Fatty LiverPhase 1NCT05039710
A Study of JNJ-75220795 in Japanese Participants
A Phase 1 study testing JNJ-75220795 in people with Fatty Liver, run by Janssen Pharmaceutical K.K. at 4 sites in Japan.
Trial summary
The purpose of this study is to assess the safety and tolerability of single subcutaneous (SC) dose of JNJ-75220795 in Japanese participants. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Fatty Liver
- What is being tested?
- JNJ-75220795
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 4 sitesJapan
- Study dates
- 8 Nov 2021to 17 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants with certain genetic predispositions 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 stable dose(s) for at least 4 weeks prior to screening
- Body mass index between 18 kilograms per meter square (kg/m^2) and 40 kg/m^2 inclusive, and body weight stable defined as no more than 5 percent (%) body weight loss or gain within 3 months prior to screening (based on participant's report) and no more than 5% body weight loss or gain from screening to randomization
Who cannot join
- Known allergies, hypersensitivity, or intolerance to excipients
- History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HbsAg or anti-HCV at screening. And/or history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV or syphilis at screening
- Participants with clinical or biochemical (international normalized ratio [INR] greater than [>] 1.2, or platelet count less than [<] lower limits of normal [LLN]) evidence of hepatic decompensation at screening or baseline
- Estimated glomerular filtration rate (eGFR) by Japanese eGFR formula below 60 milliliters per minute [mL/min] at screening
- Thyroid stimulating hormone (TSH) levels, free triiodothyronine (FT3) and free thyroxine (FT4) outside normal limits of the clinical laboratory's reference range at screening
Trial locations and contacts
4 sites in 1 country.
Japan4 sites
Souseikai Fukuoka Mirai Hospital
Fukuoka, 813-0017
Medical Corporation Heishinkai ToCROM Clinic
Shinjuku-ku, 160-0008
Heishinkai TOCROM Clinic
Suita, 565-0853
Sumida Hospital
Tokyo, 130-0004
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered JNJ-75220795 in Japanese Participants
The purpose of this study is to assess the safety and tolerability of single subcutaneous (SC) dose of JNJ-75220795 in Japanese participants.
- Conditions
- Fatty Liver
- Being tested
- JNJ-75220795, Placebo
- Medical subject headings
- Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-75220795Drug
JNJ-75220795 will be administered as SC injection.
PlaceboOther
Matching placebo will be administered as SC injection.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: JNJ-75220795 or Placebo | Experimental | Participants will receive single subcutaneous (SC) dose of JNJ-75220795 Dose 1 or matching placebo on Day 1 in Cohort 1. Receives: Drug: JNJ-75220795; Other: Placebo |
| Cohort 2: JNJ-75220795 or Placebo | Experimental | Participants will receive single SC dose of JNJ-75220795 Dose 2 or matching placebo on Day 1 in Cohort 2. Receives: Drug: JNJ-75220795; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Treatment-emergent Signs and Symptoms/Adverse Events (AEs)
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.
Measured: Up to Day 168
Number of Participants With Change From Baseline in Vital Signs Abnormalities
Number of participants with change from baseline in vital signs abnormalities including body temperature (axillary), pulse, respiratory rate and blood pressure will be reported.
Measured: Baseline, Up to Day 168
Number of Participants With Change From Baseline in Clinical Laboratory Abnormalities
Number of participants with change from baseline in clinical laboratory abnormalities including hematology, serum chemistry and urinalysis will be reported.
Measured: Baseline, Up to Day 168
Number of Participants With Change From Baseline in Physical Examination Abnormalities
Number of participants with change from baseline in physical examination abnormalities will be reported.
Measured: Baseline, Up to Day 168
Number of Participants With Change From Baseline in Electrocardiogram (ECG) Abnormalities
Number of participants with change from baseline in ECG abnormalities will be reported.
Measured: Baseline, Up to Day 168
Secondary outcomes (9)
Percent Change in Liver Fat Content Measured by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
Percent change in liver fat content as measured by MRI-PDFF will be reported.
Measured: From Baseline to Weeks 6, 12, 18, and 24
Maximum Observed Plasma Concentration (Cmax) of JNJ-75220795
Cmax of JNJ-75220795 will be reported.
Measured: Predose up to 48 hours postdose (up to Day 3)
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-75220795
Tmax of JNJ-75220795 will be reported.
Measured: Predose up to 48 hours postdose (up to Day 3)
Apparent Elimination Half-Life (t1/2) of JNJ-75220795
t1/2 is defined as apparent elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve.
Measured: Predose up to 48 hours postdose (up to Day 3)
Area Under the Plasma Concentration Time Curve of JNJ-75220795 from Time Zero to Infinite time (AUC [0-Infinity])
AUC (0-Infinity) is defined as the area under the plasma concentration versus time curve of JNJ-75220795 from time zero to infinite time.
Measured: Predose up to 48 hours postdose (up to Day 3)
Area Under the Plasma Concentration versus Time Curve of JNJ-75220795 from Time Zero to Time of the Last Measurable Concentration (AUC [0-Last])
AUC (0-Last) is defined as area under the plasma concentration versus time curve of JNJ-75220795 from time zero to time of the last measurable concentration.
Measured: Predose up to 48 hours postdose (up to Day 3)
Total Apparent Clearance (CL/F) of JNJ-75220795
CL/F is defined as total apparent clearance of JNJ-75220795.
Measured: Predose up to 48 hours postdose (up to Day 3)
Apparent Volume of Distribution (Vd/F) of JNJ-75220795
Vd/F is defined as apparent volume of distribution of JNJ-75220795.
Measured: Predose up to 48 hours postdose (up to Day 3)
Number of Participants with Treatment Emergent Anti-drug Antibody (ADA)
Number of participants with treatment emergent ADA will be reported.
Measured: Up to Day 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start8 Nov 2021
- Primary completion17 Feb 2023
- Study completion17 Feb 2023
Why it stopped: Business Judgement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fatty LiverStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutical K.K., Japan Clinical Trial, Study director, Janssen Pharmaceutical K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05039710
- Sponsor's protocol ID
- CR109081
- Other IDs
- 75220795NAS1002
- Status last verified
- Aug 2025
- First submitted
- 1 Sep 2021
- Last updated
- 15 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered JNJ-75220795 in Japanese Participants
- ClinicalTrials.gov ID
- NCT05039710
- Acronym / sponsor ID
- CR109081
- Conditions
- Fatty Liver
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Judgement
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 17 Feb 2023 (actual)
- Study completion
- 17 Feb 2023 (actual)
- First posted
- 9 Sep 2021 (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 purpose of this study is to assess the safety and tolerability of single subcutaneous (SC) dose of JNJ-75220795 in Japanese participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: JNJ-75220795 or Placebo | Experimental | Drug: JNJ-75220795, Other: PlaceboParticipants will receive single subcutaneous (SC) dose of JNJ-75220795 Dose 1 or matching placebo on Day 1 in Cohort 1. |
| Cohort 2: JNJ-75220795 or Placebo | Experimental | Drug: JNJ-75220795, Other: PlaceboParticipants will receive single SC dose of JNJ-75220795 Dose 2 or matching placebo on Day 1 in Cohort 2. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants with certain genetic predispositions 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 stable dose(s) for at least 4 weeks prior to screening
- Body mass index between 18 kilograms per meter square (kg/m^2) and 40 kg/m^2 inclusive, and body weight stable defined as no more than 5 percent (%) body weight loss or gain within 3 months prior to screening (based on participant's report) and no more than 5% body weight loss or gain from screening to randomization
Key exclusion criteria (5 listed)
- Known allergies, hypersensitivity, or intolerance to excipients
- History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HbsAg or anti-HCV at screening. And/or history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV or syphilis at screening
- Participants with clinical or biochemical (international normalized ratio [INR] greater than [>] 1.2, or platelet count less than [<] lower limits of normal [LLN]) evidence of hepatic decompensation at screening or baseline
- Estimated glomerular filtration rate (eGFR) by Japanese eGFR formula below 60 milliliters per minute [mL/min] at screening
- Thyroid stimulating hormone (TSH) levels, free triiodothyronine (FT3) and free thyroxine (FT4) outside normal limits of the clinical laboratory's reference range at screening
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 |
|---|---|---|
| JNJ-75220795JNJ-75220795 will be administered as SC injection. | Drug | Cohort 1: JNJ-75220795 or Placebo, Cohort 2: JNJ-75220795 or Placebo |
| PlaceboMatching placebo will be administered as SC injection. | Other | Cohort 1: JNJ-75220795 or Placebo, Cohort 2: JNJ-75220795 or Placebo |
Primary outcome
Number of Participants with Treatment-emergent Signs and Symptoms/Adverse Events (AEs)
Time frame: Up to Day 168
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
Time frame: Baseline, Up to Day 168
Number of participants with change from baseline in vital signs abnormalities including body temperature (axillary), pulse, respiratory rate and blood pressure will be reported.
Number of Participants With Change From Baseline in Clinical Laboratory Abnormalities
Time frame: Baseline, Up to Day 168
Number of participants with change from baseline in clinical laboratory abnormalities including hematology, serum chemistry and urinalysis will be reported.
Number of Participants With Change From Baseline in Physical Examination Abnormalities
Time frame: 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
Time frame: Baseline, Up to Day 168
Number of participants with change from baseline in ECG abnormalities will be reported.
9 secondary outcomes
Percent Change in Liver Fat Content Measured by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
Time frame: From Baseline to Weeks 6, 12, 18, and 24
Maximum Observed Plasma Concentration (Cmax) of JNJ-75220795
Time frame: Predose up to 48 hours postdose (up to Day 3)
Time to Reach Maximum Observed Plasma Concentration (Tmax) of JNJ-75220795
Time frame: Predose up to 48 hours postdose (up to Day 3)
Apparent Elimination Half-Life (t1/2) of JNJ-75220795
Time frame: Predose up to 48 hours postdose (up to Day 3)
Area Under the Plasma Concentration Time Curve of JNJ-75220795 from Time Zero to Infinite time (AUC [0-Infinity])
Time frame: Predose up to 48 hours postdose (up to Day 3)
Area Under the Plasma Concentration versus Time Curve of JNJ-75220795 from Time Zero to Time of the Last Measurable Concentration (AUC [0-Last])
Time frame: Predose up to 48 hours postdose (up to Day 3)
Total Apparent Clearance (CL/F) of JNJ-75220795
Time frame: Predose up to 48 hours postdose (up to Day 3)
Apparent Volume of Distribution (Vd/F) of JNJ-75220795
Time frame: Predose up to 48 hours postdose (up to Day 3)
Number of Participants with Treatment Emergent Anti-drug Antibody (ADA)
Time frame: Up to Day 168
Results and safety
The study was stopped early (reason given: Business Judgement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: Yes. The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Related trials for Fatty Liver
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
RecruitingPhase 3
A Study Evaluating Efruxifermin in Subjects With Non-Cirrhotic Nonalcoholic Steatohepatitis (NASH)/Metabolic Dysfunction-Associated Steatohepatitis (MASH) and Fibrosis
NASH With Fibrosis, MASH With Fibrosis
RecruitingPhase 1
A Study of INI-822 in Healthy Volunteers and Participants With Metabolic Dysfunction-Associated Steatohepatitis (MASH) or Presumed MASH
Metabolic Dysfunction-Associated Steatohepatitis
Recruiting
Dietary Intervention Study on Liver Health in Young Adults
Liver Health
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
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. This study is not recruiting at the moment.
Janssen Pharmaceutical K.K., Japan Clinical Trial study director
Janssen Pharmaceutical K.K.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-75220795 in people with Fatty Liver, run by Janssen Pharmaceutical K.K. at 4 sites in Japan.
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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 15 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Japan. 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. 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?
The study was stopped early (reason given: Business Judgement). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Treatment-emergent Signs and Symptoms/Adverse Events (AEs) (time frame: Up to Day 168). The study lists 5 primary outcomes in all. 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 15 Aug 2025.