A Research Study to See How Well Different Doses of CagriSema Help People With Excess Body Weight Lose Weight

Conditions

• Obesity

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cagrilintide — DRUG
  Participants will receive once-weekly cagrilintide subcutaneously.
• Semaglutide — DRUG
  Participants will receive once-weekly semaglutide subcutaneously.
• Placebo — DRUG
  Participants will receive once-weekly placebo matched to cagrilintide and semaglutide subcutaneously.

Study Details

This study will look at how well CagriSema helps people with excess body weight lose weight. CagriSema is a new medicine developed by Novo Nordisk that combines cagrilintide and semaglutide. CagriSema cannot yet be prescribed by doctors. In the study, participant will either get CagriSema or dummy medicine and which treatment participant get is decided by chance. The study will last for about 1½ years for each participant.

Key Dates

Start date

Jun 24, 2024

Status verified

May 2026

Primary completion

Apr 22, 2026

Completion

Apr 22, 2026

Study Design

Enrollment

300 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CagriSema Dose 1
  Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 8-week dose escalation period until target dose (dose 1) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 60 weeks.
• Placebo Comparator: Placebo Dose 1
  Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 1 (cagrilintide and semaglutide) for 68 weeks.
• Active Comparator: CagriSema Dose 2
  Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 12-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 56 weeks.
• Placebo Comparator: Placebo Dose 2
  Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 2 (cagrilintide and semaglutide) for 68 weeks.

Primary Outcome Measure

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

Locations (7)

Related coverage on Hipa.ai

• CagriSema Phase 3 Study for Excess Body Weight Reaches Primary Completion
  CagriSema (Cagrilintide B and Semaglutide I) · Apr 22, 2026 · ClinicalTrials.gov

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