A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight

Conditions

• Obesity

Eligibility Criteria

Sex

ALL

Age

N/A - N/A

Healthy Volunteers

Not accepted

Interventions

• Cagrilintide — DRUG
  Cagrilintide will be administered subcutaneously.
• Semaglutide — DRUG
  Participants will recieve semaglutide subcutaneously.
• Placebo cagrilintide — DRUG
  Participants will receive placebo matched to cagrilintide.
• Placebo semaglutide — DRUG
  Participants will receive placebo matched to semaglutide.

Study Details

This study has 2 parts: First part is the main study and second part is the extension study. During the main study participants will receive 1 of 4 study medicines. If participants continue in the extension study, they will not receive any study medicine during the extension. The main study will look at how well CagriSema helps participants with excess body weight lose weight compared to a "dummy" medicine and 2 other medicines, cagrilintide and semaglutide. Participants will either get CagriSema, cagrilintide,semaglutide or "dummy" medicine. Which treatment participants get is decided by chance. They will take one injection once a week. The study medicine is injected briefly with a thin needle, typically in the stomach, thighs or upper arms. Extension study: After the main study, not all participants will continue in the extension study. The study staff will tell the participant if they will continue or not into the extension study. In the extension study we will look at what happens to the participant's body weight and diseases related to excess body weight after the participant stops taking the study medicine. The main study will last for about 1½ years and the extension study will last for another 2 years.

Key Dates

Start date

Nov 1, 2022

Status verified

May 2026

Primary completion

Oct 30, 2024

Completion

Oct 19, 2026

Study Design

Enrollment

3,400 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Cagrisema
  Participants will receive cagrilintide and semaglutide once-weekly after a dose escalation period of 16 weeks during the maintenance period for 52 weeks in the main phase. Participants randomised to this arm will be included in the extension phase for 97 weeks.
• Active Comparator: Cagrilintide
  Participants will receive cagrilintide s.c. and placebo matching to semaglutide once-weekly after a dose escalation period of 16 weeks during the maintenance period for 52 weeks.
• Active Comparator: Semaglutide
  Participants will receive semaglutide s.c.and placebo matched to cagrilintide once-weekly after a dose escalation period of 16 weeks during the maintenance period for 52 weeks.
• Placebo Comparator: Placebo s.c.
  Participants will receive placebo matched to cagrilintide and placebo matched to semaglutide once weekly for 68 weeks. Participants randomised to this arm will be included in the extension phase for 97 weeks.

Primary Outcome Measure

CagriSema versus placebo: Relative change in body weight [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]

Locations (45)

Find similar trials in Birmingham, AL

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