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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04686994
Enrollment
20
Registered
2020-12-29
Start date
2020-12-22
Completion date
2021-02-07
Last updated
2024-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperlipidemia, NAFLD, Overweight and Obesity

Keywords

Overweight and Obesity, NAFLD, Hyperlipidemia, LDL-C, NASH

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 .

Interventions

DRUGASC 41

Oral tablets

DRUGASC 41 Placebo

Oral tablets

Sponsors

Hunan Provincial People's Hospital
CollaboratorOTHER
Gannex Pharma Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Intervention model description

Parallel Assignment 3:1 ratio

Eligibility

Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]Up to 28 daysOccurrence 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

Secondary

MeasureTime frameDescription
Cmax of ASC41Up to 28 daysEvaluate the Peak Plasma Concentration after single and multiple oral doses of ASC41 tablets.
t1/2 of ASC41Up to 28 daysEvaluate the Terminal-Phase Half-Life after single and multiple oral doses of ASC41 tables.
CL/F of ASC41Up to 28 daysEvaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables.
AUC of ASC41Up to 28 daysEvaluate the Area under the plasma concentration versus time curve after multiple oral doses of ASC41 tablets.
Tmax of ASC41Up to 28 daysEvaluate the Time to reach the maximum plasma concentration after multiple oral doses of ASC41 tables.
LDL-C and other lipid parametersUp to 28 daysTo evaluate the effect of multiple doses of ASC41 tablets on LDL-C and other lipid parameters (TG, TC, HDL-C, etc.) .
Vd/F of ASC41Up to 28 daysEvaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026