Trial · NCT01675154
Phase 2 Study of Orlistat and SLx-4090 for the Treatment of Type 1 Hyperlipoproteinemia
NCT01675154, Phase 2, Terminated, University of Texas Southwestern Medical Center; results first posted 2021-08-19
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Phase 2 Study of Orlistat and SLx-4090 for the Treatment of Type 1 Hyperlipoproteinemia. Trials, record NCT01675154. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01675154
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study of Orlistat and SLx-4090 for the Treatment of Type 1 Hyperlipoproteinemia
- NCT number
- NCT01675154
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- University of Texas Southwestern Medical Center
- Conditions
- Type 1 Hyperlipoproteinemia
- Interventions
- SLx-4090 placebo, Orlistat Placebo, Orlistat, Slx-4090
- First posted
- 2012-08-29
- Last updated
- 2021-08-19
- Results first posted
- 2021-08-19
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Serum Triglycerides at First Intervention Period | 4 weeks after the assigned treatment (first intervention period) | Serum triglyceride level will be measured after taking each assigned intervention at first intervention period. |
| Primary | Serum Triglycerides at Second Intervention Period | 4 weeks after the assigned treatment (Second Intervention Period) | Serum triglyceride level will be measured after taking each assigned intervention at second intervention period |
| Primary | Serum Triglycerides at Third Intervention Period | 4 weeks after the assigned treatment (Third Intervention Period) | Serum triglyceride level will be measured after taking each assigned intervention at intervention period |
| Primary | Serum Triglycerides at Fourth Intervention Period | 4 weeks after the assigned treatment (Fourth Intervention Period) | Serum triglyceride level will be measured after taking each assigned intervention at fourth intervention period |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Serum Triglycerides at First Intervention Period | 4 weeks after the assigned treatment (first intervention period) | 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. | mg/dL | MEAN |
| PRIMARY | Serum Triglycerides at Second Intervention Period | 4 weeks after the assigned treatment (Second Intervention Period) | Patient assigned to SLX-4090 placebo/Orlistat placebo group withdrew from the study in this phase.~One more subject was assigned to the Orlistat/SLx-4090 but could not start the study as the drug SLx-4090 was not available.~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. | mg/dL | MEAN |
| PRIMARY | Serum Triglycerides at Third Intervention Period | 4 weeks after the assigned treatment (Third Intervention Period) | Patient assigned to Orlistat/SLX-4090 placebo group did not start the assigned treatment due to lack of drugs.~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. | mg/dL | MEAN |
| PRIMARY | Serum Triglycerides at Fourth Intervention Period | 4 weeks after the assigned treatment (Fourth Intervention Period) | Patient assigned to Orlistat/SLX-4090 group did not start the assigned treatment due to lack of drugs.~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. | mg/dL | MEAN |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Serum Triglycerides at First Intervention Period | SLx-4090 Placebo/Orlistat Placebo | 2086 | Standard Deviation 481.54 | mg/dL | |
| Serum Triglycerides at First Intervention Period | Orlistat/Placebo | 3320 | mg/dL | ||
| Serum Triglycerides at First Intervention Period | Orlistat Placebo /Slx-4090 | 1576 | mg/dL | ||
| Serum Triglycerides at First Intervention Period | Orlistat/SLx-4090 | 1280 | mg/dL | ||
| Serum Triglycerides at Second Intervention Period | Orlistat/Placebo | 1419 | mg/dL | ||
| Serum Triglycerides at Second Intervention Period | Orlistat Placebo /Slx-4090 | 2040 | mg/dL | ||
| Serum Triglycerides at Second Intervention Period | Orlistat/SLx-4090 | 3478 | mg/dL | ||
| Serum Triglycerides at Third Intervention Period | SLx-4090 Placebo/Orlistat Placebo | 6220 | mg/dL | ||
| Serum Triglycerides at Third Intervention Period | Orlistat Placebo /Slx-4090 | 1320 | mg/dL | ||
| Serum Triglycerides at Fourth Intervention Period | SLx-4090 Placebo/Orlistat Placebo | 1156 | mg/dL |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow84
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention Period (4 Weeks) | STARTED | SLx-4090 Placebo/Orlistat Placebo First | 2 | |
| First Intervention Period (4 Weeks) | STARTED | Orlistat/SLx-4090 Placebo | 1 | |
| First Intervention Period (4 Weeks) | STARTED | Orlistat Placebo /SLx-4090 | 1 | |
| First Intervention Period (4 Weeks) | STARTED | Orlistat/SLx-4090 | 1 | |
| First Intervention Period (4 Weeks) | COMPLETED | SLx-4090 Placebo/Orlistat Placebo First | 2 | |
| First Intervention Period (4 Weeks) | COMPLETED | Orlistat/SLx-4090 Placebo | 1 | |
| First Intervention Period (4 Weeks) | COMPLETED | Orlistat Placebo /SLx-4090 | 1 | |
| First Intervention Period (4 Weeks) | COMPLETED | Orlistat/SLx-4090 | 1 | |
| First Intervention Period (4 Weeks) | NOT COMPLETED | SLx-4090 Placebo/Orlistat Placebo First | 0 | |
| First Intervention Period (4 Weeks) | NOT COMPLETED | Orlistat/SLx-4090 Placebo | 0 |
1 to 10 of 84Source ClinicalTrials.gov
See all 84 participant flowAdverse events64
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Diarrhea | Gastrointestinal disorders | 1st Intervention Period:SLx-4090 Placebo/Orlistat Placebo | 0 | 2 | |
| other | Diarrhea | Gastrointestinal disorders | 1st Intervention Period:Orlistat/Placebo | 0 | 1 | |
| other | Diarrhea | Gastrointestinal disorders | 1st Intervention Period:Orlistat Placebo /Slx-4090 | 1 | 1 | |
| other | Diarrhea | Gastrointestinal disorders | 1st Intervention Period:Orlistat/SLx-4090 | 1 | 1 | |
| other | Diarrhea | Gastrointestinal disorders | 2nd Intervention Period:SLx-4090 Placebo/Orlistat Placebo | 0 | 1 | |
| other | Diarrhea | Gastrointestinal disorders | 2nd Intervention Period:Orlistat/Placebo | 0 | 1 | |
| other | Diarrhea | Gastrointestinal disorders | 2nd Intervention Period:Orlistat Placebo /Slx-4090 | 0 | 1 | |
| other | Diarrhea | Gastrointestinal disorders | 2nd Intervention Period:Orlistat/SLx-4090 | 0 | 2 | |
| other | Diarrhea | Gastrointestinal disorders | 3rd Intervention Period:SLx-4090 Placebo/Orlistat Placebo | 0 | 1 | |
| other | Diarrhea | Gastrointestinal disorders | 3rd Intervention Period:Orlistat/Placebo | 0 | 1 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals48
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 1st Intervention Period:SLx-4090 Placebo/Orlistat Placebo | 0 | 2 |
| Total, all-cause mortality | 1st Intervention Period:Orlistat/Placebo | 0 | 1 |
| Total, all-cause mortality | 1st Intervention Period:Orlistat Placebo /Slx-4090 | 0 | 1 |
| Total, all-cause mortality | 1st Intervention Period:Orlistat/SLx-4090 | 0 | 1 |
| Total, all-cause mortality | 2nd Intervention Period:SLx-4090 Placebo/Orlistat Placebo | 0 | 1 |
| Total, all-cause mortality | 2nd Intervention Period:Orlistat/Placebo | 0 | 1 |
| Total, all-cause mortality | 2nd Intervention Period:Orlistat Placebo /Slx-4090 | 0 | 1 |
| Total, all-cause mortality | 2nd Intervention Period:Orlistat/SLx-4090 | 0 | 2 |
| Total, all-cause mortality | 3rd Intervention Period:SLx-4090 Placebo/Orlistat Placebo | 0 | 1 |
| Total, all-cause mortality | 3rd Intervention Period:Orlistat/Placebo | 0 | 1 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01675154
GET https://conductscience.org/api/trials/v1/NCT01675154/flow?page=2