Back to resultsA Study of Multiple Doses of HM15211 in Obese Subjects With NAFLD
Primary Purpose
NAFLD
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
HM15211
Placebo of HM15211
Sponsored by
About this trial
This is an interventional treatment trial for NAFLD
Eligibility 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
Sites / Locations
- ProSciento Inc.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
HM15211
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Adverse Events
Incidence of adverse events
Clinical lab abnormalities
Incidence of clinical lab abnormalities
Physical examination
Incidence and severity of clinical findings on physical examination
Vital signs
Change from baseline in vital signs
12-lead ECG
Change from baseline in 12-lead ECG
Secondary Outcome Measures
Full Information
NCT ID
NCT03744182
First Posted
November 12, 2018
Last Updated
September 28, 2021
Sponsor
Hanmi Pharmaceutical Company Limited
1. Study Identification
Unique Protocol Identification Number
NCT03744182
Brief Title
A Study of Multiple Doses of HM15211 in Obese Subjects With NAFLD
Official Title
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of HM15211 in Obese Subjects With NAFLD
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
March 18, 2020 (Actual)
Study Completion Date
March 18, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
NAFLD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
HM15211
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
HM15211
Intervention Description
A sterile solution of HM15211 contained in pre-filled syringes
Intervention Type
Drug
Intervention Name(s)
Placebo of HM15211
Intervention Description
A sterile, matching solution in pre-filled syringes
Primary Outcome Measure Information:
Title
Adverse Events
Description
Incidence of adverse events
Time Frame
12 weeks
Title
Clinical lab abnormalities
Description
Incidence of clinical lab abnormalities
Time Frame
12 weeks
Title
Physical examination
Description
Incidence and severity of clinical findings on physical examination
Time Frame
12 weeks
Title
Vital signs
Description
Change from baseline in vital signs
Time Frame
12 weeks
Title
12-lead ECG
Description
Change from baseline in 12-lead ECG
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
ProSciento Inc.
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Study of Multiple Doses of HM15211 in Obese Subjects With NAFLD
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