Study S002823

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Doses of HM15211(Efocipegtrutide) in Obese Subjects With NAFLD

ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT03744182
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE1
Masking: DOUBLE
Status: COMPLETED
Enrollment: 66
Start: 2018-11-01
Primary completion: 2020-03-18
Lead sponsor: Hanmi Pharmaceutical Company Limited
Conditions: NAFLD
Interventions: DRUG:HM15211; DRUG:Placebo of HM15211
Results posted: TRUE

Registered primary outcomes

Number of Participants With Adverse Events [12 weeks]
Incidence of Clinical Renal Function Lab Abnormalities [baseline and 12 weeks]
Vital Signs [baseline and 12 weeks]
12-lead ECG [baseline and 12 weeks]

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