Xinermei (mazdutide) / Eli Lilly, Innovent Biologics - LARVOL DELTA

Pre-hepatectomy Rehabilitation in Obese MASLD-Complicated Living Liver Donors With Mazdutide (PRIME) (clinicaltrials.gov) - P4 | N=60 | Recruiting | Sponsor: West China Hospital | Not yet recruiting ➔ Recruiting | Phase classification: P2/3 ➔ P4 | Trial completion date: Aug 2028 ➔ Aug 2029 | Trial primary completion date: Aug 2028 ➔ Feb 2029

Enrollment open • Phase classification • Trial completion date • Trial primary completion date • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity

A Study of IBI362 in Subjects With HFpEF or HFmrEF Combined With Obesity (clinicaltrials.gov) - P2 | N=141 | Active, not recruiting | Sponsor: Innovent Biologics (Suzhou) Co. Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Cardiovascular • Congestive Heart Failure • Genetic Disorders • Heart Failure • Obesity

Efficacy of Mazdutide for Treating PCOS (clinicaltrials.gov) - P1/2 | N=43 | Completed | Sponsor: Shanghai Zhongshan Hospital | Recruiting ➔ Completed | Trial primary completion date: Dec 2025 ➔ Sep 2026

Trial completion • Trial primary completion date • Polyendocrine Metabolic Ovarian Syndrome

Assessing the quality and reliability of health information on GLP-1 receptor agonists on TikTok and Bilibili: a cross-sectional analysis of the public health infodemic. (PubMed, Ther Adv Endocrinol Metab) - "China is currently navigating a unique market shift driven by the June 2025 approval of the domestic dual agonist mazdutide, an impending 2026 patent cliff for semaglutide, and a specific market for counterfeit products...As China approaches the 2026 patent cliff, regulatory bodies must address the specific threat of fraudulent "GLP-1" branding on illicit products. Not applicable."

Journal • Diabetes • Metabolic Disorders

Mazdutide for Weight Management and Gout in Adults With Obesity (clinicaltrials.gov) - P4 | N=30 | Not yet recruiting | Sponsor: Hongwei Jiang

New P4 trial • Genetic Disorders • Gout • Inflammatory Arthritis • Metabolic Disorders • Obesity • Rheumatology

Comparative efficacy and safety of glucagon-like peptide 1 based drugs for weight loss in adults with overweight or obesity without diabetes: network meta-analysis of randomised controlled trials. (PubMed, BMJ Med) - "Compared with placebo, weight loss was greatest with retatrutide (-22.10%, 95% confidence interval -25.60% to -18.60%), followed by tirzepatide (-19.28%, -20.39% to -18.16%), and CagriSema (a combination of cagrilintide and semaglutide, -17.32%, -19.32% to -15.32%)...Low certainty evidence suggested higher rates for discontinuing treatment with danuglipron and retatrutide, whereas mazdutide showed better tolerability...Differences in tolerability, limited head-to-head evidence, and residual uncertainty, however, should be considered when interpreting comparative treatment effects. PROSPERO CRD420261279841."

Journal • Retrospective data • Diabetes • Endocrine Disorders • Genetic Disorders • Metabolic Disorders • Obesity

B-REACH: Body-weight Reduction Effect on Portal Hypertension in Compensated Cirrhosis (clinicaltrials.gov) - P=N/A | N=50 | Not yet recruiting | Sponsor: The Second Affiliated Hospital of Chongqing Medical University

New trial • Cardiovascular • Fibrosis • Hepatology • Hypertension • Immunology • Obesity • Portal Hypertension

Efficacy of Mazdutide on Fatty Pancreas (clinicaltrials.gov) - P=N/A | N=194 | Not yet recruiting | Sponsor: Tongji Hospital

New trial • Genetic Disorders • Obesity

Defining the efficacy and tolerability ceiling of pure incretin therapies in steatotic liver disease: a network meta-analysis of phase 2 and 3 trials (EASD 2026) - "(1) Liver Fat Clearance (MRI-PDFF): The tri-agonist retatrutide achieved the highest efficacy hierarchy (SUCRA 98%), yielding a -82.4% relative reduction in hepatic steatosis. GLP-1/glucagon dual-agonists (mazdutide, efinopegdutide) consistently outperformed both GLP-1/GIP agents and pure GLP-1 mono-agonists...While earlier dual-agonists (survodutide, cotadutide) exhibited high adverse event-related discontinuation rates (15.2-20.0%), next-generation agents (mazdutide, pemvidutide) maintained placebo-like tolerability (<1.0% discontinuation) alongside profound hepatic fat clearance. Multi-receptor incretin agonism yields a stepwise, dose-and-receptor dependent superiority in clearing hepatic steatosis compared to pure GLP-1 therapy. While the addition of glucagon drives unparalleled fat clearance, optimizing the tolerability profile remains the defining factor for the clinical viability of next-generation incretins."

P2 data • Retrospective data • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

Mazdutide improves menstrual cyclicity and insulin resistance in reproductive-aged women with obesity: a subgroup analysis from the GLORY-2 trial (EASD 2026) - P3 | "In reproductive-aged women with obesity, once-weekly mazdutide 9 mg improved menstrual regularity, normalized menstrual cycles and insulin resistance, with sustained HOMA2-IR reduction through week 60. These findings support early attention to insulin resistance or menstrual disturbance in women with obesity. Mazdutide offers a therapeutic strategy for early intervention to improve PCOS outcomes."

Clinical • Late-breaking abstract • Metabolic Disorders • Obesity • GCG

Mazdutide ameliorates obesity through adipose thermogenesis and TPH2-mediated pathways (EASD 2026) - "Mazdutide is superior to semaglutide in reducing body weight and visceral fat, and this advantage is associated with enhanced adipose tissue thermogenesis and reduced inflammation. TPH2 may serve as a key molecule mediating this differential efficacy, providing a new perspective for understanding the unique metabolic benefits of dual receptor agonists. Ongoing studies are investigating the upstream regulators and downstream effectors of TPH2."

Metabolic Disorders • Obesity

The development of adipose delivery method for ALK7 siRNA (IAR134) to enable high quality weight control for monotherapy and combo with GLP-1 analogue (EASD 2026) - "IAR134 showed the potential as a quality weigh loss medicine because of the following: (1) Significantly reduces weight in DIO mouse model (2) More powerful in combo with GLP-1 RA than GLP-1 RA single agent (3) More durable than high dose GLP-1 RA after treatment withdrawal (4) More fat mass loss, less lean mass loss than GLP-1 RA"

Monotherapy • Metabolic Disorders • Obesity • GCG

Targeting hepatocyte-hepatic stellate cell crosstalk with mazdutide (GCGR/GLP-1R dual agonist) ameliorates MASH and fibrosis (EASD 2026) - "Mazdutide regulates lipid metabolism in hepatocytes, thereby indirectly inhibiting HSC activation and reducing fibrogenesis in MASH mice. These findings offer a novel therapeutic avenue for the treatment of MASH and progressive liver fibrosis."

Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis

Comparison of Mazdutide and Dulaglutide for Type 2 Diabetes: A Systematic Review and Meta-Analysis of Randomized Controlled Trials (ACG 2026) - "Three RCTs (n=960; mazdutide 659, dulaglutide 301) were included. Compared with dulaglutide, mazdutide reduced HbA1c (MD â0.25%, 95% CI â0.38 to â0.12) and body weight (MD â3.74 %, 95% CI â5.29 to â2.19), and increased >5% (OR 4.73) and >10% (OR 11.77) weight loss. Significant reductions were also seen in systolic/diastolic BP and triglycerides."

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

Effect of Mazdutide on Coronary Plaque in Patients With Coronary Atherosclerosis and Overweight or Obesity (clinicaltrials.gov) - P4 | N=116 | Not yet recruiting | Sponsor: China National Center for Cardiovascular Diseases | Initiation date: May 2026 ➔ Sep 2026

Trial initiation date • Acute Coronary Syndrome • Atherosclerosis • Cardiovascular • Coronary Artery Disease • Genetic Disorders • Heart Failure • Obesity • APOB

MELIA: Mazdutide Plus LNG-IUS for Fertility-Sparing Treatment of AEH or Early Endometrial Cancer (clinicaltrials.gov) - P2 | N=128 | Not yet recruiting | Sponsor: Tongji Hospital

New P2 trial • Endometrial Cancer • Genetic Disorders • Obesity • Oncology • Solid Tumor • ER • POLE

Renoprotective effects of tubular glucagon receptor activation mediated by V-ATPase. (PubMed, Sci Adv) - "Recent clinical trials have shown that dual GLP-1R/GCGR agonists, including mazdutide and cotadutide, provide kidney benefits in patients with type 2 diabetes and CKD, suggesting a potential contribution of GCGR activation to these renal effects. Consistently, re-expression of tubular GCGR via AAV9 restores lysosomal function, reduces phospholipid accumulation, and mitigates renal injury in DKD. Together, these findings provide genetic evidence for the renoprotective role of tubular GCGR in DKD, delineate a kidney-intrinsic GCGR-ATP6V1A-lysosome axis that protects tubular integrity, and extend prior GCGR-in-kidney observations into a more concrete GCGR-lysosome mechanism."

Journal • Diabetes • Metabolic Disorders • Renal Disease • Type 2 Diabetes Mellitus

Development and validation of a multiplexed LC-HRMS method for nine GLP-1 receptor agonists and its pharmaceutical application. (PubMed, J Chromatogr A) - "A rapid, sensitive, and selective multiplexed liquid chromatography-high-resolution mass spectrometry (LC-HRMS) method was developed and validated for the identification and quantitation of nine structurally diverse peptide-based glucagon-like peptide-1 receptor agonists (GLP-1 RAs): bofanglutide, ecnoglutide, exenatide, liraglutide, mazdutide, retatrutide, semaglutide, survodutide, and tirzepatide. It was successfully applied to marketed formulations of liraglutide, semaglutide, and tirzepatide using a simple dilute-and-shoot procedure, yielding mean recoveries of 113.7-118.4%. This LC-HRMS method offers superior selectivity and flexibility for analysing current and next-generation GLP-1 RAs."

Journal

Efficacy and safety of mazdutide in adults with obesity or overweight: a US-based, multicentre, phase 2, randomised, placebo-controlled clinical trial. (PubMed, Lancet Diabetes Endocrinol) - P2 | "Once-weekly, subcutaneous mazdutide showed clinically meaningful bodyweight reduction in adults with obesity or overweight across all studied doses, with higher doses (10 mg and 16 mg) showing additional weight reduction."

Clinical • Journal • P2 data • Diabetes • Gastroenterology • Gastrointestinal Disorder • Genetic Disorders • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

QUARTET-DKD: Quadruple Therapy for Type 2 Diabetic Nephropathy (clinicaltrials.gov) - P4 | N=820 | Not yet recruiting | Sponsor: Huijie Zhang

New P4 trial • Diabetes • Diabetic Nephropathy • Metabolic Disorders • Nephrology • Renal Disease • Type 2 Diabetes Mellitus

Mazdutide for Remission of Type 2 Diabetes: Multicentre, Double Blind, Randomised, Placebo Controlled Trial (clinicaltrials.gov) - P=N/A | N=249 | Not yet recruiting | Sponsor: Yanbing Li

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

OPKO Health Expands Strategic Relationship with HealthCare Royalty Through $125 Million Notes Issuance Secured by Mazdutide Royalty Interests (GlobeNewswire) - "The transaction provides OPKO with additional non-dilutive capital while preserving significant long-term participation in the value of the mazdutide franchise. Total payments under the expanded financing structure are capped at 1.5 times the amount funded, after which OPKO retains future royalty economics associated with the financed stream. The structure is intended to unlock immediate value from an emerging royalty stream while maintaining OPKO’s participation in long-term royalty growth."

Financing • Obesity

Cardiovascular Effects of Glucagon Receptor Signaling Alone and Combined With Glucagon-Like Peptide-1 Receptor Signaling in Multiagonists: A Narrative Review With a Translational Focus. (PubMed, J Am Heart Assoc) - "Clinical studies of GCGR/GLP-1 receptor dual agonists (eg, mazdutide, survodutide) have generally found that they increased heart rate to a similar extent as GLP-1 receptor monoagonists (which are cardioprotective despite such chronotropic effects). These between-compound differences may reflect different potencies for activating the GCGR and GLP-1 receptors. Cardiovascular effects of GCGR signaling by dual agonists should be clarified per compound by ongoing clinical trials, notably the cardiovascular outcomes trial SYNCHRONIZE-CVOT (A Study to Test the Effect of Survodutide [BI 456906] on Cardiovascular Safety in People With Overweight or Obesity) and thorough corrected QT study of survodutide."

Journal • Review • Cardiovascular • Chronic Kidney Disease • Diabetes • Genetic Disorders • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatotic Liver Disease • Nephrology • Obesity • Renal Disease • Type 2 Diabetes Mellitus

Magic-Switch: Switching to Mazdutide for Glycemia Control in Chinese Population with Type 2 Diabetes Mellitus via Continuous Glucose Monitoring: A Multicenter, Prospecetive, Single-Arm Trial (ChiCTR) - P=N/A | N=250 | Not yet recruiting | Sponsor: Tianjin Medical University Chu Hsien-I Memorial Hospital; Tianjin Medical University Chu Hsien-I Memorial Hospital

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

Pre-hepatectomy Rehabilitation in Obese MASLD-Complicated Living Liver Donors With Mazdutide (PRIME) (clinicaltrials.gov) - P2/3 | N=60 | Not yet recruiting | Sponsor: West China Hospital

New P2/3 trial • Hepatology • Metabolic Disorders • Metabolic Dysfunction-Associated Steatohepatitis • Metabolic Dysfunction-Associated Steatotic Liver Disease • Obesity