A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin With or Without an SGLT2 Inhibitor

Conditions

• Type 2 Diabetes

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Cagrilintide — DRUG
  Cagrilintide will be administered subcutaneously.
• Semaglutide — DRUG
  Semaglutide will be administered subcutaneously.
• Tirzepatide — DRUG
  Tirzepatide will be administered subcutaneously.

Study Details

This study will look at how well CagriSema helps people 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 medicine called tirzepatide that doctors may prescribe in some countries. Participants will get either CagriSema or tirzepatide. Which treatment participant get is decided by chance like flipping a coin. Participant will have an equal chance of receiving either drug. For each participant, the study will last for up to one and a half years.

Key Dates

Start date

Jan 16, 2024

Status verified

Apr 2026

Primary completion

Mar 4, 2026

Completion

Apr 6, 2026

Study Design

Enrollment

1,024 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CagriSema
  Participants will receive cagrilintide dose 1 and semaglutide dose 2 subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 68 weeks.
• Active Comparator: Tirzepatide
  Participants will receive tirzepatide dose 1 subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 68 weeks.

Primary Outcome Measure

Change in glycated haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to end of treatment (week 68) ]

Locations (117)

Related coverage on Hipa.ai

• CagriSema Phase 3 Trial for Type 2 Diabetes Completes Primary Data Collection
  CagriSema (Cagrilintide B and Semaglutide I) · Mar 4, 2026 · ClinicalTrials.gov

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