A Phase 1 interventional study of BI 3804379 and Placebo matching BI 3804379 in Healthy and Metabolic Dysfunction-associated Steatohepatitis, sponsored by Boehringer Ingelheim. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment
The main objectives of this trial are to investigate safety, tolerability and pharmacokinetics (PKs) of BI 3804379 in healthy male and female participants and in stable patients with advanced liver fibrosis due to MASH following administration of single rising doses and administration of multiple rising doses.
Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.
Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria for Part A and Part B:
Inclusion criteria for Part C:
1. Male or female patients with advanced liver fibrosis due to MASH, aged between 18 and 70 years (inclusive) Further inclusion criteria apply
Exclusion criteria for Part A and Part B:
Further exclusion criteria apply
Exclusion criteria for Part C:
Further exclusion criteria apply
SRD= Single rising dose
Drug: BI 3804379
Drug: Placebo matching BI 3804379
MRD=Multiple rising dose.
Drug: BI 3804379
Drug: Placebo matching BI 3804379
Drug: BI 3804379
Drug: Placebo matching BI 3804379
BI 3804379
Placebo matching BI 3804379
Part A, Part B and Part C: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator
Time frame: Up to Day 84 for Part A and up to Day 235 for Part B and Part C.
Part A: AUC0-∞ (area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity)
Time frame: Up to Day 84.
Part A: Cmax (maximum measured concentration of the analyte in serum)
Time frame: Up to Day 84.
Part B and Part C: AUCτ,ss (area under the concentration-time curve of the analyte in serum at steady state over a uniform dosing interval τ)
Time frame: Up to Day 235.
Part B and Part C: Cmax,ss (maximum measured concentration of the analyte in serum at steady state over a uniform dosing interval τ)
Time frame: Up to Day 235.
Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Boehringer Ingelheim