Survodutide

BInvestigationalGLP-1 and incretin agonists →BI 456906GLP-1/glucagon dual agonistBoehringer Ingelheim / Zealand
In one paragraphSurvodutide is a once-weekly peptide that activates both the GLP-1 and glucagon receptors. In SYNCHRONIZE-1, a 725-person phase 3 trial published in June 2026, it produced 12–13% weight loss at 76 weeks against 5% on placebo, with gastrointestinal symptoms in up to 90% of participants. In people who also have type 2 diabetes the figure was 8–10% against 4% (SYNCHRONIZE-2, published October 2026). Its distinctive result is in the liver: a phase 2 trial resolved MASH without worsening fibrosis in 83% of patients at the top dose. It is not approved anywhere.
Schematic 3D structure of Survodutide
29 residues · oxyntomodulin-based dual agonist, helical · schematic
Overall gradeB Probable
Human trials2 phase 3 RCTs published (n=725; n=752)
Outcomes graded6
Last reviewed7 October 2026
EvidenceWhat it isHow it worksUnknownsMolecule & PKRegulationQuestionsReferences

What the human research shows

Solid B: the phase 3 obesity data are published in a major journal, the effect is real but smaller than tirzepatide's, and the tolerability burden is high. The liver results are what make it more than another GLP-1 — and what will decide whether it gets approved for MASH first.

MetabolicCardioMuscleHealingNeuroImmuneSexualSkinAgeing

Evidence profile0–5

  • Metabolic & weightB3.5
  • Cardiovascular—0.0
  • Muscle & growth—0.0
  • Healing & repair—0.0
  • Neuro & sleep—0.0
  • Immune & inflammation—0.0
  • Sexual & hormonal—0.0
  • Skin & appearance—0.0
  • Ageing & longevity—0.0
Each score is confidence × effect size, taken from the best-evidenced benefit in that domain: the grade (A–D) sets the confidence, the measured effect sets the size. Hover a domain to see the outcomes behind it. Adverse effects are excluded and listed separately below.
OutcomeGradeEffect sizeHuman studiesWhere the evidence comes from
Body weightBProbableModerate1 phase 3 RCT + phase 2SYNCHRONIZE-1, 725 adults, 76 weeks: −12% (3.6 mg) and −13% (6.0 mg) versus −5% placebo; at least 5% loss in 73%, 72% and 46%. Phase 2: up to −14.9% at 46 weeks.12
Body weight (obesity with type 2 diabetes)BProbableModerate1 phase 3 RCT (n=752, 76 wk)SYNCHRONIZE-2, published in the New England Journal of Medicine on 1 October 2026: −8.2% (3.6 mg) and −9.8% (6.0 mg) versus −3.9% on placebo at 76 weeks, counting all participants whether or not they stayed on treatment; at least 5% loss in 57.6%, 64.5% and 35.1%. HbA1c fell 0.9 and 0.8 points against 0.2, from a baseline of 7.4%. The usual pattern: less weight loss when type 2 diabetes is present.5
Liver disease (MASH resolution)BProbableLarge1 phase 2 RCT; phase 3 runningPhase 2 in 293 patients: MASH improvement without worsening fibrosis in 83% at 4.8 mg versus 18% on placebo at 48 weeks; fibrosis improvement in 52% versus 26%. Phase 3 LIVERAGE ongoing.3
Liver fat and visceral fatBProbableLargePhase 3 (SYNCHRONIZE-MASLD)Marked reductions in liver fat and visceral fat reported in the phase 3 obesity-with-MASLD trial; consistent with the glucagon component's hepatic action.4
GI side effectsadverseBProbableLargePhase 3Mild-to-moderate gastrointestinal symptoms in 81% (3.6 mg) and 90% (6.0 mg) versus 48% on placebo in SYNCHRONIZE-1, with substantial discontinuation. SYNCHRONIZE-2: 72.8% and 77.7% versus 38.6%, generally mild to moderate and transient.15
Heart rate increaseadverseBProbableSmallPhase 2 + 3Resting heart rate rises a few beats per minute, as with other glucagon-receptor agonists; long-term significance unknown.2
AMultiple good human trials, consistentBSome human trials, mostly consistentCFew or weak human studiesDAnimal or anecdotal onlyeffect size · red = adverse

Literature searched to 7 October 2026. Human studies only; animal and cell work informs the mechanism section and nothing else.

Registered trials

ClinicalTrials.gov lists 28 interventional studies naming Survodutide as an intervention — 18 completed, 4 recruiting, and 2 with results posted to the registry.

A registration is not a result. Anyone can register a study, and many never report — so this list shows what has been attempted, not what has been shown. The graded evidence above is the answer to whether something works.

StudyPhaseStatusParticipantsSponsorResults
A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose WeightNCT04667377 · started Mar 2021Phase 2Completed387Boehringer IngelheimPosted
A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)NCT04771273 · started Apr 2021Phase 2Completed295Boehringer IngelheimPosted
A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)NCT06077864 · started Nov 2023Phase 3Completed5,531Boehringer IngelheimNone
LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver FibrosisNCT06632444 · started Oct 2024Phase 3Recruiting1,800*Boehringer IngelheimNone
LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have CirrhosisNCT06632457 · started Nov 2024Phase 3Recruiting1,590*Boehringer IngelheimNone
A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose WeightNCT06066528 · started Nov 2023Phase 3Completed755Boehringer IngelheimNone
A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose WeightNCT06066515 · started Nov 2023Phase 3Completed726Boehringer IngelheimNone
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver DiseaseNCT07850063 · started Oct 2026Phase 3Not yet recruiting600*Boehringer IngelheimNone

20 further studies are registered. Participant counts marked * are the sponsor's estimate, not a final enrolment. Source: ClinicalTrials.gov, read directly from the registry and refreshed weekly.

What it is

An oxyntomodulin-based 29-amino-acid peptide developed by Zealand Pharma and Boehringer Ingelheim, given once weekly by subcutaneous injection. Oxyntomodulin is the gut hormone that naturally hits both receptors; survodutide is a stabilised version of that idea.

The SYNCHRONIZE phase 3 programme covers obesity, obesity with type 2 diabetes, obesity with liver disease, and cardiovascular outcomes. The first results were published in the New England Journal of Medicine on 7 June 2026; the trial in obesity with type 2 diabetes followed on 1 October 2026.

How it is thought to work

GLP-1 activity reduces appetite and slows gastric emptying; glucagon activity increases energy expenditure and drives fat oxidation in the liver. The combination is designed to lose weight and clear liver fat at the same time — the liver effect is where the data are strongest.

What is still unknown

  • Whether regulators approve it for obesity, MASH, or both, and when.
  • How it compares head-to-head with tirzepatide or retatrutide; no such trial exists.
  • Whether the high discontinuation rate can be managed with slower titration.

The molecule and how long it lasts

Identity
Formula
C192H289N47O61
Molecular weight
4232 g/mol
CAS number
2805997-46-8
PubChem
CID 171378821

PubChem record, read 23 September 2026.

Pharmacokinetics
Route
Subcutaneous, once weekly
Half-life
About 6 days

From a published human pharmacokinetic study: Lawitz EJ, et al. Efficacy, tolerability and pharmacokinetics of survodutide in cirrhosis. J Hepatol 2024;81

Regulatory status

European Union
Investigational; not authorised

Phase 3; no marketing authorisation. Supply outside trials is unlawful.

United States
Investigational; not approved

Phase 3; FDA has warned sellers marketing 'research' survodutide for human use. Cannot be compounded.

United Kingdom
Unlicensed

Investigational; supply outside trials is an offence.

Australia
Unapproved

Not on the ARTG; no lawful supply outside trials.

Canada
Not authorised

Investigational; no DIN.

Sport (WADA)
Prohibited at all times

Unapproved anywhere, so it falls under S0 (non-approved substances).

Questions people actually ask

How much weight does survodutide cause people to lose?
In the phase 3 SYNCHRONIZE-1 trial, 12–13% over 76 weeks against 5% on placebo — less than tirzepatide's roughly 20% in its own trials, though trials are not directly comparable.
Why is survodutide talked about for liver disease?
Because its glucagon component acts on the liver. In a phase 2 trial, 83% of patients on the top dose had MASH resolve without worsening fibrosis, against 18% on placebo — among the strongest liver results of any drug in the class.
Is survodutide available?
No. It is investigational everywhere. The FDA has specifically warned companies selling it as a research chemical for human use.

One page per claimed effect

References

  1. 1
    Survodutide in adults with obesity: SYNCHRONIZE-1, a randomised, double-blind, placebo-controlled phase 3 trial.N Engl J Med, published online 7 June 2026725 adults, 76 weeks, 3.6 mg and 6.0 mg versus placebo.
  2. 2
  3. 3
    Sanyal AJ, et al. A phase 2 randomized trial of survodutide in MASH and fibrosis.N Engl J Med, 2024; DOI 10.1056/NEJMoa2401755293 patients, 48 weeks.
  4. 4
  5. 5
    Wharton S, et al. Survodutide once weekly in adults with obesity and type 2 diabetes (SYNCHRONIZE-2).N Engl J Med, 2026 (online 1 Oct)752 adults, 76 weeks, 3.6 mg and 6.0 mg versus placebo. NCT06066528.

Change log

  • 2026-10-07SYNCHRONIZE-2 (N Engl J Med, 1 Oct 2026) added as a new row for obesity with type 2 diabetes, graded B: −8.2% and −9.8% versus −3.9% at 76 weeks. Other grades unchanged.
  • 2026-09-03Initial publication from SYNCHRONIZE-1 and the phase 2 MASH trial.