Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06575400

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

SGS Life Science Services - Clinical Research

Edegem, 2650, Belgium

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for Part A and Part B:

  • 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)
  • 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:

  • 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:

  • 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.

Further exclusion criteria apply

Exclusion criteria

for Part C:

  • 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.

Further exclusion criteria apply

Treatment and study plan

BI 3804379

Drug

BI 3804379

Placebo matching BI 3804379

Drug

Placebo matching BI 3804379

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Boehringer Ingelheim

CONTACT

[email protected]

1-800-243-0127

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

A Phase 1, Randomised, Single-blind, Placebo-controlled Trial to Assess Safety, Tolerability, and Pharmacokinetics of Single and Multiple Rising Subcutaneous Doses of BI 3804379 in Healthy Male and Female Participants and in Stable Patients With Advanced Fibrosis Due to MASH

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Aug 28, 2024
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.