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Liver CirrhosisPhase 2NCT04874350

A Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia

A Phase 2 study testing LPCN 1148 in people with Liver Cirrhosis and Sarcopenia, run by Lipocine Inc. at 10 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of LPCN 1148 in men with cirrhosis of the liver and sarcopenia. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Liver Cirrhosis, Sarcopenia
What is being tested?
LPCN 1148
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
10 sitesUnited States
Study dates
30 Nov 2021to 18 Dec 2023
Phase
Phase 2
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 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male ≥ 18 years old
  • Currently listed, on the liver transplant waitlist for cirrhosis secondary to Hepatitis B or C infection, Alcoholic Liver Disease (ALD), Non-Alcoholic Steatohepatitis (NASH), Primary Biliary Cholangitis (PBC), or Primary Sclerosing Cholangitis (PSC)
  • Evidence of sarcopenia with appropriate cutoff recommended by clinical guidance

Who cannot join

  • Suspected or proven hepatocellular carcinoma (HCC)
  • History of current or suspected prostate or breast cancer
  • History of malignancies other than prostate, breast, or HCC, unless successfully treated with curative intent and believed to be cured (defined as complete remission lasting at least 5 years)
  • History of uncontrolled or recurrent portal hypertensive bleeding, including uncontrolled or recurrent bleeding from varices, gastropathy, colopathy, or hemorrhoidal bleeding in the past 6 months.
  • History or current thrombosis (including portal vein thrombosis), thromboembolism, or treatment for portal vein thrombosis
  • History of hemochromatosis
Show all 56Show fewer
  • History of hypercoagulable state (e.g. Factor V Leiden deficiency, protein C deficiency, protein S deficiency, anti-thrombin III deficiency, or the presence of lupus anticoagulant)
  • Prior history of complications of ascites in the past 6 months including:
  • Spontaneous bacterial peritonitis
  • Hepatic hydrothorax
  • MELD score > 25
  • Abnormal lab value in serum chemistry, hematology, or urinalysis that the PI considers clinically significant, including but not limited to:
  • PSA > 4 ng/mL
  • Polycythemia (Hematocrit > ULN) or history of polycythemia
  • ALT or AST > 5x ULN
  • ALP > 2x ULN; subjects with PBC or PSC are excluded if ALP is > 10x ULN
  • Platelet count < 30,000/mL
  • EGFR < 30 mL/min/1.73 m2 for subjects not undergoing routine, scheduled dialysis
  • Serum albumin < 2.0 g/dL
  • INR > 2.3
  • Subjects with PSA between 2.5 ng/mL and 4 ng/mL are excluded only if any of the below criteria are met at baseline:
  • Hematocrit > 48%
  • I-PSS > 19
  • Any irregularity found on digital rectal examination of the prostate
  • Subjects with PSA > 3 ng/mL are excluded only if any of the below criteria are met at baseline:
  • Subject is African American
  • Subject has a first-degree relative who has a history of prostate cancer
  • Hematocrit > 48%
  • I-PSS > 19
  • Any irregularity found on digital rectal examination of the prostate
  • Clinically significant abnormal prostate digital rectal examination (DRE) in the opinion of the PI, with DRE screening initiated at International Prostate Symptom Score (I-PSS) > 19
  • History of bariatric surgery
  • History of stroke or myocardial infarction within the past 5 years
  • History of TIPS within the past 6 months, or TIPS procedure expected within 6 months of Day 1
  • Known positivity for Human Immunodeficiency Virus (HIV) infection
  • Acute liver failure as the indication for addition to the liver transplant waitlist
  • Estimated life expectancy less than 3 months or expected to undergo liver transplant within 3 months
  • Known heart failure of New York Heart Association class III or IV
  • Evidence of severe encephalopathy at screening encephalopathy that is not controlled despite adequate medical therapy
  • History of prior organ transplant
  • History of Fontan physiology
  • History of pulmonary embolus
  • Porto-pulmonary hypertension
  • Hepatopulmonary syndrome requiring standing home supplemental oxygen therapy, or MELD exception points for hepatopulmonary syndrome
  • Uncontrolled epilepsy or migraine
  • Active substance abuse or dependency extending to within the previous 3 months
  • History of significant sensitivity or allergy to testosterone, or product excipients.
  • Use of known strong inhibitors (e.g., ketoconazole) or inducers (e.g., dexamethasone, phenytoin, rifampin, carbamazepine) of cytochrome P450 3A (CYP3A) within 30 days prior to study drug administration and through the end of the study
  • Subjects who are currently receiving any androgens (testosterone or other androgens or androgen-containing supplements) and are unwilling to washout prior to screening
  • Washout: 12 weeks following long-acting intramuscular androgen injections; 4 weeks following topical or buccal androgens; 3 weeks following oral androgens
  • Uncontrolled hypertension (>160/90 mmHg despite treatment)
  • Uncontrolled obstructive sleep apnea
  • Use of any investigational drug within 5 half-lives of the last dose or in the past 6 months prior to Study Day -2 without medical monitor and/or Sponsor approval
  • Subject who is not willing to use adequate contraception for the duration of the study
  • Any other condition, which in the opinion of the investigator would impede compliance to the study protocol (including diet, exercise, and alcohol abstinence) or hinder completion of the study
  • Failure to give informed consent

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

United States10 sites

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Methodist Health System

    Dallas, Texas, 75203

  • University of Texas Southwestern

    Dallas, Texas, 75309

  • Mt.Olympus Medical Research

    Houston, Texas, 77030

  • University of California, Los Angeles

    Los Angeles, California, 90095

  • Intermountain Healthcare

    Murray, Utah, 84107

  • University of Utah

    Salt Lake City, Utah, 84132

  • University of California San Francisco

    San Francisco, California, 94117

  • Mayo Clinic

    Scottsdale, Arizona, 85259

Other trials in United States

About this study

Official title: A Phase 2, Randomized Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of Oral LPCN 1148 in Male Subjects With Cirrhosis of the Liver and Sarcopenia

This is a randomized, double-blind, placebo-controlled study to assess the efficacy, safety, and tolerability of LPCN 1148 in men with cirrhosis of the liver and sarcopenia.

Read the detailed description

This is a 52-week, multicenter, double-blind, placebo-controlled, two arm study of LPCN 1148 in adult men with cirrhosis of the liver and sarcopenia on the liver transplant waitlist. This study will evaluate the efficacy, safety, and tolerability of LPCN 1148, determined through a range of clinical outcomes and functional and laboratory tests.

Approximately 48 subjects will be randomized 1:1 ratio to receive one of the following treatments:

  • Treatment A: Oral LPCN 1148
  • Treatment B: Oral matching placebo.

Subjects will undergo a screening period to determine study eligibility. Adult male subjects with liver cirrhosis and sarcopenia on the transplant list will be enrolled into the study.

There are two treatment phases to this study.

  • Stage 1: 24 weeks of blinded study treatment (LPCN 1148 or matching placebo)
  • Stage 2: 28-week open-label extension. Subjects who participate in Stage 1 of this trial will roll over to a 28-week open-label extension phase. All subjects will receive LPCN 1148; there will be no placebo in the extension period.
Being tested
LPCN 1148, Placebo
Medical subject headings
Liver Cirrhosis, Sarcopenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LPCN 1148Drug

    LPCN 1148 is an oral capsule product containing an ester prodrug of bioidentical testosterone, designed to enable absorption via intestinal lymphatics.

  • PlaceboDrug

    Oral matching placebo capsule

Study groups in NCT04874350
Study groupRoleWhat they receive
LPCN 1148ExperimentalOral LPCN 1148 capsules, administered as BID.
Receives: Drug: LPCN 1148
PlaceboPlacebo comparatorOral matching placebo capsules, administered as BID.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in Skeletal Muscle Index in LPCN 1148 treated subjects compared to placebo

    Measured: 24 weeks

Secondary outcomes (2)

  1. Change from baseline in Liver Frailty Index in LPCN 1148 treated subjects compared to placebo

    Measured: 24 weeks

  2. Change in number of breakthrough hepatic encephalopathy events in LPCN 1148 treated subjects compared to placebo

    Breakthrough hepatic encephalopathy was defined as events of hepatic encephalopathy with a Common Terminology Criteria for Adverse Events grade greater than grade 1

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2021
  2. Study start30 Nov 2021
  3. Primary completion18 Dec 2023
  4. Study completion18 Dec 2023

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Randomized 1:1 to LPCN 1148 or placebo
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04874350
Sponsor's protocol ID
LPCN 1148-21-001
Status last verified
Mar 2024
First submitted
3 May 2021
Last updated
15 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Bruno BJ, Weavil JC, Ogle J, Chidambaram N, Carey EJ, Danford CJ, Fricker ZP, Galati JS, Lee WM, Mantry PS, Shetty K, DelConte A, Patel MV, Lai JC, Sanyal AJ. Oral LPCN 1148 improves sarcopenia and hepatic encephalopathy in male patients with cirrhosis: A randomized, placebo-controlled phase 2 trial. Hepatology. 2025 Jun 1;81(6):1764-1775. doi: 10.1097/HEP.0000000000001146. Epub 2025 Jan 31.

    PubMed 39513970

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LPCN 1148 in people with Liver Cirrhosis and Sarcopenia, 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 3 inclusion and 56 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 15 Mar 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. Some participants in this study may receive a placebo. 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?

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?

Change from baseline in Skeletal Muscle Index in LPCN 1148 treated subjects compared to placebo (time frame: 24 weeks). 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 NCT04874350, 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 15 Mar 2024.

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