Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04874350
Recruitment Status : Recruiting
First Posted : May 5, 2021
Last Update Posted : June 23, 2022
Sponsor:
Information provided by (Responsible Party):
Lipocine Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Liver Cirrhosis Sarcopenia Drug: LPCN 1148 Drug: Placebo Phase 2

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 60 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized 1:1 to LPCN 1148 or placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 20, 2021
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LPCN 1148
Oral LPCN 1148 capsules, administered as BID.
Drug: LPCN 1148
LPCN 1148 is an oral capsule product containing an ester prodrug of bioidentical testosterone, designed to enable absorption via intestinal lymphatics.

Placebo Comparator: Placebo
Oral matching placebo capsules, administered as BID.
Drug: Placebo
Oral matching placebo capsule




Primary Outcome Measures :
  1. Change from baseline in Skeletal Muscle Index in LPCN 1148 treated subjects compared to placebo [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in Liver Frailty Index in LPCN 1148 treated subjects compared to placebo [ Time Frame: Up to 52 weeks ]
  2. Change in number of waitlist events in LPCN 1148 treated subjects compared to placebo [ Time Frame: Up to 52 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male ≥ 18 years old
  2. Currently listed, on the liver transplant waitlist for cirrhosis secondary to Hepatitis B or C infection, Alcoholic Liver Disease (ALD), or Non-Alcoholic Steatohepatitis (NASH)
  3. Evidence of sarcopenia with appropriate cutoff recommended by clinical guidance

Exclusion Criteria:

  1. Suspected or proven hepatocellular carcinoma (HCC)
  2. History of current or suspected prostate or breast cancer
  3. 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)
  4. History of uncontrolled or recurrent portal hypertensive bleeding, including uncontrolled or recurrent bleeding from varices, gastropathy, colopathy, or hemorrhoidal bleeding.
  5. History or current thrombosis (including portal vein thrombosis), thromboembolism, or treatment for portal vein thrombosis
  6. History of hemochromatosis
  7. 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)
  8. Prior history of complications of ascites including:

    1. Spontaneous bacterial peritonitis
    2. Hepatic hydrothorax
  9. MELD score > 25
  10. Abnormal lab value in serum chemistry, hematology, or urinalysis that the PI considers clinically significant, including but not limited to:

    1. PSA > 4 ng/mL
    2. Polycythemia (Hematocrit >54%) or history of polycythemia
    3. ALT or AST > 5x ULN
    4. ALP > 1.5x ULN
    5. Platelet count < 30,000/mL
    6. EGFR < 60 mL/min/1.73 m2
    7. Total bilirubin > 3.0 mg/dL
    8. Serum albumin < 2.8 g/dL
    9. INR > 2.3 or PT prolongation > 6.0 seconds
  11. 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:

    1. Hematocrit > 48%
    2. I-PSS > 19
    3. Any irregularity found on digital rectal examination of the prostate
  12. Subjects with PSA > 3 ng/mL are excluded only if any of the below criteria are met at baseline:

    1. Subject is African American
    2. Subject has a first-degree relative who has a history of prostate cancer
    3. Hematocrit > 48%
    4. I-PSS > 19
    5. Any irregularity found on digital rectal examination of the prostate
  13. 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
  14. History of bariatric surgery
  15. History of stroke or myocardial infarction within the past 5 years
  16. Known positivity for Human Immunodeficiency Virus (HIV) infection
  17. Acute liver failure as the indication for addition to the liver transplant waitlist
  18. Estimated life expectancy less than 3 months or expected to undergo liver transplant within 3 months
  19. Known heart failure of New York Heart Association class III or IV
  20. Evidence of severe encephalopathy or encephalopathy that is not controlled despite adequate medical therapy
  21. History of prior organ transplant
  22. History of Fontan physiology
  23. History of pulmonary embolus
  24. Porto-pulmonary hypertension
  25. Hepatopulmonary syndrome
  26. Uncontrolled epilepsy or migraine
  27. Active substance abuse or dependency extending to within the previous 6 months
  28. History of significant sensitivity or allergy to testosterone, or product excipients.
  29. 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
  30. Subjects who are currently receiving any androgens (testosterone or other androgens or androgen-containing supplements) and are unwilling to washout prior to screening

    a. Washout: 12 weeks following long-acting intramuscular androgen injections; 4 weeks following topical or buccal androgens; 3 weeks following oral androgens

  31. Uncontrolled hypertension (>160/90 mmHg despite treatment)
  32. Uncontrolled obstructive sleep apnea
  33. 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
  34. Subject who is not willing to use adequate contraception for the duration of the study
  35. 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
  36. Failure to give informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04874350


Contacts
Layout table for location contacts
Contact: Ben Bruno 801.994.7383 bjb@lipocine.com

Locations
Layout table for location information
United States, Arizona
Mayo Clinic Recruiting
Scottsdale, Arizona, United States, 85259
United States, California
University of California, Los Angeles Recruiting
Los Angeles, California, United States, 90095
University of California San Francisco Recruiting
San Francisco, California, United States, 94117
United States, Maryland
University of Maryland Medical Center Recruiting
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
United States, Texas
Methodist Health System Recruiting
Dallas, Texas, United States, 75203
University of Texas Southwestern Recruiting
Dallas, Texas, United States, 75309
Mt.Olympus Medical Research Recruiting
Houston, Texas, United States, 77030
United States, Utah
Intermountain Healthcare Recruiting
Murray, Utah, United States, 84107
University of Utah Recruiting
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
Lipocine Inc.
Layout table for additonal information
Responsible Party: Lipocine Inc.
ClinicalTrials.gov Identifier: NCT04874350    
Other Study ID Numbers: LPCN 1148-21-001
First Posted: May 5, 2021    Key Record Dates
Last Update Posted: June 23, 2022
Last Verified: June 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Cirrhosis
Sarcopenia
Fibrosis
Pathologic Processes
Liver Diseases
Digestive System Diseases
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Atrophy
Pathological Conditions, Anatomical