Fu Laimei (polyethylene glycol loxenatide) / Jiangsu Hansoh Pharma - LARVOL DELTA

Glucagon-like peptide-1 receptor agonists in the treatment of type 2 diabetes with metabolic dysfunction-associated steatotic liver disease: a real-world study (EASD 2026) - "Semaglutide and liraglutide improve hepatic steatosis in T2DM with MASLD, with semaglutide showing greater efficacy. All three GLP-1RAs reduce fat distribution; semaglutide and liraglutide decrease both visceral and subcutaneous fat, whereas PEG- loxenatide mainly reduces visceral fat."

Clinical • Real-world • Real-world evidence • Diabetes • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Type 2 Diabetes Mellitus

Quantitative analysis of free polyethylene glycols in PEGylated peptides using reverse-phase high-performance liquid chromatography and charged aerosol detection. (PubMed, PLoS One) - "Herein, systematically optimized reverse-phase high-performance liquid chromatography (RP-HPLC) coupled with charged aerosol detection (CAD) was developed and validated for the quantification of free PEG in three representative PEGylated peptide therapeutics: PEG-loxenatide, pegmolesatide, and visepegenatide...Practical applicability was confirmed by analyzing multiple drug batches and accelerated stability samples.A Wilcoxon signed-rank test showed no statistically significant difference between the results obtained under the default and co-optimized settings (P > 0.05), indicating that the two settings produced comparable results under the conditions evaluated. The proposed HPLC-CAD method provides a practical analytical approach in the analysis of PEGylated peptide pharmaceuticals by achieving a linearized CAD response through PFV and PL co-optimization, providing an effective approach for free PEG quantification in routine quality control."

Journal

Efficacy and safety of different once-weekly glucagon-like peptide-1 receptor agonists-A systematic review and Bayesian network meta-analysis. (PubMed, Diabetes Res Clin Pract) - "Tirzepatide demonstrates superior efficacy in glycemic control, weight reduction, and blood pressure reduction, yet is associated with high risk of adverse events. In contrast, polyethylene glycol loxenatide offers effective glycemic management with the lowest withdrawal probability. For patients with Type 2 diabetes mellitus and cardiovascular disease, dulaglutide is preferable."

Clinical • Journal • Retrospective data • Review • Cardiovascular • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Polyethylene Glycol Loxenatide Selectively Reduces Adiposity While Preserving Lean Body Mass in Type 2 Diabetes: A 12-Week Clinical Study. (PubMed, Diabetes Metab Syndr Obes) - P4 | "PEX168 treatment for 12 weeks not only effectively improves glycemic control, lipid profiles, and glycemic variability in patients with T2DM, but also significantly reduces visceral fat, ameliorates central obesity, and preserves skeletal muscle mass, thereby achieving "high-quality weight loss.". www.clinicaltrials.gov identifier is NCT05611684."

Clinical • Journal • Diabetes • Endocrine Disorders • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Efficacy of 12-week treatment with polyethylene glycol loxenatide in obesity or overweight patients with type 2 diabetes: a multicenter, prospective cohort study based on the flash glucose monitoring system. (PubMed, Front Endocrinol (Lausanne)) - P4 | "Beyond glycemic control, PEG-Loxe might also show additional benefits across multiple cardiometabolic indices. www.clinicaltrials.gov, identifier NCT05611684."

Clinical • Journal • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Effects of the glucagon-like peptide-1 receptor agonist PEG-Loxe on diabetic osteoporosis: a mechanistic study. (PubMed, Mol Metab) - "PEG-Loxe exerts comprehensive osteoprotective effects in type 2 diabetes by simultaneously promoting osteogenesis and suppressing osteoclastogenesis, through modulation of HMGB-1 signaling. PEG-Loxe can significantly improve bone turnover status and reduce bone resorption levels, with potential osteoprotective effects."

Journal • Diabetes • Metabolic Disorders • Osteoporosis • Rheumatology • Type 2 Diabetes Mellitus • APOE • IL1B • RUNX2 • TNFA

Effect of Polyethylene Glycol Loxenatide Treatment on Body Weight in Patients With Type 2 Diabetes With Different Body Mass Index: A Retrospective Real-World Study. (PubMed, Int J Endocrinol) - P=N/A | "The weight loss was negatively correlated with baseline BMI without excessive weight loss in normal BMI, supporting PEG-Loxe's use in this group. Trial Registration: Chinese Registry of Clinical Trials: ChiCTR2400087532."

Journal • Real-world evidence • Retrospective data • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Wound Healing Effects of Polyethylene Glycol Loxenatide via PI3K/AKT Pathway: In Vitro Evaluation in Human Keratinocytes. (PubMed, J Diabetes Res) - "Our study suggested that GLP-1RA PEG-Lox could promote wound healing by activating the PI3K/AKT/EGR1 signaling pathway, which further uncovered the potential pro-healing effect of GLP-1RAs in wounds."

Journal • Preclinical • Diabetes • EGR1

Real-world glycemic control, exploratory cardiorenal indicators, and safety of polyethylene glycol loxenatide versus semaglutide in type 2 diabetes patients: a Chinese two-center retrospective cohort study. (PubMed, Front Endocrinol (Lausanne)) - "Conversely, semaglutide offered more substantial improvement of cardiorenal parameters. These findings highlight the clinical utility of both agents in personalized T2DM management."

Clinical • Journal • Real-world evidence • Retrospective data • Diabetes • Dyslipidemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Loxenatide Plus LNG-IUS in Endometrial Atypical Hyperplasia (clinicaltrials.gov) - P2/3 | N=30 | Completed | Sponsor: Fudan University | Active, not recruiting ➔ Completed | Trial completion date: Jun 2026 ➔ Feb 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Trial completion • Trial completion date • Trial primary completion date • Genetic Disorders • Obesity

A Clinical Comprehensive Evaluation of Long-Acting GLP-1 Receptor Agonists in Type 2 Diabetes Management. (PubMed, Diabetes Metab Syndr Obes) - "Dulaglutide, semaglutide, polyethylene glycol loxenatide, tirzepatide, and mazdutide were evaluated using a 100-point scoring system based on drug labels, systematic literature review, and real-world data. This evaluation identifies semaglutide and dulaglutide as the preferred long-acting GLP-1RAs in China's current therapeutic landscape. The standardized, transparent six-dimensional framework provides a replicable methodology for the comprehensive assessment of chronic disease therapies, supporting rational drug selection and resource allocation."

Journal • Cardiovascular • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Effect of polyethylene glycol loxenatide on weight loss in super-obese patients with type 2 diabetes: a randomized controlled trial. (PubMed, Front Endocrinol (Lausanne)) - P=N/A | "For super-obese patients with T2DM, continuous treatment with PEG-Loxe for 24 weeks can effectively reduce body weight and achieve good glycemic control. www.chictr.org.cn, identifier ChiCTR2100052922."

Clinical • Journal • Diabetes • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Polyethylene glycol loxenatide improves cognitive and emotional performance in patients with type 2 diabetes: a 12-week multicenter clinical observational study. (PubMed, J Endocrinol Invest) - No abstract available

Journal • Observational data • Alzheimer's Disease • Cognitive Disorders • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Polyethylene glycol loxenatide reduces NETosis and immunofluorescence hyperactivation in Behçet's disease. (PubMed, Eur J Med Res) - "PEX168 attenuates neutrophil hyperactivation and NETosis in Behçet's disease via ROS suppression and upstream inflammasome regulation, disrupting inflammatory signaling without provoking pyroptosis. These findings support GLP-1 RAs as a targeted treatment for neutrophil-driven autoimmune disorders."

Journal • Immunology • Inflammation • Rare Diseases • IL1B • NLRP3

Digital multicriteria evaluation of negotiated medicines using Chinese mini-HTA: application of structured methodologies in assessing once-weekly GLP-1 RAs for improved clinical decision-making. (PubMed, Front Pharmacol) - "Semaglutide (77.8) and dulaglutide (76.3) achieved the highest totals, driven by superior HbA1c reduction and proven cardiovascular benefit, and were strongly recommended. Exenatide microspheres scored 70.2, mainly owing to favourable acquisition cost, and was also strongly recommended. PEG loxenatide scored 62.9, limited by narrower reimbursement coverage and lower international uptake, and received a weak recommendation...Key differentiators among agents were efficacy (notably cardiovascular benefit) and economic/policy factors, while safety differences were minimal. This replicable approach improves transparency, consistency, and evidence-based decision-making in clinical pharmacy and institutional formulary management."

Journal • Cardiovascular

Animal studies on the modulation of differential efficacy of polyethylene glycol loxenatide by intestinal flora. (PubMed, Front Endocrinol (Lausanne)) - "The difference in intestinal flora between individuals can affect the therapeutic effect of drugs. Moreover, FMT therapy can affect multiple metabolic pathways and colonization of beneficial bacteria to maintain the drug's therapeutic effect on T2DM mice."

Journal • Diabetes • Metabolic Disorders • Transplantation • Type 2 Diabetes Mellitus

A randomized, open-label, parallel, conventionally controlled clinical study to evaluate the metabolic effects of polyethylene glycol loxenatide in combination with whey protein therapy in patients with obesity (ChiCTR) - P4 | N=100 | Completed | Sponsor: The First Affiliated Hospital of Nanjing Medical University; The First Affiliated Hospital of Nanjing Medical University

New P4 trial • Genetic Disorders • Obesity

Efficacy of Polyethylene Glycol Loxenatide in Combination with Basal Insulin in Patients with Type 2 Diabetes Mellitus: A Retrospective Real-World Study. (PubMed, Diabetes Ther) - P=N/A | "PEG-Loxe + basal insulin combined therapy was safe and effective in patients with T2DM who did not achieve optimal glycemic control with insulin therapy alone."

Journal • Real-world evidence • Retrospective data • Diabetes • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Polyethylene Glycol Loxenatide Accelerates Diabetic Wound Healing by Downregulating Systemic Inflammation and Improving Endothelial Progenitor Cell Functions. (PubMed, Int J Mol Sci) - "In vitro, PEG-loxe restored EPC function by enhancing NO production, reducing mitochondrial ROS, improving cellular respiratory function, and restoring autophagic flux. These findings suggest that PEG-loxe offers therapeutic benefits for diabetic wound healing by downregulating systemic inflammation, enhancing angiogenesis, and improving mitochondrial quality control in EPCs, highlighting GLP-1RAs as potential therapies for diabetic vascular complications."

Journal • Cardiovascular • Diabetes • Inflammation • Metabolic Disorders • CXCL12 • HIF1A • IL5 • NOS3

Loxenatide Plus LNG-IUS in Endometrial Atypical Hyperplasia (clinicaltrials.gov) - P2/3 | N=30 | Active, not recruiting | Sponsor: Fudan University | Recruiting ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Obesity

Once-weekly glucagon-like peptide receptor agonist polyethylene glycol loxenatide protects against major adverse cardiovascular events in patients with type 2 diabetes: a multicenter ambispective cohort study (FLYING trial). (PubMed, MedComm (2020)) - "In the PEG-Loxe versus control cohorts, 21 (1.6%) versus 476 (4.3%) patients experienced nonfatal stroke (HR 0.63; p = 0.041), whereas 22 (1.7%) versus 545 (4.9%) experienced nonfatal myocardial infarction (HR 0.66; p = 0.058), and the incidence of cardiovascular death was 8 (0.6%) versus 240 (2.2%), respectively (HR 0.56; p = 0.118). We found a significantly lower incidence of first nonfatal myocardial infarction, nonfatal stroke, or cardiovascular deaths in the PEG-Loxe cohort than the control cohort."

Adverse events • Journal • Cardiovascular • Diabetes • Metabolic Disorders • Myocardial Infarction • Type 2 Diabetes Mellitus

Polyethylene glycol loxenatide protects diabetic kidneys by inhibiting GRP78/PERK/eIF2α pathway, and improves cardiac injury by suppressing TLR4/NF-κB inflammatory pathway. (PubMed, BMC Cardiovasc Disord) - "We showed that PEG-Loxe could decrease renal stress response and improve renal injury in T2DM by inhibiting endoplasmic reticulum stress via the GRP78/PERK/eIF2α pathway. Additionally, PEG-Loxe could hinder the TLR4/NF-κB inflammatory pathway and myocardial apoptosis and boost cardiac function, thus exerting protective effects on the cardiovascular system in T2DM."

Journal • Cardiovascular • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Renal Disease • Type 2 Diabetes Mellitus • ATF4 • HSPA5 • MYD88 • TLR4

Polyethylene glycol loxenatide modulates lipid metabolism and insulin resistance through lncRNA steroid receptor RNA activator/cellular nucleic acid binding protein/Rho-associated coiled-coil kinase 2 axis in type 2 diabetes mellitus. (PubMed, J Diabetes Investig) - "High-PEG-Loxe relieves insulin resistance and lipid metabolism disorder in type 2 diabetes mellitus through SRA/CNBP/ROCK2 axis. This research provides a molecular mechanism of PEG-Loxe for treating type 2 diabetes mellitus."

Journal • Diabetes • Dyslipidemia • Inflammation • Metabolic Disorders • Type 2 Diabetes Mellitus • LEP • LIPI • RHOA

Warfarin pharmacokinetics and pharmacodynamics are not affected by concomitant administration of the long-acting GLP-1 receptor agonist polyethylene glycol loxenatide. (PubMed, Int J Clin Pharmacol Ther) - "Concomitant administration of PEX-168 and single-dose warfarin was well tolerated. PEX-168 had no effect on the pharmacokinetics or pharmacodynamics of warfarin."

Journal • PK/PD data

Effect of polyethylene glycol loxenatide treatment on body weight in patients with type 2 diabetes with different body mass index: a retrospective cohort study (ChiCTR) - P=N/A | N=200 | Not yet recruiting | Sponsor: Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology; Tongji Hospital affiliated to Tongji Medical

New trial • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus