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

NCT06575400 | Recruiting Phase 1

• 3 other identifiers: 1524-00012024-513549-36U1111-1306-8874
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy; Metabolic Dysfunction-associated Steatohepatitis

Outcome Measures

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

  Up to Day 84 for Part A and up to Day 235 for Part B and Part C.

Secondary Outcomes (4)

• Part A: AUC0-∞ (area under the concentration-time curve of the analyte in serum over the time interval from 0 extrapolated to infinity)

  Up to Day 84.

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

  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)

  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)

  Up to Day 235.

Study Arms (6)

Part A (SRD): BI 3804379

EXPERIMENTAL

SRD= Single rising dose

Drug: BI 3804379

Part A (SRD): Placebo matching BI 3804379

PLACEBO COMPARATOR

Drug: Placebo matching BI 3804379

Part B (MRD): BI 3804379

EXPERIMENTAL

MRD=Multiple rising dose.

Drug: BI 3804379

Part B (MRD): Placebo matching BI 3804379

PLACEBO COMPARATOR

Drug: Placebo matching BI 3804379

Part C (MASH MRD): BI 3804379

EXPERIMENTAL

Drug: BI 3804379

Part C (MASH MRD): Placebo matching BI 3804379

PLACEBO COMPARATOR

Drug: Placebo matching BI 3804379

Interventions

BI 3804379 DRUG

BI 3804379

Part A (SRD): BI 3804379; Part B (MRD): BI 3804379; Part C (MASH MRD): BI 3804379

Placebo matching BI 3804379 DRUG

Placebo matching BI 3804379

Part A (SRD): Placebo matching BI 3804379; Part B (MRD): Placebo matching BI 3804379; Part C (MASH MRD): Placebo matching BI 3804379

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age of 18 to 65 years (inclusive)
• Body mass index (BMI) of 18.5 to 30.0 kg/m2 (inclusive)

You may not qualify if:

• Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator.
• 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).
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance.
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders that the investigator considers to be of clinical relevance.
• Type 1 diabetes or uncontrolled type 2 diabetes (e.g., hemoglobin A1C (HbA1c) ≥10%, recent major treatment changes, or severe hypoglycemia).
• Significant weight loss (≥10%) between diagnosis and screening.
• Relevant surgery after diagnosis or planned during the study period.
• Evidence of clinically significant or unstable disease increasing risk to the participant.
• Severe renal impairment (estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m²).
• Uncontrolled hypertension or significant cardiovascular disease (e.g., recent myocardial infarction, stroke, or heart failure New York Heart Association (NYHA) class III/IV).
• Clinically relevant ECG abnormalities, including QT interval corrected for heart rate (QTc) prolongation or risk factors for Torsade de Pointes.
• Participation in another clinical trial or exposure to an investigational drug within 60 days prior to study treatment.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

SGS Life Science Services - Clinical Research

Edegem, 2650, Belgium

RECRUITING

Related Links

• Related Info

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127; clintriage.rdg@boehringer-ingelheim.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 28, 2024
• Study Start: September 12, 2024
• Primary Completion (Estimated): February 2, 2028
• Study Completion (Estimated): March 20, 2028
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)