Trial · NCT02739217
Safety and Tolerability of PBI-4050 and Its Effects on the Biomarkers in Subjects With Alström Syndrome
NCT02739217, Phase 2, Completed, Liminal BioSciences Ltd.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety and Tolerability of PBI-4050 and Its Effects on the Biomarkers in Subjects With Alström Syndrome. Trials, record NCT02739217. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02739217
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Tolerability of PBI-4050 and Its Effects on the Biomarkers in Subjects With Alström Syndrome
- NCT number
- NCT02739217
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 12 participants, actual
- Lead sponsor
- Liminal BioSciences Ltd.
- Conditions
- Inflammation and Fibrosis, Diabetes
- Interventions
- PBI-4050
- First posted
- 2016-04-15
- Last updated
- 2018-08-29
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Description and number of abnormal laboratory values and adverse events that are related to treatment. | Primary on 24 weeks; Final on all data (including Extension Period) | |
| Secondary | Change from baseline in metabolic syndrome parameters over time. | 24 weeks and end of Extension Period | Change from baseline in fasting plasma glucose over time. Change from baseline in fasting plasma insulin over time. Change from baseline in glycated hemoglobin (HbA1c) over time. Change from baseline in Homeostasis Model Assessment for steady state beta cell function (HOMA-B) and insulin sensitivity (HOMA-S) over time. |
| Secondary | Change from baseline in biomarkers in blood and urine over time | 24 weeks and end of Extension Phase | Percentage of reduction and/or increase of level of biomarkers |
| Secondary | Change from baseline in cardiac function parameter: NT-proBNP | 24 weeks and end of Extension Phase | |
| Secondary | Change from baseline of antidiabetic treatment | 24 weeks and end of Extension Phase | Dosing change, new medication added or treatment discontinuation |
| Other | Changes from baseline in histological appearances in fat biopsies | 24 weeks and end of Extension Phase | Measuring the degree of fibrosis |
| Other | Changes from baseline in global metabolome and microdialysate fractions | 24 weeks and end of Extension Phase | |
| Other | Change from baseline in the liver stiffness | 24 weeks and end of Extension Phase | Measured in kilopascal (kPa) correlated to fibrosis by using a FibroScan |
| Other | Change from baseline in fat content and fibrosis burden in liver MRI | 24 weeks and end of Extension Phase | |
| Other | Change from baseline in left ventricular ejection fraction in cardiac MRI | 24 weeks and end of Extension Phase |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30477455 | DERIVED |
Source PubMed
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/NCT02739217
GET https://conductscience.org/api/trials/v1/NCT02739217/registered