketing surveillance will certainly contribute to establishing if LCV represents a less rare than expected side effect of both oral and subcutaneous semaglutide formulations.
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Journal: Elucidating the Degradation Pathways of Human Insulin in the Solid State. (Pubmed Central) - Aug 26, 2024 Semaglutide improves lipid profile, liver steatosis, and fibrosis parameters and reduces the BMI in T2D and obese patients with NAFLD. While there have been significant advances in the development of peptide oral dosage forms in recent years, highlighted by the clinical and commercial success of approved peptides such as Rybelsus
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Journal: Reversible bilateral central scotoma under scotopic conditions associated with oral semaglutide. (Pubmed Central) - Aug 23, 2024 A subsequent clinical evaluation revealed no abnormalities on macular optical coherence tomography, fundus photography, fundus autofluorescence or Humphrey visual field. This case of a bilateral central scotoma under scotopic conditions that resolved after medication discontinuation expands the knowledge of potential side effects from this increasingly popular diabetic and weight loss medication.
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Journal, Real-world evidence, Real-world: PIONEER REAL Japan: Primary results from a multicenter, prospective, real-world study of oral semaglutide in adults with type?2 diabetes in Japanese clinical practice. (Pubmed Central) - Aug 22, 2024 This involvement has been critical to optimising the trial design, successfully obtaining regulatory and ethical approval, and conducting the trial. In routine clinical practice, HbA1c and bodyweight were significantly reduced from baseline in adults initiating oral semaglutide, including those aged ?75?years, with no new safety concerns.
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Journal: Forecasting Trial Milestones: A Predictive Analysis for Early Termination of the SOUL Study. (Pubmed Central) - Aug 8, 2024 The mathematical model based on the meta-analysis predicts that the SOUL study on oral semaglutide will be terminated early, with oral semaglutide showing benefits in terms of MACE compared to placebo. If the SOUL study corroborates the findings of this model, it may not only form the basis for the calculation of power but also define the duration of such studies, reducing costs and easing the process of designing cardiovascular outcome trials (CVOTs).
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Observational data, Retrospective data, Journal: Efficacy and Safety of Escalating the Dose of Oral Semaglutide from 7 to 14 (Pubmed Central) - Aug 7, 2024 If the SOUL study corroborates the findings of this model, it may not only form the basis for the calculation of power but also define the duration of such studies, reducing costs and easing the process of designing cardiovascular outcome trials (CVOTs). Escalating the dose of oral semaglutide to 14
- |||||||||| Rybelsus (semaglutide oral) / Novo Nordisk, Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Journal, FDG PET: FDG PET in a Patient on a GLP-1 Agonist/Insulin Secretagogue. (Pubmed Central) - Aug 5, 2024 Clinicians should be aware of the presence of these drugs and their potential effect on biodistribution in FDG PET. Further study is needed to best understand the effects of these medications on FDG biodistribution.
- |||||||||| Rybelsus (semaglutide oral) / Novo Nordisk, Ozempic (semaglutide SC once-weekly) / Novo Nordisk
Review, Journal: Semaglutide and obesity: beyond the nutritional and lifestyle intervention? (Pubmed Central) - Jul 19, 2024 Data in the literature on the anti-obesity action of semaglutide are available for both routes of administration of the drug, with a prevalence of studies using the s.c. one. However, given its dosage, oral semaglutide may provide greater attractiveness and better treatment adherence, but further research is needed in this field.
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Enrollment open, Surgery, Metastases: FLAMES: Fibrosis Lessens After Metabolic Surgery (clinicaltrials.gov) - Jul 18, 2024 P4, N=120, Recruiting, In adults with overweight or obesity but without type 2 diabetes, oral Semaglutide combined with dietary and lifestyle modifications resulted in a significant and clinically meaningful reduction in body weight compared to dietary and lifestyle modifications alone. Not yet recruiting --> Recruiting
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Phase classification, Surgery, Metastases: FLAMES: Fibrosis Lessens After Metabolic Surgery (clinicaltrials.gov) - Jul 16, 2024 P4, N=120, Not yet recruiting, Not yet recruiting --> Recruiting Phase classification: P=N/A --> P4
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Review, Journal, HEOR, Real-world evidence, Real-world: Efficacy and safety of oral semaglutide in type 2 diabetes: A systematic review of real-world evidence. (Pubmed Central) - Jul 13, 2024 Oral semaglutide exhibited a reasonable reduction in HbA1c and weight in people with T2D, consistent with the findings from PIONEER trials. While no new safety issues emerged, the inherent limitations of RWS underscore the necessity of long-term investigations to comprehensively assess safety.
- |||||||||| Rybelsus (semaglutide oral) / Novo Nordisk, Ozempic (semaglutide SC once-weekly) / Novo Nordisk
PK/PD data, Review, Journal: Clinical Pharmacokinetics of Semaglutide: A Systematic Review. (Pubmed Central) - Jul 2, 2024 Food and various dosing conditions including water volume and dosing schedules can affect the oral semaglutide exposure...The existing pharmacokinetic data can assist in developing and evaluating pharmacokinetic models of semaglutide and will help clinicians predict semaglutide dosages. In addition, it can also help optimize future clinical trials.
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