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Survodutide

Emerging
aka BI 456906 · Zealand glucagon/GLP-1 dual agonist
Weight Management Investigational — not approved by the FDA or other major regulators; in Phase III clinical trials.

Educational information only — not medical advice. Many listed compounds are not FDA-approved for human use. Consult a licensed clinician before starting, changing, or stopping any protocol.

Overview

Survodutide is an investigational peptide being developed as a once-weekly injection for weight management and liver disease. It belongs to a newer class of dual-receptor agonists that act on more than one metabolic pathway at the same time, in this case the GLP-1 and glucagon receptors.

It is being evaluated in a large Phase III program, including the SYNCHRONIZE studies in people with overweight or obesity and the LIVERAGE studies in adults with metabolic dysfunction-associated steatohepatitis (MASH) and fibrosis. In 2024 the U.S. FDA granted survodutide Breakthrough Therapy designation for non-cirrhotic MASH with moderate to advanced fibrosis.

Survodutide is not approved for use by the FDA or other major regulators. All human data to date comes from clinical trials, and it is not available as a prescription medicine.

How it works

Survodutide is a single molecule engineered to activate two receptors. The GLP-1 component is associated with reduced appetite, slower gastric emptying, and improved blood-sugar handling, effects shared with other GLP-1 medications. The glucagon component is thought to add a distinct mechanism: increasing energy expenditure and promoting fat oxidation, which researchers hypothesize may contribute to weight loss and to reduced liver fat.

In published Phase 2 trials, this dual approach produced dose-dependent weight loss in people with obesity and improvement in MASH without worsening of fibrosis compared with placebo. The relative contribution of each receptor pathway in humans is still being characterized.

Reported benefits

  • Dose-dependent body-weight reduction in obesity trials (clinical data)
  • Improvement in MASH without worsening of fibrosis in a Phase 2 liver trial
  • Reductions in liver fat content studied for metabolic liver disease
  • Glucagon-driven fat oxidation and energy expenditure proposed as an added mechanism

These are outcomes reported in clinical research, not guaranteed results, and the evidence is still emerging.

Considerations & side effects

Because survodutide is still in clinical development, its full long-term safety profile is not yet established. In trials, the most commonly reported adverse events were gastrointestinal, including nausea, vomiting, diarrhea, and constipation, consistent with the broader class of GLP-1-based therapies. These effects were generally more frequent at higher doses and during dose escalation.

Survodutide is investigational and is not a substitute for evaluation and treatment by a qualified clinician. Any material sold outside of a registered clinical trial is not the studied pharmaceutical product, and its identity, purity, and safety cannot be assumed.

Frequently asked

What is survodutide?

Survodutide (development code BI 456906) is an investigational, once-weekly injectable dual agonist that activates both the GLP-1 and glucagon receptors. It is being studied for obesity and metabolic dysfunction-associated steatohepatitis (MASH).

Is survodutide FDA-approved?

No. Survodutide is investigational and not approved by the FDA or any other major regulator. It is being evaluated in Phase III trials, and the FDA granted it Breakthrough Therapy designation for MASH with fibrosis in 2024.

How is survodutide different from a GLP-1 drug like semaglutide?

GLP-1-only medications act on a single receptor. Survodutide adds glucagon-receptor activity, which is thought to increase energy expenditure and fat oxidation in addition to the appetite and glucose effects of GLP-1.

What is survodutide being studied for?

Its main clinical programs are the SYNCHRONIZE trials in overweight and obesity and the LIVERAGE trials in MASH (formerly NASH) with liver fibrosis.

References

  1. Le Roux CW, et al. Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial. Lancet Diabetes Endocrinol. 2024.
  2. Sanyal AJ, et al. A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis. N Engl J Med. 2024.

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