Phase 1
Completed N=84
Safety and Tolerability Study of SHP626 in Overweight and Obese Adults
Source: ClinicalTrials.gov NCT02287779 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology — 0; 0; 0; 0 participants
Summary
This study will investigate the safety and tolerability of daily dosing regimens of SHP626 in overweight and obese adults.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Hematology |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Fat Soluble Vitamins (Vitamin A, D, & E) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Lipid Panel |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Thyroid Hormone Panel |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Coagulation |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Standard Chemistry |
0; 0; 0; 1; 0; 0 | — |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Urinalysis Parameters |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Vital Signs |
0; 1; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) Related to Electrocardiogram (12-lead) |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious Treatment-emergent Adverse Events (STEAEs) |
14; 9; 9; 9; 9; 9 | — |
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) Who Discontinued From the Study |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Average Total Fecal Bile Acid (FBA) Concentration |
183.84; 166.95; 172.49; 238.22; 364.78; 408.49 | — |
| SECONDARY Mean Serum 7- Alpha-hydroxy-4-cholesten-3-one (C4) Concentration |
15.702; 10.956; 13.806; 11.129; 19.549; 24.726 | — |
| SECONDARY Number of Participants With Stool Hardness Using Bristol Stool Chart |
4; 0; 1; 0; 0; 0 | — |
| SECONDARY Maximum Observed Plasma Concentration (Cmax) of Volixibat |
— | — |
| SECONDARY Area Under the Plasma Concentration-Time Curve (AUC) of Volixibat (SHP626) |
— | — |
Eligibility Criteria
Inclusion Criteria
- Males that comply with any applicable contraceptive requirements or females of non-childbearing potential
- No history of active or chronic disease other than that allowed by study (hypertension, hyperlipidemia and GERD or heartburn)
- Has a body mass index of 25-35 kg/m2 with a body weight of greater than 140lbs (assessed at screening)
Exclusion Criteria
- No history of alcohol or substance abuse, including use of tobacco
- No substantial changes in eating habits or exercise routine.
Data sourced from ClinicalTrials.gov (NCT02287779). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.