MetabolicPhase III

Survodutide

BI 456906

A dual GLP-1/glucagon receptor agonist in Phase 3 trials showing up to 19% weight loss and significant MASH improvement with FDA Breakthrough Therapy designation.

Survodutide (BI 456906) is a next-generation dual glucagon receptor (GCGR) and GLP-1 receptor agonist developed by Boehringer Ingelheim.

Structure & Design

Survodutide is derived from native glucagon with modifications including a C18 fatty diacid for once-weekly dosing. It provides balanced dual agonism at both GCGR and GLP-1R.

Dual Mechanism

GLP-1 Receptor Activation

  • Glucose-dependent insulin secretion
  • Appetite suppression
  • Delayed gastric emptying

Glucagon Receptor Activation

  • Increased energy expenditure
  • Enhanced lipid oxidation
  • Hepatic fat reduction
  • Thermogenesis stimulation

Clinical Trial Results

Obesity Phase 2 (2024)

  • 4.8mg dose: -14.9% weight loss vs -2.8% placebo

MASH Phase 2 (NEJM 2024)

  • MASH improvement: 62% (4.8mg) vs 14% placebo
  • ≥30% liver fat reduction: 67% vs 14% placebo

Regulatory Status

  • FDA Breakthrough Therapy designation for noncirrhotic MASH
  • Phase 3 trials initiated October 2024:
    • LIVERAGE: ~1,800 adults with MASH fibrosis stages 2-3
    • LIVERAGE-Cirrhosis: ~1,590 adults with compensated cirrhosis
    • SYNCHRONIZE-CVOT: Cardiovascular outcomes

Safety

Adverse events primarily gastrointestinal (nausea, vomiting, diarrhea). All tested doses tolerated.

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