Mazdutide
Mazdutide is a dual agonist of the GLP-1 and glucagon receptors based on the gut hormone oxyntomodulin, developed mainly for the Chinese market by Innovent Biologics (in-licensed from Eli Lilly). Clinical trials, conducted largely in China, report dose-dependent reductions in body weight and blood glucose. China's National Medical Products Administration (NMPA) approved mazdutide in 2025, first for chronic weight management and subsequently for glycemic control in adults with type 2 diabetes. It is not approved by the FDA, EMA, or Australia's TGA, and in those jurisdictions it remains investigational.
Mechanism
In plain terms, mazdutide mimics two hormones at once to reduce appetite and improve how the body uses sugar and fat. Technically, it is a synthetic analogue of oxyntomodulin that agonizes both the glucagon-like peptide-1 (GLP-1) receptor and the glucagon receptor. GLP-1 activity promotes satiety and glucose-dependent insulin secretion, while glucagon-receptor agonism is thought to increase energy expenditure and lipid metabolism, a combination intended to enhance weight loss.
Regulatory Status by Region
- China (NMPA)Approved. China's National Medical Products Administration approved mazdutide in 2025, first for chronic weight management in adults with overweight or obesity and subsequently for glycemic control in adults with type 2 diabetes (Innovent Biologics).
- United States (FDA)Investigational in the United States; not approved. Developed and studied predominantly in China (Innovent Biologics, in-licensed from Eli Lilly).
- Australia (TGA)Not entered on the Australian Register of Therapeutic Goods (ARTG); investigational only and not approved for supply.
- European Union (EMA)Not authorized; investigational, no marketing authorization.
- WADANot listed on the WADA Prohibited List. As an incretin-class agent (a GLP-1/glucagon dual agonist) it is not a banned substance.
Key Studies
Related Clinical Trials
- Mazdutide for Adults With Prediabetes: A Randomized, Double-Blind, Placebo-Controlled Trial (DREAM-PRE)Phase 4 · Not Yet Recruiting
- Effect of Mazdutide on Coronary Plaque in Patients With Coronary Atherosclerosis and Overweight or ObesityPhase 4 · Not Yet Recruiting
- Efficacy and Safety of IBI362 in Hypertensive Patients With Overweight/ObesityPhase 3 · Recruiting
- ASCEND-1: Lifestyle Intervention Plus Mazdutide for Weight ManagementN/A · Recruiting
- A Study of HDM1005 in Participants With T2DM Not Controlled With Metformin Alone or in Combination With a Sodium-Glucose Cotransporter 2 (SGLT2) InhibitorPhase 3 · Not Yet Recruiting
- A Study of IBI362 in Chinese Adolescents With Obesity or OverweightPhase 3 · Recruiting
- Mazdutide as Adjuvant Therapy Following Sleeve Gastrectomy in Severe ObesityN/A · Not Yet Recruiting
- GLP-1/GCG Dual Agonist in Type 2 Diabetes With Early Dementia (LIGHT-COG Study)Phase 3 · Recruiting