NCT01675154|TerminatedPhase 2ResultsDMC
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Due to unavailability of the drug.
Sponsor study identifier
Secondary identifiers
interventional
5
1 country
2
Study Start
November 2015
Actual (reported)Primary Completion
June 30, 2020
Actual (reported)Study Completion
June 30, 2020
Actual (reported)Funding Source - FDA OOPD This study is being done to find out whether an investigational (not approved by FDA ) drug called SLx-4090 or Orlistat (FDA approved medication for weight loss) when given alone or in combination can treat the high blood fat (elevated triglycerides)levels found in the condition Type 1 Hyperlipoproteinemia (T1HLP) better or more safely than low fat diet alone, the current standard medical care. It is also not clear whether Orlistat, that is FDA approved for weight loss, is effective in lowering blood fat levels in patients with Type 1 hyperlipoproteinemia (T1HLP). The researchers are interested in learning whether any one of these drugs when given alone or in combination is more effective and safe in treating T1HLP.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 27, 2012
Actual (reported)August 29, 2012
Actual (reported)November 2015
Actual (reported)June 30, 2020
Actual (reported)June 30, 2020
Actual (reported)August 19, 2021
Actual (reported)Serum Triglycerides at First Intervention Period
Serum triglyceride level will be measured after taking each assigned intervention at first intervention period.
4 weeks after the assigned treatment (first intervention period)
Serum Triglycerides at Second Intervention Period
Serum triglyceride level will be measured after taking each assigned intervention at second intervention period
4 weeks after the assigned treatment (Second Intervention Period)
Serum Triglycerides at Third Intervention Period
Serum triglyceride level will be measured after taking each assigned intervention at intervention period
4 weeks after the assigned treatment (Third Intervention Period)
Serum Triglycerides at Fourth Intervention Period
Serum triglyceride level will be measured after taking each assigned intervention at fourth intervention period
4 weeks after the assigned treatment (Fourth Intervention Period)
Slx-4090(placebo) is dosed as 4 tablets of 50 mg, three times per day with meals. Orlistat (placebo) is dosed as 2 capsules of 60 mg, three times per day with meals. This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment.
Orlistat two capsules 60mg each, three times per day with meals. Placebo for SLx-4090, 4 tablets 50mg each, three times per day with meals. This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment.
Given for 4 weeks
Given for 4 weeks
UT Southwestern Medical Center 5323 Harry Hines Blvd
Dallas, Texas, 75390-8537, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Only five patients were enrolled in the study. Two patients completed the study. One subject dropped our after Second Intervention Period. Participation of other two subjects was halted due to unavailability of study medications. Study Design: Although protocol states "This trial is randomized, double-blind cross-over trial", study design was actually not a cross over design, but adaptive/flexible design using a responsive adaptive randomization. Thus Arm/Group were not listed "per sequence".
Abhimanyu Garg, MD
University of Texas Southwestern Medical Center
5 participants (actual enrollment reported by the registry).
First Submitted
August 27, 2012
First Posted
August 29, 2012
Study Start
November 2015
A Comparison of SLx-4090 in Combination With Metformin Versus Metformin Therapy Alone in Patients With Type 2 Diabetes
Orlistat placebo 2 capsules, 60mg each three times per day with meals. Slx-4090 4 tablets, 50mg each. three times per day with meals. This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment.
Orlistat, 2 capsules 60 mg each, three times per day with meals. SLx-4090 4 tablets 50mg each, three times per day with meals. This trial is adaptive design/flexible design. The participants were either randomized from the start of the study or after the completion of each treatment.
Given for 4 weeks
Given for 4 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
June 30, 2020
Actual (reported)Study Completion
June 30, 2020
Actual (reported)Last Updated
August 19, 2021
Results First Posted
August 19, 2021
Record last verified: 2021-07
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Source: ClinicalTrials.gov.
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