NASH - Nonalcoholic SteatohepatitisPhase 2NCT04685993
A Study of the Safety and Tolerability of LPCN 1144 in Subjects Who Completed the LPCN 1144-18-002 Trial
A Phase 2 study testing LPCN 1144 in people with NASH - Nonalcoholic Steatohepatitis, run by Lipocine Inc. at 10 sites in United States.
Trial summary
This is an open-label extension to Study LPCN 1144-18-002. The study is aimed at evaluating the safety and tolerability of LPCN 1144 in adult men with NASH. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- NASH - Nonalcoholic Steatohepatitis
- What is being tested?
- LPCN 1144
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 10 sitesUnited States
- Study dates
- 11 Nov 2020to 1 Mar 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who have completed the 38 week study LPCN 1144-18-002 and wish to be treated with LPCN 1144
- Subject must sign the Informed Consent Form to participate in the study
Who cannot join
- Has participated or is participating in any other clinical (investigational) study after completion of LPCN 1144-18-002 study
- Subjects who are currently receiving any androgens or estrogens
- Subjects who are not willing to use adequate contraception for the duration of the study
- Use of drugs historically associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens, anabolic steroids, valproic acid, other known hepatotoxins) for more than 2 weeks in the 2 years prior to enrollment
- Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
R&H Clinical Research
Katy, Texas, 77494
Jubilee Clinical Research, Inc.
Las Vegas, Nevada, 89106
Manassas Clinical Research Center
Manassas, Virginia, 20110
Sensible Healthcare, LLC
Ocoee, Florida, 34761
Advanced Clinical Research - Gut Whisperer
Riverton, Utah, 84065
Clinical Trials Research
Roseville, California, 95661
Sun Research Institute
San Antonio, Texas, 78215
Endeavor Clinical Trials
San Antonio, Texas, 78229
Pioneer Research Soultions
Sugar Land, Texas, 77479
Granger Medical Clinic
West Valley City, Utah, 84120
About this study
Official title: An Open Label Extension Study of the Safety and Tolerability of LPCN 1144 for the Treatment of Subjects With Nonalcoholic Steatohepatitis (NASH) Who Have Completed the LPCN 1144-18-002 Trial
This is an open-label extension to Study LPCN 1144-18-002. The study is aimed at evaluating the safety and tolerability of LPCN 1144 in adult men with NASH.
Read the detailed description
This is a multicenter, open-label extension protocol to provide LPCN 1144, an investigational drug, to subjects with NASH who have completed the LPCN 1144-18-002 protocol. Enrolled subjects will be given LPCN 1144 for up to 36 weeks. Subjects will be seen periodically to evaluate safety clinical laboratory tests, tolerability of LPCN 1144, adverse events, and overall subject health. Subjects will be given the option of having a liver biopsy performed at Week 36.
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Being tested
- LPCN 1144
- 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.
LPCN 1144Drug
Also called testosterone undecanoate
Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose).
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | LPCN 1144 Receives: Drug: LPCN 1144 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of LPCN 1144
Number of subjects presenting with a treatment-emergent adverse events
Measured: Baseline to Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2020
- Study start11 Nov 2020
- Primary completion1 Mar 2022
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for NASH - Nonalcoholic SteatohepatitisStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lipocine Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anthony DelConte, Study director, Lipocine Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04685993
- Sponsor's protocol ID
- LPCN 1144-20-002
- Status last verified
- Mar 2024
- First submitted
- 8 Dec 2020
- Last updated
- 17 Jul 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Extension Study of the Safety and Tolerability of LPCN 1144 for the Treatment of Subjects With Nonalcoholic Steatohepatitis (NASH) Who Have Completed the LPCN 1144-18-002 Trial
- ClinicalTrials.gov ID
- NCT04685993
- Acronym / sponsor ID
- LPCN 1144-20-002
- Conditions
- NASH - Nonalcoholic Steatohepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Lipocine Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 1 Mar 2022 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 28 Dec 2020 (actual)
- Results
- Posted 17 Jul 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label extension to Study LPCN 1144-18-002. The study is aimed at evaluating the safety and tolerability of LPCN 1144 in adult men with NASH.
Detailed description
This is a multicenter, open-label extension protocol to provide LPCN 1144, an investigational drug, to subjects with NASH who have completed the LPCN 1144-18-002 protocol. Enrolled subjects will be given LPCN 1144 for up to 36 weeks. Subjects will be seen periodically to evaluate safety clinical laboratory tests, tolerability of LPCN 1144, adverse events, and overall subject health. Subjects will be given the option of having a liver biopsy performed at Week 36.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: LPCN 1144LPCN 1144 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects who have completed the 38 week study LPCN 1144-18-002 and wish to be treated with LPCN 1144
- Subject must sign the Informed Consent Form to participate in the study
Key exclusion criteria (5 listed)
- Has participated or is participating in any other clinical (investigational) study after completion of LPCN 1144-18-002 study
- Subjects who are currently receiving any androgens or estrogens
- Subjects who are not willing to use adequate contraception for the duration of the study
- Use of drugs historically associated with NAFLD (amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens, anabolic steroids, valproic acid, other known hepatotoxins) for more than 2 weeks in the 2 years prior to enrollment
- Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study
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 |
|---|---|---|
| LPCN 1144Also: testosterone undecanoateOral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose). | Drug | Treatment A |
Primary outcome
Safety and Tolerability of LPCN 1144
Time frame: Baseline to Week 36
Number of subjects presenting with a treatment-emergent adverse events
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Anthony DelConte study director
Lipocine Inc.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LPCN 1144 in people with NASH - Nonalcoholic Steatohepatitis, run by Lipocine Inc. at 10 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 2 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: finished, as of the sponsor's last update on 17 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety and Tolerability of LPCN 1144 (time frame: Baseline to Week 36). 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 17 Jul 2024.