NCT05486065

A Research Study to Look Into How Well Semaglutide Medicine Works at Different Doses in People With Type 2 Diabetes and Overweight

Investigation of Once-weekly Semaglutide S.C. Dose-Response in Patients With Type 2 Diabetes and Overweight - a Participant- and Investigator-blinded and Sponsor Open-label Study

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 245 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

Summary

This study compares how three doses of semaglutide work in participants with type 2 diabetes (T2D) and overweight who are taking metformin. The study will look mainly at how well participant's blood sugar and participant's body weight are controlled when they are taking the study medicine at different doses. Participants will either get semaglutide \[2 milligrams (mg), 8 mg, or 16 mg\] or semaglutide placebo (a dummy medicine). Participants will take the study medicine with an injection pen called NovoPen®4. The injection pen is a medical tool with a needle used to inject the study medicine under the skin. The study will last for about 52 weeks. Participants will have 13 clinic visits and 4 phone calls.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Semaglutide	Semaglutide s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period.
DRUG	Placebo	Semaglutide placebo s.c. injection once-weekly for 40 weeks. Dose gradually increased over 24 weeks, followed by a 16 week maintenance period.

Timeline

• Start date: 2022-08-08
• Primary completion: 2023-10-12
• Completion: 2023-12-13
• First posted: 2022-08-03
• Last updated: 2025-12-12
• Results posted: 2024-11-05

Locations

130 sites across 5 countries: United States, Greece, Hungary, Poland, Puerto Rico

Regulatory

• FDA-regulated drug study