Study for Multiple Doses of HM15136(Efpegerglucagon) in Obese or Overweight Subjects With Comorbidities
Фаза 1
Завершено
NCT04167553
| Заболевание | Obese With Comorbidities, Overweight With Comorbidities, Type2 Diabetes |
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| Фаза | Фаза 1 |
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| Спонсор | Hanmi Pharmaceutical Company Limited |
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| Статус | Завершено |
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| Участники | 52 участн. |
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| Вмешательство | HM15136 |
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| Дата начала | 30.08.2019 |
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| Дата завершения | 9.12.2020 |
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| Публикация результатов | 27.01.2025 |
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Кратко
The planned period of each cohort is 22 weeks including subject screening, treatments for 12 weeks, and follow up period.
To Evaluate the Incidence of AEs
after multiple subcutaneous (SC) doses for 12 weeks · Participants
| HM15136 0.02 mg/kg Part 1 | 1 Participants |
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| HM15136 0.04 mg/kg Part 1 | 2 Participants |
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| HM15136 0.06 mg/kg Part 1 | 4 Participants |
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| Placebo Part 1 | 2 Participants |
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| HM15136 0.02 mg/kg Part 2 | 2 Participants |
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| HM15136 0.06 mg/kg Part 2 | 0 Participants |
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To Evaluate Serum Amylase Levels at 12 Weeks
after multiple subcutaneous (SC) doses for 12 weeks · U/L
| HM15136 0.02 mg/kg Part 1 | 0.1 ± 12.17 U/L |
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| HM15136 0.04 mg/kg Part 1 | -1.1 ± 8.13 U/L |
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| HM15136 0.06 mg/kg Part 1 | 7.8 ± 8.93 U/L |
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| Placebo Part 1 | -3.6 ± 8.18 U/L |
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| HM15136 0.02 mg/kg Part 2 | -12.5 ± 50.69 U/L |
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| HM15136 0.06 mg/kg Part 2 | -2 ± NA U/L |
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Change From Baseline in Tympanic Temperature
after multiple subcutaneous (SC) doses for 12 weeks · Celsius
| HM15136 0.02 mg/kg Part 1 | -0.28 ± 0.471 Celsius |
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| HM15136 0.04 mg/kg Part 1 | -0.08 ± 0.291 Celsius |
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| HM15136 0.06 mg/kg Part 1 | -0.23 ± 0.372 Celsius |
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| Placebo Part 1 | -0.10 ± 0.408 Celsius |
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| HM15136 0.02 mg/kg Part 2 | -0.1 ± 0.533 Celsius |
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| HM15136 0.06 mg/kg Part 2 | -0.1 ± NA Celsius |
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