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GLP-1s & incretins · Metabolic & endocrine

Survodutide

An investigational glucagon/GLP-1 dual agonist now supported by peer-reviewed Phase 3 obesity trials with and without type 2 diabetes.

L4Good human trialsIn clinical trialsIn clinical development
How settled this rating is:
moderate confidence in the current evidence rating
Routes studied:
Subcutaneous injection
Also known as:
BI 456906, glucagon/GLP-1 dual agonist
Last reviewed:
2026-10-05
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Evidence passport

Survodutide

A one-screen evidence identity for this compound. These fields describe research maturity, confidence and legal status. They are not a safety guarantee, efficacy percentage or recommendation.

Reviewed 2026-10-05
Evidence level
L4Good human trials
Confidence
Moderate confidence in rating
Regulatory status
In clinical trials
Development status
In clinical development

Evidence strength

Human efficacy evidence78 of 100 evidence strength

Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.

Human safety evidence52 of 100 evidence strength

Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number.

The 0-100 values rate the strength and maturity of evidence, not how effective or safe the compound is.

Evidence base
Includes human studies
Furthest established stage
Phase III
Human research maturity
Multiple Phase 3 trials published in a peer-reviewed journal; not approved
Source curation
Sources fully curated

Routes recorded

SC injection

Overview

Human efficacy evidence strength78 of 100 evidence strength

Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.

Preclinical (animal / lab) evidence strength72 of 100 evidence strength

Higher = more animal, tissue or cell research. Preclinical results are a starting point, not proof of a human benefit.

Human safety evidence strength52 of 100 evidence strength

Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number.

How to read these scores

Every number here rates the evidence, not the compound. They are editorial 0-100 strength ratings, not percentages, and not a rating out of five stars.

  • Human efficacy evidence strength — Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.
  • Preclinical evidence strength — Higher = more animal, tissue or cell research. Preclinical results are a starting point, not proof of a human benefit.
  • Human safety evidence strength — Higher = more mature, better-documented human safety data. It does not mean the compound is safer than one with a lower number. A score of 80 does not mean “80% safe”.
  • Evidence level (L0-L5) — the strongest type of study behind the compound, from anecdote (L0) to large replicated human trials (L5). It is a description of the study evidence, not a quality, safety or recommendation rating.
  • Confidence — how likely we think it is that this rating changes as new research lands. Low confidence means the picture is unsettled, not that the compound is bad.

None of these ratings is medical advice, a safety guarantee, or a recommendation to use anything. How we grade evidence.

How far human research has progressed: Multiple Phase 3 trials published in a peer-reviewed journal; not approved

Routes & formulations

Studied / approved routes

SC injection

Route availability is not evidence of efficacy, and evidence from one route does not transfer to another. The Registry never provides dosing or sourcing information.

Peptide lifecycle

  1. Discovery

  2. Preclinical

  3. Phase I

  4. Phase II

  5. Phase III

    Furthest established stage

  6. Approved

In clinical development

Active global Phase 3 development. Peer-reviewed SYNCHRONIZE-1 and SYNCHRONIZE-2 results establish substantial controlled human efficacy evidence, while regulatory approval and long-term cardiovascular, renal and hepatic outcome evidence remain outstanding.

Last documented development: 1 October 2026 — Phase 3 SYNCHRONIZE-2 published in NEJM and presented at EASD

What it is

A peptide that activates both the GLP-1 and glucagon receptors, pairing appetite suppression with glucagon-driven energy expenditure and hepatic fat mobilisation.

What people claim

  • Substantial weight reduction
  • Liver fat reduction

What the evidence actually says

Survodutide now has peer-reviewed Phase 3 evidence in obesity populations both without and with type 2 diabetes. In SYNCHRONIZE-2 (752 participants analysed), the treatment-regimen estimand at week 76 showed mean weight changes of -8.2% with 3.6 mg and -9.8% with 6.0 mg versus -3.9% with placebo; at least 5% weight loss occurred in 57.6%, 64.5% and 35.1%, respectively. Sponsor-reported efficacy-estimand results reached up to -13.1% versus -3.1% placebo and up to 79.3% achieving at least 5% loss. These estimands answer different questions and should not be conflated. Survodutide remains investigational and unapproved, and longer-term outcome and tolerability data remain important gaps.

Useful next reads based on this compound — not recommendations.

Human evidence

  • Phase 3 SYNCHRONIZE-1 randomised placebo-controlled trial, published in the New England Journal of Medicine (2026), reporting significantly greater weight reduction than placebo.
  • Phase 3 SYNCHRONIZE-2 (NCT06066528), multinational double-blind placebo-controlled trial in adults with obesity or overweight and type 2 diabetes: 752 participants analysed; at week 76 the treatment-regimen estimand showed -8.2% and -9.8% mean weight change with 3.6 mg and 6.0 mg versus -3.9% placebo, with significant >=5% responder differences.
  • SYNCHRONIZE-2 also improved glycated haemoglobin from a baseline of 7.4%; mean changes in the peer-reviewed primary analysis were -0.9 and -0.8 percentage points versus -0.2 with placebo.
  • Earlier randomised Phase 2 work in obesity and metabolic liver disease.

Preclinical evidence

  • Dual glucagon/GLP-1 agonist pharmacology in rodent metabolic models.

Animal and cell findings are Level 1–2 evidence.

Mechanism and pathways

  • GLP-1 receptor agonism reduces appetite and improves glycaemic handling.
  • Glucagon receptor agonism increases energy expenditure and mobilises hepatic fat.

Safety and unknowns

  • SYNCHRONIZE-2 gastrointestinal adverse events occurred in 72.8% (3.6 mg), 77.7% (6.0 mg) and 38.6% (placebo); events were generally mild-to-moderate and transient.
  • Treatment discontinuation due to gastrointestinal adverse effects is a material tolerability issue in the wider Phase 3 programme and should be considered alongside efficacy.
  • Glucagon-related effects, including heart-rate changes, require monitoring in trials.
  • Long-term safety is not established.

Cancer relevance

This section covers questions raised by how the compound works in the body, plus anything regulators and trial teams keep an eye on. It is not a statement that this compound causes cancer — for most compounds here, no human data exist in either direction.

Monitored in trials; not demonstrated in humans

No demonstrated human cancer signal. Class-level incretin precautions apply and remain under trial surveillance.

Regulatory status

Regulatory decisions apply to specific jurisdictions, products, formulations and indications. An approval elsewhere is not automatically an approval in your country.

Check the regulatory note and linked primary sources for jurisdiction-specific details.

Investigational and not approved for use. Phase 3 development is active across obesity, type 2 diabetes, cardiovascular/renal risk and MASH programmes; SYNCHRONIZE-1 and SYNCHRONIZE-2 have peer-reviewed Phase 3 publications.

Evidence grade

L4Good human trialsModerate confidence in rating

Completed, adequately informative controlled human trials supporting a specified outcome; replication and longer-term safety may remain uncertain.

What would change our rating?

  • Publication of the remaining Phase 3 programme with full safety data.
  • A regulatory decision in a major region.

References and sources

Source transparency

A provenance snapshot of this profile. Counts show what kinds of sources are cited, not how much scientific weight each source deserves.

Sources fully curated
Last editorial review
2026-10-05
Recently reviewed · 16 days ago
Linked curated sources
3
Sources still pending
0
External specialist reviews
0
None recorded for this profile
Peer-reviewed: 2Sponsor / official: 1

Review provenance

Registry editorial review: Colin Jackson-White, creator and editor, who is not a doctor or clinician. External specialist review is credited only when a named reviewer has completed a review of this exact profile.

Literature-discovery and AI tools may help locate or challenge candidate evidence, but they are not counted as evidence sources here. Registry judgements are tied to the underlying papers, trial records, regulator documents and official study records.

Source hierarchy: regulatory documents and trial registries first, peer-reviewed work next, sponsor material flagged as non-independent. We never use supplier or clinic marketing as evidence, and where a verified source has not yet been curated we say so rather than inventing one.

Evidence change history

These entries record changes to our assessment of the published evidence — not changes to the compound itself.

  1. Added peer-reviewed SYNCHRONIZE-2 Phase 3 results in adults with obesity or overweight and type 2 diabetes. The NEJM treatment-regimen estimand showed mean weight changes of -8.2% (3.6 mg) and -9.8% (6.0 mg) versus -3.9% placebo at 76 weeks; sponsor-reported efficacy-estimand results reached up to -13.1% versus -3.1%.

    Change 1 of 1
    L4Good human trials
    The new Phase 3 publication materially strengthens the human evidence base but does not justify L5: survodutide remains investigational, the wider Phase 3 programme and long-term outcomes are incomplete, and gastrointestinal tolerability/discontinuation remains a material limitation. Estimands are labelled separately to avoid presenting efficacy-estimand results as the primary treatment-regimen result.