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LPCN 1148 for Liver Cirrhosis and Sarcopenia
Phase 2
Waitlist Available
Research Sponsored by Lipocine Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 weeks
Awards & highlights
Study Summary
This trial will test whether LPCN 1148 is safe and effective in treating men with cirrhosis and sarcopenia.
Eligible Conditions
- Liver Cirrhosis
- Sarcopenia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in Skeletal Muscle Index in LPCN 1148 treated subjects compared to placebo
Secondary outcome measures
Change from baseline in Liver Frailty Index in LPCN 1148 treated subjects compared to placebo
Change in number of breakthrough hepatic encephalopathy events in LPCN 1148 treated subjects compared to placebo
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: LPCN 1148Experimental Treatment1 Intervention
Oral LPCN 1148 capsules, administered as BID.
Group II: PlaceboPlacebo Group1 Intervention
Oral matching placebo capsules, administered as BID.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
LPCN 1148
2021
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
Lipocine Inc.Lead Sponsor
6 Previous Clinical Trials
724 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have taken certain strong medications that affect how the study drug works within the past month and will continue to take them during the study.You have sleep apnea that is not being managed well.You have or might have had prostate or breast cancer.You had cancer in the past, except for prostate, breast, or HCC (liver cancer), and it was treated successfully at least 5 years ago.Men who are 18 years old or older.You have had uncontrolled or repeated bleeding from certain areas in your stomach or intestines in the past 6 months.You have had a blood clot in your lungs before.You have high blood pressure in the blood vessels of the lungs.You have suspected or confirmed liver cancer.You have a history of blood clotting issues or have been treated for blood clotting problems.You have a history of conditions that make your blood more likely to clot.You exhibit signs of muscle weakness as recommended by medical guidelines.Your blood and urine tests show values that are not normal and are considered significant by the study doctor. This includes high levels of PSA, red blood cells, liver enzymes, alkaline phosphatase, low platelet count, low kidney function, low serum albumin, or high INR.If your PSA level is between 2.5 ng/mL and 4 ng/mL, you will be excluded if you have high hematocrit, high I-PSS score, or any irregularity found during a prostate examination.If you have a PSA level higher than 3 ng/mL and you are African American, have a family member with prostate cancer, have a high hematocrit level, score high on a prostate symptom test, or have any irregularity found during a prostate exam, you may not be able to participate.You have had weight loss surgery in the past.You had a stroke or heart attack in the last 5 years.You had a TIPS procedure in the past 6 months, or you are expected to have a TIPS procedure within the next 6 months.Your doctor thinks you may not live for more than 3 months, or you are planning to have a liver transplant within the next 3 months.You have been diagnosed with severe heart failure.You have severe encephalopathy that is not controlled with medication.You have epilepsy or migraines that are not under control.You have been addicted to drugs or alcohol in the last 3 months.You are currently taking testosterone or other similar supplements and are not willing to stop taking them for a certain period of time before the screening.You have a history of hemochromatosis.Your high blood pressure is not well controlled even with treatment.You have had serious fluid buildup in your abdomen or chest, or your MELD score is higher than 25 in the past 6 months.You have been diagnosed with HIV.You cannot join the liver transplant waitlist if you have sudden and severe liver failure.You have a history of Fontan heart surgery.You need to use oxygen at home because of a liver and lung condition, or you have specific points for a liver and lung condition.You are waiting for a liver transplant due to certain liver conditions like Hepatitis B or C, alcoholic liver disease, non-alcoholic fatty liver disease, primary biliary cholangitis, or primary sclerosing cholangitis.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: LPCN 1148
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being monitored for this clinical investigation?
"Affirmative. Clinicaltrials.gov clarifies that this medical study, which was initially published on December 20th 2021, is still recruiting participants. A total of 60 volunteers are needed between 10 different clinical sites."
Answered by AI
How many venues are conducting this research experiment?
"This clinical trial is being conducted at the University of Utah in Salt Lake City, as well as at other universities such as UCLA and UCSF. An additional 10 sites are also involved."
Answered by AI
Is participation in this research program open to the public?
"The information located on clinicaltrials.gov verifies that recruitment is ongoing for this medical trial, which was initially posted in December 2021 and updated last June 2022."
Answered by AI
Has the drug LPCN 1148 been accorded regulatory approval by the FDA?
"Our team assigned LPCN 1148 a safety score of 2 out of 3, taking into account the evidence for its safety but lack thereof for efficacy as it is currently in Phase 2."
Answered by AI
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