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JNJ-75220795 for Non-alcoholic Fatty Liver Disease

Phase 1
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, weeks 6, 12, 18 and 24
Awards & highlights

Study Summary

This trial tests the safety and side effects of a new drug, JNJ-75220795.

Eligible Conditions
  • Non-alcoholic Fatty Liver Disease (NAFLD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, weeks 6, 12, 18 and 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, weeks 6, 12, 18 and 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Change From Baseline in Clinical Laboratory Abnormalities
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Abnormalities
Number of Participants With Change From Baseline in Physical Examination Abnormalities
+2 more
Secondary outcome measures
Percent Change From Baseline in Liver Fat Content
Anti-Antibodies
Plasma Concentration of JNJ-75220795 Over Time

Trial Design

2Treatment groups
Experimental Treatment
Group I: Single Ascending Dose (SAD)Experimental Treatment2 Interventions
Participants in cohorts 1-5 and cohorts 3a-5a will receive subcutaneous (SC) injection of single dose (Part A) of JNJ-75220795 or matching placebo.
Group II: Multiple Ascending Dose (MAD)Experimental Treatment2 Interventions
Participants in cohorts 6-8 will receive SC injection of 2 doses (Part B) of JNJ-75220795 or matching placebo. Participants in cohorts 9-11 will receive SC injection of 4 doses (Part C) of JNJ-75220795 or matching placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
JNJ-75220795
2021
Completed Phase 1
~60
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,253 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,850 Total Patients Enrolled

Frequently Asked Questions

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

What is the aggregate tally of participants in this experiment?

"To bring this clinical trial to fruition, 112 participants who satisfy the eligibility criteria must be recruited. The sponsor of said research project is Janssen Research & Development LLC, and it will take place in multiple locations such as Research Centers of America, LLC (Hollywood, Florida) and Altasciences Inc. (Cypress, California)."

Answered by AI

Are any new participants being welcomed into the research?

"Verifiable information on clinicaltrials.gov outlines that this medical trial is actively enrolling patients, commencing from April 29th 2021 and having since been updated as of November 8th 2022."

Answered by AI

Are applicants younger than 55 years of age being accepted for inclusion in this research?

"To participate in this clinical trial, individuals must be of legal age and younger than 65 years old."

Answered by AI

To what degree is participation in this trial restricted?

"To qualify for this research project, individuals must have fatty liver and be within the specified age range of 18-65. The total sample size is 112 participants."

Answered by AI

Could you elaborate on the potential hazards of taking JNJ-75220795?

"We rate the safety of JNJ-75220795 at 1 given its current status as a Phase 1 trial, indicating there is limited evidence to show efficacy and security."

Answered by AI

Who else is applying?

What state do they live in?
Texas
Florida
How old are they?
18 - 65
What site did they apply to?
Research Centers of America, LLC
Endeavor Clinical Trials, LLC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I’ll like to address my fatty liver.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Single and Multiple Ascending Dose Study of Subcutaneously Administered JNJ-75220795
2021. "A Single and Multiple Ascending Dose Study of Subcutaneously Administered JNJ-75220795". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04844450.
~14 spots leftby Apr 2025
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