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Survodutide

Evidence: A-/B+ — Established Human Evidence

Metabolic / Weight Management

2 min readLast reviewed July 11, 2026

Key facts

  • Research areaMetabolic / Weight Management
  • Research statusinvestigational
  • Study records126 human
  • Last updated2026-07-11

Evidence Snapshot

Evidence: A-/B+ — Established Human Evidence
2026-07-11Last updated

Regulatory Context

Investigational; not FDA-approved as a marketed medicine. In Phase 3 clinical trials (SYNCHRONIZE-1, SYNCHRONIZE-2, LIVERAGE, LIVERAGE-Cirrhosis) for obesity, type 2 diabetes, and MASH/liver fibrosis.

In Plain English

A quick, research-focused overview. It does not replace, and cannot outrank, the detailed evidence below.

What is it?

A synthetic peptide dual agonist of the glucagon and GLP-1 receptors, developed by Boehringer Ingelheim with Zealand Pharma.

Why are researchers interested in it?

Studied for weight loss in obesity/overweight (with and without type 2 diabetes) and for MASH with liver fibrosis, including in patients with cirrhosis.

What is it being studied for?

  • Weight management (obesity)Human Studies & Clinical Data
  • MASH and liver fibrosisHuman Studies & Clinical Data
  • Cardiovascular outcomesRegulatory Documents & Official Trial Registries
  • Dual glucagon/GLP-1 receptor mechanismAnimal / Cell / Preclinical Data

What does the evidence look like?

Multiple completed Phase 2 human trials and four active/completed Phase 3 trials (SYNCHRONIZE-1/2, LIVERAGE, LIVERAGE-Cirrhosis); not yet regulatory-approved.

Biggest things to know

Investigational only - no approved product exists. A company-disclosed Phase 3 obesity figure (16.6% body-weight loss at 76 weeks) has not yet appeared in an independent peer-reviewed publication and should be attributed as 'per company disclosure' if used.

What don't we know yet?

Survodutide remains investigational in the United States despite positive Phase 3 obesity-program results — gastrointestinal adverse events were common in trials and influenced dose escalation and discontinuation. A dedicated cardiovascular-outcomes trial is still ongoing, so no reduction in major cardiovascular events can be claimed until it (or another adequately powered outcomes trial) is completed. The MASH/liver-fibrosis program (LIVERAGE, LIVERAGE-Cirrhosis) is still recruiting, so its results are not yet available, and grey-market survodutide products are unapproved and cannot be presumed equivalent to sponsor-manufactured clinical-trial material.

Research status

Investigational

Reviewed August 25, 2026

Research Takeaway

Fully activates the GLP-1 receptor and partially activates the glucagon receptor at therapeutic exposure, producing greater preclinical body-weight reduction than GLP-1-receptor activation alone.

See all 11 evidence claims →

Quick Summary

Metabolic / Weight Management

Survodutide is an investigational dual agonist that activates both the glucagon receptor and the GLP-1 receptor, combining GLP-1-driven appetite suppression with glucagon-driven energy expenditure. It is in Phase 3 development for obesity and type 2 diabetes, and separately for MASH (metabolic dysfunction-associated steatohepatitis) with liver fibrosis.

Mechanism & Research Overview

Fully activates the GLP-1 receptor and partially activates the glucagon receptor at therapeutic exposure. In preclinical models, this dual activity produced greater body-weight reduction than GLP-1-receptor activation alone, while preserving glucose-lowering effects.

Mechanism pathway

Relationship-support labels describe the type and directness of the research available, not proof of safety or effectiveness. Indirectly supported, inferred and uncertain relationships are not equivalent to directly supported ones.

Glucagon receptor

  1. CompoundSurvodutide
  2. Directly supported (Directly supported relationship)
    Biological targetGlucagon receptorReceptor
  3. Leads to
    PathwayIncretin & Glucagon Signaling
  4. Contributes to
    • Biological processEnergy expenditure (preclinical)

Relationship details

  1. Survodutide → Glucagon receptor — Directly supportedPartial agonist at the glucagon receptor at therapeutic exposure.
  2. Energy expenditure (preclinical) — contributes to the pathway (structural link, no support rating)Sources: survodutide-thomas-2024-mechanism

A biological process is not the same as a proven health or treatment outcome.

GLP-1 receptor

  1. CompoundSurvodutide
  2. Directly supported (Directly supported relationship)
    Biological targetGLP-1 receptorReceptor
  3. Leads to
    PathwayIncretin & Glucagon Signaling
  4. Contributes to
    • Biological processAppetite suppression

Relationship details

  1. Survodutide → GLP-1 receptor — Directly supportedFull agonist at the GLP-1 receptor at therapeutic exposure.
  2. Appetite suppression — contributes to the pathway (structural link, no support rating)Sources: survodutide-thomas-2024-mechanism

A biological process is not the same as a proven health or treatment outcome.

Open in the Mechanism & Pathway Explorer→

Evidence Claims

Individual scientific statements drawn from the sources cited below, each shown with the specific evidence boundary that statement does not establish.

Mechanism

Supported

Fully activates the GLP-1 receptor and partially activates the glucagon receptor at therapeutic exposure, producing greater preclinical body-weight reduction than GLP-1-receptor activation alone.

Sources: The dual GCGR/GLP-1R agonist survodutide: Biomarkers and pharmacological profiling for clinical candidate selection

human_evidence

Supported

In a Phase 2 trial, survodutide produced higher rates of MASH improvement without worsening fibrosis versus placebo over 48 weeks.

Sources: A phase 2 randomized trial of survodutide in MASH and fibrosis

human_evidence

Supported

In a Phase I cirrhosis study, survodutide reduced liver fat, stiffness, volume, and body weight, with no pharmacokinetic dose adjustment needed by cirrhosis severity.

Sources: Efficacy, tolerability and pharmacokinetics of survodutide, a glucagon/glucagon-like peptide-1 receptor dual agonist, in cirrhosis

other

Supported

A company-disclosed topline figure of 16.6% body-weight loss at 76 weeks in Phase 3 obesity trials has not yet appeared in an independent peer-reviewed publication.

Sources: Survodutide Once Weekly for the Treatment of Adults with Obesity

Regulatory Status

Supported

Survodutide is investigational and not FDA-approved as a marketed medicine; it is in Phase 3 trials (SYNCHRONIZE-1, SYNCHRONIZE-2, LIVERAGE, LIVERAGE-Cirrhosis).

Sources: Survodutide for treatment of obesity: rationale and design of two randomized phase 3 clinical trials (SYNCHRONIZE-1 and -2)

Mechanism

Supported

Survodutide (BI 456906) is an investigational dual agonist of the glucagon and GLP-1 receptors and is not the same molecule as semaglutide, tirzepatide, retatrutide, or cagrilintide.

Sources: Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial; A phase 2 randomized trial of survodutide in MASH and fibrosis

human_evidence

Supported

Randomized Phase 2 trials established human signals for weight reduction in obesity and for histologic MASH improvement without worsening fibrosis.

Sources: Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial; A phase 2 randomized trial of survodutide in MASH and fibrosis

Regulatory Status

Supported

As of August 10, 2026, survodutide remains investigational in the United States despite positive Phase 3 obesity-program results; FDA has stated that marketed survodutide products referenced in enforcement actions lacked approved applications.

Sources: A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity to Lose Weight; Positive data from two Phase III SYNCHRONIZE obesity trials; Xcel Research LLC - 694608 - 12/10/2024

Safety

Supported

Gastrointestinal adverse events were common in survodutide clinical trials and tolerability influenced dose escalation and discontinuation patterns.

Sources: Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial; A phase 2 randomized trial of survodutide in MASH and fibrosis

Evidence Boundary

Supported

A Phase 3 cardiovascular-outcomes trial is registered, so no claim of proven reduction in major cardiovascular events should be made unless and until that trial or another adequately powered outcomes trial is completed and supports it.

Sources: A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Events in People Living With Overweight or Obesity

Evidence Boundary

Supported

Grey-market survodutide products are unapproved and cannot be presumed equivalent to sponsor-manufactured clinical-trial material.

Sources: Xcel Research LLC - 694608 - 12/10/2024

Safety & Evidence Limitations

Considerations reported in the sources cited on this page — not a complete list of every possible risk, and not medical advice.

  • Safety Consideration

    Drug-related adverse events ranged from 25% to 87.5% in a small Phase I cirrhosis cohort (n=82), depending on dose and cirrhosis severity.

  • Safety Consideration

    Survodutide is an investigational compound with no marketed product, so it has no established real-world safety profile.

  • Safety Consideration

    A peer-reviewed publication of the Phase 3 obesity trial results (NEJM, June 2026) is now available, superseding the earlier press-release-only figure. The specific 16.6% weight-loss figure should be reconfirmed against the published paper's own reported number before being restated as final.

Research Areas Being Studied

Yes, in a published Phase 2 trial (NEJM 2024) and ongoing Phase 3 trials (LIVERAGE/LIVERAGE-Cirrhosis) for MASH and liver fibrosis, including in cirrhosis.

Findings Reported in Studies

Educational summary only — reported in cited studies, not a claim of proven benefit.

Show findings from 6 human studies
  • Survodutide Once Weekly for the Treatment of Adults with Obesity (2026):
  • Survodutide for treatment of obesity: rationale and design of two randomized phase 3 clinical trials (SYNCHRONIZE-1 and -2) (2025):
  • Survodutide improves blood pressure in adults with obesity: A post hoc analysis (2025):
  • A phase 2 randomized trial of survodutide in MASH and fibrosis (2024):
  • Efficacy, tolerability and pharmacokinetics of survodutide, a glucagon/glucagon-like peptide-1 receptor dual agonist, in cirrhosis (2024):
  • Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial (2024):

Study Tables by Evidence Type

12 study records

Human Studies & Clinical Data(6)

Survodutide Once Weekly for the Treatment of Adults with Obesity

2026

DOI 10.1056/NEJMoa2600751

Population / Model
Dose / Duration / Finding

Peer-reviewed publication of Phase 3 obesity trial results (SYNCHRONIZE program), superseding the previously press-release-only topline figure.

Duration:
76 weeks
DOI

Survodutide for treatment of obesity: rationale and design of two randomized phase 3 clinical trials (SYNCHRONIZE-1 and -2)

2025

NCT06066515 · DOI 10.1002/oby.24184

Population / Model
SYNCHRONIZE-1 (n=726, no T2D); SYNCHRONIZE-2 (n=755, with T2D)
Dose / Duration / Finding

Trial-design publication for two ongoing/completed Phase 3 obesity trials.

Study/Trial Dosing:
3.6 mg or 6.0 mg once weekly
Duration:
76 weeks
DOIClinicalTrials.gov

Survodutide improves blood pressure in adults with obesity: A post hoc analysis

2025

DOI 10.1111/dom.16052

Population / Model
Post-hoc analysis of obesity trial participants
Dose / Duration / Finding

Improved systolic/diastolic blood pressure vs. baseline (hypothesis-generating, post-hoc).

Duration:
46 weeks
DOI

A phase 2 randomized trial of survodutide in MASH and fibrosis

2024

PMID 38847460 · DOI 10.1056/NEJMoa2401755

Population / Model
293 adults with non-cirrhotic MASH (39% with type 2 diabetes)
Dose / Duration / Finding

Higher rates of MASH improvement without worsening fibrosis vs. placebo.

Study/Trial Dosing:
2.4, 4.8, or 6.0 mg once weekly
Duration:
48 weeks
DOIPubMed

Efficacy, tolerability and pharmacokinetics of survodutide, a glucagon/glucagon-like peptide-1 receptor dual agonist, in cirrhosis

2024

PMID 38857788 · DOI 10.1016/j.jhep.2024.06.003

Population / Model
82 participants: healthy + Child-Pugh A/B/C cirrhosis
Dose / Duration / Finding

Reduced liver fat/stiffness/volume/body weight; no PK dose adjustment needed by cirrhosis status. Drug-related adverse events ranged 25-87.5% depending on dose and cirrhosis severity.

Duration:
Phase I, single-dose 0.3 mg and multiple-dose escalation 0.3-6.0 mg over 24 weeks + 4-week maintenance
DOIPubMed

Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial

2024

PMID 38330987

Population / Model
Dose / Duration / Finding

In adults with overweight or obesity without diabetes, survodutide produced dose-dependent body-weight reduction versus placebo. Gastrointestinal adverse events were common and the study was designed for dose finding rather than regulatory approval.

View sourcePubMed

Animal / Cell / Preclinical Data(1)

The dual GCGR/GLP-1R agonist survodutide: Biomarkers and pharmacological profiling for clinical candidate selection

2024

DOI 10.1111/dom.15551

Population / Model
CHO-K1 cells (in vitro); diet-induced-obese mice; db/db mice
Dose / Duration / Finding

~25% body-weight reduction in diet-induced-obese mice; HbA1c reduction in db/db mice.

Study/Trial Dosing:
10-30 nmol/kg/day
DOI

Regulatory Documents & Official Trial Registries(3)

Xcel Research LLC - 694608 - 12/10/2024

2024
Population / Model
Dose / Duration / Finding

FDA stated that marketed survodutide and cagrilintide products referenced in the warning letter had no FDA-approved applications in effect. The letter supports the non-equivalence of unauthorized research-market products and approved drugs.

View source

A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Events in People Living With Overweight or Obesity

2023

NCT06077864

Population / Model
Dose / Duration / Finding

The registry documents an ongoing Phase 3 cardiovascular-outcomes study of survodutide in people with overweight or obesity. Until completed and reported, it cannot establish a reduction in major cardiovascular events.

View sourceClinicalTrials.gov

A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity to Lose Weight

2023

NCT06066515

Population / Model
Dose / Duration / Finding

This registry documents a Phase 3 randomized trial evaluating survodutide for chronic weight management in adults with overweight or obesity. Its existence establishes late-stage investigational development but not FDA approval.

View sourceClinicalTrials.gov

Review Articles / Secondary Sources(2)

A review of survodutide: a new dual acting agonist

2026

PMID 41855048 · DOI 10.23736/S2724-6507.26.04406-4

Population / Model
Review article
Dose / Duration / Finding

General review of survodutide's mechanism and development.

DOIPubMed

Positive data from two Phase III SYNCHRONIZE obesity trials

2026
Population / Model
Dose / Duration / Finding

The sponsor reported positive 76-week Phase 3 SYNCHRONIZE obesity-program results, including significant weight loss versus placebo. These are late-stage sponsor-reported results and do not by themselves represent FDA approval or a completed independent regulatory review.

Show full finding
View source

Anecdotal Reported Patterns — Not Medical Advice

Anecdotal Reported Patterns — Not Medical Advice

Reported dosing patterns are included for educational context only. They are self-reported, unverified, not medical advice, and not instructions for human use. Community-submitted patterns are not yet available in this Phase 1 prototype; this section is a placeholder reserved for moderated, aggregated community data.

Lab Markers to Discuss With a Clinician

Educational topics only — not self-monitoring instructions.

HbA1cfasting glucoseALT/AST/GGTliver fat/stiffness imagingblood pressurebody composition

FAQ

No. It is investigational and in Phase 3 trials as of the sources reviewed.

Disclaimer

Survodutide is an investigational compound with no FDA-approved product. Information here reflects published Phase 1-3 trial data only and is not a claim of safety, effectiveness, or approval status beyond what each cited source states.

Educational use only. This content is provided for informational and research-summary purposes only. It is not medical advice, not a treatment recommendation, not a dosing guide, and not a substitute for care from a licensed medical professional. Nothing here is intended to diagnose, treat, cure, prevent, or mitigate disease. Reported dosing patterns, when shown elsewhere on the site, must be labeled either as Study / Trial Dosing or Anecdotal Reported Patterns — Not Medical Advice. Community reports are self-reported, unverified, and not scientific proof.

Community-reported experiences, once enabled, must be displayed only as moderated, anonymized, or aggregated data. They are anecdotal, self-reported, unverified, and should never be presented as proof of safety, efficacy, or expected results.

Content status: Published. Last updated 2026-07-11.

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