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RECRUITING
NCT06575400
PHASE1

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

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

124

Start Date

2024-09-12

Completion Date

2028-03-20

Last Updated

2026-07-07

Healthy Volunteers

Yes

Interventions

DRUG

BI 3804379

BI 3804379

DRUG

Placebo matching BI 3804379

Placebo matching BI 3804379

Locations (1)

SGS Life Science Services - Clinical Research

Edegem, Belgium