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

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

Efficacy and safety of polyethylene glycol loxenatide in treating mild-to-moderate diabetic kidney disease in type 2 diabetes patients: a randomized, open-label, clinical trial. (PubMed, Front Endocrinol (Lausanne)) - "This study aimed to evaluate the efficacy and safety of polyethylene glycol loxenatide (PEG-Loxe) compared to those of dapagliflozin in patients with mild-to-moderate diabetic kidney disease (DKD), a prevalent microvascular complication of type 2 diabetes mellitus (T2DM). These findings support the use of PEG-Loxe in DKD management, contributing to evidence-based treatment options. www.chictr.org.cn, identifier ChiCTR2300070919."

Clinical • Journal • Diabetes • Diabetic Nephropathy • Gastrointestinal Disorder • Glomerulonephritis • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Health Technology Assessment: Evaluation of 7 Glucagon-Like Peptide-1 Receptor Agonists for the Treatment of Type 2 Diabetes Mellitus. (PubMed, Risk Manag Healthc Policy) - "The final assessment result scores from highest to lowest were semaglutide (71.5 points), dulaglutide (68.9 points), liraglutide (68.7 points), exenatide (62.5 points), lixisenatide (59.9 points), polyethylene glycol loxenatide (55.9 points), and benaglutide (45.1 points). When a healthcare organization introduces GLP-1RAs to their hospital, they can refer to the assessment results and use the top three recommended medications: semaglutide, dulaglutide, and liraglutide."

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

Is polyethylene glycol loxenatide 100 μg the preferred glucagon-like peptide-1 receptor agonist for type 2 diabetes mellitus? A meta-analysis and trial sequential analysis. (PubMed, Eur Rev Med Pharmacol Sci) - "PEX168 100 μg can significantly lower blood glucose and does not increase the risk of total AEs, GI AEs, and hypoglycemia, which may be a preferred glucagon-like peptide-1 receptor agonist for type 2 diabetes mellitus."

Journal • Retrospective data • Diabetes • Gastrointestinal Disorder • Hypoglycemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Real-world effectiveness of GLP-1 receptor agonist-based treatment strategies on "time in range" in patients with type 2 diabetes. (PubMed, Front Pharmacol) - "Subgroup analysis revealed that, compared with the administration of liraglutide, the administration of semaglutide and polyethylene glycol loxenatide (PEG-Loxe) significantly improved TIR over 3-6 months of treatment (p < 0.05). These real-world findings indicate that GLP-1RA-based treatment strategies could be superior to oral treatment strategies for improving TIR among patients with T2DM and that once-weekly GLP-1RA may be more effective than a once-daily GLP-1RA. Clinical trial registration: http://www.chinadrugtrials.org.cn/index.html, identifier number ChiCTR2300073697."

Journal • Real-world • Real-world effectiveness • Real-world evidence • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Efficacy of polyethylene glycol loxenatide for type 2 diabetes mellitus patients: a systematic review and meta-analysis. (PubMed, Front Pharmacol) - "And the combination of conventional hypoglycemic drugs (CHD) and PEG-Loxe could more effectively improve the levels of HbA1c, FPG, 2-h PBG, TC, TG, BMI, and BW compared with CHD in T2DM patients. Systematic Review Registration: www.inplasy.com, identifier INPLASY202350106."

Journal • Retrospective data • Review • Diabetes • Dyslipidemia • Metabolic Disorders • Type 2 Diabetes Mellitus

Loxenatide Plus LNG-IUS in Endometrial Atypical Hyperplasia (clinicaltrials.gov) - P2/3 | N=28 | Recruiting | Sponsor: Fudan University | Trial primary completion date: Dec 2023 ➔ Dec 2024

Trial primary completion date • Genetic Disorders • Obesity

Efficacy Comparison of Polyethylene Glycol Loxenatide and Gliclazide on the Brain Function in T2DM Patients (clinicaltrials.gov) - P=N/A | N=58 | Recruiting | Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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

Role of Novel Glucagon-like Peptide-1 Receptor Analogue Polyethylene Glycol Loxenatide in Type 2 Diabetes: A Systematic Review and Meta-analysis. (PubMed, Indian J Endocrinol Metab) - "Occurrence of nausea [RR 16.85 (95% CI: 3.89 to 72.92); P < 0.01; I = 10%], vomiting [RR 15.90 (95% CI: 2.99 to 84.55); P < 0.01; I = 0%], and anorexia [RR 3.85 (95% CI: 1.24 to 11.88); P = 0.02; I = 0%] was significantly higher with high-dose peg-loxenatide, as compared to placebo. Peg-loxenatide (100 mcg/week) is the most appropriate dose for clinical use as it is associated with good glycaemic efficacy with minimal gastro-intestinal side effects."

Journal • Retrospective data • Review • Anorexia • Diabetes • Metabolic Disorders • Type 2 Diabetes Mellitus

Clinical Efficacy of Polyethylene Glycol Loxenatide in the Treatment of Obese or Overweight Patients with Type 2 Diabetes Mellitus. (PubMed, J Coll Physicians Surg Pak) - "PEG Loxenatide considerably affects obese and overweight T2DM patients. With no noticeable adverse reactions, this drug is highly recommended for application and clinical promotion."

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