Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564584
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Phase 2a Study of Safety Tolerability and Efficacy of TLC-2716 in Subjects With Hypertriglyceridemia and NAFLD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 2a Study Evaluating the Safety Tolerability and Efficacy of TLC-2716 in Subjects With Hypertriglyceridemia and Nonalcoholic Fatty Liver Disease
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a Phase 2a randomized double-blind placebo-controlled study evaluating the safety tolerability and efficacy of 2 dose levels of TLC-2716 in subjects with hypertriglyceridemia and nonalcoholic fatty liver disease as assessed by changes in fasting triglycerides liver steatosis by MRI and other biomarkers
Detailed Description:
This is a Phase 2a randomized double-blind placebo-controlled study evaluating the safety tolerability and efficacy of 2 dose levels of TLC-2716 in subjects with hypertriglyceridemia and nonalcoholic fatty liver disease as assessed by changes in fasting triglycerides liver steatosis by MRI and other biomarkers
Participation in the study can last up to approximately 10 weeks including a 4 week Screening period a 4-week treatment period during which study drugs will be administered and a 2-week follow-up period
Participation in the study can last up to approximately 10 weeks including a 4 week Screening period a 4-week treatment period during which study drugs will be administered and a 2-week follow-up period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None