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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
This study will be single-blind and conducted in up to 6 cohorts comprising a total of up to 72 obese subjects with NAFLD. Each cohort will enroll subjects to ensure that at least 12 subjects per cohort will complete the study. Subjects will be randomized to investigational product (IP) or placebo in a 3:1 ratio via an Interactive Web Response System (IWRS). Per cohort (n=12 subjects), 9 subjects will be randomized to IP and 3 subjects to placebo. Cohorts may partially overlap after at least 9 subjects have completed 2-4 weeks of treatment (2 weeks of treatment is reached at Visit week 3) and a dose escalation decision has been made. Study drug will be administered weekly over a period of 12 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HM15211 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM15211 | Drug | A sterile solution of HM15211 contained in pre-filled syringes |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events | Cardiovascular events, rash/inflammatory dermatitis and other skin disorders, GI events, and gallstone formation [cholelithiasis] were managed following a separate AE guidance document | 12 weeks |
| Incidence of Clinical Renal Function Lab Abnormalities | Observed Values and Change from Baseline in Renal Function of Urea Nitrogen | baseline and 12 weeks |
| Vital Signs | Change from baseline in vital signs (Systolic Blood) | baseline and 12 weeks |
| 12-lead ECG | Change from baseline in 12-lead ECG; the primary ECG endpoint was QTcF | baseline and 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Body Mass Index | Change of Body Mass Index from baseline to 12 weeks after IP injection | baseline and 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ProSciento Inc. | Chula Vista | California | 91911 | United States |
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Date of first enrollment was November 1st, 2018. Last subject was enrolled on March 3rd, 2020.
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| ID | Title | Description |
|---|---|---|
| FG000 | 0.01 mg/kg HM15211 | HM15211: A sterile solution of HM15211 contained in pre-filled syringes 0.01 mg/kg HM15211 |
| FG001 | 0.02 mg/kg HM15211 | HM15211: A sterile solution of HM15211 contained in pre-filled syringes 0.02 mg/kg HM15211 |
| FG002 | 0.04 mg/kg HM15211 | HM15211: A sterile solution of HM15211 contained in pre-filled syringes 0.04 mg/kg HM15211 |
| FG003 | 0.06 mg/kg HM15211 | HM15211: A sterile solution of HM15211 contained in pre-filled syringes 0.06 mg/kg HM15211 |
| FG004 | 0.08 mg/kg HM15211 | HM15211: A sterile solution of HM15211 contained in pre-filled syringes 0.08 mg/kg HM15211 |
| FG005 | Placebo | Placebo of HM15211: A sterile, matching solution in pre-filled syringes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HM15211 0.01 mg/kg | HM15211: A sterile solution of HM15211 contained in pre-filled syringes |
| BG001 | HM15211 0.02 mg/kg | HM15211: A sterile solution of HM15211 contained in pre-filled syringes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events | Cardiovascular events, rash/inflammatory dermatitis and other skin disorders, GI events, and gallstone formation [cholelithiasis] were managed following a separate AE guidance document | Posted | Count of Participants | Participants | 12 weeks |
|
23 weeks
All AEs were collected over 23 weeks in safety analysis set.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0.01 mg/kg HM15211 | HM15211: A sterile solution of HM15211 contained in pre-filled syringes 0.01 mg/kg HM15211 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GAEUN PARK | Hanmi Pharmaceutical Co., Ltd. | +824108746 | 8746 | gaeun.park@hanmi.co.kr |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 2, 2019 | Mar 29, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 23, 2020 | Mar 29, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| Placebo of HM15211 |
| Drug |
A sterile, matching solution in pre-filled syringes |
|
| BG002 | HM15211 0.04 mg/kg | HM15211: A sterile solution of HM15211 contained in pre-filled syringes |
| BG003 | HM15211 0.06 mg/kg | HM15211: A sterile solution of HM15211 contained in pre-filled syringes |
| BG004 | HM15211 0.08 mg/kg | HM15211: A sterile solution of HM15211 contained in pre-filled syringes |
| BG005 | Placebo | Placebo of HM15211: A sterile, matching solution in pre-filled syringes |
| BG006 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
HM15211: A sterile solution of HM15211 contained in pre-filled syringes |
| OG003 | HM15211 0.06 mg/kg | HM15211: A sterile solution of HM15211 contained in pre-filled syringes |
| OG004 | HM15211 0.08 mg/kg | HM15211: A sterile solution of HM15211 contained in pre-filled syringes |
| OG005 | Placebo | Placebo of HM15211: A sterile, matching solution in pre-filled syringes |
|
|
| Primary | Incidence of Clinical Renal Function Lab Abnormalities | Observed Values and Change from Baseline in Renal Function of Urea Nitrogen | Posted | Mean | Standard Deviation | mmol/L | baseline and 12 weeks |
|
|
|
| Primary | Vital Signs | Change from baseline in vital signs (Systolic Blood) | Posted | Mean | Standard Deviation | mmHg | baseline and 12 weeks |
|
|
|
| Primary | 12-lead ECG | Change from baseline in 12-lead ECG; the primary ECG endpoint was QTcF | Posted | Mean | Standard Deviation | milliseconds | baseline and 12 weeks |
|
|
|
| Secondary | Body Mass Index | Change of Body Mass Index from baseline to 12 weeks after IP injection | Posted | Mean | Standard Deviation | kg/m2 | baseline and 12 weeks |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 7 |
| 9 |
| EG001 | 0.02 mg/kg HM15211 | HM15211: A sterile solution of HM15211 contained in pre-filled syringes 0.02 mg/kg HM15211 | 0 | 10 | 0 | 10 | 9 | 10 |
| EG002 | 0.04 mg/kg HM15211 | HM15211: A sterile solution of HM15211 contained in pre-filled syringes 0.04 mg/kg HM15211 | 0 | 12 | 0 | 12 | 9 | 12 |
| EG003 | 0.06 mg/kg HM15211 | HM15211: A sterile solution of HM15211 contained in pre-filled syringes 0.06 mg/kg HM15211 | 0 | 9 | 0 | 9 | 8 | 9 |
| EG004 | 0.08 mg/kg HM15211 | HM15211: A sterile solution of HM15211 contained in pre-filled syringes 0.08 mg/kg HM15211 | 0 | 9 | 0 | 9 | 6 | 9 |
| EG005 | Placebo | Placebo of HM15211: A sterile, matching solution in pre-filled syringes | 0 | 17 | 0 | 17 | 8 | 17 |
| Vomiting | Gastrointestinal disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Chest pain | General disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Injection site erythema | General disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Pyelonephritis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
|
| Sinusitis | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 23.0 | Non-systematic Assessment |
|
| Animal bite | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
|
| Bone contusion | Injury, poisoning and procedural complications | MedDRA 23.0 | Non-systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA 23.0 | Non-systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Non-systematic Assessment |
|
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