Summary

Eligibility
for males ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

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.

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

Details

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.

Keywords

Liver Cirrhosis Sarcopenia Fibrosis LPCN 1148

Eligibility

You can join if…

Open to males ages 18 years and up

  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

You CAN'T join if...

  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:
  9. Spontaneous bacterial peritonitis
  10. Hepatic hydrothorax
  11. MELD score > 25
  12. . Abnormal lab value in serum chemistry, hematology, or urinalysis that the PI considers clinically significant, including but not limited to:
  13. PSA > 4 ng/mL
  14. Polycythemia (Hematocrit >54%) or history of polycythemia
  15. ALT or AST > 5x ULN
  16. ALP > 1.5x ULN
  17. Platelet count < 30,000/mL
  18. EGFR < 60 mL/min/1.73 m2
  19. Total bilirubin > 3.0 mg/dL
  20. Serum albumin < 2.8 g/dL
  21. INR > 2.3 or PT prolongation > 6.0 seconds
  22. . 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:
  23. Hematocrit > 48%
  24. I-PSS > 19
  25. Any irregularity found on digital rectal examination of the prostate
  26. . Subjects with PSA > 3 ng/mL are excluded only if any of the below criteria are met at baseline:
  27. Subject is African American
  28. Subject has a first-degree relative who has a history of prostate cancer
  29. Hematocrit > 48%
  30. I-PSS > 19
  31. Any irregularity found on digital rectal examination of the prostate
  32. . 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
  33. . History of bariatric surgery
  34. . History of stroke or myocardial infarction within the past 5 years
  35. . Known positivity for Human Immunodeficiency Virus (HIV) infection
  36. . Acute liver failure as the indication for addition to the liver transplant waitlist
  37. . Estimated life expectancy less than 3 months or expected to undergo liver transplant within 3 months
  38. . Known heart failure of New York Heart Association class III or IV
  39. . Evidence of severe encephalopathy or encephalopathy that is not controlled despite adequate medical therapy
  40. . History of prior organ transplant
  41. . History of Fontan physiology
  42. . History of pulmonary embolus
  43. . Porto-pulmonary hypertension
  44. . Hepatopulmonary syndrome
  45. . Uncontrolled epilepsy or migraine
  46. . Active substance abuse or dependency extending to within the previous 6 months
  47. . History of significant sensitivity or allergy to testosterone, or product excipients.
  48. . 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
  49. . Subjects who are currently receiving any androgens (testosterone or other androgens or androgen-containing supplements) and are unwilling to washout prior to screening
  50. Washout: 12 weeks following long-acting intramuscular androgen injections; 4 weeks following topical or buccal androgens; 3 weeks following oral androgens
  51. . Uncontrolled hypertension (>160/90 mmHg despite treatment)
  52. . Uncontrolled obstructive sleep apnea
  53. . 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
  54. . Subject who is not willing to use adequate contraception for the duration of the study
  55. . 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
  56. . Failure to give informed consent

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94117 United States
  • University of California, Los Angeles accepting new patients
    Los Angeles California 90095 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Lipocine Inc.
ID
NCT04874350
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated