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Study to Evaluate Efficacy, Safety and Tolerability of HM15211 in Subjects

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ClinicalTrials.gov Identifier: NCT04505436
Recruitment Status : Recruiting
First Posted : August 10, 2020
Last Update Posted : January 27, 2021
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Brief Summary:
This study is a phase 2 study to Evaluate Efficacy, Safety and Tolerability of HM15211 Treatment for 12 Months in Subjects with Biopsy Confirmed NASH

Condition or disease Intervention/treatment Phase
NASH - Nonalcoholic Steatohepatitis Drug: HM15211 Drug: Placebo of HM15211 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy, Safety and Tolerability of HM15211 Treatment for 12 Months in Subjects With Biopsy Confirmed NASH
Actual Study Start Date : July 29, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: HM15211 Drug: HM15211
A sterile solution of HM15211 contained in pre-filled syringes

Placebo Comparator: Placebo Drug: Placebo of HM15211
A sterile, matching solution in pre-filled syringes




Primary Outcome Measures :
  1. pharmacodynamic (PD) effect of HM15211 [ Time Frame: 12 months ]
    • Proportion of subjects who achieve at least 30% relative reduction of liver fat from baseline by MRI-PDFF compared to placebo. PD assessment liver fat MRI-PDFF will be measured at prior to the first dosing on Day 1, Day 183 and Day 365.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adults ≥ 18 to ≤ 70 years.
  • BMI ≥ 18 kg/m2, with stable body weight (defined as change < 5%) by history for 3 months prior to screening or since baseline liver biopsy, whichever is earlier.
  • Subjects have a diagnosis of noncirrhotic NASH with liver fibrosis (Fibrosis stage F1-F3) confirmed by liver biopsy within 6 months of Day -7.
  • MRI-PDFF performed at screening with ≥ 8% steatosis.

Exclusion Criteria:

  • Subjects with a history of active or chronic liver disease, including alcoholic liver disease, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency, human immunodeficiency virus (HIV).
  • Any history of clinically significant chronic liver disease including esophageal varices, ascites, hepatic encephalopathy, splenomegaly, or any hospitalization for treatment of chronic liver disease; or Model for End Stage Liver Disease >12.
  • Recent (within 3 months of baseline biopsy) use of therapies associated with development of NAFLD (e.g., systemic corticosteroids, methotrexate, tamoxifen, aromatase inhibitors, amiodarone, or long-term use of tetracyclines).
  • Type 1 diabetes subjects, or T2DM subjects on insulin and/or GLP-1 receptor agonist therapy, or other therapies not allowed for this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04505436


Contacts
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Contact: Sujin Jung, Clinical Operation Manager +82 2 410 0473 sujin.jung@hanmi.co.kr

Locations
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Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited
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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT04505436    
Other Study ID Numbers: HM-TRIA-201
First Posted: August 10, 2020    Key Record Dates
Last Update Posted: January 27, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Liver Diseases
Digestive System Diseases