NCT04982575

Research Study to Look at How Well Cagrilintide Together With Semaglutide Works in People With Type 2 Diabetes

Efficacy and Safety of Co-administration of Cagrilintide s.c. 2.4 mg and Semaglutide s.c. 2.4 mg Once Weekly in Subjects With Type 2 Diabetes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study looks at how well a new medicine called cagrilintide works together with semaglutide on blood sugar levels in people with type 2 diabetes compared to cagrilintide alone or semaglutide alone. Before a new medicine can be prescribed to people it needs to be tested to see if it is safe and effective. Participants will either get cagrilintide and semaglutide together or cagrilintide and a dummy medicine or semaglutide and a dummy medicine. Which treatment participants get is decided by chance. A dummy medicine (placebo) looks like the study medicine but does not contain any active medicine. The dummy medicine is in the study to see if the study medicine works as expected. Participants will get 2 injections per week on the same day. Participants will take the study medicine with a pen. A pen is a medical tool with a needle used for injections under the skin. The study doctor or staff will show how. The study will last for about 39 weeks. Participants will have 12 visits at the clinic and 5 phone calls with the study doctor. At 6 of the clinic visits participants must not eat and drink for 8 hours before the visit (water is allowed). Women who can become pregnant cannot take part in this study. Only women that are surgically sterilised or post-menopausal are allowed to participate in this study Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Semaglutide 2.4 mg	Semaglutide administered s.c. (subcutaneously, under the skin) once weekly. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks
DRUG	Cagrilintide 2.4 mg	Cagrilintide administered s.c. (subcutaneously, under the skin) once weekly. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks
DRUG	Placebo (semaglutide)	Placebo (semaglutide) administered s.c. (subcutaneously, under the skin) once weekly. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks
DRUG	Placebo (cagrilintide)	Placebo (cagrilintide) administered s.c. (subcutaneously, under the skin) once weekly. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks

Timeline

• Start date: 2021-08-02
• Primary completion: 2022-07-07
• Completion: 2022-07-07
• First posted: 2021-07-29
• Last updated: 2025-12-23
• Results posted: 2023-07-27

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study