C3711005

  • STATUS
    Recruiting
  • End date
    Jun 12, 2023
  • participants needed
    180
Updated on 10 January 2022

Summary

The study will evaluate the effect of coadministration of a range of doses of DGAT2i with 1 dose of ACCi, on hepatic steatosis and the ability of DGAT2i to mitigate ACCi-induced elevations in serum triglycerides. The study has a 2-part design with sequential conduct of Part 1 and Part 2 with each part conducted in distinct/separate cohorts of participants. The overall study design, objectives/endpoints, eligibility criteria for both parts is envisioned to be identical, however, data from Part 1 will be used to determine whether to conduct Part 2.

Description



Details
Condition Nonalcoholic Steatohepatitis (NASH)
Clinical Study IdentifierTX251103
Last Modified on10 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

BMI ≥25 and ≤ 40 kg/m2
concomitant medical conditions associated with NAFLD

Exclusion Criteria

Evidence of other causes of liver disease such as Alcoholic steatohepatitis, (de)compensated cirrhosis, active viral hepatitis
Any condition possibly affecting drug absorption
Unstable liver function tests
Recent cardiovascular event(s)
Malignancies
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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