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, 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

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy; Metabolic Dysfunction-associated Steatohepatitis
• Intervention / Treatment: Drug: BI 3804379; Drug: Placebo matching BI 3804379

• Study Type: Interventional
• Enrollment (Estimated): 124
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Boehringer Ingelheim; Phone Number: 1-800-243-0127; Email: clintriage.rdg@boehringer-ingelheim.com

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • Recruiting
    • SGS Life Science Services - Clinical Research
    • Contact: Boehringer Ingelheim; Phone Number: 080049616; Email: belgique@bitrialsupport.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A (SRD): BI 3804379; SRD= Single rising dose	Drug: BI 3804379; BI 3804379
Placebo Comparator: Part A (SRD): Placebo matching BI 3804379	Drug: Placebo matching BI 3804379; Placebo matching BI 3804379
Experimental: Part B (MRD): BI 3804379; MRD=Multiple rising dose.	Drug: BI 3804379; BI 3804379
Placebo Comparator: Part B (MRD): Placebo matching BI 3804379	Drug: Placebo matching BI 3804379; Placebo matching BI 3804379
Experimental: Part C (MASH MRD): BI 3804379	Drug: BI 3804379; BI 3804379
Placebo Comparator: Part C (MASH MRD): Placebo matching BI 3804379	Drug: Placebo matching BI 3804379; Placebo matching BI 3804379

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2024
• Primary Completion (Estimated): February 2, 2028
• Study Completion (Estimated): March 20, 2028

Study Registration Dates

• First Submitted: August 27, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): July 7, 2026
• Last Update Submitted That Met QC Criteria: July 6, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 1524-0001; U1111-1306-8874 (Registry Identifier: WHO International Clinical Trials Registry Platform (ICTRP)); 2024-513549-36 (Registry Identifier: CTIS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No