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Survodutide

Glucagon and GLP-1 receptor dual agonist

Status

In clinical trials

Not approved anywhere; Boehringer Ingelheim (under license from Zealand Pharma) reported positive phase 3 SYNCHRONIZE-1 and SYNCHRONIZE-MASLD results in 2026, and further phase 3 readouts (SYNCHRONIZE-2, the cardiovascular outcomes trial) plus the ongoing MASH trial LIVERAGE could, the companies say, pave the way for regulatory submissions.

Evidence

Moderate

Two published phase 3 trials (SYNCHRONIZE-1, SYNCHRONIZE-MASLD) and phase 2 trials in obesity and MASH are positive; other phase 3 trials, including cardiovascular outcomes, are pending.

In sport

WADAProhibited (WADA)

Survodutide is an investigational once-weekly injected peptide that activates both glucagon and GLP-1 receptors. Developed by Boehringer Ingelheim for obesity and fatty liver disease (MASH), it produced up to 16.6% average weight loss in a 76-week phase 3 trial.

Structure

29 residues
  1. aK24C18 fatty diacid via γGlu-Gly-Ser-Gly-Ser-Gly-Gly linker (albumin binding)

Point at a bead, or focus the chain and use the arrow keys, to name it. Pick a chemistry to highlight it.

Sequence as text
H-H-Ac4c-Q-G-T-F-T-S-D-Y-S-K-Y-L-D-E-R-A-A-K-D-F-I-K-W-L-E-S-A-NH2

What it is used for

  • Obesity and overweight (studied)
  • MASH with liver fibrosis (studied)
  • Obesity with metabolic dysfunction-associated steatotic liver disease (studied)

How it works

Survodutide is modeled on oxyntomodulin, a gut hormone that activates both glucagon and GLP-1 receptors and lowers body weight by reducing food intake and raising energy expenditure. GLP-1 activity reduces appetite and improves glucose control, while glucagon receptor activity aims to increase energy expenditure; in trials survodutide also markedly reduced liver fat. A C18 fatty diacid attached to Lys24 binds albumin, prolonging its half-life enough for weekly injection.

How strong the evidence is

ModerateAt least one good randomised trial, or consistent smaller human trials.

SYNCHRONIZE-1 (NEJM 2026; 725 adults with obesity, no diabetes) found mean weight changes at 76 weeks of -12.2% (3.6 mg) and -13.0% (6.0 mg) versus -5.4% with placebo in the treatment-regimen analysis, and up to 16.6% among those who stayed on treatment. In SYNCHRONIZE-MASLD (216 adults), 84% on 6.0 mg reduced liver fat by at least 30% at 48 weeks versus 24% on placebo. A phase 2 MASH trial (NEJM 2024, 293 participants) improved MASH without worsening fibrosis in up to 62% versus 14% with placebo.

Risks and side effects

  • Nausea, diarrhea and vomiting are very common (66%, 49% and 41% vs 23%, 23% and 4% with placebo in the phase 2 MASH trial)
  • Gastrointestinal effects cluster during dose escalation
  • Cardiovascular outcome results (SYNCHRONIZE-CVOT) not yet reported
  • Not approved: products sold outside clinical trials are unregulated, with unknown identity, purity, dose and sterility

Regulatory status

No regulator has approved this peptide for any use.

Status by country

JurisdictionStatusSource
USUnited StatesNo authorised medicineSource 13
EUEuropean UnionNo authorised medicineSource 14
UKUnited KingdomNo authorised medicineSource 15
AUAustraliaNo authorised medicineSource 16
CACanadaNo authorised medicineSource 17
Whether a medicine containing it is authorised, checked in each regulator’s records on Oct 1, 2026.

Status of every peptide by country

Trials of Survodutide to watch

  1. Phase 2Not yet recruiting

    ARTIST-CKD(opens the source in a new tab)

    Albuminuria Reduction Study With Survodutide Treatment in Kidney Disease

    Primary completion expected Nov 30, 2027120 participantsSponsor: University Medical Center GroningenNCT07206290

  2. Phase 3Recruiting

    Survodutide in type 2 diabetes(opens the source in a new tab)

    A Study to Test Whether Survodutide Helps People With Type 2 Diabetes Control Their Blood Sugar

    Primary completion expected Jan 17, 2028600 participantsSponsor: Boehringer IngelheimNCT07754461

  3. Phase 3Not yet recruiting

    SYNCHRONIZE-HERA(opens the source in a new tab)

    SYNCHRONIZE®-HERA: A Study to Test Whether Survodutide Helps Women Who Are Living With Overweight or Obesity and Are Going Through or Have Finished Menopause, to Lose Weight

    Primary completion expected Jul 26, 2028600 participantsSponsor: Boehringer IngelheimNCT07850050

  4. Phase 3Completed

    SYNCHRONIZE-CVOT(opens the source in a new tab)

    A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)

    Primary completion Jun 1, 20265,531 participantsSponsor: Boehringer IngelheimNCT06077864

  5. Phase 3Completed

    SYNCHRONIZE-2(opens the source in a new tab)

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

    Primary completion Dec 12, 2025755 participantsSponsor: Boehringer IngelheimNCT06066528

  6. Phase 3Completed

    SYNCHRONIZE-1(opens the source in a new tab)

    A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight

    Primary completion Dec 2, 2025726 participantsSponsor: Boehringer IngelheimNCT06066515

  7. Phase 3Completed

    SYNCHRONIZE-MASLD(opens the source in a new tab)

    A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis (NASH) to Reduce Liver Fat and to Lose Weight (SYNCHRONIZE-MASLD)

    Primary completion Oct 9, 2025218 participantsSponsor: Boehringer IngelheimNCT06309992

All trials to watch

Timeline

  1. 2028

    1. SYNCHRONIZE-HERA
    2. Survodutide in type 2 diabetes

  2. 2027

    1. ARTIST-CKD

  3. 2026

    1. Trial resultSYNCHRONIZE-2: survodutide reduces weight in adults with type 2 diabetes
    2. RegulatoryFDA warning letters reject 'research use only' labels on online GLP-1 peptide sales
    3. Trial resultSurvodutide phase 3 SYNCHRONIZE-1 published: up to 16.6% weight loss at 76 weeks
    4. SYNCHRONIZE-CVOT

  4. 2025

    1. SYNCHRONIZE-2
    2. SYNCHRONIZE-1
    3. SYNCHRONIZE-MASLD

Sources

  1. 01International Nonproprietary Names for Pharmaceutical Substances: Proposed INN List 128(opens the source in a new tab) World Health Organization (WHO Drug Information), 2022
  2. 02Survodutide (D12898): sequence and structure entry(opens the source in a new tab) KEGG DRUG
  3. 03BI 456906: Discovery and preclinical pharmacology of a novel GCGR/GLP-1R dual agonist with robust anti-obesity efficacy(opens the source in a new tab) Molecular Metabolism, 2022
  4. 04Perspectives in weight control in diabetes: Survodutide(opens the source in a new tab) Diabetes Research and Clinical Practice, 2024
  5. 05Survodutide Once Weekly for the Treatment of Adults with Obesity (SYNCHRONIZE-1)(opens the source in a new tab) New England Journal of Medicine, 2026
  6. 06Survodutide in adults with obesity and metabolic dysfunction-associated steatotic liver disease (SYNCHRONIZE-MASLD)(opens the source in a new tab) Nature Medicine, 2026
  7. 07A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis(opens the source in a new tab) New England Journal of Medicine, 2024
  8. 08Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial(opens the source in a new tab) The Lancet Diabetes & Endocrinology, 2024
  9. 09A study to test the effect of survodutide on cardiovascular safety in people with overweight or obesity (SYNCHRONIZE-CVOT, NCT06077864)(opens the source in a new tab) ClinicalTrials.gov, 2026
  10. 10LIVERAGE: a study to test whether survodutide helps people with MASH and moderate or advanced liver fibrosis (NCT06632444)(opens the source in a new tab) ClinicalTrials.gov, 2026
  11. 11Zealand Pharma announces financial results for the first half of 2026(opens the source in a new tab) Zealand Pharma via GlobeNewswire, 2026
  12. 12World Anti-Doping Code International Standard: Prohibited List 2026(opens the source in a new tab) World Anti-Doping Agency, 2025
  13. 13FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss(opens the source in a new tab) U.S. Food and Drug Administration, 2026
  14. 14Find medicine: centrally authorised medicines(opens the source in a new tab) European Medicines Agency, 2026
  15. 15MHRA Products: active substances beginning with S(opens the source in a new tab) Medicines and Healthcare products Regulatory Agency, 2026
  16. 16Australian Register of Therapeutic Goods (ARTG)(opens the source in a new tab) Therapeutic Goods Administration
  17. 17Drug Product Database online query(opens the source in a new tab) Health Canada
  1. In clinical trialsAmycretinUnimolecular GLP-1 and amylin receptor agonistNo single sequence68 WADA banned
  2. Not approvedAOD-9604Modified growth hormone fragment (research peptide)16 WADA banned
  3. In clinical trialsCagrilintideLong-acting amylin analog (amylin and calcitonin receptor agonist)37 WADA banned
  4. ApprovedDulaglutideGLP-1 receptor agonist (Fc fusion protein)31
  5. ApprovedExenatideGLP-1 receptor agonist39

Educational information, not medical advice. Talk to a licensed clinician before starting, stopping or changing any medicine.