Survodutide

Also known as: BI 456906

Not FDA-approved

Last verified: October 30, 2026

At a glance

FDA approval Not FDA-approved No record in Drugs@FDA
Randomized controlled trials 10 of 93 publications on PubMed
Registered clinical trials 36 11 active
Adverse event reports 3 3 classified as serious
  • Survodutide is not an FDA-approved drug: Drugs@FDA has no record of it.
  • PubMed lists 93 publications mentioning it, including 10 randomized controlled trials and 0 animal-only studies.
  • ClinicalTrials.gov lists 36 registered studies testing it (11 active).
  • FDA's adverse event system (FAERS) holds 3 reports mentioning it; 3 classified as serious. Reports do not prove causation.

Research topics

  • Glucagon-Like Peptide-1 Receptor Agonists 42
  • Obesity 39
  • Diabetes Mellitus, Type 2 32
  • Hypoglycemic Agents 27
  • Receptors, Glucagon 15
  • Glucagon-Like Peptide 1 14
  • Weight Loss 14
  • Fatty Liver 12
  • Semaglutide 12
  • Anti-Obesity Agents 11

Most frequent MeSH subject headings in the latest PubMed records (English, as indexed).

Regulatory status

Drugs@FDA applications

No application found in Drugs@FDA, FDA's database of approved drugs.

Source: Drugs@FDA (openFDA) · verified October 30, 2026 · API query

FDA compounding safety list

Not on FDA's list of bulk drug substances that may present significant safety risks in compounding.

Source: FDA.gov — Category 2 bulk drug substances · verified October 30, 2026

Removal of a substance from a regulatory list does not mean it has been approved. A "research use only" label does not make a product safe or legal for human use.

Scientific publications

  • All publications 93
  • Human (MeSH) 57
  • Animal only 0
  • Clinical trials 12
  • Randomized controlled trials 10
  • Systematic reviews & meta-analyses 9
  • Case reports 0
  • Retracted 0

Counts are PubMed records that mention the peptide in the title or abstract. Categories overlap, and a mention is not the same as testing the peptide as a treatment. Each number opens the exact PubMed search. Effects seen in laboratory or animal studies may not occur in humans. A registered clinical trial does not show that a substance is effective or safe.

Latest publications

Source: PubMed (NCBI) · verified October 30, 2026

Clinical trials

Registered
36
Active
11
With posted results
3

Conditions studied

  • Obesity 22
  • Healthy 13
  • Overweight 5
  • Diabetes Mellitus, Type 2 2
  • Metabolic Dysfunction-associated Steatotic Liver Disease 1
  • Type 2 Diabetes 1
  • Chronic Kidney Disease 1
  • Metabolic Dysfunction Associated Steatohepatitis 1
  • Metabolic Dysfunction Associated Steatohepatitis (MASH) 1
  • Liver Fibrosis 1
  • Renal Impairment 1
  • Non-Alcoholic SteatoHepatitis (NASH) 1
Study Status Phase Start
SYNCHRONIZE®-START- A Study to Test Whether Survodutide Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
NCT07855900 Boehringer Ingelheim
Not yet recruiting Phase 3 November 7, 2026
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
NCT07850063 Boehringer Ingelheim
Not yet recruiting Phase 3 November 2, 2026
SYNCHRONIZE®-HERA: A Study to Test Whether Survodutide Helps Women Who Are Living With Overweight or Obesity and Are Going Through or Have Finished Menopause, to Lose Weight
NCT07850050 Boehringer Ingelheim
Not yet recruiting Phase 3 October 31, 2026
A Study to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body When Given by Injection in Healthy Men and Women With and Without Overweight or Obesity
NCT07768813 Boehringer Ingelheim
Active, not recruiting Phase 1 September 2, 2026
A Study to Test Whether Survodutide Helps People With Type 2 Diabetes Control Their Blood Sugar
NCT07754461 Boehringer Ingelheim
Recruiting Phase 3 August 24, 2026
A Study in People With Overweight or Obesity to Compare How 2 Different Formulations of Survodutide Are Taken up by the Body
NCT07407348 Boehringer Ingelheim
Active, not recruiting Phase 1 March 11, 2026
Albuminuria Reduction Study With Survodutide Treatment in Kidney Disease
NCT07206290 University Medical Center Groningen
Not yet recruiting Phase 2 March 2, 2026
A Study to Test Whether Survodutide Improves How the Body Uses Energy and Breaks Down Fat in People With Obesity
NCT06745284 Boehringer Ingelheim
Active, not recruiting Phase 1 March 26, 2025
LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis
NCT06632457 Boehringer Ingelheim
Recruiting Phase 3 November 12, 2024
A Study in People With Obesity to Test the Effects of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity in the Liver
NCT05202353 Boehringer Ingelheim
Active, not recruiting Phase 1 November 1, 2024
Show 26 more studies
Study Status Phase Start
LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibrosis
NCT06632444 Boehringer Ingelheim
Recruiting Phase 3 October 14, 2024
A Study in Healthy People or Otherwise Healthy With Overweight or Obesity to Compare 2 Formulations of Survodutide Given in Different Ways, Either as a Pre-filled Syringe or a Pen-like Injector
NCT07413913 Boehringer Ingelheim
Completed Phase 1 March 3, 2026
A Study in Healthy People to Compare How 2 Different Formulations of Survodutide Are Taken up by the Body
NCT07221591 Boehringer Ingelheim
Completed Phase 1 November 5, 2025
A Study in Healthy People to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body
NCT07071974 Boehringer Ingelheim
Completed Phase 1 July 28, 2025
A Study in Healthy People to Compare How 3 Different Formulations of Survodutide Are Taken up in the Body
NCT06772532 Boehringer Ingelheim
Completed Phase 1 February 10, 2025
A Study to Test Whether BI 456906 (Survodutide) Influences the Amount of Bupropion, Caffeine and Midazolam in the Blood in People With Overweight or Obesity
NCT06564441 Boehringer Ingelheim
Completed Phase 1 October 1, 2024
A Study in Chinese People With Overweight or Obesity to Test How Different Doses of Survodutide Are Taken up in the Body
NCT06492135 Boehringer Ingelheim
Completed Phase 1 August 12, 2024
A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems
NCT06352411 Boehringer Ingelheim
Completed Phase 1 May 15, 2024
A Study in People With Overweight or Obesity to Test How BI 1820237, BI 456906, or a Combination of Both Affects Brain Activity
NCT06352424 Boehringer Ingelheim
Completed Phase 1 April 30, 2024
A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non-alcoholic Steatohepatitis (NASH) to Reduce Liver Fat and to Lose Weight (SYNCHRONIZE-MASLD)
NCT06309992 Boehringer Ingelheim
Completed Phase 3 April 2, 2024
A Study to Test Whether Multiple Doses of BI 456906 Have an Effect on Cardiac Safety in People With Overweight or Obesity
NCT06200467 Boehringer Ingelheim
Completed Phase 1 March 13, 2024
A Study to Test Whether Survodutide (BI 456906) Helps Chinese People Living With Overweight or Obesity to Lose Weight
NCT06214741 Boehringer Ingelheim
Completed Phase 3 February 6, 2024
A Study to Test Whether Survodutide Helps Japanese People Living With Obesity Disease
NCT06176365 Boehringer Ingelheim
Completed Phase 3 January 16, 2024
A Study in Women With Overweight or Obesity to Test Whether Different Doses of BI 456906 Influence the Amount of a Contraceptive in the Blood
NCT05896384 Boehringer Ingelheim
Completed Phase 1 December 21, 2023
A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight
NCT06066528 Boehringer Ingelheim
Completed Phase 3 November 27, 2023
A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
NCT06066515 Boehringer Ingelheim
Completed Phase 3 November 25, 2023
A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)
NCT06077864 Boehringer Ingelheim
Completed Phase 3 November 20, 2023
A Study in People With Overweight or Obesity to Test How Well Different Doses of BI 1820237 Are Tolerated When Given Alone or in Combination With Either Semaglutide or BI 456906
NCT05751226 Boehringer Ingelheim
Completed Phase 1 April 11, 2023
A Study in Healthy Men to Test How BI 456906 is Processed in the Body
NCT05421338 Boehringer Ingelheim
Completed Phase 1 July 4, 2022
A Study to (1) Compare How BI 456906 is Taken up in the Body of Healthy People and People With Liver Problems and (2) Find Out How People With Overweight and Obesity, With and Without Liver Problems, Tolerate Different Doses of BI 456906
NCT05296733 Boehringer Ingelheim
Completed Phase 1 April 27, 2022
A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)
NCT04771273 Boehringer Ingelheim Results posted
Completed Phase 2 April 27, 2021
A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight
NCT04667377 Boehringer Ingelheim Results posted
Completed Phase 2 March 8, 2021
A Study to Test How Different Doses of BI 456906 Are Tolerated in Japanese Men With a Body Mass Index (BMI) Between 23 and 40 kg/m2
NCT04384081 Boehringer Ingelheim
Completed Phase 1 June 1, 2020
A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.
NCT04153929 Boehringer Ingelheim Results posted
Completed Phase 2 April 30, 2020
A Study to Test Different Doses of BI 456906 in Patients With Obesity
NCT03591718 Boehringer Ingelheim
Completed Phase 1 July 26, 2018
Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 456906 in Healthy Male Volunteers
NCT03175211 Boehringer Ingelheim
Completed Phase 1 June 30, 2017

All 36 studies on ClinicalTrials.gov ↗

Source: ClinicalTrials.gov · verified October 30, 2026

Adverse event reports

Reports
3
Serious
3
With death outcome
0

Most reported reactions

  • Acute kidney injury 2
  • Acute myocardial infarction 1
  • Atrial fibrillation 1
  • Scrotal cellulitis 1
  • Upper gastrointestinal haemorrhage 1
  • Vomiting 1

Adverse event reports do not prove that the substance caused these effects. Side effects not listed here may still occur. Reaction terms are MedDRA terms as reported to FAERS.

Source: FDA FAERS (FAERS data as of July 30, 2026) · verified October 30, 2026 · API query

Change history

No changes since monitoring began on October 30, 2026.