NCT06633783

A Phase III Study Comparing the Weight Loss Effects of Semaglutide Injection and Wegovy®

A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Study Comparing the Efficacy and Safety of Semaglutide Injection and Wegovy® for Weight Loss in Obese Subjects

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 370 (estimated)
• Sponsor: Hangzhou Jiuyuan Gene Engineering Co. Ltd., · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to compare the effect on body weight in subjects taking semaglutide injection or subjects taking Wegovy®.

Detailed description

The study will involve participants engaging in discussions with study staff regarding healthy dietary choices, strategies for increasing physical activity, and additional methods for achieving weight loss, alongside the administration of the study medication. Participants will be randomly assigned to receive either semaglutide injection or Wegovy®. The study medication will be administered via a weekly subcutaneous injection using a fine needle in the abdominal skinfold. The duration of the study will be approximately 2 years, during which participants will attend 13 clinic visits with the study physician.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Semaglutide	The dose escalation phase, starting with 0.25mg once weekly and increasing every 4 weeks (0.5mg, 1.0mg, 1.7mg), is expected to last 16 weeks; In the dose maintenance phase, the target dose of 2.4mg was maintained for 28 weeks.Treatment duration 44 weeks.
DRUG	Semaglutide	The dose escalation phase, starting with 0.25mg once weekly and increasing every 4 weeks (0.5mg, 1.0mg, 1.7mg), is expected to last 16 weeks; In the dose maintenance phase, the target dose of 2.4mg was maintained for 28 weeks.Treatment duration 44 weeks.

Timeline

• Start date: 2024-10-30
• Primary completion: 2026-05-30
• Completion: 2026-10-30
• First posted: 2024-10-09
• Last updated: 2024-10-09

Locations

14 sites across 1 country: China