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title: "Survodutide | PepTracker Pro"
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# Survodutide

Medium Evidence 

A dual GLP-1/glucagon receptor agonist with FDA Breakthrough Therapy designation for MASH and Priority Review NDA filed February 2026. Phase 3 SYNCHRONIZE-1 reported 16.6% weight loss at 76 weeks; approval possible Q3 2026.

Aliases BI 456906 

Evidence Medium Evidence 

Last Updated  2026-07-02 

Reading Time  3 min 

## Table of Contents

1.  [What It Is](#what-it-is)
2.  [Regulatory Status](#regulatory-status)
3.  [Proposed Mechanisms](#proposed-mechanisms)
4.  [Evidence Snapshot](#evidence-snapshot)
5.  [Commonly Discussed Benefits](#benefits)
6.  [Safety & Cautions](#safety)
7.  [Comparisons](#comparisons)
8.  [Calculator Tools](#calculator)
9.  [Citations](#citations)

## What It Is

Survodutide (BI 456906) is a dual agonist targeting both GLP-1 and glucagon receptors, developed by Boehringer Ingelheim and Zealand Pharma. The glucagon receptor component increases energy expenditure and promotes hepatic fat oxidation, while GLP-1 reduces appetite — a complementary dual mechanism. In April 2026, Boehringer announced positive Phase 3 SYNCHRONIZE-1 topline results: adults with obesity or overweight (without T2D) achieved 16.6% mean weight loss at 76 weeks versus 3.2% with placebo, and 85.1% reached ≥5% body weight reduction. Statistically significant reductions in waist circumference — a marker of visceral fat and cardiometabolic risk — were also reported. Full SYNCHRONIZE-1 and SYNCHRONIZE-MASLD data were presented at the ADA 2026 Scientific Sessions in New Orleans (June 5–8), providing detailed efficacy breakdowns, cardiometabolic biomarker endpoints, and safety characterization that confirmed the topline 16.6% weight loss result. Results from the Phase 3 SYNCHRONIZE-2 (obesity with T2D) and SYNCHRONIZE-CVOT (cardiovascular outcomes) trials are expected later in 2026. The LIVERAGE Phase 3 program in MASH is also enrolling. Survodutide's liver-targeted glucagon activity distinguishes it from pure GLP-1 agonists and positions it as a leading candidate in the MASH therapeutic space alongside pemvidutide. In the emerging competitive landscape, survodutide's 16.6% weight loss at 76 weeks in SYNCHRONIZE-1 positions it below tirzepatide and retatrutide for weight loss magnitude but its dual mechanism (GLP-1 + glucagon rather than GLP-1 + GIP) offers a differentiated approach — particularly for liver fat reduction in MASH, where glucagon-mediated hepatic fat oxidation is the key therapeutic advantage. The Phase 3 SYNCHRONIZE program includes both obesity (SYNCHRONIZE-1) and MASH-specific (SYNCHRONIZE-NASH) arms, making survodutide one of the only peptides pursuing simultaneous registration for both indications. In Phase 2 MASH data, survodutide demonstrated histological improvement in liver fibrosis and MASH resolution at rates significantly exceeding placebo, with substantial reductions in hepatic fat content. A 2026 Priority Review NDA filing with the FDA positions survodutide for potential approval as the first peptide therapy specifically indicated for MASH. Full SYNCHRONIZE-1 and SYNCHRONIZE-MASLD data are being presented at the ADA 2026 Scientific Sessions (June 5–8, New Orleans), providing detailed efficacy breakdowns, cardiometabolic biomarker endpoints, and safety characterization confirming the 16.6% vs 3.2% placebo topline result. The Phase 3 LIVERAGE trial in MASH with fibrosis stages 2-3 and LIVERAGE-Cirrhosis trial in compensated MASH cirrhosis (stage 4) continue enrolling, with readouts expected later in 2026. These MASH-specific Phase 3 data will be critical for the anticipated NDA filing for MASH indication, building on the February 2026 Priority Review NDA filing for obesity.

Also known as:  BI 456906 

## Regulatory Status

Priority Review NDA — Pre-Approval 

NDA filed under Priority Review in February 2026 for obesity indication; FDA decision expected Q3 2026. FDA Breakthrough Therapy designation granted for MASH (non-cirrhotic, fibrosis stages 2–3). Full Phase 3 SYNCHRONIZE-1 (obesity) and SYNCHRONIZE-MASLD data presented at ADA 2026 Scientific Sessions (June 5–8, 2026, New Orleans), confirming 16.6% weight loss topline result with detailed efficacy, biomarker, and safety characterization.

Effective: February 2026

[View FDA Source](https://www.boehringer-ingelheim.com/us/human-health/metabolic-diseases/results-phase-iii-synchronize-1-obesity-trial)

## Proposed Mechanisms

-   GLP-1 receptor agonism suppresses appetite and reduces caloric intake
-   Glucagon receptor activation increases hepatic energy expenditure and lipid oxidation
-   Dual mechanism promotes weight loss through both reduced intake and increased expenditure
-   Improves hepatic lipid metabolism, reducing liver fat accumulation
-   Enhances insulin sensitivity through combined metabolic pathway modulation

## Evidence Snapshot

Medium Evidence 

Low 

Medium 

High 

Study Type

Model

Outcome

Link

Human (Phase 2)

Adults with obesity, no T2D (n=387)

Up to 18.7% weight loss at 46 weeks with 4.8mg dose

[Source](https://pubmed.ncbi.nlm.nih.gov/38330987/)

Human (Phase 2, NEJM)

Adults with MASH and fibrosis (n=293)

62% MASH improvement at 4.8mg vs 14% placebo; ≥30% liver fat reduction in 67%; fibrosis improvement in 34–36%

[Source](https://www.nejm.org/doi/full/10.1056/NEJMoa2401755)

Human (Phase 3, SYNCHRONIZE-1)

Adults with obesity/overweight without T2D (n=725, 14 countries)

16.6% mean weight loss with meaningful metabolic improvement; topline results April 2026

[Source](https://www.boehringer-ingelheim.com/human-health/metabolic-diseases/glp-1-dual-agonist-survodutide-weightloss-obesity-overweight-improvement)

Human (Phase 3, SYNCHRONIZE-1 topline)

Adults with obesity/overweight without T2D (n=725, 14 countries), 76 weeks

16.6% mean weight loss vs 3.2% placebo; 85.1% achieved ≥5% loss; significant waist circumference reduction

[Source](https://www.boehringer-ingelheim.com/us/human-health/metabolic-diseases/results-phase-iii-synchronize-1-obesity-trial)

Human (Phase 3, SYNCHRONIZE-1 — ADA 2026 full presentation confirmed)

Adults with obesity/overweight without T2D — full data presentation

Full efficacy breakdowns, cardiometabolic biomarker endpoints, and safety characterization to be presented at ADA 2026 (June 5-8); LIVERAGE MASH Phase 3 trials enrolling with readouts expected H2 2026

[Source](https://www.boehringer-ingelheim.com/us/human-health/metabolic-diseases/results-phase-iii-synchronize-1-obesity-trial)

## Commonly Discussed Benefits

[Weight Management](/benefits/weight-management)[Appetite Regulation](/benefits/appetite-regulation)[Metabolism](/benefits/metabolism)[Fat Loss](/benefits/fat-loss)

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## Safety & Cautions

-   NDA filed February 2026 under Priority Review; FDA decision expected Q3 2026 at earliest
-   FDA Breakthrough Therapy designation granted for MASH (non-cirrhotic, fibrosis stages 2–3)
-   Gastrointestinal side effects reported in trials (nausea, vomiting)
-   Long-term cardiovascular safety data not yet available; SYNCHRONIZE-CVOT planned
-   Not yet FDA-approved; available only through clinical trial participation until approval

## Comparisons

See how Survodutide compares to related peptides:

[Survodutide vs Dapiglutide](/compare/survodutide-vs-dapiglutide) [Survodutide vs Efinopegdutide](/compare/survodutide-vs-efinopegdutide) [Survodutide vs Efocipegtrutide](/compare/survodutide-vs-efocipegtrutide) [Survodutide vs Efpeglenatide](/compare/survodutide-vs-efpeglenatide) [Survodutide vs Efruxifermin](/compare/survodutide-vs-efruxifermin) [Survodutide vs Glepaglutide](/compare/survodutide-vs-glepaglutide) [Survodutide vs Maridebart Cafraglutide (MariTide)](/compare/survodutide-vs-maridebart-cafraglutide) [Survodutide vs MariTide](/compare/survodutide-vs-maritide) [Survodutide vs Mazdutide](/compare/survodutide-vs-mazdutide) [Survodutide vs NA-931 (Bioglutide)](/compare/survodutide-vs-na-931) [Survodutide vs Pegozafermin](/compare/survodutide-vs-pegozafermin) [Survodutide vs Retatrutide](/compare/survodutide-vs-retatrutide) [Survodutide vs Semaglutide](/compare/survodutide-vs-semaglutide) [Survodutide vs Tirzepatide](/compare/survodutide-vs-tirzepatide) [Survodutide vs UBT251](/compare/survodutide-vs-ubt251)

## Calculator Tools

Use our research tools to explore dosing and reconstitution data:

[Reconstitution Calculator](/calculators)

## Citations

1.  \[1\]  Survodutide Phase 2 MASH trial — NEJM 2024 [PubMed](https://www.nejm.org/doi/full/10.1056/NEJMoa2401755)
2.  \[2\]  Survodutide Phase 2 obesity trial — Lancet 2024 [PubMed](https://pubmed.ncbi.nlm.nih.gov/38330987/)
3.  \[3\]  SYNCHRONIZE-2 baseline characteristics — Diabetes Obes Metab 2026 [PubMed](https://dom-pubs.onlinelibrary.wiley.com/doi/full/10.1111/dom.70263)
4.  \[4\]  SYNCHRONIZE-1 baseline characteristics — PubMed 2026 [PubMed](https://pubmed.ncbi.nlm.nih.gov/41187967/)
5.  \[5\]  Boehringer Ingelheim — SYNCHRONIZE-1 Phase 3 topline results, April 2026 [PubMed](https://www.boehringer-ingelheim.com/human-health/metabolic-diseases/glp-1-dual-agonist-survodutide-weightloss-obesity-overweight-improvement)
6.  \[6\]  FDA Grants Survodutide Breakthrough Therapy Designation for MASH — Pharmacy Times 2026 [PubMed](https://www.pharmacytimes.com/view/fda-grants-survodutide-breakthrough-therapy-designation-for-treatment-of-adults-with-mash)
7.  \[7\]  Boehringer Ingelheim — Phase III SYNCHRONIZE-1 topline results. April 28, 2026 [PubMed](https://www.globenewswire.com/news-release/2026/04/28/3282218/0/en/boehringer-ingelheim-s-novel-glucagon-glp-1-dual-agonist-survodutide-achieved-significant-weight-loss-of-16-6-delivering-meaningful-metabolic-improvement-in-people-with-obesity-or-.html)

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## Related Peptides

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### Efinopegdutide

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Pegozafermin (development code BIO89-100) is an investigational, long-acting analog of fibroblast growth factor 21 (FGF21) being developed for metabolic dysfunction-associated steatohepatitis (MASH, formerly NASH) and for severe hypertriglyceridemia (SHTG). Originally developed by 89bio and acquired by Roche in a deal announced in September 2025 (about $2.4 billion upfront and up to roughly $3.5 billion including a contingent value right), it uses site-specific glycoPEGylation to extend the very short half-life of native FGF21 to roughly 55-100 hours, enabling once-weekly or once-every-two-weeks subcutaneous dosing. FGF21 is a metabolic hormone that acts on liver, fat, and other tissues to improve insulin sensitivity, lower triglycerides, and exert direct anti-fibrotic and anti-inflammatory effects. In the Phase 2b ENLIVEN trial in biopsy-confirmed F2-F3 MASH, the 44 mg every-two-weeks dose produced at least a one-stage fibrosis improvement without worsening of MASH in about 27% of patients versus 7% on placebo, and MASH resolution without worsening of fibrosis in about 26% versus 2% on placebo, with benefits sustained through week 48. Pegozafermin holds FDA Breakthrough Therapy designation and EMA PRIME status for MASH and has advanced into the Phase 3 ENLIGHTEN program (ENLIGHTEN-Fibrosis in non-cirrhotic F2-F3 MASH and ENLIGHTEN-Cirrhosis in compensated F4 cirrhosis), plus the Phase 3 ENTRUST trial in SHTG.

[metabolic dysfunction-associated steatohepatitis (MASH/NASH) - fibrosis improvement, MASH resolution, and reduced liver fat (investigational)](</benefits/metabolic dysfunction-associated steatohepatitis \(MASH/NASH\) - fibrosis improvement, MASH resolution, and reduced liver fat \(investigational\)>)[severe hypertriglyceridemia (SHTG) - large reductions in blood triglycerides (investigational; Phase 3 ENTRUST)](</benefits/severe hypertriglyceridemia \(SHTG\) - large reductions in blood triglycerides \(investigational; Phase 3 ENTRUST\)>)[improved insulin sensitivity and glycemic markers](</benefits/improved insulin sensitivity and glycemic markers>)[improvements in non-invasive markers of liver injury and fibrosis (liver fat by MRI-PDFF, liver enzymes, fibrosis biomarkers)](</benefits/improvements in non-invasive markers of liver injury and fibrosis \(liver fat by MRI-PDFF, liver enzymes, fibrosis biomarkers\)>)+1 more 

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### Retatrutide

High Evidence 

An investigational triple agonist (GIP/GLP-1/glucagon) studied for obesity and metabolic disease.

[Weight Management](/benefits/weight-management)[Appetite Regulation](/benefits/appetite-regulation)[Metabolism](/benefits/metabolism)[Fat Loss](/benefits/fat-loss)

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### Semaglutide

High Evidence 

A GLP-1 receptor agonist FDA-approved for type 2 diabetes and chronic weight management.

[Weight Management](/benefits/weight-management)[Appetite Regulation](/benefits/appetite-regulation)[Metabolism](/benefits/metabolism)[Fat Loss](/benefits/fat-loss)+3 more 

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### Tirzepatide

High Evidence 

A dual GIP/GLP-1 receptor agonist FDA-approved for type 2 diabetes, weight management, and MASH with liver fibrosis.

[Weight Management](/benefits/weight-management)[Appetite Regulation](/benefits/appetite-regulation)[Metabolism](/benefits/metabolism)[Fat Loss](/benefits/fat-loss)+1 more 

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### UBT251

Medium Evidence 

A GLP-1/GIP/glucagon triple receptor agonist in Phase 2 development for type 2 diabetes and obesity, competing with retatrutide in the triple-agonist space.

[Weight Management](/benefits/weight-management)[Fat Loss](/benefits/fat-loss)[Metabolism](/benefits/metabolism)[Appetite Regulation](/benefits/appetite-regulation)

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