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Peptide · Fact sheet

Survodutide

Also known as BI 456906

Survodutide is not FDA approved. Phase 2 and Phase 3 trials have reported weight loss, reduced liver fat, and MASH-resolution signals, while fibrosis outcomes, longer-term benefits, safety, and regulatory decisions remain under study.

In clinical trialsModerate human evidence

What is Survodutide?

Survodutide is a manufactured peptide that activates both the glucagon and GLP-1 receptors.

The dual design aims to combine appetite and glucose effects with glucagon-related energy and liver biology, but mechanistic breadth can also create tradeoffs.

Benefits people look for

It is among the most advanced dual glucagon/GLP-1 candidates for obesity and metabolic liver disease.

Phase 3 liver-fat results strengthen the human evidence without turning an investigational program into an approved medicine.

What the evidence supports

  • A Phase 2 obesity trial reported substantial average weight reduction compared with placebo.
  • MASH and MASLD trials reported favorable resolution or liver-fat endpoints, while fibrosis and long-term clinical outcomes require further evidence.
All research areas
  • Obesity
  • Metabolic dysfunction-associated steatohepatitis
  • Liver fat and fibrosis
  • Type 2 diabetes
  • Chronic weight management
  • MASH and MASLD
  • Obesity with or without type 2 diabetes

Anecdotal reports & lived experiences

Reports describe what someone noticed. They cannot establish cause, typical results, or how often a side effect happens.

No attributable personal reports are summarized here yet. The benefits above describe research interests; the side effects below come from the cited medical sources.

We do not fill this gap with unsourced testimonials or estimated success rates.

Side effects & risks

  • Gastrointestinal adverse effects were the most frequent treatment-emergent problems in trials.
  • Discontinuation and incomplete exposure complicate estimates of real-world benefit.
  • Long-term glucagon-receptor effects and uncommon harms remain under study.

This is a summary of the cited evidence, not a complete product label. A lack of human safety data does not establish safety.

Clinical research: how strong is it?

Moderate human evidence

Randomized Phase 2 studies and a Phase 3 MASLD study report meaningful weight and liver-fat effects. Those endpoints do not yet establish broad liver-outcome, cardiovascular, or long-term clinical benefit.

Selected research to read

FDA approval & research status

Survodutide remains investigational in the United States and is being evaluated in Phase 3 obesity and metabolic liver-disease programs.

No FDA-approved use is documented in the records summarized on this page.

Late-stage obesity and liver-disease research

Survodutide has Phase 3 trial evidence and registry records, but it remains investigational until an FDA review supports approval for a defined use.

This summarizes the cited product or research record. Trial phases do not establish successful completion of earlier stages, and a stopped program is not ongoing development. Approval applies only to the labeled product, use and population.

What we still don’t know

  • Whether liver-fat and MASH-resolution changes translate into fewer liver complications
  • Long-term cardiovascular, gallbladder, pancreatic, and metabolic outcomes
  • Durability of weight and liver effects
  • Whether the benefit-risk profile will support FDA approval

The takeaway

Survodutide is a credible late-stage metabolic and liver candidate. Its trial results are promising, but approval and patient-centered long-term outcomes remain open questions.

Sources & further reading

Medical evidence and regulatory sources are listed here. Personal reports are linked separately in the experiences section.

  1. 1
    pubmedRandomized Phase 2 obesity trial

    Controlled human study of body-weight efficacy, tolerability, and adverse events.

  2. 2
    pubmedRandomized Phase 2 MASH trial

    Biopsy-based MASH and fibrosis study with condition-specific endpoints.

  3. 3
    pubmedSYNCHRONIZE-MASLD Phase 3 trial

    Phase 3 liver-fat and body-weight trial with limited duration and geography.

  4. 4
    clinical trialsClinicalTrials.gov: SYNCHRONIZE-1

    Official Phase 3 obesity-study record and endpoint definitions.

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