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

Conditions

• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Semaglutide 2.4 mg — DRUG
  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
• Cagrilintide 2.4 mg — DRUG
  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
• Placebo (semaglutide) — DRUG
  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
• Placebo (cagrilintide) — DRUG
  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

Study Details

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

Key Dates

Start date

Aug 2, 2021

Status verified

Dec 2025

Primary completion

Jul 7, 2022

Completion

Jul 7, 2022

Study Design

Enrollment

92 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cagrilintide 2.4 mg and semaglutide 2.4 mg
  Participants will receive cagrilintide and semaglutide once a week as injections for 32 weeks.
• Active Comparator: Cagrilintide 2.4 mg and placebo (semaglutide)
  Participants will receive cagrilintide and placebo (semaglutide) once a week as injections for 32 weeks
• Active Comparator: Semaglutide 2.4 mg and Placebo (cagrilintide)
  Participants will receive semaglutide and placebo (cagrilintide) once a week as injections for 32 weeks

Primary Outcome Measure

Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide) [ Time Frame: Week 0, Week 32 ]

Locations (23)

Find similar trials in Birmingham, AL

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