Study Stopped
This study was terminated due to expired drug with possibility of re-starting in the future.
A Randomized, Double-blind Study of the Effects of Fenretinide Administered in Subjects With Obesity
Phase 2 Study of the Assessment of the Insulin Sensitizing Activity of Fenretinide in Subjects With Insulin Resistance With BMI >30Kg/m2, and Liver Inflammation Related to Non-alcoholic Fatty Liver
1 other identifier
interventional
21
1 country
1
Brief Summary
Many metabolic complications of obesity are a consequence of abnormal responses of the liver, muscle, and fat to insulin actions. Fenretinide may improve the effects of insulin, preventing metabolic complications.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 obesity
Started Dec 2007
Longer than P75 for phase_2 obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2007
CompletedFirst Posted
Study publicly available on registry
October 19, 2007
CompletedStudy Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedResults Posted
Study results publicly available
February 10, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2099
ExpectedFebruary 10, 2021
January 1, 2021
4.1 years
October 17, 2007
November 27, 2019
January 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of the Effect on Insulin Resistance
This study was terminated due to expired drug with possibility of re-starting in the future. For this reason the randomization code has not been broken and the data has not been analyzed and there is no way to report the outcome measures.
30 days
Secondary Outcomes (1)
Assessment of the Biochemical Response in Cholesterol, Glucose and Related Blood Tests.
30 days
Study Arms (2)
A
EXPERIMENTALSubjects in this cohort will be given Fenretinide
B
PLACEBO COMPARATORSubjects in this cohort will be given placebo.
Interventions
Eligibility Criteria
You may qualify if:
- BMI \>30
You may not qualify if:
- Diabetes Requiring Medication
- Poorly Controlled Co-Morbidities
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of California at San Diego Hospitals
San Diego, California, 92161, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
This study was terminated due to expired drug with possibility of re-starting in the future. For this reason the randomization code has not been broken and the data has not been analyzed and there is no way to report the participant flow.
Results Point of Contact
- Title
- MARIO CHOJKIER
- Organization
- UCSD
Study Officials
- PRINCIPAL INVESTIGATOR
Mario Chojkier, M.D.
University of California, San Diego and San Diego VA Healthcare Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
October 17, 2007
First Posted
October 19, 2007
Study Start
December 1, 2007
Primary Completion
January 1, 2012
Study Completion (Estimated)
January 1, 2099
Last Updated
February 10, 2021
Results First Posted
February 10, 2021
Record last verified: 2021-01