A Randomized, Double-Blind, Placebo-Controlled Phase Ib Study to Evaluate Safety, Tolerability and Pharmacokinetics and Pharmacodynamics (Biomarkers) of ASC41 Tables in Overweight and Obese Subjects

Gannex Pharma Co., Ltd.1 site in 1 country20 target enrollmentDecember 22, 2020

ConditionsOverweight and Obesity NAFLD Hyperlipidemia

InterventionsASC 41 ASC 41 Placebo

DrugsASC 41 ASC 41 Placebo

Overview

Phase: Phase 1
Intervention: ASC 41
Conditions: Overweight and Obesity
Sponsor: Gannex Pharma Co., Ltd.
Enrollment: 20
Locations: 1
Primary Endpoint: Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of this study is to evaluate the safety, tolerability and compare the pharmacokinetic parameters of ASC41, a THR beta agonist tables in overweight and obese subjects who have elevated LDL-C .

Registry

clinicaltrials.gov

Start Date

December 22, 2020

End Date

February 7, 2021

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Gannex Pharma Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•23kg/m2 ≤ BMI \<40kg/m

Exclusion Criteria

•A history of thyroid disease.
•A positive HBsAg, HCV Ab and/or HIV Ab.

Arms & Interventions

ASC41

ASC41 two tablets, once daily, from Day 1 to Day 28.

Intervention: ASC 41

ASC41 placebo

ASC41 placebo two tablets, once daily, from Day 1 to Day 28.

Intervention: ASC 41 Placebo

Outcomes

Primary Outcomes

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Time Frame: Up to 28 days

Occurrence of Serious Adverse Event (SAE), Adverse Event (AE) resulting in treatment discontinuation and/or dose reductions, and AE of special interest, from baseline up to 28 days