A Research Study to See How Well CagriSema Compared to Tirzepatide Helps People With Obesity Lose Weight

Conditions

• Obesity

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 compared to Tirzepatide helps people lower their body weight. CagriSema is a new investigational medicine developed by Novo Nordisk that combines Cagrilintide and Semaglutide. CagriSema is not yet being prescribed by doctors. Participant will get injections once a week throughout the treatment period. Participant will inject the study medicine under the skin with a pen injector in the thigh, stomach, or upper arm. After a first low dose, the study medicine will be gradually increased until reaching the planned dose (2.4 mg CagriSema or 15 mg Tirzepatide). The study will last for about one and a half year for each participant.

Key Dates

Start date

Nov 27, 2023

Status verified

Feb 2026

Primary completion

Dec 8, 2025

Completion

Jan 9, 2026

Study Design

Enrollment

809 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CagriSema 2.4 mg/2.4 mg
  Participants will receive 2.4 mg cagrilintide and 2.4 mg semaglutide subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 84 weeks.
• Active Comparator: Tirzepatide 15 mg
  Participants will receive 15 mg tirzepatide subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 84 weeks.

Primary Outcome Measure

To confirm non-inferiority of CagriSema versus tirzepatide: Relative change in body weight [ Time Frame: From baseline (week 0) to end of treatment (week 84) ]

Locations (46)

Related coverage on Hipa.ai

• CagriSema Trial for Obesity Reaches Primary Completion on December 8, 2025
  CagriSema (Cagrilintide B and Semaglutide I) · Dec 8, 2025 · ClinicalTrials.gov

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