CClinicalTrials.gg
RecruitingNCT06575400Updated Jul 7, 2026

A Study to Test How Well Different Doses of BI 3804379 Are Tolerated by Healthy People and Patients With Metabolic Dysfunction-associated Steatohepatitis (MASH)

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

From the registry’s dates

  • Started Sep 2024; still recruiting 2 years later.
Phase
Phase 1
Study type
Interventional
Enrollment
124
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy
  • Metabolic Dysfunction-associated Steatohepatitis
03

In context

Lead sponsor

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.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion criteria for Part A and Part B:

  1. Healthy male or female (of non-child-bearing potential) participants according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure (BP), pulse rate (PR), respiratory rate (RR), temperature (TEMP)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
  2. Age of 18 to 65 years (inclusive)
  3. Body mass index (BMI) of 18.5 to 30.0 kg/m2 (inclusive)
  4. Signed and dated written informed consent in accordance with ICH Harmonized Guideline for Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial Further inclusion criteria apply

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:

  1. Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
  2. Repeated measurement of systolic BP outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic BP outside the range of 45 to 90 mmHg, or PR outside the range of 45 to 100 beats per minute (bpm).
  3. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
  4. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders that the investigator considers to be of clinical relevance.

Further exclusion criteria apply

Exclusion criteria for Part C:

  1. Type 1 diabetes or uncontrolled type 2 diabetes (e.g., hemoglobin A1C (HbA1c) ≥10%, recent major treatment changes, or severe hypoglycemia).
  2. Significant weight loss (≥10%) between diagnosis and screening.
  3. Relevant surgery after diagnosis or planned during the study period.
  4. Evidence of clinically significant or unstable disease increasing risk to the participant.
  5. Severe renal impairment (estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m²).
  6. Uncontrolled hypertension or significant cardiovascular disease (e.g., recent myocardial infarction, stroke, or heart failure New York Heart Association (NYHA) class III/IV).
  7. Clinically relevant ECG abnormalities, including QT interval corrected for heart rate (QTc) prolongation or risk factors for Torsade de Pointes.
  8. Participation in another clinical trial or exposure to an investigational drug within 60 days prior to study treatment.

Further exclusion criteria apply

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Single (Participant)
Enrollment
124 participants (estimated)

Study arms

  • Experimental
    Part A (SRD): BI 3804379

    SRD= Single rising dose

    Drug: BI 3804379

  • Placebo comparator
    Part A (SRD): Placebo matching BI 3804379

    Drug: Placebo matching BI 3804379

  • Experimental
    Part B (MRD): BI 3804379

    MRD=Multiple rising dose.

    Drug: BI 3804379

  • Placebo comparator
    Part B (MRD): Placebo matching BI 3804379

    Drug: Placebo matching BI 3804379

  • Experimental
    Part C (MASH MRD): BI 3804379

    Drug: BI 3804379

  • Placebo comparator
    Part C (MASH MRD): Placebo matching BI 3804379

    Drug: Placebo matching BI 3804379

Interventions

  • DrugBI 3804379

    BI 3804379

  • DrugPlacebo matching BI 3804379

    Placebo matching BI 3804379

06

What researchers measure

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Part A: Cmax (maximum measured concentration of the analyte in serum)

    Time frame: Up to Day 84.

  3. 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.

  4. 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.

07

Study locations

1 of 1 sites recruiting
  • SGS Life Science Services - Clinical Research
    Edegem, 2650, Belgium
    Recruiting
08

References and documents

Related links

Individual participant data

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

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06575400
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Aug 28, 2024
Start date
Sep 12, 2024
Primary completion
Feb 2, 2028 (estimated)
Completion
Mar 20, 2028 (estimated)
Last update
Jul 7, 2026

Study contacts

Boehringer Ingelheim
Contact
clintriage.rdg@boehringer-ingelheim.com
1-800-243-0127

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions 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.

Start the discussion