Survodutide
Survodutide is an experimental single-molecule dual agonist of the GLP-1 and glucagon receptors studied for chronic weight management and for MASH (formerly NASH). A published Phase 2 trial in MASH reported improvements in liver histology, and Phase 2 obesity data showed substantial weight reductions; a Phase 3 program (SYNCHRONIZE) is ongoing. It remains investigational and is not authorized for clinical use.
Mechanism
In plain terms, survodutide mimics two hormones at once to reduce appetite and influence how the liver and body handle fat and sugar. Technically, it is a synthetic peptide that simultaneously agonizes 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 hepatic lipid metabolism, a combination proposed to drive weight loss and reduce liver fat.
Regulatory Status by Region
- United States (FDA)Investigational; not approved. Being evaluated in a Phase 3 program (SYNCHRONIZE) for obesity, with additional trials in MASH.
- 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 investigational incretin-class agent (a GLP-1/glucagon dual agonist) it is not a banned substance.
Key Studies
- A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis (Sanyal et al.) (N Engl J Med 2024)
Related Clinical Trials
- A Study in People With Overweight or Obesity to Compare How 2 Different Formulations of Survodutide Are Taken up by the BodyPhase 1 · Recruiting
- A Study in Healthy People or Otherwise Healthy With Overweight or Obesity to Compare 2 Formulations of Survodutide Given in Different Ways, Either as a Pre-filled Syringe or a Pen-like InjectorPhase 1 · Completed
- Albuminuria Reduction Study With Survodutide Treatment in Kidney DiseasePhase 2 · Not Yet Recruiting
- A Study in Healthy People to Compare How 2 Different Formulations of Survodutide Are Taken up by the BodyPhase 1 · Active Not Recruiting
- A Study in Healthy People to Compare How 2 Different Formulations of Survodutide Are Taken up in the BodyPhase 1 · Completed
- A Study in Healthy People to Compare How 3 Different Formulations of Survodutide Are Taken up in the BodyPhase 1 · Completed
- LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have CirrhosisPhase 3 · Recruiting
- A Study to Test Whether BI 456906 (Survodutide) Influences the Amount of Bupropion, Caffeine and Midazolam in the Blood in People With Overweight or ObesityPhase 1 · Completed