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NCT01963845 · ClinicalTrials.gov registry record · Phase 2
Sitagliptin Versus Placebo in the Treatment of Non-alcoholic Fatty Liver Disease
A Phase 2 study of Non-alcoholic Fatty Liver Disease, sponsored by University of California, San Diego.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
- 1
- Study location
NCT01963845: Completed Phase 2 study of Non-alcoholic Fatty Liver Disease, sponsored by University of California, San Diego.
NCT01963845 is a Phase 2 study of Non-alcoholic Fatty Liver Disease that has completed, run by University of California, San Diego. The registered enrollment target is 50 participants, below the 176-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (72% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01963845, a Phase 2 study of Non-alcoholic Fatty Liver Disease, has completed, sponsored by University of California, San Diego.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
- 1
- Study location
Study Summary
Nonalcoholic fatty liver disease (NAFLD) represents a spectrum of diseases ranging from simple steatosis to nonalcoholic steatohepatitis (NASH), the progressive form of liver disease that can lead to cirrhosis and liver-related mortality in persons who drink little or no alcohol. NAFLD is defined as the presence of hepatic steatosis with no evidence of hepatocellular injury in the form of ballooning of the hepatocytes. NASH is defined as the presence of hepatic steatosis and inflammation with hepatocyte injury (ballooning) with or without fibrosis. NASH is benign in many affected individuals but can cause progressive liver injury and, indeed, may be the major cause of cryptogenic cirrhosis1. Currently, there is no FDA approved treatment for NAFLD. Weight loss and exercise are the recommended but often difficult maintain these lifestyle changes in the long term and therefore therapeutic agents have been investigated. In this study, we propose to treat 50 patients with NAFLD and diabetes with either sitagliptin or placebo for 24 weeks. After an initial evaluation for insulin sensitivity and MRI liver fat distribution, patients will receive either 100 mg/day of sitagliptin or placebo. Patients will be monitored at regular intervals for symptoms of liver disease, side effects of sitagliptin and serum biochemical and metabolic indices. At the end of 24-weeks, patients will have a repeat medical evaluation, liver MRI and an optional liver biopsy. Pre and post treatment MRI-derived liver fat content and insulin sensitivity will be compared. The primary end point of successful therapy will be improvement in hepatic steatosis measured by MRI. Secondary end points will be improvement in insulin sensitivity and liver biochemistry.
Primary Outcome
Participants liver fat was measured at baseline and 24 weeks. This is the percentage change in liver fat assessed by MRI-PDFF and stratified by treatment group.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sitagliptin
Study Locations (1)
California
- University of California, San Diego - San Diego
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2014-01 |
| Est. Completion | 2016-01 |
| Phase | Phase 2 |
What the finished NCT01963845 record still lists
NCT01963845 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 176-participant average among 57 other Non-alcoholic Fatty Liver Disease trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Non-alcoholic Fatty Liver Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01963845 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01963845 about?
NCT01963845 is a clinical study titled "Sitagliptin Versus Placebo in the Treatment of Non-alcoholic Fatty Liver Disease". Nonalcoholic fatty liver disease (NAFLD) represents a spectrum of diseases ranging from simple steatosis to nonalcoholic steatohepatitis (NASH), the progressive form of liver disease that can lead to cirrhosis and liver-related mortality in persons who drink little or no alcohol. NAFLD is defined as...
What is the current status of trial NCT01963845?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2014-01. Estimated completion is 2016-01.
What conditions does trial NCT01963845 study?
This clinical trial studies the following conditions: Non-alcoholic Fatty Liver Disease.
What interventions are being tested in trial NCT01963845?
The interventions under investigation include: Placebo (DRUG), Sitagliptin (DRUG).
Who is sponsoring clinical trial NCT01963845?
This trial is sponsored by University of California, San Diego, which has 775 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01963845 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01963845's enrollment target sits among peer trials
50 34th of 57 higher than 24 of 57 other Non-alcoholic Fatty Liver Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-alcoholic Fatty Liver Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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