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Completed

NCT Number: NCT04686994

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

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 .

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Key information

Conditions

Overweight and Obesity Body Weight Digestive System Diseases Dyslipidemias Fatty Liver Hyperlipidemia Hyperlipidemias Lipid Metabolism Disorders Liver Diseases Metabolic Diseases NAFLD Non-alcoholic Fatty Liver Disease Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hunan provincial people's hospital

Changsha, Hunan, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ASC 41

Drug

Oral tablets

ASC 41 Placebo

Drug

Oral tablets

Primary outcomes

  1. 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

Secondary outcomes

  1. AUC of ASC41

    Time frame: Up to 28 days

    Evaluate the Area under the plasma concentration versus time curve after multiple oral doses of ASC41 tablets.

  2. Cmax of ASC41

    Time frame: Up to 28 days

    Evaluate the Peak Plasma Concentration after single and multiple oral doses of ASC41 tablets.

  3. t1/2 of ASC41

    Time frame: Up to 28 days

    Evaluate the Terminal-Phase Half-Life after single and multiple oral doses of ASC41 tables.

  4. CL/F of ASC41

    Time frame: Up to 28 days

    Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables.

  5. Vd/F of ASC41

    Time frame: Up to 28 days

    Evaluate the Apparent Systemic Clearance after multiple oral dose of ASC41 tables.

  6. Tmax of ASC41

    Time frame: Up to 28 days

    Evaluate the Time to reach the maximum plasma concentration after multiple oral doses of ASC41 tables.

  7. LDL-C and other lipid parameters

    Time frame: Up to 28 days

    To evaluate the effect of multiple doses of ASC41 tablets on LDL-C and other lipid parameters (TG, TC, HDL-C, etc.) .

Sponsors and collaborators

Lead sponsor

Gannex Pharma Co., Ltd.

Industry

Collaborators

  • Hunan Provincial People's Hospital

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 29, 2020
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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