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Survodutide

Dual glucagon receptor / GLP-1 receptor agonist peptide

ObesityMASH
Generic peptide vial illustrationSurvodutide
Entity typePeptide
Evidence reviewed2026-09-20
Canonical recordSURVODUTIDE
Page updated2026-09-20
Evidence profilePublished Phase 3 human evidence; investigational
Human evidencePhase III
Regulatory statusInvestigational / not authorised
Choose your depthStart simple, then open the evidence or technical detail only if you need it.
Quick answerPlain languageEvidenceOutcomes and studiesStudiesPrimary recordsTechnicalMechanism, route and identifiers

In plain English

30-second evidence answer

What does the evidence mean in simple terms?

Survodutide now has published Phase 3 human evidence showing meaningful weight loss, alongside late-stage liver-disease research. It remains investigational, so positive trial results are not the same as regulatory approval.

Still uncertain: Long-term cardiovascular benefit and safety, durable liver outcomes and the final benefit-risk profile required for routine use.

New to terms such as “preclinical”, “randomized” or “investigational”? Use the plain-English glossary →

What does the evidence mean in simple terms? table
What is it?Dual glucagon receptor / GLP-1 receptor agonist peptide
Entity typePeptide
Research focusObesity, MASH, liver fibrosis, cardiovascular outcomes
Human evidenceSYNCHRONIZE-1 showed significant body-weight reduction in adults with obesity without diabetes. SYNCHRONIZE-MASLD showed large MRI-assessed liver-fat reductions and weight loss in adults with obesity and at-risk MASLD.
Regulatory statusInvestigational; no general marketing authorisation for obesity or MASLD identified in the reviewed jurisdictions.
Main limitationsLong-term cardiovascular safety/benefit, durable MASH outcomes and routine-use dosing remain under Phase 3 investigation.
SafetyGI effects are common; long-term and rare-event safety is not yet established.
Evidence reviewed2026-09-20
i
Published Phase 3 SYNCHRONIZE-1 evidence now shows significant weight loss in adults with obesity, alongside late-stage MASLD/MASH evidence. Survodutide remains investigational.
Outcome-level evidence

Evidence is not one score.

Each record below answers a narrower question about an outcome, population or context. Evidence status and the study finding are shown separately so strong evidence is not mistaken for a positive effect.

How to read this →

Weight loss

Human evidence
Randomized Phase 2 human evidence

Context: Adults with overweight/obesity

Finding: Clear dose-related human efficacy signal.

Safety / tolerability context: GI tolerability burden was high

Regulatory / scope context: no approved regimen or mature outcomes data yet.

MASH resolution / fibrosis

Human evidence
Randomized Phase 2 human evidence

Context: Biopsy-confirmed MASH F1–F3

Finding: Strong signal on MASH activity.

Uncertainty / evidence gap: Fibrosis improvement was modest and not clearly dose-responsive

Safety / tolerability context: GI AEs frequent.

Verified 2026-09-18Primary source ↗
Evidence rule: an outcome-specific evidence label is not a recommendation, a safety rating or an overall score for the compound.

Evidence synthesis

  • ✓Clear dose-related human efficacy signal.
  • ✓Strong signal on MASH activity.

Important limitations

  • !Phase 2; discontinuations/estimands and escalation matter.
  • !Phase 2, histologic surrogate outcomes, non-monotonic dose response.

Selected study & evidence records

Survodutide for obesity: randomized Phase 2 dose-finding trial

2024 · Randomized, double-blind, placebo-controlled dose-finding trial · n=387

Mean weight changes were approximately -6.2%, -12.5%, -13.2% and -14.9% across ascending doses vs -2.8% placebo.

Study detail → Primary source ↗

A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis

2024 · Randomized, double-blind, placebo-controlled trial · n=293

Primary response 47%, 62%, 43% vs 14% placebo; ≥1-stage fibrosis improvement 34%, 36%, 34% vs 22%.

Study detail → Primary source ↗

SYNCHRONIZE-MASLD: Survodutide in adults with obesity and at-risk MASLD

2026 · Randomized, double-blind, placebo-controlled Phase 3 trial · n=216

Using the efficacy estimand, 84.2% of survodutide participants versus 24.3% with placebo achieved at least 30% liver-fat reduction; mean body-weight change was -12.2% versus -1.0%.

Study detail → Primary source ↗

SYNCHRONIZE-1: Survodutide once weekly for adults with obesity

2026 · Randomized, double-blind, placebo-controlled Phase 3 trial · n=725

At week 76, mean body-weight change was -12.2% with 3.6 mg and -13.0% with 6.0 mg versus -5.4% with placebo; 72.6%, 71.9% and 46.3%, respectively, achieved at least 5% weight reduction.

Study detail → Primary source ↗

Safety and unknowns

GI effects are common; long-term and rare-event safety is not yet established.

Nausea, diarrhoea and vomiting are frequent. In the Phase 2 MASH trial serious adverse events occurred in 8% on survodutide versus 7% on placebo.

Technical details

Mechanism / biologyDual glucagon and GLP-1 receptor agonism targets appetite, glycaemia, energy balance and hepatic metabolism.
Route / formulation boundaryEvidence is from trial-grade once-weekly subcutaneous product with protocol-driven escalation.
Identity / data-quality noteDo not conflate obesity and MASH trial regimens; doses and escalation differed.
Study / label regimen evidenceMultiple randomized Phase 2 regimens verified. Obesity dose-finding studied up to 4.8 mg weekly; MASH trial studied 2.4, 4.8 and 6.0 mg weekly with escalation.
Identifiers & alternate namesBI 456906 · BI456906

Source depth & provenance

WhichPeps does not rely on a single headline study when the evidence base is broader. Primary research, registries, regulators and supporting records are kept distinct.

4structured study records
2outcome records
6linked source records

How to read these counts: they show evidence coverage, not evidence strength. One large, well-designed study can be more informative than several weak or indirect records.

Show supporting and discovery sources

Study pages above contain the records used for public evidence summaries. The links below include supporting, regulatory and literature-discovery sources; a registry or search result is not treated as proof of benefit.

Evidence rule: WhichPeps keeps human, animal, laboratory, regulatory and product/formulation evidence distinct. Common names help people find the page; they do not change the underlying scientific identity.