Compound record · Metabolic (incretin-based)

Survodutide

Also BI 456906 · Survo

Dual glucagon/GLP-1 receptor agonist

Metabolic (incretin-based)Evidence · ModerateLate-stage clinical trials

Investigational weekly glucagon/GLP-1 dual agonist in phase 3 for obesity and MASH

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Record reviewed 1 September 2026 · 5 references

Status: Investigational — phase 3 (SYNCHRONIZE); not authorised anywhere
Class: Dual glucagon/GLP-1 receptor agonist
Route: Weekly subcutaneous injection (trials only)
Trial weight loss: ≈ 13% mean at 76 weeks (SYNCHRONIZE-1, 6.0 mg)
Prescription: Not available by prescription; clinical trials only

01 Overview

What Survodutide is

Summary

Survodutide (BI 456906) is an investigational once-weekly peptide that activates both glucagon and GLP-1 receptors. In a 46-week phase 2 trial the 4.8 mg dose produced a mean 14.9% weight loss, and the phase 3 SYNCHRONIZE-1 trial published in 2026 reported 12.2–13.0% at 76 weeks versus 5.4% with placebo. It is also being studied in metabolic dysfunction-associated steatohepatitis (MASH). No regulator has authorised it.

Mechanism

GLP-1 receptor activation reduces appetite, slows gastric emptying and improves glucose-dependent insulin secretion; glucagon receptor activation increases energy expenditure and liver fat oxidation, which is thought to add weight and liver-fat reduction but can raise glucose and heart rate.

Routes studiedSubcutaneous injection

Anti-dopingNot prohibited

02 Evidence by goal

What has been shown, for which goal

Grades follow one scale across the site. Moderate overall means: at least one well-conducted randomised trial or consistent controlled human studies.

Weight management
Moderate
Phase 2 (n = 387): mean weight loss of 6.2%, 12.5%, 13.2% and 14.9% at 46 weeks with 0.6, 2.4, 3.6 and 4.8 mg weekly versus 2.8% with placebo (up to 18.7% in those who stayed on treatment). Phase 3 SYNCHRONIZE-1 (n = 725): 12.2% (3.6 mg) and 13.0% (6.0 mg) versus 5.4% at 76 weeks, or up to 16.6% versus 3.2% among those who stayed on treatment.
Fat loss / body composition
Limited
In an MRI sub-study of SYNCHRONIZE-1 (25 participants per group), 6.0 mg reduced visceral fat by 34% and liver fat by 63% versus 12% and 25% with placebo; fat-versus-lean-mass data have not yet been published.
Longevity
Preliminary
In a 48-week phase 2 trial in biopsy-confirmed MASH (n = 293), MASH improved without worsening fibrosis in 47–62% versus 14% with placebo. A cardiovascular-outcome trial is ongoing; no outcome data exist yet.

03 Regulatory status

Where it is authorised, and for what

Status is recorded per jurisdiction from regulator sources and reviewed by hand. It is never inferred from another region's decision.

United Kingdom

Investigational

Not authorised; in phase 3 trials (SYNCHRONIZE programme).

No MHRA marketing authorisation. Survodutide is available only within clinical trials; products sold online as 'survodutide' are unregulated and cannot lawfully be supplied as a medicine.

StatusInvestigational

Status last reviewed1 September 2026

SourceOur maintained database — never inferred

04 Dosing research

What the evidence says about exposure

Published human studies and the doses, routes and durations they used — reported as research information, not a recommendation.

Research information — not a recommendation. These are the exposures used in published human studies, reported so you can see what has been tested. They are not dosing instructions and do not apply to any individual.

Study 01

Phase 2 — survodutide dose-finding in adults with overweight or obesity

le Roux CW et al., Lancet Diabetes Endocrinol 2024;12:162–173 · Source

Phase 22024

Design: Randomised, double-blind, placebo-controlled, dose-finding
Population: Adults aged 18–75 with BMI ≥ 27, without diabetes
Participants: n = 387
Duration: 46 weeks (20 weeks rapid dose escalation, 26 weeks maintenance)
Route: Subcutaneous injection

Doses studied: 0.6, 2.4, 3.6 or 4.8 mg once weekly
Outcome at this exposure: Mean weight change −6.2% (0.6 mg), −12.5% (2.4 mg), −13.2% (3.6 mg) and −14.9% (4.8 mg) vs −2.8% with placebo (planned-treatment analysis); up to −18.7% in the actual-treatment analysis.
Adverse events observed: Adverse events in 91% vs 75%, primarily gastrointestinal (75% vs 42%); adverse events led to discontinuation in 25% of survodutide recipients vs 4% with placebo, mostly gastrointestinal and during rapid escalation; two serious drug-related events (dehydration with renal failure; angioedema).

Study 02

SYNCHRONIZE-1 — once-weekly survodutide in adults with obesity without diabetes

SYNCHRONIZE-1 trial, N Engl J Med 2026 (DOI 10.1056/NEJMoa2600751) · Source

Phase 32026

Design: Randomised, double-blind, placebo-controlled
Population: Adults with BMI ≥ 30, or ≥ 27 with ≥ 1 obesity-related complication, without diabetes
Participants: n = 725
Duration: 76 weeks
Route: Subcutaneous injection

Doses studied: Escalated to 3.6 mg or 6.0 mg once weekly, with lifestyle counselling
Outcome at this exposure: Mean weight change −12.2% (3.6 mg) and −13.0% (6.0 mg) vs −5.4% with placebo (treatment-regimen estimand); up to −16.6% vs −3.2% in the efficacy estimand; ≥ 5% weight loss in 72.6% and 71.9% vs 46.3%.
Adverse events observed: Gastrointestinal events in 80.9% (3.6 mg) and 89.7% (6.0 mg) vs 47.9% with placebo, typically mild-to-moderate; no deaths reported.

Study 03

Phase 2 — survodutide in MASH with fibrosis

Sanyal AJ et al., N Engl J Med 2024;391:311–319 · Source

Phase 22024

Design: Randomised, double-blind, placebo-controlled
Population: Adults with biopsy-confirmed MASH and fibrosis stage F1–F3
Participants: n = 293
Duration: 48 weeks (24 weeks rapid escalation, 24 weeks maintenance)
Route: Subcutaneous injection

Doses studied: 2.4, 4.8 or 6.0 mg once weekly
Outcome at this exposure: Improvement in MASH without worsening fibrosis in 47% (2.4 mg), 62% (4.8 mg) and 43% (6.0 mg) vs 14% with placebo; ≥ 30% liver-fat reduction in 57–67% vs 14%; fibrosis improved by ≥ 1 stage in 34–36% vs 22%.
Adverse events observed: Nausea (66% vs 23%), diarrhoea (49% vs 23%) and vomiting (41% vs 4%); discontinuation for adverse events 20% vs 3%; serious adverse events 8% vs 7%; asymptomatic rises in pancreatic enzymes more frequent.

05 Safety

Adverse effects and contraindications

Common effects seen in trials or reports, serious effects that warrant urgent review, and conditions under which use is not appropriate or needs assessment.

Common adverse effects

Nausea
Vomiting
Diarrhoea
Constipation
Reduced appetite
Abdominal pain and dyspepsia
Fatigue
Increased heart rate
Injection-site reactions
Headache

Serious adverse effects

Dehydration with acute kidney injury from persistent vomiting or diarrhoea (reported in phase 2)
Angioedema (one serious drug-related case in phase 2)
Increased heart rate and possible arrhythmia (glucagon receptor effect)
Acute pancreatitis (class effect; asymptomatic enzyme rises more frequent)
Gallbladder disease with rapid weight loss (class effect)
Severe hypoglycaemia when combined with insulin or sulfonylureas
Unknown long-term safety — no data beyond 76 weeks
Aspiration during anaesthesia due to retained stomach contents (class warning)

Contraindications

Personal or family history of medullary thyroid cancer or MEN2Do not use
Trials exclude people with a personal or family history of medullary thyroid carcinoma or MEN2, and authorised GLP-1 medicines carry a thyroid C-cell warning; treated as a class contraindication.
Previous pancreatitisDo not use
Trials exclude previous pancreatitis; asymptomatic pancreatic-enzyme rises were more frequent with survodutide and pancreatitis is a class effect of GLP-1 medicines.
Gastroparesis (slow stomach emptying)Do not use
Slows gastric emptying further; excluded from trials and treated as a class contraindication.
Thyroid diseaseCaution
Any thyroid cancer history must be clarified; slowed gastric emptying may change levothyroxine absorption.
Pancreatic diseaseCaution
Pancreatic disease warrants specialist assessment before considering any GLP-1-based compound.
Gallbladder diseaseCaution
Gallstone disease is more common with rapid weight loss.
DiabetesCaution
Glucagon receptor activation can raise glucose; hypoglycaemia risk rises with insulin or sulfonylureas. Data in type 2 diabetes come from SYNCHRONIZE-2 (results awaited at last review); type 1 diabetes has not been studied.
Diabetic retinopathy (eye disease)Caution
Rapid glucose improvement can temporarily worsen retinopathy with GLP-1 medicines; no survodutide-specific data.
Kidney diseaseCaution
Dehydration with renal failure occurred as a serious adverse event in phase 2; hydration must be maintained during vomiting or diarrhoea.
Liver diseaseCaution
Studied in MASH with fibrosis stage F1–F3; there are no data in cirrhosis or decompensated liver disease.
Gastrointestinal diseaseCaution
Not studied in severe gastrointestinal disease; slowed gastric emptying may worsen symptoms.
Cardiovascular diseaseCaution
Glucagon receptor agonists raise heart rate; people with arrhythmia or unstable cardiovascular disease need specialist review, and outcome data are awaited.
Mental health conditionCaution
Authorised weight-management medicines carry monitoring advice for depression and suicidal thoughts; no survodutide-specific data.
Current or previous eating disorderCaution
Appetite-suppressing compounds require specialist assessment where there is a current or previous eating disorder.

Do not use = should not be used · Caution = needs assessment

06 Interactions

Medicine classes that need review

Grouped by how seriously the combination should be taken. Class labels match the medicines questionnaire in the assessment.

Major
Moderate
Minor

Major

Combination should be reviewed by a prescriber before use.

Insulin
Lantus, NovoRapid, Humalog, Tresiba
Combined use would increase hypoglycaemia risk; SYNCHRONIZE-2 excluded insulin users.
Sulfonylurea
Gliclazide, glimepiride, glipizide
Combined use would increase hypoglycaemia risk; no dedicated interaction data.
GLP-1 / incretin medicine
Ozempic, Wegovy, Mounjaro, Saxenda
Survodutide already contains GLP-1 receptor activity — adding another incretin medicine duplicates mechanism with no safety data.

Moderate

Monitoring or dose review is usually advised.

Anticoagulant (blood thinner)
Warfarin, apixaban, rivaroxaban
Delayed gastric emptying can alter absorption; closer INR monitoring would be prudent with warfarin.
Thyroid hormone
Levothyroxine, liothyronine
Levothyroxine exposure may change with slowed gastric emptying.
Narrow-therapeutic-index medicine
Lithium, digoxin, ciclosporin
Medicines that depend on rapid absorption or have a narrow therapeutic window may need closer monitoring.

Minor

Generally compatible; awareness is sufficient.

Oral contraceptive
Combined pill, progestogen-only pill
No interaction data; vomiting can reduce pill effectiveness and a barrier method is a reasonable precaution to discuss.
Beta blocker
Bisoprolol, propranolol, atenolol
No interaction studies; beta-blockers may mask the heart-rate increase seen with glucagon receptor agonists.
Other glucose-lowering medicine
Metformin, SGLT2 inhibitors, DPP-4 inhibitors
Studied alongside metformin and other oral agents in SYNCHRONIZE-2; glucose monitoring advised.

07 Pregnancy & breastfeeding

Status in pregnancy

Insufficient data

No human data; trials exclude pregnant and breastfeeding women and require effective contraception. Authorised GLP-1 medicines are not recommended in pregnancy.

08 Monitoring

What is usually monitored

Parameters that trials and product information track. A clinician decides what applies to an individual.

01Gastrointestinal tolerability and hydration — discontinuations clustered during rapid escalation
02Kidney function during vomiting or diarrhoea
03Heart rate and blood pressure
04Blood glucose if on insulin or other glucose-lowering medicines
05Liver enzymes and pancreatic enzymes if symptoms suggest a problem
06Muscle mass, nutrition and mood during rapid weight loss

09 Combinations

What is known about combining it

Notes on pairing with other compounds in the directory: whether the combination has been studied in people, and where mechanisms overlap.

Semaglutide
No human studies
Overlap · Both include GLP-1 receptor activity.
Duplicate incretin mechanism with no human data; two GLP-1-based compounds should not be combined.
Tirzepatide
No human studies
Overlap · Both include GLP-1 receptor activity.
Duplicate incretin mechanism with no human data.
Liraglutide
No human studies
Overlap · Both include GLP-1 receptor activity.
Duplicate mechanism with no human data.
Retatrutide
No human studies
Overlap · Both include glucagon and GLP-1 receptor activity.
Duplicate mechanism; both are investigational and neither has been studied in combination.
Cagrilintide
No human studies
Overlap · Both suppress appetite and slow gastric emptying.
Never studied together; both are investigational.
CJC-1295
No human studies
No human studies of incretin-based compounds combined with growth-hormone secretagogues.
Ipamorelin
No human studies
No human studies of incretin-based compounds combined with growth-hormone secretagogues.
BPC-157
No human studies
No human data on this combination; BPC-157 itself lacks human efficacy data.

Discuss any proposed combination with a qualified healthcare professional.

10 Source considerations

Supply, quality and legitimacy

How the compound reaches people in practice, and what that means for product quality.

01No authorised product exists anywhere — vials sold as 'survodutide' online are unregulated, with no assurance of identity, purity, sterility or dose.
02The only lawful route of access is enrolment in a registered clinical trial.
03Regulators including the FDA and MHRA have warned about unapproved GLP-1-type injections sold online and through social media.
04Athletes: survodutide is not named on the WADA Prohibited List, but WADA's S0 category covers substances without regulatory approval for human use; competitors should seek anti-doping advice.

11 Questions for your clinician

Take these to your appointment

Specific to this compound. The personal assessment adds questions drawn from your own history and medicines.

01Is there a clinical trial of survodutide I could be eligible for in my country?
02Given that tirzepatide and semaglutide are authorised and produced larger weight loss in their trials, what would survodutide add for my goal?
03How would nausea, hydration and kidney function be managed given the high discontinuation rate during rapid escalation in trials?
04If I have fatty liver disease, what authorised options exist and how would liver health be monitored?
05What is known about weight regain after stopping?

The personal assessment tailors this list to your responses.

12 Alternatives

Compounds with stronger evidence or firmer regulatory footing

Listed for overlapping goals. Whether any is appropriate depends on your history — the assessment maps that for you.

13 References

Sources behind this record

Regulator documents and peer-reviewed publications used to derive every grade and statement above.

The Peptide Checkup provides educational information and a structured summary of published research and regulatory status. It is not medical advice, does not diagnose or treat any condition, and does not replace a consultation with a qualified healthcare professional.

Personal assessment

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