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A Study of Multiple Doses of HM15211 in Obese Subjects With NAFLD and in Subjects With NASH

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ClinicalTrials.gov Identifier: NCT03744182
Recruitment Status : Recruiting
First Posted : November 16, 2018
Last Update Posted : November 16, 2018
Sponsor:
Information provided by (Responsible Party):
Hanmi Pharmaceutical Company Limited

Brief Summary:
This study is a phase 1 study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of HM15211 in obese subjects with NAFLD and in subjects with NASH

Condition or disease Intervention/treatment Phase
NAFLD NASH - Nonalcoholic Steatohepatitis Drug: HM15211 Drug: Placebo of HM15211 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of HM15211 in Obese Subjects With NAFLD and in Subjects With NASH
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : June 20, 2019
Estimated Study Completion Date : September 28, 2019


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. Adverse Events [ Time Frame: 12 weeks ]
    Incidence of adverse events

  2. Clinical lab abnormalities [ Time Frame: 12 weeks ]
    Incidence of clinical lab abnormalities

  3. Physical examination [ Time Frame: 12 weeks ]
    Incidence and severity of clinical findings on physical examination

  4. Vital signs [ Time Frame: 12 weeks ]
    Change from baseline in vital signs

  5. 12-lead ECG [ Time Frame: 12 weeks ]
    Change from baseline in 12-lead ECG



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body mass index ≥ 30 kg/m2
  • Waist circumference ≤ 57 inches
  • Fasting Plasma Glucose < 7 mmol/L (126 mg/dL)
  • HbA1c < 6.5%
  • Controlled Attenuation Parameter ≥ 300 dB/m by FibroScan
  • Liver fat by MRI-PDFF ≥ 10%.

Exclusion Criteria:

  • A history of or active chronic liver disease due to alcohol, auto-immune, HIV, HBV or active HCV-infection or NASH disease
  • Any history of clinically significant chronic liver disease including esophageal varices, ascites, encephalopathy or any hospitalization for treatment of chronic liver disease; or Model for End Stage Liver Disease (MELD) ≥ 10
  • Previous surgical treatment for obesity
  • Uncontrolled hypertension
  • Any weight control treatment
  • History or current diagnosis of acute or chronic pancreatitis or factors for pancreatitis
  • History of major depression, anxiety, suicidal behavior or attempts, or other psychiatric disorder requiring medical treatment
  • History or current diagnosis of heart disease
  • Presence of clinically significant ECG findings
  • History of renal disease or abnormal kidney function tests
  • History of alcohol or illicit drug abuse
  • Daily heavy use of cigarettes or any tobacco product

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): NCT03744182


Contacts
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Contact: Jahoon Kang, Executive Director +82 2 410 9041 jhkang@hanmi.co.kr

Locations
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United States, California
ProSciento Inc. Recruiting
Chula Vista, California, United States, 91911
Contact: Marcus Hompesch, CEO         
Principal Investigator: Linda Morrow, VP, CMO         
Sponsors and Collaborators
Hanmi Pharmaceutical Company Limited

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Responsible Party: Hanmi Pharmaceutical Company Limited
ClinicalTrials.gov Identifier: NCT03744182     History of Changes
Other Study ID Numbers: HM-TRIA-102
First Posted: November 16, 2018    Key Record Dates
Last Update Posted: November 16, 2018
Last Verified: November 2018

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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