Survodutide History and Updates

95 events · 2017 – present

Synced daily from openFDA and ClinicalTrials.gov. Last sync: .

0
FDA Approvals
0
Label Revisions
95
Trial Milestones
0
Pivotal Publications
Survodutide — history and updatesFDA approvals, label revisions, recalls, trials, and pivotal publicationsFDA approvalsLabel revisionsRecalls + safetyTrialsPublications2017201820192020202120222023202420252026202720282029203020312032Trial: NCT07413913 2026-03-03 → 2026-05-28 (primary completion)Trial: NCT07206290 2026-03-02 → 2027-11-30 (primary completion)Trial: NCT07221591 2025-11-05 → 2026-08-04 (primary completion)Trial: NCT07071974 2025-07-28 → 2025-10-07 (primary completion)Trial: NCT06745284 2025-03-26 → 2027-01-08 (primary completion)Trial: NCT06772532 2025-02-10 → 2025-05-29 (primary completion)Trial: NCT06632457 2024-11-07 → 2029-06-05 (primary completion)Trial: NCT05202353 2024-10-01 → 2026-12-02 (primary completion)Trial: NCT06564441 2024-10-01 → 2025-12-16 (primary completion)Trial: NCT06632444 2024-09-17 → 2031-12-27 (primary completion)Trial: NCT06492135 2024-08-12 → 2025-04-15 (primary completion)Trial: NCT06352411 2024-05-15 → 2025-09-16 (primary completion)Trial: NCT06352424 2024-04-30 → 2025-02-24 (primary completion)Trial: NCT06309992 2024-04-02 → 2025-10-09 (primary completion)Trial: NCT06200467 2024-03-13 → 2025-10-22 (primary completion)Trial: NCT06214741 2024-02-06 → 2025-07-29 (primary completion)Trial: NCT06176365 2024-01-16 → 2025-12-03 (primary completion)Trial: NCT05896384 2023-12-21 → 2025-02-14 (primary completion)Trial: NCT06066528 2023-11-27 → 2025-12-12 (primary completion)Trial: NCT06066515 2023-11-25 → 2025-12-02 (primary completion)Trial: NCT06077864 2023-11-20 → 2026-05-08 (primary completion)Trial: NCT05751226 2023-04-11 → 2024-08-01 (primary completion)Trial: NCT05421338 2022-07-04 → 2022-11-17 (primary completion)Trial: NCT05296733 2022-04-27 → 2023-12-29 (primary completion)Trial: NCT04771273 2021-04-27 → 2023-11-09 (primary completion)Trial: NCT04667377 2021-03-08 → 2022-09-15 (primary completion)Trial: NCT04384081 2020-06-01 → 2020-11-17 (primary completion)Trial: NCT04153929 2020-04-30 → 2021-10-08 (primary completion)Trial: NCT03591718 2018-07-26 → 2020-04-20 (primary completion)Trial: NCT03175211 2017-06-30 → 2018-02-19 (primary completion)Results posted — 2022-11-29 Trial results posted: NCT04153929 A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.Results posted — 2023-11-02 Trial results posted: NCT04667377 A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose WeightResults posted — 2024-12-03 Trial results posted: NCT04771273 A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)today (2026-06-12)FDA approvalLabel revisionRecall or safetyTrial activityPivotal publication

Source: openFDA, ClinicalTrials.gov via AACT, PubMed · Hipa.ai, 2026-06-12Download chart as PNG

This page tracks every FDA action, clinical trial milestone, and major publication for Survodutide since 2017, drawn from openFDA, ClinicalTrials.gov, and PubMed.

All published updates (7)

2026
2025

Upcoming & expected milestones

Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05202353
A Study in People With Obesity to Test the Effects of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity in the Liver
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05202353
A Study in People With Obesity to Test the Effects of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity in the Liver
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06745284
A Study to Test Whether Survodutide Improves How the Body Uses Energy and Breaks Down Fat in People With Obesity
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06632457
LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06632444
LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibros

Past events

2026
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT07413913
A Study in Healthy People or Otherwise Healthy With Overweight or Obesity to Compare 2 Formulations of Survodutide Given in Different Ways,
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06077864
A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06077864
A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07413913
A Study in Healthy People or Otherwise Healthy With Overweight or Obesity to Compare 2 Formulations of Survodutide Given in Different Ways,
2025
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06564441
A Study to Test Whether BI 456906 (Survodutide) Influences the Amount of Bupropion, Caffeine and Midazolam in the Blood in People With Overw
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06066528
A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06066515
A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07221591
A Study in Healthy People to Compare How 2 Different Formulations of Survodutide Are Taken up by the Body
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06200467
A Study to Test Whether Multiple Doses of BI 456906 Have an Effect on Cardiac Safety in People With Overweight or Obesity
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06309992
A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non
Primary completion· ClinicalTrials.gov
Phase 3 primary completion: NCT06214741
A Study to Test Whether Survodutide (BI 456906) Helps Chinese People Living With Overweight or Obesity to Lose Weight
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT07071974
A Study in Healthy People to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06772532
A Study in Healthy People to Compare How 3 Different Formulations of Survodutide Are Taken up in the Body
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06492135
A Study in Chinese People With Overweight or Obesity to Test How Different Doses of Survodutide Are Taken up in the Body
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06745284
A Study to Test Whether Survodutide Improves How the Body Uses Energy and Breaks Down Fat in People With Obesity
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT06352424
A Study in People With Overweight or Obesity to Test How BI 1820237, BI 456906, or a Combination of Both Affects Brain Activity
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05896384
A Study in Women With Overweight or Obesity to Test Whether Different Doses of BI 456906 Influence the Amount of a Contraceptive in the Bloo
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06772532
A Study in Healthy People to Compare How 3 Different Formulations of Survodutide Are Taken up in the Body
2024
Results posted· ClinicalTrials.gov
Trial results posted: NCT04771273
A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06632457
LIVERAGE™ - Cirrhosis: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Cirrhosis
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05202353
A Study in People With Obesity to Test the Effects of BI 456906 Compared With Semaglutide on Glucagon Receptor Activity in the Liver
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06564441
A Study to Test Whether BI 456906 (Survodutide) Influences the Amount of Bupropion, Caffeine and Midazolam in the Blood in People With Overw
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06632444
LIVERAGE™: A Study to Test Whether Survodutide Helps People With a Liver Disease Called NASH/MASH Who Have Moderate or Advanced Liver Fibros
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06492135
A Study in Chinese People With Overweight or Obesity to Test How Different Doses of Survodutide Are Taken up in the Body
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05751226
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
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06352411
A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06352424
A Study in People With Overweight or Obesity to Test How BI 1820237, BI 456906, or a Combination of Both Affects Brain Activity
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06309992
A Study to Test Whether Survodutide Helps People Living With Obesity or Overweight and With a Confirmed or Presumed Liver Disease Called Non
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT06200467
A Study to Test Whether Multiple Doses of BI 456906 Have an Effect on Cardiac Safety in People With Overweight or Obesity
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06214741
A Study to Test Whether Survodutide (BI 456906) Helps Chinese People Living With Overweight or Obesity to Lose Weight
2023
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT05296733
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 Wi
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05896384
A Study in Women With Overweight or Obesity to Test Whether Different Doses of BI 456906 Influence the Amount of a Contraceptive in the Bloo
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06066528
A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who Also Have Diabetes to Lose Weight
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06066515
A Study to Test Whether Survodutide (BI 456906) Helps People Living With Overweight or Obesity Who do Not Have Diabetes to Lose Weight
Trial started· ClinicalTrials.gov
Phase 3 trial started: NCT06077864
A Study to Test the Effect of Survodutide (BI 456906) on Cardiovascular Safety in People With Overweight or Obesity (SYNCHRONIZE™ - CVOT)
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT04771273
A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)
Results posted· ClinicalTrials.gov
Trial results posted: NCT04667377
A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05751226
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
2022
Results posted· ClinicalTrials.gov
Trial results posted: NCT04153929
A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT04667377
A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT05296733
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 Wi
2021
Primary completion· ClinicalTrials.gov
Phase 2 primary completion: NCT04153929
A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT04771273
A Study to Test Safety and Efficacy of Survodutide (BI456906) in Adults With Non-alcoholic Steatohepatitis (NASH) and Fibrosis (F1-F3)
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT04667377
A Study to Test Whether Different Doses of BI 456906 Help People With Overweight or Obesity to Lose Weight
2020
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT04384081
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
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT04384081
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
Trial started· ClinicalTrials.gov
Phase 2 trial started: NCT04153929
A Study to Test Whether Different Doses of BI 456906 Are Effective in Treating Adults With Type 2 Diabetes.
2019
2018
Primary completion· ClinicalTrials.gov
Phase 1 primary completion: NCT03175211
Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 456906 in Healthy Male Volunteers
2017
Trial started· ClinicalTrials.gov
Phase 1 trial started: NCT03175211
Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 456906 in Healthy Male Volunteers

Sources

FDA approvals, label revisions, and recalls come from the public openFDA APIs (Drugs@FDA, Drug Label, Drug Enforcement). Drug-safety communications come from the FDA RSS feed. Trial milestones come from ClinicalTrials.gov via the AACT pg dump. Pivotal-publication events come from PubMed, filtered to high-impact journals linked to a Phase 3 trial in our inventory.