Survodutide
Evidence: A-/B+ — Established Human EvidenceMetabolic / Weight Management
Evidence Snapshot
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.
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
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.
Evidence Claims
Individual scientific statements drawn from the sources cited below, each shown with the specific evidence boundary that statement does not establish.
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.
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
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.
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
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).
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
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
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
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
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.
Supported
Grey-market survodutide products are unapproved and cannot be presumed equivalent to sponsor-manufactured clinical-trial material.
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.
- 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
Human Studies & Clinical Data
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Survodutide Once Weekly for the Treatment of Adults with Obesity | 2026 | Peer-reviewed publication of Phase 3 obesity trial results (SYNCHRONIZE program), superseding the previously press-release-only topline figure.
| |||
| Survodutide for treatment of obesity: rationale and design of two randomized phase 3 clinical trials (SYNCHRONIZE-1 and -2) | 2025 | SYNCHRONIZE-1 (n=726, no T2D); SYNCHRONIZE-2 (n=755, with T2D) | Trial-design publication for two ongoing/completed Phase 3 obesity trials.
| ||
| Survodutide improves blood pressure in adults with obesity: A post hoc analysis | 2025 | Post-hoc analysis of obesity trial participants | Improved systolic/diastolic blood pressure vs. baseline (hypothesis-generating, post-hoc).
| ||
| A phase 2 randomized trial of survodutide in MASH and fibrosis | 2024 | 293 adults with non-cirrhotic MASH (39% with type 2 diabetes) | Higher rates of MASH improvement without worsening fibrosis vs. placebo.
| ||
| Efficacy, tolerability and pharmacokinetics of survodutide, a glucagon/glucagon-like peptide-1 receptor dual agonist, in cirrhosis | 2024 | 82 participants: healthy + Child-Pugh A/B/C cirrhosis | 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.
| ||
| Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial | 2024 | 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. |
Animal / Cell / Preclinical Data
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| The dual GCGR/GLP-1R agonist survodutide: Biomarkers and pharmacological profiling for clinical candidate selection | 2024 | CHO-K1 cells (in vitro); diet-induced-obese mice; db/db mice | ~25% body-weight reduction in diet-induced-obese mice; HbA1c reduction in db/db mice.
|
Regulatory Documents & Official Trial Registries
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| Xcel Research LLC - 694608 - 12/10/2024 | 2024 | 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. | |||
| A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Events in People Living With Overweight or Obesity | 2023 | 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. | |||
| A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity to Lose Weight | 2023 | 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. |
Review Articles / Secondary Sources
| Title | Year | Population / Model | Dose / Duration / Finding | Safety Notes | Source |
|---|---|---|---|---|---|
| A review of survodutide: a new dual acting agonist | 2026 | Review article | General review of survodutide's mechanism and development. | ||
| Positive data from two Phase III SYNCHRONIZE obesity trials | 2026 | 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. |
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.
FAQ
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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