| Trial ID: | L0464 |
| Source ID: | NCT04004325
|
| Associated Drug: |
FT-4101
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| Title: |
A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability and Efficacy of FT-4101 in Overweight/Obese Subjects With NASH
|
| Acronym: |
--
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| Status: |
Not recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
Nonalcoholic Steatohepatitis (NASH);Overweight or Obesity
|
| Interventions: |
Drug: FT-4101;Drug: FT-4101 placebo;Other: Deuterated Water
|
| Outcome Measures: |
Incidence of adverse events;Incidence of clinical lab abnormalities;Change from baseline in vital signs (blood pressure [BP]: mmHg);Change from baseline in vital signs (heart rate [HR]: beats/min);Change from baseline in vital signs (respiratory rate [RR]: breaths/min);Change from baseline in vital signs (temperature [aural]: degrees Celsius);Change from baseline in 12-lead electrocardiogram (ECG) parameters (heart rate [HR]: beats/min);Change from baseline in 12-lead electrocardiogram (ECG) parameters (QT interval: milliseconds);Change from baseline in 12-lead electrocardiogram (ECG) parameters (PR interval: milliseconds);Change from baseline in 12-lead electrocardiogram (ECG) parameters (QRS interval: milliseconds);Change from baseline in 12-lead electrocardiogram (ECG) parameters (RR interval: milliseconds);Change from baseline in 12-lead electrocardiogram (ECG) parameters (QTcF interval: milliseconds);Reduction (absolute and relative) of % liver fat on MRI-PDFFReduction (absolute and relative) of % liver fat on MRI-PDFF;Proportion of patients experiencing a relative reduction of 30% or greater of liver fat as assessed by MRI-PDFF;Assess the PD effect of FT-4101 on circulation biomarkers of liver inflammation after administration of multiple doses by assessment of the reduction of the following liver biochemistry markers: ALT, AST, ?GT, Alkaline phosphatase, Total bilirubin;Maximum concentration (Cmax);Time to maximum concentration (Tmax);Area under the concentration-time curve for a dosing interval (AUCtau);Trough plasma concentrations (Ctrough) at steady state
|
| Sponsor/Collaborators: |
Forma Therapeutics, Inc.
|
| Gender: |
All
|
| Age: |
18 Years75 Years
|
| Phases: |
Phase 1/Phase 2
|
| Enrollment: |
14
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
|
| Start Date: |
10/06/2019
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
25 January 2021
|
| Locations: |
United States
|
| URL: |
https://clinicaltrials.gov/show/NCT04004325
|
