A Phase 2 interventional study of LPCN 1144 Formulation A and LPCN 1144 Formulation B in Nonalcoholic Steatohepatitis (NASH), sponsored by Lipocine Inc.. Completed at 19 sites in United States. Open to male participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-12-14.
Sponsored by Lipocine Inc. · Phase 2, Interventional, and Treatment
This is a Phase 2, randomized, double-blind, placebo controlled, three arm study in adult men with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of LPCN 1144 in adult men with NASH.
This is a Phase 2, randomized, double-blind, placebo controlled, three arm study in adult men with biopsy confirmed NASH. The study is aimed at evaluating efficacy and tolerability of LPCN 1144 in adult men with NASH. The study will be conducted across multiple centers in the United States.
Approximately 75 subjects will be randomized in 1:1:1 ratio to receive one of the following treatments:
Subjects will undergo a screening period to determine study eligibility. As a part of screening, liver biopsies will be performed for subjects who have not had a liver biopsy within 6 months of Day 1, and fat fraction will be measured by magnetic resonance imaging derived proton density fat fraction (MRI-PDFF) in all subjects. Adult male subjects with histologic evidence of NASH will be enrolled into the study.
Eligible subjects will be randomized to one of the three treatment arms. The treatment phase will be for a duration of 36-weeks with assessments of liver biopsies, hepatic fat fraction, liver enzymes, lipid levels and other safety parameters. Safety and tolerability will be assessed throughout the study.
1,617 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 324 are open to participants now.
This study's enrollment of 56 is close to the median of 60 across 1,176 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Browse Non-alcoholic Fatty Liver Disease studies →Lipocine Inc. is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Subject with histologic evidence of NASH upon central read of a liver .
i. A historical biopsy no more than 4 months before Screening may be considered for use with medical monitor approval if the following criteria are met:
Exclusion Criteria:
abnormal laboratory value, in the opinion of the investigator, in serum chemistry, hematology, or urinalysis including but not limited to:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LPCN 1144 Formulation A
Drug: LPCN 1144 Formulation A
LPCN 1144 Formulation B
Drug: LPCN 1144 Formulation B
Placebo
Drug: Placebo
Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as 225 mg testosterone undecanoate twice daily (BID).
Also known as: testosterone undecanoate
Oral LPCN 1144 + d-alpha tocopherol total daily dose of 450 mg testosterone undecanoate + 476 mg d-alpha tocopherol administered as 225 mg testosterone undecanoate + 238 mg d-alpha tocopherol BID
Also known as: testosterone undecanoate with d-alpha tocopherol
Oral matching placebo capsule administered as BID
Also known as: Oral placebo
Absolute Change in Hepatic Fat Fraction Based on MRI-PDFF Measurements in LPCN 1144 Treated Subjects Compared to Placebo.
The change in magnetic resonance imaging derived proton fat fraction (MRI-PDFF) from baseline to week 12 in LPCN 1144 treated subjects and subjects given placebo.
Time frame: Baseline and Week 12
Relative Change in MRI-PDFF Measurements in LPCN 1144 Treated Subjects Compared to Placebo.
Requirement for inclusion in analysis was having a baseline hepatic fat fraction ≥ 5% based on MRI-PDFF.
Time frame: Baseline and week 12
Number of Participants With Resolution of NASH on Overall Histopathological Reading in LPCN 1144 Treated Subjects Compared to Placebo
Resolution of nonalcoholic steatohepatitis (NASH) is defined as the nonalcoholic fatty liver disease activity score (NAS) score of 0-1 for inflammation, 0 for ballooning, and any value for steatosis. These data are based on the NASH-clinical research network (CRN) histology scoring system. The range of scores are as follows (with higher scores equating to a more pathological feature): Steatosis 0-3, inflammation 0-3, ballooning 0-2, fibrosis state 0-4, and NAS 0-8.
Time frame: Baseline and Week 36
Number of Subjects Achieving Resolution of NASH on Overall Histopathological Reading and no Worsening of Liver Fibrosis in LPCN 1144 Treated Subjects Compared to Placebo.
Resolution of NASH is defined as NAS score of 0-1 for inflammation, 0 for ballooning, and any value for steatosis. These data are based on the NASH-CRN histology scoring system. The range of scores are as follows (with higher scores equating to a more pathological feature): Steatosis 0-3, inflammation 0-3, ballooning 0-2, fibrosis state 0-4, and NAS 0-8. No worsening was defined as a score in fibrosis equal to, or lower, than baseline.
Time frame: Baseline and Week 36
Number of Subjects With Improvement in NASH Evaluated by Paired Biopsies Analysis and no Worsening of Liver Fibrosis in LPCN 1144 Treated Subjects Compared to Placebo.
Paired biopsies are randomly assigned A or B and are scored by a blinded pathologist as better, worse or same for change in fibrosis, steatosis, inflammation, and ballooning. Improvement in NASH requires no worsening of fibrosis, an improvement in ballooning or inflammation, and no worsening of ballooning or inflammation. Assessment of better or same is considered as no worsening.
Time frame: Baseline and week 36
Change in the Mean Score of NAS Components at Baseline and After 36 Weeks of Treatment in LPCN 1144 Treated Subjects Compared to Placebo.
These data are based on the NASH-CRN histology scoring system. The range of scores are as follows (with higher scores equating to a more pathological feature): Steatosis 0-3, inflammation 0-3, ballooning 0-2, fibrosis state 0-4, and NAS 0-8.
Time frame: Baseline and Week 36
Number of Subjects With an Improvement in Liver Fibrosis Greater Than or Equal to One Stage and no Worsening of NASH in LPCN 1144 Treated Subjects Compared to Placebo.
These data are based on the NASH-CRN histology scoring system. The range of scores are as follows (with higher scores equating to a more pathological feature): Steatosis 0-3, inflammation 0-3, ballooning 0-2, and fibrosis stage 0-4. Improvement in liver fibrosis was defined as an improvement in fibrosis greater than or equal to one stage using the NASH CRN fibrosis score with no worsening of ballooning, inflammation, or steatosis.
Time frame: Baseline and Week 36
Number of Subjects With Improvement in Fibrosis Evaluated by Paired Biopsies Analysis and no Worsening of NASH in LPCN 1144 Treated Subjects Compared to Placebo
Paired biopsies are randomly assigned A or B and are scored by a blinded pathologist as better, worse or same for change in fibrosis, steatosis, inflammation, and ballooning. Improvement in fibrosis requires a better score in fibrosis and no worsening of ballooning or inflammation. Assessment of better or same is considered as no worsening.
Time frame: Baseline to week 36
Number of Subjects With Improvement in Fibrosis Evaluated Via FibroNest Scores
Improvement in Fibrosis is defined as improvement in parenchymal tissue normalized phenotypic fibrosis composite value compared to baseline. FibroNest is an image analysis system for the assessment of the severity and progression of fibrosis in NASH, produced by PharmaNest LLC.
Time frame: Baseline and week 36
Relative Change in Appendicular Lean Muscle Mass
Relative change in appendicular lean muscle mass measured by dual-energy absorptiometry (DXA) in LPCN 1144 treated subjects compared to Placebo. Data were last observation carried forward.
Time frame: Baseline and 36 weeks
Relative Change in Whole Body Fat Mass
Relative change in whole body fat mass measured by dual-energy absorptiometry (DXA) in LPCN 1144 treated subjects compared to Placebo. Data were last observation carried forward.
Time frame: Baseline and week 36
Mean Change From Baseline in Liver Enzymes in LPCN 1144 Treated Subjects Compared to Placebo.
Liver enzymes analyzed were aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), and gamma-glutamyltransferase (GGT)
Time frame: Baseline and Week 36
Mean Changes in Serum Lipid Profile Parameters in LPCN 1144 Treated Subjects Compared to Placebo.
Lipid profile parameters included total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides.
Time frame: Baseline and Week 36
| Milestone | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Started | 18 | 19 | 19 |
| Completed week 12 | 18 | 19 | 18 |
| Completed | 18 | 17 | 17 |
| Not completed | 0 | 2 | 2 |
The change in magnetic resonance imaging derived proton fat fraction (MRI-PDFF) from baseline to week 12 in LPCN 1144 treated subjects and subjects given placebo.
| Percentage of liver fat | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Absolute Change in Hepatic Fat Fraction Based on MRI-PDFF Measurements in LPCN 1144 Treated Subjects Compared to Placebo. | -7.68 (-9.82 to -5.54) | -9.17 (-11.26 to -7.08) | -1.54 (-3.65 to 0.58) |
Requirement for inclusion in analysis was having a baseline hepatic fat fraction ≥ 5% based on MRI-PDFF.
| Percentage change | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Relative Change in MRI-PDFF Measurements in LPCN 1144 Treated Subjects Compared to Placebo. | -39.94 (-50.76 to -29.11) | -46.84 (-57.30 to -36.38) | -9.34 (-20.20 to 1.53) |
Resolution of nonalcoholic steatohepatitis (NASH) is defined as the nonalcoholic fatty liver disease activity score (NAS) score of 0-1 for inflammation, 0 for ballooning, and any value for steatosis. These data are based on the NASH-clinical research network (CRN) histology scoring system. The range of scores are as follows (with higher scores equating to a more pathological feature): Steatosis 0-3, inflammation 0-3, ballooning 0-2, fibrosis state 0-4, and NAS 0-8.
| Participants | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Number of Participants With Resolution of NASH on Overall Histopathological Reading in LPCN 1144 Treated Subjects Compared to Placebo | 7 | 9 | 1 |
Resolution of NASH is defined as NAS score of 0-1 for inflammation, 0 for ballooning, and any value for steatosis. These data are based on the NASH-CRN histology scoring system. The range of scores are as follows (with higher scores equating to a more pathological feature): Steatosis 0-3, inflammation 0-3, ballooning 0-2, fibrosis state 0-4, and NAS 0-8. No worsening was defined as a score in fibrosis equal to, or lower, than baseline.
| Participants | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Number of Subjects Achieving Resolution of NASH on Overall Histopathological Reading and no Worsening of Liver Fibrosis in LPCN 1144 Treated Subjects Compared to Placebo. | 6 | 9 | 0 |
Paired biopsies are randomly assigned A or B and are scored by a blinded pathologist as better, worse or same for change in fibrosis, steatosis, inflammation, and ballooning. Improvement in NASH requires no worsening of fibrosis, an improvement in ballooning or inflammation, and no worsening of ballooning or inflammation. Assessment of better or same is considered as no worsening.
| Participants | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Number of Subjects With Improvement in NASH Evaluated by Paired Biopsies Analysis and no Worsening of Liver Fibrosis in LPCN 1144 Treated Subjects Compared to Placebo. | 9 | 8 | 2 |
These data are based on the NASH-CRN histology scoring system. The range of scores are as follows (with higher scores equating to a more pathological feature): Steatosis 0-3, inflammation 0-3, ballooning 0-2, fibrosis state 0-4, and NAS 0-8.
| NAS score | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Hepatocyte ballooning score | -0.7 (-1.1 to -0.3) | -0.9 (-1.3 to -0.5) | -0.2 (-0.6 to 0.2) |
| Lobular inflammation score | -0.2 (-0.5 to 0.1) | -0.5 (-0.8 to -0.1) | -0.1 (-0.4 to 0.2) |
| Steatosis score | -0.9 (-1.3 to -0.6) | -1.2 (-1.6 to -0.8) | -0.1 (-0.5 to 0.2) |
These data are based on the NASH-CRN histology scoring system. The range of scores are as follows (with higher scores equating to a more pathological feature): Steatosis 0-3, inflammation 0-3, ballooning 0-2, and fibrosis stage 0-4. Improvement in liver fibrosis was defined as an improvement in fibrosis greater than or equal to one stage using the NASH CRN fibrosis score with no worsening of ballooning, inflammation, or steatosis.
| Participants | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Number of Subjects With an Improvement in Liver Fibrosis Greater Than or Equal to One Stage and no Worsening of NASH in LPCN 1144 Treated Subjects Compared to Placebo. | 4 | 2 | 6 |
Paired biopsies are randomly assigned A or B and are scored by a blinded pathologist as better, worse or same for change in fibrosis, steatosis, inflammation, and ballooning. Improvement in fibrosis requires a better score in fibrosis and no worsening of ballooning or inflammation. Assessment of better or same is considered as no worsening.
| Participants | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Number of Subjects With Improvement in Fibrosis Evaluated by Paired Biopsies Analysis and no Worsening of NASH in LPCN 1144 Treated Subjects Compared to Placebo | 6 | 8 | 3 |
Improvement in Fibrosis is defined as improvement in parenchymal tissue normalized phenotypic fibrosis composite value compared to baseline. FibroNest is an image analysis system for the assessment of the severity and progression of fibrosis in NASH, produced by PharmaNest LLC.
| Participants | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Number of Subjects With Improvement in Fibrosis Evaluated Via FibroNest Scores | 12 | 6 | 5 |
Relative change in appendicular lean muscle mass measured by dual-energy absorptiometry (DXA) in LPCN 1144 treated subjects compared to Placebo. Data were last observation carried forward.
| Percentage change | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Relative Change in Appendicular Lean Muscle Mass | 2.75 (-0.04 to 5.54) | 1.90 (-0.87 to 4.67) | -1.42 (-4.12 to 1.28) |
Relative change in whole body fat mass measured by dual-energy absorptiometry (DXA) in LPCN 1144 treated subjects compared to Placebo. Data were last observation carried forward.
| Percentage change | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Relative Change in Whole Body Fat Mass | -3.68 (-9.60 to 2.24) | -7.33 (-13.35 to -1.31) | 1.78 (-4.01 to 7.57) |
Liver enzymes analyzed were aspartate transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP), and gamma-glutamyltransferase (GGT)
| U/L | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Aspartate transaminase (AST) | -8.0 (-14.9 to -1.0) | -12.0 (-18.9 to -5.1) | 1.3 (-5.8 to 8.3) |
| Alanine transaminase (ALT) | -11.4 (-23.1 to 0.3) | -22.9 (-34.5 to -11.2) | 0.6 (-11.3 to 12.4) |
| Alkaline phosphatase (ALP) | -6.1 (-11.4 to -0.9) | -8.5 (-13.7 to -3.3) | 0.1 (-5.1 to 5.4) |
| Gamma-glutamyltransferase (GGT) | -2.9 (-11.4 to 5.6) | -13.4 (-22.0 to -4.9) | 0.7 (-8.0 to 9.4) |
Lipid profile parameters included total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), and triglycerides.
| mg/dL | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Total Cholesterol | -1.7 (-17.7 to 14.2) | 7.3 (-8.8 to 23.4) | 1.1 (-15.4 to 17.7) |
| LDL | 1.8 (-11.4 to 15.1) | 8.7 (-3.6 to 21.1) | -6.0 (-20.0 to 7.9) |
| HDL | -3.3 (-5.8 to -0.7) | -2.0 (-4.6 to 0.6) | -0.0 (-2.7 to 2.7) |
| Triglycerides | -11.5 (-78.6 to 55.6) | -3.9 (-70.8 to 63.0) | 67.3 (-0.2 to 134.9) |
Collected over Adverse event data were collected for a duration of 36 weeks for each participant while enrolled in study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Treatment A | 1/18 (5.6%) | 2/18 (11.1%) | 12/18 (66.7%) |
| Treatment B | 0/19 (0%) | 2/19 (10.5%) | 11/19 (57.9%) |
| Treatment C | 1/19 (5.3%) | 1/19 (5.3%) | 16/19 (84.2%) |
| Event | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| Acute myocardial infarctionCardiac disorders | 1/18 | 0/19 | 0/19 |
| Cardio-respiratory arrestCardiac disorders | 1/18 | 0/19 | 0/19 |
| Coronary artery diseaseCardiac disorders | 1/18 | 0/19 | 0/19 |
| HyperprolactinemiaEndocrine disorders | 1/18 | 0/19 | 0/19 |
| Lung cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/18 | 0/19 | 0/19 |
| Corona virus infectionInfections and infestations | 0/18 | 1/19 | 1/19 |
| PolycythemiaBlood and lymphatic system disorders | 0/18 | 1/19 | 0/19 |
| Mental status changePsychiatric disorders | 0/18 | 0/19 | 1/19 |
| Event | Treatment A | Treatment B | Treatment C |
|---|---|---|---|
| HypertensionVascular disorders | 3/18 | 0/19 | 1/19 |
| Corona virus infectionInfections and infestations | 2/18 | 1/19 | 2/19 |
| BronchitisInfections and infestations | 1/18 | 0/19 | 2/19 |
| Urinary tract infectionInfections and infestations | 1/18 | 2/19 | 0/19 |
| DiarrheaGastrointestinal disorders | 1/18 | 0/19 | 2/19 |
| Abdominal painGastrointestinal disorders | 0/18 | 0/19 | 2/19 |
| Type 2 diabetes mellitusMetabolism and nutrition disorders | 0/18 | 1/19 | 2/19 |
| Edema peripheralGeneral disorders | 1/18 | 1/19 | 2/19 |
| AnxietyPsychiatric disorders | 1/18 | 2/19 | 0/19 |
| Back painMusculoskeletal and connective tissue disorders | 1/18 | 1/19 | 1/19 |
All randomized participants.
| Age, Categorical(Participants) | Treatment A | Treatment B | Treatment C | Total |
|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 17 | 15 | 15 | 47 |
| >=65 years | 1 | 4 | 4 | 9 |
| Age, Continuous(years) | Treatment A | Treatment B | Treatment C | Total |
|---|---|---|---|---|
| Mean | 51.3 ± 8.66 | 53.4 ± 10.68 | 53.6 ± 11.2 | 52.8 ± 10.13 |
| Sex: Female, Male(Participants) | Treatment A | Treatment B | Treatment C | Total |
|---|---|---|---|---|
| Female | 0 | 0 | 0 | 0 |
| Male | 18 | 19 | 19 | 56 |
| Ethnicity (NIH/OMB)(Participants) | Treatment A | Treatment B | Treatment C | Total |
|---|---|---|---|---|
| Hispanic or Latino | 7 | 6 | 6 | 19 |
| Not Hispanic or Latino | 11 | 13 | 13 | 37 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Treatment A | Treatment B | Treatment C | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 1 | 1 |
| Asian | 0 | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 | 2 |
| White | 18 | 18 | 16 | 52 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Aug 2019 to primary completion in Jun 2021, 21 months.
Results were first posted in Dec 2023, 2 years 5 months after primary completion.
Of 132 industry-sponsored phase 2 interventional studies under Non-alcoholic Fatty Liver Disease, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 30. This study's 21 months is close to that.
Counting every sponsor, half of 185 studies reached it within 26 months; a quarter within 16 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Testosterone undecanoate
Non-alcoholic Fatty Liver Disease →
Lipocine Inc.