A Research Study to Compare Blood Levels of Cagrilintide and Semaglutide After Combined Versus Separate Injections in People With Overweight or Obesity

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Obesity & Overweight

Treatments: Drug: Cagrilintide; Drug: Cagrilintide and semaglutide; Drug: semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT04940078

U1111-1250-7789 (Other Identifier)

NN9838-4614

Details and patient eligibility

About

This study will compare two different ways of giving cagrilintide and semaglutide for treating overweight and obesity. The medicines will either be given together in 1 injection or as 2 separate injections.

The aim of the study is to find out how the different ways of injection affect the level of the medicines in the blood.

For the first 14 weeks of the study, participants will get cagrilintide and semaglutide as 2 separate injections. Then participants will either switch to getting the medicines as a combined injection or continue to get the separate injections for 8 weeks. Which treatment participants get after the first 14 weeks is decided by chance.

Participants will get the study medicines once a week for 22 weeks. A study nurse at the clinic will inject the medicines with a thin needle in participants stomach area.

The study will last for about 8 months.Participants will have 28 clinic visits with the study staff. For 4 of these visits, participants will stay in the clinic for 5 nights.

Participants will have blood drawn at 21 visits. Participants will have clinical assessments and participants will be asked about their health, medical history and habits including mental health questionnaires.

For women: Participants must not be able to become pregnant if they wish to participate in this study.

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female of non-childbearing potential (NCBP)
• Aged 18-55 years (both inclusive) at the time of signing informed consent
• Body mass index (BMI) between 27.0 and 39.9 kg/m^2 (both inclusive) at screening. Overweight should be due to excess adipose tissue, as judged by the investigator

Exclusion criteria

• Previous participation in trial(s) with an amylin analogue unless documented that the subject was assigned to placebo treatment. Participation is defined as randomisation
• Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 3 patient groups

Part A: Cagrilintide and semaglutide in separate syringes

Experimental group

Description:

Participants will up-titrated for 14 weeks (dose escalation every 4 weeks and 2 weeks at last dose escalation step prior to randomisation) with cagrilintide and semaglutide administered as separate injections. Followed by 8 weeks treatment with cagrilintide and semaglutide administered as separate injections. The 8-week treatment period covers 2 different doses of cagrilintide and semaglutide (1.7/1.7 mg and 2.4/2.4 mg with 4 weeks on each dose combination). Followed by a 38 days follow-up period.

Treatment:

Drug: semaglutide

Drug: Cagrilintide

Part A: Cagrilintide and semaglutide combined in DV3384 device

Experimental group

Description:

Participants will be up-titrated for 14 weeks (dose escalation every 4 weeks and 2 weeks at last dose escalation step prior to randomisation) with cagrilintide and semaglutide administered as separate injections. Followed by 8 weeks of treatment with cagrilintide and semaglutide administered using the DV3384 manual syringe. The 8-week treatment period covers 2 different doses of cagrilintide and semaglutide (1.7/1.7 mg and 2.4/2.4 mg with 4 weeks on each dose combination. Followed by a 38 days follow-up period.

Treatment:

Drug: Cagrilintide and semaglutide

Part B: Cagrilintide and semaglutide combined in DV3384 device

Experimental group

Description:

Participants will receive a single injection of Cagrilintide 0.25 mg/semaglutide 0.25 mg using the DV3384 manual syringe followed by a 28 days follow-up period.

Treatment:

Drug: Cagrilintide and semaglutide