A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Placebo in People With Type 2 Diabetes Treated With Diet and Exercise

Conditions

• Type 2 Diabetes

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 placebo matched to cagrilintide and semaglutide subcutaneously.

Study Details

This study will look at how much CagriSema helps participants with type 2 diabetes lower their blood sugar and body weight. CagriSema is a new investigational medicine. Doctors may not yet prescribe CagriSema. CagriSema will be compared to a "dummy" medicine (also called "placebo") that has no effect on the body. Participants will get either CagriSema or "dummy" medicine. Which treatment participants get is decided by chance. For each participant, the study will last for about one year.

Key Dates

Start date

Mar 19, 2024

Status verified

Mar 2026

Primary completion

Oct 1, 2025

Completion

Dec 22, 2025

Study Design

Enrollment

189 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: CagriSema Dose 2
  Participants will receive once-weekly subcutaneous (s.c) injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 16-week dose escalation period until target dose (dose 2) of CagriSema (cagrilintide and semaglutide) is achieved and maintained up to 24 weeks.
• Placebo Comparator: Placebo Dose 2
  Participants will receive once-weekly s.c injection of placebo matched to Cagrisema (cagrilintide and semaglutide) dose 2 for 40 weeks.
• Active Comparator: 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 32 weeks.
• Placebo Comparator: Placebo Dose 1
  Participants will receive once-weekly s.c injection of placebo matched to Cagrisema (cagrilintide and semaglutide) dose 1 for 40 weeks.

Primary Outcome Measure

Change in glycated haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to end of treatment (week 40) ]

Locations (21)

Related coverage on Hipa.ai

• CagriSema Phase 3 Trial for Type 2 Diabetes Reaches Primary Completion
  CagriSema (Cagrilintide B and Semaglutide I) · Oct 1, 2025 · ClinicalTrials.gov

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