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BI 3006337 for Fatty Liver Disease

Phase 1
Recruiting
Research Sponsored by Boehringer Ingelheim
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female trial participants ≥18 years and ≤75 years of age at time of consent
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 99 days
Awards & highlights

Study Summary

This trial tests the highest safe dose of BI 3006337 for adults with overweight/obesity and fatty liver disease. Participants visit the study center 18 times over 4 months for tests/check-ups.

Who is the study for?
Adults aged 18-75 with overweight or obesity (BMI of 25-40) and fatty liver disease can join this study. They must not drink alcohol excessively, use certain medications that affect the liver, or have other types of liver diseases. Women who can bear children and men with partners who can must agree to effective birth control.Check my eligibility
What is being tested?
The trial is testing different doses of a new medicine called BI 3006337 versus a placebo in people with fatty liver disease and obesity. Participants are randomly assigned to one of four groups for about four months, receiving weekly injections while their health is monitored.See study design
What are the potential side effects?
Potential side effects aren't specified here but will be closely monitored during the visits, especially any health problems possibly caused by BI 3006337.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 75 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 99 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 99 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Occurrence of drug-related adverse events (AEs)
Secondary outcome measures
Area under the concentration-time curve of the analyte in serum over the dosing interval tau at steady state (AUCτ,ss) after the last dose in Week 12
Maximum measured concentration of the analyte in serum at steady state (Cmax,ss) after the last dose in Week 12
Relative percentage change in liver steatosis from baseline after 12 weeks of treatment
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Group I: BI 3006337 dose group 4Experimental Treatment1 Intervention
Group II: BI 3006337 dose group 3 or placeboExperimental Treatment2 Interventions
Group III: BI 3006337 dose group 2 or placeboExperimental Treatment2 Interventions
Group IV: BI 3006337 dose group 1 or placeboExperimental Treatment2 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
BI 3006337
2021
Completed Phase 1
~80

Find a Location

Who is running the clinical trial?

Boehringer IngelheimLead Sponsor
2,507 Previous Clinical Trials
11,340,851 Total Patients Enrolled
7 Trials studying Non-alcoholic Fatty Liver Disease
1,331 Patients Enrolled for Non-alcoholic Fatty Liver Disease

Media Library

BI 3006337 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05970640 — Phase 1
Non-alcoholic Fatty Liver Disease Research Study Groups: BI 3006337 dose group 3 or placebo, BI 3006337 dose group 2 or placebo, BI 3006337 dose group 4, BI 3006337 dose group 1 or placebo
Non-alcoholic Fatty Liver Disease Clinical Trial 2023: BI 3006337 Highlights & Side Effects. Trial Name: NCT05970640 — Phase 1
BI 3006337 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05970640 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this trial restricted to individuals aged 65 or over?

"This study is accepting applicants aged 18 and above, up to 75 years in age."

Answered by AI

Is this research endeavor in need of more participants?

"That is correct. The records on clinicaltrials.gov state that this research program, which launched on August 2nd 2023, is currently searching for subjects to join the trial. 56 participants need to be recruited from two different medical centres."

Answered by AI

What is the total enrollment count for this clinical experiment?

"Affirmative. According to clinicaltrials.gov, this investigation is actively recruiting patients and was first posted on August 2nd 2023; the most recent update being made 14 days later. The trial necessitates 56 participants from two sites for completion."

Answered by AI

What evidence has been found to suggest BI 3006337 dose group 4 is safe for patients?

"Given the limited amount of supporting data, our team rated BI 3006337 dose group 4 a 1 on the safety scale. This is in line with it being a Phase I clinical trial."

Answered by AI

Who is eligible to sign up for this research initiative?

"This study requires 56 participants, aged 18 to 75 years old with non-alcoholic fatty liver disease (NAFLD). Additional criteria need to be met by qualified patients: the capacity for written informed consent in accordance with ICH - GCP and local regulations; female subjects of childbearing potential must utilize two forms of reliable contraception, one being a low failure rate method while men are required to use condoms; body mass index greater than or equal to 25 and less than 40 kg/m^2; MRI-PDFF liver fat fraction higher than 8%."

Answered by AI

Who else is applying?

What site did they apply to?
Centricity Research
Accel Research Sites
Other
Catalina Research Institute, LLC
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Test How Well Different Doses of BI 3006337 Are Tolerated by People With Overweight or Obesity and With Fatty Liver Disease
2023. "A Study to Test How Well Different Doses of BI 3006337 Are Tolerated by People With Overweight or Obesity and With Fatty Liver Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05970640.
All > Nonalcoholic Fatty Liver Disease > Knoxville
~24 spots leftby Dec 2024
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