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Survodutide (BI 456906) Phase 3 Results: SYNCHRONIZE Data, GLP-1/Glucagon Mechanism and Status

Short answer: survodutide (BI 456906) is a GLP-1 + glucagon dual agonist from Boehringer Ingelheim and Zealand Pharma, given once weekly. The glucagon arm makes it as much a liver drug as a weight drug — it holds U.S. FDA Breakthrough Therapy status for the liver disease MASH, and in the Phase 3 SYNCHRONIZE-1 obesity trial ( NEJM 2026) mean body weight changed by −12.2% and −13.0% on the two survodutide doses at week 76, against −5.4% on placebo (treatment-regimen estimand). It has no marketing authorisation anywhere as of mid-2026. New-U does not sell survodutide. Part of our next obesity-research wave overview.

Plain-English summary. Survodutide is an unapproved, investigational drug. Breakthrough Therapy designation speeds FDA review — it is not an approval. The FDA, MHRA and EMA have not authorised survodutide. This page is general information, not legal or medical advice; do not use unapproved compounds on people.

What survodutide actually is

Survodutide (developmental code BI 456906 ) is a synthetic peptide dual agonist of the GLP-1 and glucagon receptors, given as a once-weekly subcutaneous injection. It was discovered at Zealand Pharma and licensed to Boehringer Ingelheim, which leads its global development and commercialisation. Molecular and trial detail is indexed under PubMed: survodutide / BI 456906.

Why the glucagon arm is the story

Adding glucagon to GLP-1 changes what the drug does :

GLP-1 receptor — appetite suppression, slowed gastric emptying, glucose-dependent insulin secretion (the familiar incretin effects).

Glucagon receptor — raises energy expenditure and, crucially, drives hepatic fat mobilisation . On its own glucagon would raise blood glucose; paired with GLP-1 that effect is offset, leaving the energy-expenditure and liver-fat arms.

This is the same dual logic behind the glucagon arm of retatrutide — except retatrutide adds GIP on top, whereas survodutide stays a focused GLP-1/glucagon pairing aimed squarely at weight and liver.

The MASH angle

Because the glucagon arm pulls fat out of the liver, survodutide is being developed for MASH (metabolic dysfunction-associated steatohepatitis — the serious, fibrosing form of fatty liver disease) as well as obesity. The U.S. FDA granted survodutide Breakthrough Therapy designation for non-cirrhotic MASH with moderate-to-advanced fibrosis in September 2024. Its liver programme runs under the LIVERAGE Phase 3 studies.

The trial evidence

Trial Indication Result SYNCHRONIZE-1 (Phase 3, 76 wks, n=725; NEJM 2026) Obesity, no diabetes Both primary endpoints met. Mean body-weight change −12.2% (3.6 mg) and −13.0% (6.0 mg) vs −5.4% placebo (treatment-regimen estimand) SYNCHRONIZE-2 (Phase 3, 76 wks, n=752; NEJM 2026, online ahead of print) Obesity with type 2 diabetes Mean body-weight change −8.2% (3.6 mg) and −9.8% (6.0 mg) vs −3.9% placebo (treatment-regimen estimand); HbA1c −0.9 and −0.8 vs −0.2 percentage points SYNCHRONIZE-MASLD (Phase 3, 48 wks, n=216; Nat Med 2026) Obesity with at-risk MASLD ≥30% liver-fat reduction (MRI-PDFF) in 68.5% vs 28.6% on placebo (treatment-regimen estimand; 84.2% vs 24.3% on the efficacy estimand); body weight −8.7% vs −1.4% (treatment-regimen) Phase 2 obesity (46 wks, n=387; Lancet Diabetes Endocrinol 2024) BMI ≥27, no diabetes Mean body-weight change −6.2% to −14.9% across doses vs −2.8% placebo (planned-treatment analysis) Phase 2 MASH (48 wks, n=293; NEJM 2024) Biopsy-confirmed MASH, fibrosis F1–F3 MASH improvement without worsening of fibrosis in 43–62% vs 14% placebo (primary endpoint); ≥1-stage fibrosis improvement in 34–36% vs 22%

The SYNCHRONIZE-1 results were published in the New England Journal of Medicine (le Roux et al., 2026; PMID 42253238). Its primary analysis uses the treatment-regimen estimand , which incorporates early discontinuation of survodutide or placebo, use of protocol-prohibited obesity medications and a prolonged dose-escalation period. Figures from the sponsor’s topline announcement on an efficacy estimand are a different analysis and are not the paper’s primary result. SYNCHRONIZE-MASLD reports both estimands, shown above. The SYNCHRONIZE-CVOT cardiovascular outcomes trial has published its design and baseline characteristics ( JACC: Heart Failure ) but no outcome results, and no peer-reviewed LIVERAGE Phase 3 results are indexed in PubMed, as of this update.

How survodutide compares

Compound Receptor profile Standout indication Status Survodutide GLP-1 + glucagon Obesity + MASH Phase 3, no approval Retatrutide GLP-1 + GIP + glucagon Obesity (incl. MASH arm) Phase 3, no approval Tirzepatide GLP-1 + GIP Obesity / type-2 diabetes Approved Semaglutide GLP-1 Obesity / cardiovascular Approved

Survodutide and research compounds

Survodutide is a proprietary Boehringer Ingelheim / Zealand molecule and is not catalogued by research-compound suppliers. New-U does not sell survodutide. The closest established research reference that also carries a glucagon arm is the triple agonist:

Retatrutide — the GLP-1 / GIP / glucagon triple-agonist reference peptide.

Semaglutide and tirzepatide for the GLP-1 and GLP-1/GIP baselines.

Each ships as a sealed, lyophilised reference peptide verified to >99% HPLC purity, with the per-batch Certificate of Analysis published online — research use only .

Frequently Asked Questions

What is survodutide? A GLP-1 + glucagon dual agonist (BI 456906) from Boehringer Ingelheim and Zealand Pharma, dosed once weekly, developed for obesity and MASH.

Is survodutide approved? No. As of mid-2026 it has no marketing authorisation; it is in Phase 3. Its MASH Breakthrough Therapy status speeds review but is not approval.

How is it different from semaglutide? It adds glucagon-receptor agonism, which raises energy expenditure and mobilises liver fat — a weight-and-liver drug.

What did the trials show? In SYNCHRONIZE-1 (Phase 3, adults with obesity without diabetes; NEJM 2026), mean body-weight change at week 76 was −12.2% and −13.0% on the two survodutide doses vs −5.4% on placebo (treatment-regimen estimand). In SYNCHRONIZE-MASLD ( Nature Medicine 2026), 68.5% vs 28.6% had a ≥30% liver-fat reduction at week 48 (treatment-regimen estimand). In the Phase 2 MASH trial, MASH improved without worsening of fibrosis in 43–62% vs 14% on placebo.

Can I buy survodutide for research? No — it is proprietary. New-U catalogues the glucagon-arm reference retatrutide instead. Research use only.

Primary sources & further reading

New England Journal of Medicine — Survodutide Once Weekly for the Treatment of Adults with Obesity (le Roux et al., 2026; SYNCHRONIZE-1; PMID 42253238)

New England Journal of Medicine — Survodutide Once Weekly in Adults with Obesity and Type 2 Diabetes (Wharton et al., 2026; SYNCHRONIZE-2; PMID 42820639)

Nature Medicine — Survodutide in adults with obesity and MASLD: SYNCHRONIZE-MASLD (Kaplan et al., 2026; PMID 42252333; author correction PMID 42642663)

The Lancet Diabetes & Endocrinology — Survodutide for obesity: dose-finding Phase 2 trial (le Roux et al., 2024; PMID 38330987)

New England Journal of Medicine — A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis (Sanyal et al., 2024; PMID 38847460)

JACC: Heart Failure — Rationale and design of the SYNCHRONIZE cardiovascular outcomes trial (Kosiborod et al., 2024; PMID 39453356)

Boehringer Ingelheim — SYNCHRONIZE-1 Phase 3 topline announcement (sponsor)

Boehringer Ingelheim — Survodutide MASH Breakthrough Therapy & Phase 3

U.S. National Library of Medicine — PubMed: survodutide / BI 456906

ClinicalTrials.gov — SYNCHRONIZE & LIVERAGE programmes

U.S. FDA — FDA (no survodutide approval as of publication)

External links are provided for research reference only; New-U is not affiliated with the cited organisations and links carry no endorsement either way.

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Lab-Verified Glucagon-Arm Research Reference

New-U Research Compounds catalogues retatrutide — the triple agonist whose glucagon arm parallels survodutide’s — plus semaglutide and tirzepatide, as sealed 10-vial packs of lyophilised reference peptide, independently verified by Janoshik and Freedom Diagnostics for >99% HPLC purity, with the per-batch Certificate of Analysis published online. Research use only - all claims made on this site are for testing and research use only.

Research-grade · >99% HPLC purity · COA per lot

Buy research peptides from New-U Research Compounds

Lab-verified by Janoshik Analytical (RP-HPLC + ESI-MS), sealed vials, discreet tracked worldwide shipping. Research use only - all claims made on this site are for testing and research use only.

PRECISION. PURITY. PERFORMANCE.

Research peptides. Third-party Certificates of Analysis (Janoshik Analytical & Freedom Diagnostics) are published on the website. Supplied strictly for laboratory research use.

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