A Study of Multiple Doses of HM15211(Efocipegtrutide) in Obese Subjects With NAFLD
Phase 1
Completed
NCT03744182
| Condition | NAFLD |
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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 | 66 participants |
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| Interventions | HM15211, Placebo of HM15211 |
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| Start date | Nov 1, 2018 |
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| Completion date | Mar 18, 2020 |
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| Results posted | Jan 27, 2025 |
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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
Number of Participants With Adverse Events
12 weeks · Participants
| HM15211 0.01 mg/kg | 7 Participants |
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| HM15211 0.02 mg/kg | 9 Participants |
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| HM15211 0.04 mg/kg | 9 Participants |
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| HM15211 0.06 mg/kg | 8 Participants |
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| HM15211 0.08 mg/kg | 6 Participants |
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| Placebo | 8 Participants |
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Incidence of Clinical Renal Function Lab Abnormalities
baseline and 12 weeks · mmol/L
| HM15211 0.01 mg/kg | -1.111 ± 0.7240 mmol/L |
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| HM15211 0.02 mg/kg | -0.238 ± 0.7142 mmol/L |
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| HM15211 0.04 mg/kg | 0.036 ± 1.1350 mmol/L |
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| HM15211 0.06 mg/kg | -0.754 ± 0.7242 mmol/L |
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| HM15211 0.08 mg/kg | -0.893 ± 0.5414 mmol/L |
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| Placebo | 0.190 ± 1.4962 mmol/L |
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Vital Signs
baseline and 12 weeks · mmHg
| HM15211 0.01 mg/kg | 7.2 ± 14.96 mmHg |
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| HM15211 0.02 mg/kg | 7.1 ± 12.64 mmHg |
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| HM15211 0.04 mg/kg | -0.7 ± 13.33 mmHg |
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| HM15211 0.06 mg/kg | -3.3 ± 8.67 mmHg |
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| HM15211 0.08 mg/kg | -4.5 ± 18.80 mmHg |
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| Placebo | 2.2 ± 12.27 mmHg |
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Open in BENITIONS
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