P Palthera
Hormone Analogues

Survodutide

BI 456906

Survodutide (BI 456906) is a once-weekly dual at GLP-1 and glucagon developed by Boehringer Ingelheim. Phase II evidence has been published in adults with obesity and in adults with MASH (metabolic dysfunction-associated steatohepatitis). It is investigational — not FDA-approved at the time of writing.

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Hormone Analogues
Classification
Dual GLP-1 / glucagon receptor agonist · Investigational (Phase III ongoing)
Research stage
Phase II clinical evidence published in obesity and metabolic dysfunction-associated steatohepatitis (MASH); Phase III development underway
Sequence
Lipidated dual-agonist peptide based on glucagon / GLP-1 scaffolds
Molecular weight
Approx. 4400 Da

Snapshot

Key takeaways

A three-bullet snapshot before reading the full dossier.

  1. 01

    Dual GLP-1 + glucagon designed for once-weekly subcutaneous dosing.

  2. 02

    Phase II evidence in two distinct populations: obesity and MASH liver disease.

  3. 03

    Investigational at the time of writing; Phase III trials are ongoing.

Dossier overview

4

research areas

3

references

3

handling notes

01

Mechanism of action

Survodutide activates GLP-1 and glucagon . The GLP-1 component contributes the incretin effects shared with semaglutide / tirzepatide (insulin release, appetite suppression, gastric emptying delay). The glucagon component contributes additional energy-expenditure and hepatic-fat effects in research models.

02

Research applications

  • Obesity clinical research (Phase II + III)
  • MASH / NASH clinical research
  • Dual- incretin pharmacology
  • Glucagon- metabolic research

Evidence at a glance

What's behind this profile

3 citations · 2022–2024

Human
2

Studies in human volunteers or patients (incl. early-phase trials).

Other
1

Studies that did not match the categories above.

Publication years

  1. 22
  2. 23
  3. 24
20222024

Counts are derived from the cited studies below. A study covering both in vivo and in vitro work is counted by its primary model. Sample size is reported in 2 of 3 citations. Findings remain model-specific and are not extrapolated to therapeutic use.

03

Study references

Each profile cites a minimum of two peer-reviewed sources, with model type and reported sample size where the source provides it. Findings are model-specific and must not be extrapolated to therapeutic use.

BI 456906: Discovery and preclinical pharmacology of a novel GCGR/GLP-1R dual agonist with robust anti-obesity efficacy

2022

Zimmermann T et al. · Molecular Metabolism

Model
Preclinical pharmacology characterisation in rodent models
Sample
Not reported in abstract

Reported the discovery and characterisation of BI 456906 (survodutide), showing dual GCGR/GLP-1R agonism with greater body-weight reduction than semaglutide monotherapy in rodent obesity models.

PMID 36356832 DOI 10.1016/j.molmet.2022.101633

Glucagon and GLP-1 receptor dual agonist survodutide for obesity: a randomised, double-blind, placebo-controlled, dose-finding phase 2 trial

2024

le Roux CW et al. · The Lancet Diabetes & Endocrinology

Model
Phase 2 dose-finding double-blind RCT in adults with obesity
Sample
n=386

Survodutide was associated with dose-dependent body-weight reductions up to 14.9% over 46 weeks; gastrointestinal events were the most common adverse events.

PMID 38330987 DOI 10.1016/S2213-8587(23)00356-X

A Phase 2 Randomized Trial of Survodutide in MASH and Fibrosis

2024

Sanyal AJ et al. · New England Journal of Medicine

Model
Phase 2 double-blind RCT in adults with biopsy-confirmed MASH and significant fibrosis
Sample
n=293

Survodutide was associated with higher rates of MASH improvement without worsening fibrosis versus placebo at 48 weeks.

PMID 38847460 DOI 10.1056/NEJMoa2401755

Evidence caveats

  • Survodutide is investigational. Phase III trials are ongoing; no Phase III outcome data are published at the time of writing.
  • All efficacy data are from Phase II trials. Long-term safety, cardiovascular outcomes, and head-to-head comparison with tirzepatide / retatrutide have not been established.

04

Storage and handling

Trial material follows the clinical trial protocol cold-chain. Research-grade material must be stored under controlled laboratory conditions per protocol.

  • Investigational compound — use is restricted to authorised clinical trials and research settings.
  • Trial product cold-chain follows the clinical trial protocol.
  • Maintain full batch and supplier traceability.

Common questions

Survodutide FAQ

Plain-English answers backed by the citations on this profile — what it is, what's been studied, regulatory status, evidence limits.

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