Fatty Liver DiseasePhase 1NCT04844450
A Single and Multiple Ascending Dose Study of Subcutaneously Administered JNJ-75220795
A Phase 1 study testing JNJ-75220795 in people with Fatty Liver Disease, run by Janssen Research & Development, LLC at 2 sites in United States.
Trial summary
The purpose of the study is to assess the safety and tolerability of single and multiple subcutaneous (SC) doses of JNJ-75220795. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fatty Liver Disease
- 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
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Apr 2021to 31 Mar 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 stable dose(s) for at least 4 weeks prior to screening
- Weight stable defined as no more than 5% body weight loss or gain within 3 months prior to screening and no more than 5% body weight loss or gain from screening to randomization
Who cannot join
- Known allergies, hypersensitivity, or intolerance to JNJ-75220795 or its 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
- History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at screening
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Research Centers of America, LLC
Hollywood, Florida, 33024
Endeavor Clinical Trials, LLC
San Antonio, Texas, 78240
About this study
Official title: A Double-Blind, Placebo-Controlled, Randomized, Multipart, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered JNJ-75220795
The purpose of the study is to assess the safety and tolerability of single and multiple subcutaneous (SC) doses of JNJ-75220795.
- Conditions
- Fatty Liver Disease
- Being tested
- JNJ-75220795, Placebo
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
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 subcutaneously.
PlaceboDrug
Matching placebo will be administered subcutaneously.
| Study group | Role | What they receive |
|---|---|---|
| Single Ascending Dose (SAD) | Experimental | 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. Receives: Drug: JNJ-75220795; Drug: Placebo |
| Multiple Ascending Dose (MAD) | Experimental | 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. Receives: Drug: JNJ-75220795; Drug: 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 182
Number of Participants With Change From Baseline in Vital Signs Abnormalities
Number of participants with change from baseline in vital signs abnormalities including temperature, heart rate, respiratory rate, and blood pressure (supine) 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, 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 (3)
Percent Change From Baseline in Liver Fat Content
Percent change from baseline in liver fat content will be reported.
Measured: Baseline, weeks 6, 12, 18 and 24
Plasma Concentration of JNJ-75220795 Over Time
Plasma samples will be analyzed to determine concentrations of JNJ-75220795.
Measured: SAD: Predose, up to Day 3 and MAD: Predose, up to Day 86
Percentage of Participants With Treatment-emergent Anti Drug Antibodies (ADA)
Percentage of participants with treatment-emergent ADA will be assessed using a validated assay for ADA analysis.
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 posted14 Apr 2021
- Study start29 Apr 2021
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- 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
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04844450
- Sponsor's protocol ID
- CR108997
- Other IDs
- 75220795NAS1001
- Status last verified
- Mar 2025
- First submitted
- 13 Apr 2021
- Last updated
- 30 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- 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
Publications
Wang C, Guo P, Liu X, Xu X, Zou L, Meng S, Guo Q, Wen Q, Yang C. Association Between PNPLA3 Inhibition and Gout: A Drug Target Mendelian Randomization Study. Int J Endocrinol. 2025 Aug 20;2025:6664846. doi: 10.1155/ije/6664846. eCollection 2025.
PubMed 40881642
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Placebo-Controlled, Randomized, Multipart, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered JNJ-75220795
- ClinicalTrials.gov ID
- NCT04844450
- Acronym / sponsor ID
- CR108997
- Conditions
- Fatty Liver Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2021 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 14 Apr 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 the study is to assess the safety and tolerability of single and multiple subcutaneous (SC) doses of JNJ-75220795.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Ascending Dose (SAD) | Experimental | Drug: JNJ-75220795, Drug: PlaceboParticipants 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) | Experimental | Drug: JNJ-75220795, Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 stable dose(s) for at least 4 weeks prior to screening
- Weight stable defined as no more than 5% body weight loss or gain within 3 months prior to screening and no more than 5% body weight loss or gain from screening to randomization
Key exclusion criteria (3 listed)
- Known allergies, hypersensitivity, or intolerance to JNJ-75220795 or its 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
- History of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV 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 subcutaneously. | Drug | Multiple Ascending Dose (MAD), Single Ascending Dose (SAD) |
| PlaceboMatching placebo will be administered subcutaneously. | Drug | Multiple Ascending Dose (MAD), Single Ascending Dose (SAD) |
Primary outcome
Number of Participants With Treatment-Emergent Signs and Symptoms/ Adverse Events (AEs)
Time frame: 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
Time frame: 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
Time frame: 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
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.
3 secondary outcomes
Percent Change From Baseline in Liver Fat Content
Time frame: Baseline, weeks 6, 12, 18 and 24
Plasma Concentration of JNJ-75220795 Over Time
Time frame: SAD: Predose, up to Day 3 and MAD: Predose, up to Day 86
Percentage of Participants With Treatment-emergent Anti Drug Antibodies (ADA)
Time frame: Up to Day 168
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2025.
- Derived from this study: PubMed 40881642Wang C, Guo P, Liu X, Xu X, Zou L, Meng S, Guo Q, Wen Q, Yang C. Association Between PNPLA3 Inhibition and Gout: A Drug Target Mendelian Randomization Study. Int J Endocrinol. 2025 Aug 20;2025:6664846. doi: 10.1155/ije/6664846. eCollection 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
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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 Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
2 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 Disease, run by Janssen Research & Development, LLC at 2 sites in United States.
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 3 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: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 182). 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?
On the ClinicalTrials.gov record for NCT04844450, which also lists 1 linked publication.
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 30 Mar 2025.