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.
- 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.
- Evidence level
- L4Good human trials
- Confidence
- Moderate confidence in rating
- Regulatory status
- In clinical trials
- Development status
- In clinical development
Evidence strength
Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.
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
Overview
Higher = more and better-quality human evidence. It does not mean the effect is bigger or that the compound works for you.
Higher = more animal, tissue or cell research. Preclinical results are a starting point, not proof of a human benefit.
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
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
Discovery
Preclinical
Phase I
Phase II
Phase III
Furthest established stage
Approved
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.
Related evidence
Useful next reads based on this compound — not recommendations.
- Related compound
Mazdutide evidence profile
A GLP-1/glucagon dual agonist developed largely in Chinese trial populations.
- Compare
Compare Survodutide vs Mazdutide evidence
Same questions, same fields, side by side — including how much human evidence exists.
- Checked claim
Claim review: “Retatrutide produces more weight loss than currently approved GLP-1 medicines.”
A closely related claim we have graded, from GLP-1s.
- Context
GLP-1 Centre
How the incretin medicines compare on trial evidence and where they are actually licensed.
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
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
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.
- 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
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.
- Peer-reviewedWharton et al. — Survodutide Once Weekly in Adults with Obesity and Type 2 Diabetes, NEJM (1 October 2026)
- Sponsor / officialBoehringer Ingelheim — SYNCHRONIZE-2 detailed Phase III results (1 October 2026)
- Peer-reviewedSYNCHRONIZE-1 Phase 3 trial of survodutide, New England Journal of Medicine (2026)
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.
- Change 1 of 1L4Good human trialsThe 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.