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a clear glass vial containing off-white powder, labeled ‘SURVODUTIDE 10 mg – Batch No.002 – 17-07-2025,’ sealed with a gray rubber stopper and matte cap, set against a neutral beige background
Survodutide 10mg vial

Survodutide 10mg vial

€90,00 EUR
Taxes included.

                                    NOT FOR HUMAN CONSUMPTION

Survodutide is a once-weekly, injectable dual agonist of the glucagon receptor (GCGR) and the GLP-1 receptor (GLP-1R) being co-developed by Zealand Pharma and Boehringer Ingelheim for obesity, metabolic dysfunction-associated steatohepatitis (MASH), and related cardiometabolic complications. By uniting appetite suppression (via GLP-1R) with a glucagon-driven rise in energy expenditure and hepatic fat mobilisation, it aims to deliver larger, metabolically healthier weight loss than GLP-1-only drugs. 

Benefit Key take-aways
1 Liver disease reversal In the Phase 2 MASH study, 83 % of patients achieved complete histologic resolution and one-third showed ≥1-stage fibrosis regression after 48 weeks—rates not yet matched by GLP-1–only drugs
2 Powerful lipid lowering Exploratory analyses reported triglyceride falls of up to 75 %, free-fatty-acid drops of 49 %, and modest LDL/VLDL reductions, pointing to a cardiometabolic benefit that goes beyond weight loss.
3 Blood-pressure reduction Mean systolic/diastolic BP fell by roughly 10/5 mmHg alongside a 17 cm shrinkage in waist circumference—clinically relevant for hypertension and visceral-fat risk.
4 Higher energy expenditure Pre-clinical work with BI 456906 shows a ~10 % rise in resting metabolic rate, suggesting the dual agonist can counteract the adaptive metabolic slowdown seen with calorie-restriction or GLP-1 monotherapy.
5 Lean-mass preservation MRI sub-studies indicate that the majority of weight lost is adipose tissue, with lean-mass loss proportionally lower than the ≈25 % seen after diet or bariatric surgery.
6 Early glycaemic gains in pre-diabetes Participants with HbA1c 5.7–6.5 % saw fasting-glucose drops of up to 13 mg/dL by week 46, before substantial weight had even been lost.
7 Cardiac function signal In a diet-induced-obese hamster HFpEF model, survodutide improved diastolic function and lipid parameters independent of weight change, supporting the rationale for the ongoing cardiovascular-outcomes trial.
8 Durable visceral-fat shrinkage A meta-analysis (1 029 participants) found average waist-circumference reductions of 8.4 cm, scaling with dose (>2 mg) and exposure (>16 weeks).
9 Medication de-intensification in type 2 diabetes In Phase 2 diabetes cohorts, HbA1c fell by up to 1.6 % within 16 weeks, allowing one-third of subjects to down-titrate or stop other glucose-lowering agents.

2. Pre-clinical insights

Rodent models fed a high-fat diet showed that survodutide increased total energy expenditure, lowered body weight and improved glycaemic control more than either semaglutide or long-acting glucagon analogues alone. Mechanistically, hepatic GCGR activation ramped up β-oxidation and thermogenesis, while GLP-1R agonism curbed intake. 

3. Pharmacokinetics & dosing principle

A proprietary fatty-acid side-chain extends half-life to ≈5 days, enabling once-weekly SC administration. Phase 1 studies established linear PK, no significant accumulation, and a tolerability-guided step-up schedule now standard in late-stage trials (0.3 mg start, titrated to 3.6 mg or 6.0 mg). 

4. Clinical evidence so far

Indication Key study (phase) Population & dose Duration Top-line efficacy
Obesity (no diabetes) NCT04667377 (Phase 2) 4 weekly doses up to 4.8 mg 46 w −18.7 % mean weight in 4.8 mg completers; ≥15 % loss in 55 % of all-comers
Type 2 diabetes Randomised Phase 2 0.6–3.6 mg 16 w HbA1c −1.6 % and weight −8.7 % at 3.6 mg
MASH with F2–F3 fibrosis Phase 2 (NEJM) 2.4–6.0 mg 48 w 83 % histologic MASH resolution vs 18 % placebo; ≥1-stage fibrosis improvement in 34–36 %

Obesity trial sources AJMCPMC – Diabetes PMC – MASH New England Journal of MedicinePubMedFinancial Times

Safety profile – Across trials, gastrointestinal events dominate (nausea ≈ 66 %, vomiting ≈ 41 %, diarrhoea ≈ 49 % at therapeutic doses). Serious AEs were comparable to placebo, but discontinuation risk is ~4-fold higher than placebo—driving the lengthened titration in phase 3. PubMedPMC

5. Phase 3 programme (2025 status)

Programme Target cohort (N) Primary end-point Status / read-out
SYNCHRONIZE-1 Obesity, no T2D (≈ 7 00) ≥ 5 % & ≥ 10 % weight loss at wk 76 Last patient out expected Dec 2025 
SYNCHRONIZE-2 Obesity + T2D Same Parallel timeline
LIVERAGE / LIVERAGE-Cirrhosis MASH F2–F3 / F4 Histologic resolution ± fibrosis Recruiting; baseline imaging & NIT poster at EASL 2025 
SYNCHRONIZE-CVOT Obesity/overweight with CV risk (4 935) 5-point MACE Active, not recruiting; last update Jul 2025 

Boehringer projects first filings in 2027–28 if these trials meet endpoints

References

  1. Sanyal AJ et al. A Phase 2 Randomized Trial of Survodutide in Adults with MASH and Fibrosis Stages 1–3. N Engl J Med 2024.

  2. Lucas KJ et al. “Survodutide Weight Loss Is Associated with Changes in Plasma Free-Fatty Acids and Triglycerides.” ADA abstract 1635-P, 2024; and Le Roux CW et al. Survodutide Improves Cardiometabolic Parameters in Adults with Obesity. Eur Heart J Suppl 2024. 

  3. Le Roux CW et al. Survodutide Improves Cardiometabolic Parameters in Adults with Obesity. Eur Heart J Suppl 2024; plus Hennige AM et al. “Survodutide: A Promising Agent for Obesity and Type 2 Diabetes.” Auctores Online 2025. 

  4. Müller TD et al. “Discovery and Pre-clinical Pharmacology of the GCGR/GLP-1R Dual Agonist BI 456906.” Molecular Metabolism 2023. 

  5. Le Roux CW et al. “Glucagon and GLP-1 Receptor Dual Agonist Survodutide for Obesity: Body-Composition Findings.” Lancet Diabetes Endocrinol 2024. 

  6. Abstract 6926. 19th Cardiometabolic Health Congress, 2024. 

  7. ADA 2025 abstract 1704-P. “Survodutide Improves HFpEF and Dyslipidaemia in a Hamster Model.” 

  8. Shi LL et al. “Effect of Survodutide on Weight, BMI and Waist Circumference: Meta-analysis of 18 Study Groups.” Diabetol Metab Syndr 2024. 

  9. Nuijten MAH et al. Survodutide Trial Rationale in Type 2 Diabetes (SYNCHRONIZE-2). Obesity 2025.