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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

Tracking Information
First Submitted Date  ICMJE August 7, 2020
First Posted Date  ICMJE August 10, 2020
Last Update Posted Date January 27, 2021
Actual Study Start Date  ICMJE July 29, 2020
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 7, 2020)
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
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Efficacy, Safety and Tolerability of HM15211 in Subjects
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE NASH - Nonalcoholic Steatohepatitis
Intervention  ICMJE
  • Drug: HM15211
    A sterile solution of HM15211 contained in pre-filled syringes
  • Drug: Placebo of HM15211
    A sterile, matching solution in pre-filled syringes
Study Arms  ICMJE
  • Experimental: HM15211
    Intervention: Drug: HM15211
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo of HM15211
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 7, 2020)
112
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sujin Jung, Clinical Operation Manager +82 2 410 0473 sujin.jung@hanmi.co.kr
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04505436
Other Study ID Numbers  ICMJE HM-TRIA-201
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Hanmi Pharmaceutical Company Limited
Study Sponsor  ICMJE Hanmi Pharmaceutical Company Limited
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Hanmi Pharmaceutical Company Limited
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP