HealthyPhase 1NCT06575400
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 study testing BI 3804379 in people with Healthy and Metabolic Dysfunction-associated Steatohepatitis, run by Boehringer Ingelheim at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Metabolic Dysfunction-associated Steatohepatitis
- What is being tested?
- BI 3804379
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteBelgium
- Study dates
- 12 Sep 2024to 20 Mar 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- 1. Male or female patients with advanced liver fibrosis due to MASH, aged between 18 and 70 years (inclusive) Further inclusion criteria apply
Who cannot join
- 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
- Type 1 diabetes or uncontrolled type 2 diabetes (e.g., hemoglobin A1C (HbA1c) ≥10%, recent major treatment changes, or severe hypoglycemia).
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
SGS Life Science Services - Clinical Research
Edegem, 2650
About this study
Official 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
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.
- Being tested
- BI 3804379, Placebo matching BI 3804379
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI 3804379Drug
BI 3804379
Placebo matching BI 3804379Drug
Placebo matching BI 3804379
| Study group | Role | What they receive |
|---|---|---|
| Part A (SRD): BI 3804379 | Experimental | SRD= Single rising dose Receives: Drug: BI 3804379 |
| Part A (SRD): Placebo matching BI 3804379 | Placebo comparator | Not described Receives: Drug: Placebo matching BI 3804379 |
| Part B (MRD): BI 3804379 | Experimental | MRD=Multiple rising dose. Receives: Drug: BI 3804379 |
| Part B (MRD): Placebo matching BI 3804379 | Placebo comparator | Not described Receives: Drug: Placebo matching BI 3804379 |
| Part C (MASH MRD): BI 3804379 | Experimental | Not described Receives: Drug: BI 3804379 |
| Part C (MASH MRD): Placebo matching BI 3804379 | Placebo comparator | Not described Receives: Drug: Placebo matching BI 3804379 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A, Part B and Part C: Occurrence of any treatment-emergent adverse event (AE) assessed as drug-related by the investigator
Measured: 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)
Measured: Up to Day 84.
Part A: Cmax (maximum measured concentration of the analyte in serum)
Measured: 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)
Measured: 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)
Measured: Up to Day 235.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start12 Sep 2024
- Primary completion2 Feb 2028 (estimated)
- Study completion20 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06575400
- Sponsor's protocol ID
- 1524-0001
- Other IDs
- 2024-513549-36, U1111-1306-8874
- Status last verified
- Jul 2026
- First submitted
- 27 Aug 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06575400
- Acronym / sponsor ID
- 1524-0001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- 2 Feb 2028 (estimated)
- Study completion
- 20 Mar 2028 (estimated)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Part A (SRD): BI 3804379 | Experimental | Drug: BI 3804379SRD= Single rising dose |
| Part A (SRD): Placebo matching BI 3804379 | Placebo comparator | Drug: Placebo matching BI 3804379 |
| Part B (MRD): BI 3804379 | Experimental | Drug: BI 3804379MRD=Multiple rising dose. |
| 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- 1. Male or female patients with advanced liver fibrosis due to MASH, aged between 18 and 70 years (inclusive) Further inclusion criteria apply
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BI 3804379BI 3804379 | Drug | Part A (SRD): BI 3804379, Part B (MRD): BI 3804379, Part C (MASH MRD): BI 3804379 |
| Placebo matching BI 3804379Placebo matching BI 3804379 | Drug | Part A (SRD): Placebo matching BI 3804379, Part B (MRD): Placebo matching BI 3804379, Part C (MASH MRD): Placebo matching BI 3804379 |
Primary outcome
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.
4 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BI 3804379 in people with Healthy and Metabolic Dysfunction-associated Steatohepatitis, run by Boehringer Ingelheim at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.