| Trial ID: | L0332 |
| Source ID: | NCT02287779
|
| Associated Drug: |
SHP??626.00
|
| Title: |
Safety and Tolerability Study of SHP626 in Overweight and Obese Adults
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
Has Results
|
| Results: |
https://ClinicalTrials.gov/show/NCT02287779/results
|
| Conditions: |
Non-Alcoholic Steatohepatitis
|
| Interventions: |
Drug: SHP626|Drug: Placebo
|
| Outcome Measures: |
Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Fat Soluble Vitamins (Vitamin A, D, & E)|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Lipid Panel|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Thyroid Hormone Panel|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Coagulation|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Chemistry|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Urinalysis Parameters|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (12-lead)|Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs)|Number of Participants With Treatment-emergent Adverse Events (TEAEs) Who Discontinued From the Study|Average Total Fecal Bile Acid (FBA) Concentration|Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration|Number of Participants With Stool Hardness Using Bristol Stool Chart|Maximum Observed Plasma Concentration (Cmax) of Volixibat|Area Under the Plasma Concentration-Time Curve (AUC) of Volixibat (SHP626)
|
| Sponsor/Collaborators: |
Mirum Pharmaceuticals, Inc.
|
| Gender: |
All
|
| Age: |
18 Years to 65 Years ?? (Adult, Older Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
84
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|Primary Purpose: Treatment
|
| Start Date: |
January 19, 2015
|
| Completion Date: |
June 19, 2015
|
| Results First Posted: |
December 7, 2016
|
| Last Update Posted: |
March 26, 2019
|
| Locations: |
New Orleans Center for Clinical Research, Knoxville, Tennessee, United States
|
| URL: |
https://ClinicalTrials.gov/show/NCT02287779
|
