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The planned period of each cohort is 22 weeks including subject screening, treatments for 12 weeks, and follow up period.
The current Phase I study was a two-part study. Part 1 was designed to assess the safety, PK, and pharmacodynamics (PD) after repeated doses of HM15136 in obese or overweight subjects with comorbidities (i.e., dyslipidemia and/or hypertension). Part 2 was designed to assess the safety, PK, and PD after repeated doses of HM15136 in obese or overweight subjects with T2DM and comorbidities (i.e., dyslipidemia and/or
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HM15136 | Experimental | HM15136 0.02mg/kg, 0.04mg/kg, 0.06mg/kg |
|
| Placebo | Placebo Comparator | Matching placebo: 0.02mg/kg, 0.04mg/kg, 0.06mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM15136 | Drug | In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort. In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional. In the end of study, Part 2 of the study consisted of 2 cohorts comprising 16 subjects total. |
| Measure | Description | Time Frame |
|---|---|---|
| To Evaluate the Incidence of AEs | To evaluate the incidence of AEs: Skin and subcutaneous tissue disorders | after multiple subcutaneous (SC) doses for 12 weeks |
| To Evaluate Serum Amylase Levels at 12 Weeks | To evaluate the incidence of clinical lab abnormalities of serum amylase | after multiple subcutaneous (SC) doses for 12 weeks |
| Change From Baseline in Tympanic Temperature | tympanic temperature change | after multiple subcutaneous (SC) doses for 12 weeks |
| Change From Baseline in 12-lead ECG Parameters | QT interval corrected for HR using Fridericia's correction [QTcF] | after multiple subcutaneous (SC) doses for 12 weeks |
| Injection Site Reactions | Injection site reactions occurance | after multiple subcutaneous (SC) doses for 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Lipid Profiles | Change Cholesterol from baseline to end of treatment (12 weeks) | Change from baseline to end of treatment (12 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prosciento | San Diego | California | 91911 | United States |
During cohort 0.06mg/kg in Part 2(cohort 5), enrolled subjects safety data were evaluated, and decided to stop the cohort. The following cohorts, cohort 6-7, were not conducted since those were optional.
The study was to consist of up to 7 cohorts with a total of 102 subjects. Part 1 of the study was to consist of 3 sequential dosing cohorts, enrolling 12 subjects per cohort, for a total of 36 subjects. Part 2 of the study was to consist of up to 4 cohorts, with 30 subjects in Cohort 4 and 12 subjects per cohort for Cohorts 5-7, for a total of 66 subjects. However, during cohort 5 (0.06mg/kg) in Part 2, enrolled subjects safety data were evaluated, and decided to stop the cohort.
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| ID | Title | Description |
|---|---|---|
| FG000 | HM15136 0.02 mg/kg Part 1 | In Part 1, 0.02mg/kg cohort, there are 9 subjects. |
| FG001 | HM15136 0.04 mg/kg Part 1 | In Part 1, 0.04mg/kg cohort, there are 9 subjects. |
| FG002 | HM15136 0.06 mg/kg Part 1 | In Part 1, 0.06mg/kg cohort, there are 9 subjects. |
| FG003 | Placebo Part 1 | Placebo: In Part 1, placebo cohort, there are 9 subjects. |
| FG004 | HM15136 0.02 mg/kg Part 2 | In Part 2, 0.02mg/kg cohort 4, there are 9 subjects. |
| FG005 | HM15136 0.06 mg/kg Part 2 | In Part 2, 0.06mg/kg cohort 5, there are 3 subjects enrollment of new subjects into Cohort 5 terminated with a lower number of subjects than planned (30). |
| FG006 | Placebo Part 2 | In Part 2, placebo cohort, there are 4 subjects |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
During Part 2 0.06mg/kg(cohort 5), the safety profile of enrolled subjects were evaluated, and decided to stop enrolling subjects. Planned cohorts, cohort 6 to 7, were not conducted since those were optional.
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| ID | Title | Description |
|---|---|---|
| BG000 | HM15136 0.02 mg/kg Part 1 | HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort. |
| BG001 | HM15136 0.04 mg/kg Part 1 |
| 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 | To Evaluate the Incidence of AEs | To evaluate the incidence of AEs: Skin and subcutaneous tissue disorders | To evaluate Skin and subcutaneous tissue disorders occurance from baseline to end of treatment | Posted | Count of Participants | Participants | after multiple subcutaneous (SC) doses for 12 weeks |
|
Screening, week 1, week 3, week 5, week 9, week 13, week 17
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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 | HM15136 0.02 mg/kg Part 1 | HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Rash | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jiyeon Kang | Hanmi Pharmaceutical Co., Ltd. | +8224100377 | jiyeon.kang@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 | Oct 29, 2020 | Mar 29, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 8, 2021 | Mar 29, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| C000726310 | HM15136 |
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|
|
| Placebo | Drug | In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort. In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional. In the end of study, Part 2 of the study consisted of 2 cohorts comprising 16 subjects total. |
|
|
| Physician Decision |
|
| Lost to Follow-up |
|
HM15136 0.04 mg/kg
HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort.
| BG002 | HM15136 0.06 mg/kg Part 1 | HM15136 0.06 mg/kg HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort. |
| BG003 | Placebo Part 1 | Placebo: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort. |
| BG004 | HM15136 0.02 mg/kg Part 2 | In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional. |
| BG005 | HM15136 0.06 mg/kg Part 2 | HM15136 0.06 mg/kg Part 2 In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional. |
| BG006 | Placebo Part 2 | In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional. |
| BG007 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | HM15136 0.06 mg/kg Part 1 | HM15136 0.06 mg/kg HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort. |
| OG003 | Placebo Part 1 | Placebo: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort. |
| OG004 | HM15136 0.02 mg/kg Part 2 | In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional. |
| OG005 | HM15136 0.06 mg/kg Part 2 | HM15136 0.06 mg/kg Part 2 In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional. |
| OG006 | Placebo Part 2 | In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional. |
|
|
| Primary | To Evaluate Serum Amylase Levels at 12 Weeks | To evaluate the incidence of clinical lab abnormalities of serum amylase | incidence of clinical lab abnormalities comparing from baseline to end of treatment | Posted | Mean | Standard Deviation | U/L | after multiple subcutaneous (SC) doses for 12 weeks |
|
|
|
| Primary | Change From Baseline in Tympanic Temperature | tympanic temperature change | Evaluation of body temperature from baseline to end or treatment | Posted | Mean | Standard Deviation | Celsius | after multiple subcutaneous (SC) doses for 12 weeks |
|
|
|
| Primary | Change From Baseline in 12-lead ECG Parameters | QT interval corrected for HR using Fridericia's correction [QTcF] | To evaluate 12-lead ECG parameters changes from baseline to end of treatment | Posted | Mean | Standard Deviation | msec | after multiple subcutaneous (SC) doses for 12 weeks |
|
|
|
| Primary | Injection Site Reactions | Injection site reactions occurance | Posted | Count of Participants | Participants | after multiple subcutaneous (SC) doses for 12 weeks |
|
|
|
| Secondary | Serum Lipid Profiles | Change Cholesterol from baseline to end of treatment (12 weeks) | Change Cholesterol from baseline to end of treatment | Posted | Least Squares Mean | Standard Error | mg/dL | Change from baseline to end of treatment (12 weeks) |
|
|
|
| 0 |
| 9 |
| 0 |
| 9 |
| 1 |
| 9 |
| EG001 | HM15136 0.04 mg/kg Part 1 | HM15136 0.04 mg/kg HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort. | 0 | 9 | 0 | 9 | 2 | 9 |
| EG002 | HM15136 0.06 mg/kg Part 1 | HM15136 0.06 mg/kg HM15136: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort. | 0 | 9 | 0 | 9 | 4 | 9 |
| EG003 | Placebo Part 1 | Placebo: In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort. | 0 | 9 | 0 | 9 | 2 | 9 |
| EG004 | HM15136 0.02 mg/kg Part 2 | In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional. | 0 | 9 | 0 | 9 | 2 | 9 |
| EG005 | HM15136 0.06 mg/kg Part 2 | HM15136 0.06 mg/kg Part 2 In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG006 | Placebo Part 2 | In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional. | 0 | 4 | 0 | 4 | 3 | 4 |
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