Recent Updates
Recently added Catalysts

JNJ-75220795

Phase 1

Fatty Liver Disease | Small molecule | Gastrointestinal |Johnson & Johnson|Last Updated: Mar 30, 2025

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment55

FDA Designations

No designations recorded

Clinical trial landscape

JNJ-75220795 · 1 trial · 1 indication

Phase 1 1
NCT04844450A Single and Multiple Ascending Dose Study of Subcutaneously Administered JNJ-75220795Fatty Liver Disease
COMPLETED55 Analytics
PHASE1COMPLETED
A Single and Multiple Ascending Dose Study of Subcutaneously Administered JNJ-75220795
Fatty Liver DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants With Treatment-Emergent Signs and Symptoms/ Adverse Events (AEs)
Up to Day 182

Number of participants with treatment-emergent signs and symptoms/adverse events (including allergic reactions/hypersensitivity and local injection site reactions) will be reported. An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. Treatment-emergent adverse events (TEAEs) are defined as AEs with onset or worsening on or after date of first dose of study treatment.

Number of Participants With Change From Baseline in Vital Signs Abnormalities
Baseline, up to Day 168

Number of participants with change from baseline in vital signs abnormalities including temperature, heart rate, respiratory rate, and blood pressure (supine) will be reported.

Number of Participants With Change From Baseline in Clinical Laboratory Abnormalities
Baseline, up to Day 168

Number of participants with change from baseline in clinical laboratory abnormalities including hematology, chemistry and urinalysis will be reported.

Number of Participants With Change From Baseline in Physical Examination Abnormalities
Baseline, up to Day 168

Number of participants with change from baseline in physical examination abnormalities will be reported.

Number of Participants With Change From Baseline in Electrocardiogram (ECG) Abnormalities
Baseline, up to Day 168

Number of participants with change from baseline in ECG abnormalities will be reported.

Secondary Endpoints

Percent Change From Baseline in Liver Fat Content
Baseline, weeks 6, 12, 18 and 24
Plasma Concentration of JNJ-75220795 Over Time
SAD: Predose, up to Day 3 and MAD: Predose, up to Day 86
Percentage of Participants With Treatment-emergent Anti Drug Antibodies (ADA)
Up to Day 168
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single Ascending Dose (SAD)EXPERIMENTALParticipants in cohorts 1-5 and cohorts 3a-5a will receive subcutaneous (SC) injection of single dose (Part A) of JNJ-75220795 or matching placebo.
Multiple Ascending Dose (MAD)EXPERIMENTALParticipants 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.

Interventions

NameTypeDescription
JNJ-75220795DRUGJNJ-75220795 will be administered subcutaneously.
PlaceboDRUGMatching placebo will be administered subcutaneously.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Participants with certain genetic predisposition to non-alcoholic fatty liver disease (NAFLD) determined at screening * Presence of liver steatosis at screening * Participants on anti-hypertensive and/or lipid lowering medications and/or glucose lowering medications must be on...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about JNJ-75220795

What is JNJ-75220795 used for in fatty liver disease?

JNJ-75220795 is an investigational small molecule being developed for the treatment of fatty liver disease. It is administered subcutaneously and is currently in Phase 1 clinical development. The drug is being studied in patients with fatty liver disease, a condition characterized by excess fat accumulation in the liver.

How does JNJ-75220795 work?

The specific molecular target of JNJ-75220795 has not been disclosed. It is a small molecule administered subcutaneously, and its mechanism of action in treating fatty liver disease is under investigation in clinical trials. The drug is being evaluated for its safety, tolerability, and pharmacokinetics in patients with fatty liver disease.

Who is developing JNJ-75220795?

JNJ-75220795 is being developed by Johnson & Johnson, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol JNJ. The drug is in Phase 1 clinical development for the treatment of fatty liver disease.

What phase is JNJ-75220795 in?

JNJ-75220795 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is being studied for its safety and tolerability in patients with fatty liver disease.

What clinical trials is JNJ-75220795 in?

JNJ-75220795 has one completed Phase 1 clinical trial registered under NCT04844450, titled "A Single and Multiple Ascending Dose Study of Subcutaneously Administered JNJ-75220795." The trial enrolled 55 participants with fatty liver disease in the United States and was a randomized, double-blind, controlled study.

Is JNJ-75220795 the same as any other drug?

No alternative names for JNJ-75220795 have been reported. The drug is identified solely by its investigational code, JNJ-75220795, in clinical trial registrations and development documentation.