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The trial is taking place at:
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Spartanburg Medical Research | Spartanburg, SC

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

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Novo Nordisk

Status and phase

Enrolling
Phase 3

Conditions

Obesity

Treatments

Drug: Cagrilintide
Drug: Tirzepatide
Drug: Semaglutide

Study type

Interventional

Funder types

Industry

Identifiers

NCT06131437
U1111-1292-4835 (Other Identifier)
NN9838-7832

Details and patient eligibility

About

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.

Enrollment

800 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Male or female
  • Age 18 years or above at the time of signing the informed consent
  • Body mass index (BMI) of ≥ 30.0 kilogram per square meter (kg/m^2)

Exclusion criteria

  • Glycated haemoglobin (HbA1c) ≥ 6.5 % (48 millimoles per mole [mmol/mol]) as measured by the central laboratory at screening
  • History of type 1 or type 2 diabetes mellitus

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

800 participants in 2 patient groups

CagriSema 2.4 mg/2.4 mg
Experimental group
Description:
Participants will receive 2.4 mg cagrilintide and 2.4 mg semaglutide subcutaneously once-weekly (dose escalation period of 16 weeks) for up to 72 weeks.
Treatment:
Drug: Semaglutide
Drug: Cagrilintide
Tirzepatide 15 mg
Active Comparator group
Description:
Participants will receive 15 mg tirzepatide subcutaneously once-weekly (dose escalation period of 20 weeks) for up to 72 weeks.
Treatment:
Drug: Tirzepatide

Trial contacts and locations

46

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Central trial contact

Novo Nordisk

Data sourced from clinicaltrials.gov

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