A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight

Conditions

• Obesity
• Overweight

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cagrisema — DRUG
  Cagrisema (Cagrilintide and Semaglutide) will be administered subcutaneously using device 1 or device 2.
• Placebo CagriSema — DRUG
  Placebo matched to Cagrilintide and Placebo matched to Semaglutide will be administered subcutaneously using device 1 or device 2.

Study Details

This study is being done to find out how well a medicine called CagriSema helps people with overweight or obesity lose weight. CagriSema is still being tested in studies and is not yet available for doctors to prescribe. In this study the sponsor will compare two version of CagriSema injected by two different types of injection devices. Which treatment participants get is decided by chance using a computer program, so neither participants nor study staff will know which treatment is given. The study will last for about one year.

Key Dates

First listed

Jan 22, 2026

Start date

Jun 22, 2026

Status verified

Jul 2026

Primary completion

Nov 29, 2027

Completion

Jan 17, 2028

Study Design

Enrollment

0 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CagriSema B in device 2 + Placebo in device 1
  Participants will receive CagriSema B in device 2 followed by placebo matched to CagriSema in device 1 subcutaneously once weekly in a dose escalation manner for 16 weeks until the target maintenance dose and further continue to receive the same dose for up to 44 weeks.
• Experimental: CagriSema in device 1 + Placebo in device 2
  Participants will receive CagriSema in device 1 followed by placebo matched to CagriSema B in device 2 subcutaneously once weekly in a dose escalation manner for 16 weeks until the target maintenance dose and further continue to receive the same dose for up to 44 weeks.
• Placebo Comparator: Placebo in device 1 + Placebo in device 2
  Participants will receive placebo matched to Cagrisema in device 1 followed by placebo matched to CagriSema B in device 2 subcutaneously once weekly for up to 44 weeks.

Primary Outcome Measure

Relative change in body weight [ Time Frame: From baseline (week 0) to end of treatment (week 44) ]

Locations (26)

Find similar trials in Birmingham, AL

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