NCT04686994

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 .

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2020

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 22, 2020

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 23, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 29, 2020

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 19, 2021

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2021

Completed
Last Updated

September 27, 2024

Status Verified

September 1, 2024

Enrollment Period

28 days

First QC Date

December 23, 2020

Last Update Submit

September 25, 2024

Conditions

Overweight and ObesityNAFLDHyperlipidemia

Keywords

Overweight and ObesityNAFLDHyperlipidemiaLDL-CNASH

Outcome Measures

Primary Outcomes (1)

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

    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

    Up to 28 days

Secondary Outcomes (7)

  • AUC of ASC41

    Up to 28 days

  • Cmax of ASC41

    Up to 28 days

  • t1/2 of ASC41

    Up to 28 days

  • CL/F of ASC41

    Up to 28 days

  • Vd/F of ASC41

    Up to 28 days

  • +2 more secondary outcomes

Study Arms (2)

ASC41

EXPERIMENTAL

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

Drug: ASC 41

ASC41 placebo

PLACEBO COMPARATOR

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

Drug: ASC 41 Placebo

Interventions

ASC 41DRUG

Oral tablets

ASC41
ASC 41 PlaceboDRUG

Oral tablets

ASC41 placebo

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • kg/m2 ≤ BMI \<40kg/m2.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hunan provincial people's hospital

Changsha, Hunan, China

Location

MeSH Terms

Conditions

OverweightObesityNon-alcoholic Fatty Liver DiseaseHyperlipidemias

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsFatty LiverLiver DiseasesDigestive System DiseasesDyslipidemiasLipid Metabolism DisordersMetabolic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment 3:1 ratio
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2020

First Posted

December 29, 2020

Study Start

December 22, 2020

Primary Completion

January 19, 2021

Study Completion

February 7, 2021

Last Updated

September 27, 2024

Record last verified: 2024-09

Locations

CN(1)