NCT05616052

Comparison of Body Weight Change Through Different Smeglutide Administration Methods

Prospective Randomized Controlled Study on the Improvement of Body Weight Among Overweight and Obese Patients Through Different Smeglutide Administration Methods

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Huashan Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Investigators determined to detect the effect of smeglutide on body weight and metabolic indexes among overweight and obese participants through two different dosing programs.

Detailed description

Participants will be randomized into either group. One group will start from 0.25mg per week for four weeks, then increase to 0.5mg per week for four weeks, and 1mg per week maintenance dose for 8 weeks. The other group dosage regime depends on the tolerance of the semaglutide from participants. The dosage will stabilize on the dose how much participant could tolerate. At the end of 16 weeks treatment, comparison will be carried out on weight change before and after treatment and (1) Comparison of different administration methods (standards and titrations) on participant compliance, appetite and quality of life improvement; (2) Comparison of metabolism (waist hip circumference, body fat and body composition, blood pressure, blood lipid, blood glucose, insulin resistance) in different administration modes; (3) Comparison of adverse reactions of metabolic drugs in different administration modes.

Conditions

• Weight Change, Body

Interventions

Type	Name	Description
DRUG	Semaglutide	treatment with different dosage regimes

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2022-11-15
• Last updated: 2022-11-15

Locations

1 site across 1 country: China