Comparing Two HS-20094 Injection Pens in Adults with Overweight or Obesity Aged 18 to 65

What this Trial Is About

Researchers are evaluating the bioequivalence of two forms of HS-20094 injection pens in adults who are overweight or obese. This multicenter, randomized, open-label, parallel clinical study aims to compare the HS-20094 MDV multi-dose vial pen and the HS-20094 AI auto-injector pen during multiple doses. The study is sponsored by Jiangsu Hansoh Pharmaceutical Co., Ltd. and focuses on participants aged 18 to 65 years with a body mass index BMI of 24.0 kgm2 or higher. Participants will receive either the HS-20094 AI pen or the HS-20094 MDV pen administered subcutaneously once a week. The dose starts at 2.5 mg and is gradually increased every 4 weeks until reaching the target dose of 15 mg. Both groups follow the same dose escalation schedule. The study includes a treatment period lasting up to Day 169, with safety and immunogenicity monitored through Day 204. During the study, participants will undergo multiple evaluations including laboratory tests, vital sign checks, and immunogenicity assessments at scheduled visits Days 1, 29, 57, 85, 106, 141, and 169. Researchers will measure the bioequivalence of the two pens by examining how the drug acts in the body at the 15 mg and 10 mg doses. Safety monitoring continues through Day 204. The total study duration per participant is approximately 204 days.

A Study of HS-20094 in Overweight or Obese Participants