Study for Multiple Doses of HM15136(Efpegerglucagon) in Obese or Overweight Subjects With Comorbidities
Phase 1
Completed
NCT04167553
| Condition | Obese With Comorbidities, Overweight With Comorbidities, Type2 Diabetes |
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| Phase | Phase 1 |
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| Sponsor | Hanmi Pharmaceutical Company Limited |
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| Status | Completed |
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| Enrollment | 52 participants |
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| Interventions | HM15136 |
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| Start date | Aug 30, 2019 |
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| Completion date | Dec 9, 2020 |
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| Results posted | Jan 27, 2025 |
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Summary
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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Open in BENITIONS
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