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

NCT ID: NCT04686994

Last Updated: 2024-09-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-22

Study Completion Date

2021-02-07

Brief Summary

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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 .

Detailed Description

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Conditions

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Overweight and Obesity NAFLD Hyperlipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Parallel Assignment 3:1 ratio
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ASC41

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

Group Type EXPERIMENTAL

ASC 41

Intervention Type DRUG

Oral tablets

ASC41 placebo

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

Group Type PLACEBO_COMPARATOR

ASC 41 Placebo

Intervention Type DRUG

Oral tablets

Interventions

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ASC 41

Oral tablets

Intervention Type DRUG

ASC 41 Placebo

Oral tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 23kg/m2 ≤ BMI \<40kg/m2.

Exclusion Criteria

* A history of thyroid disease.
* A positive HBsAg, HCV Ab and/or HIV Ab.
Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hunan Provincial People's Hospital

OTHER

Sponsor Role collaborator

Gannex Pharma Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hunan provincial people's hospital

Changsha, Hunan, China

Site Status

Countries

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China

Other Identifiers

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ASC41-104

Identifier Type: -

Identifier Source: org_study_id

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