NCT03744182

A Study of Multiple Doses of HM15211(Efocipegtrutide) in Obese Subjects With NAFLD

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Hanmi Pharmaceutical Company Limited · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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

Detailed description

This study will be single-blind and conducted in up to 6 cohorts comprising a total of up to 72 obese subjects with NAFLD. Each cohort will enroll subjects to ensure that at least 12 subjects per cohort will complete the study. Subjects will be randomized to investigational product (IP) or placebo in a 3:1 ratio via an Interactive Web Response System (IWRS). Per cohort (n=12 subjects), 9 subjects will be randomized to IP and 3 subjects to placebo. Cohorts may partially overlap after at least 9 subjects have completed 2-4 weeks of treatment (2 weeks of treatment is reached at Visit week 3) and a dose escalation decision has been made. Study drug will be administered weekly over a period of 12 weeks.

Conditions

• NAFLD

Interventions

Type	Name	Description
DRUG	HM15211	A sterile solution of HM15211 contained in pre-filled syringes
DRUG	Placebo of HM15211	A sterile, matching solution in pre-filled syringes

Timeline

• Start date: 2018-11-01
• Primary completion: 2020-03-18
• Completion: 2020-03-18
• First posted: 2018-11-16
• Last updated: 2025-01-27
• Results posted: 2025-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study