Study to Evaluate the Safety and Efficacy of ASC41 in Overweight and Obese Subjects

Gannex Pharma

Status and phase: Completed; Phase 1

Conditions: Hyperlipidemia; Overweight and Obesity; NAFLD

Treatments: Drug: ASC 41 Placebo; Drug: ASC 41

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04686994

ASC41-104

Details and patient eligibility

About

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 .

Enrollment: 20 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• 23kg/m2 ≤ BMI <40kg/m2.

Key Exclusion Criteria:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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20 participants in 2 patient groups, including a placebo group

ASC41

Experimental group

Description:

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

Treatment:

Drug: ASC 41

ASC41 placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: ASC 41 Placebo