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

Obesity Clinical Trial

Official title:

Efficacy and Safety of Cagrilintide s.c. in Combination With Semaglutide s.c.(CagriSema s.c. 1.0 mg/1.0 mg and 1.7 mg/1.7 mg) Once-weekly in Participants With Overweight or Obesity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06388187
• Other study ID #: NN9838-7749
• Secondary ID: U1111-1298-34512
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: June 24, 2024
• Est. completion date: April 10, 2026

Study information

• Verified date: April 2024
• Source: Novo Nordisk A/S
• Contact: Novo Nordisk
• Phone: (+1) 866-867-7178
• Email: clinicaltrials[@]novonordisk.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: April 10, 2026
• Est. primary completion date: February 27, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female

• Age above or equal to 18 years at the time of signing informed consent

1. Body Mass index (BMI) greater than or equal to (=) 30.0 kilogram per meter square (kg/m^2) or

2. BMI =27.0 kg/m2 with the presence of at least one obesity related complication including, but not limited to hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease

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

Related Conditions & MeSH terms

• Obesity

Intervention

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

Locations

Country	Name	City	State
Canada	Nova Scotia Health Authority	Halifax	Nova Scotia
Canada	Wharton Med Clin Trials	Hamilton	Ontario
Canada	Ocean West Research Clinic	Surrey	British Columbia
France	Hospices Civils de Lyon-Hopital Lyon Sud-1	Pierre-Benite
France	Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1	Saint Herblain
France	Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1	Toulouse Cedex 9
Germany	InnoDiab Forschung GmbH	Essen
Germany	Wendisch/Dahl Hamburg	Hamburg
Germany	AmBeNet GmbH	Leipzig
Germany	Institut für Diabetesforschung GmbH Münster - Dr. med. Rose	Münster
Germany	Forschungszentrum Ruhr KliFoCenter GmbH, Dr. med. Kahrmann	Witten
United Kingdom	The Health Centre	Bradford-on-Avon
United Kingdom	Southmead Hospital	Bristol
United Kingdom	Addenbrooke's Hospital_Cambridge	Cambridge
United Kingdom	WISDEM Centre	Coventry
United Kingdom	The Staploe Medical Centre	Soham
United Kingdom	Joint Clinical Research Facility - Swansea	Swansea
United States	Washington Cntr Weight Mgmt	Arlington	Virginia
United States	Aurora FDRC Inc.	Costa Mesa	California
United States	Velocity Clinical Res-Dallas	Dallas	Texas
United States	Midwest Inst For Clin Res	Indianapolis	Indiana
United States	Capital Clin Res Ctr,LLC	Olympia	Washington
United States	Clinical Trial Res Assoc,Inc	Plantation	Florida
United States	Accellacare	Wilmington	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Canada,  France,  Germany,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative change in body weight	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 68)
Primary	Achievement of =5% weight reduction	Measured as count of participant.	From baseline (week 0) to end of treatment (week 68)
Secondary	Achievement of =10% weight reduction	Measured as count of participant.	From baseline (week 0) to end of treatment (week 68)
Secondary	Achievement of =15% weight reduction	Measured as count of participant.	From baseline (week 0) to end of treatment (week 68)
Secondary	Achievement of =20% weight reduction	Measured as count of participant.	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in waist circumference	Measured in centimeter (cm).	From baseline (week 0) to end of treatment (week 68)
Secondary	Change in systolic blood pressure	Measured in millimeters of mercury.	From baseline (week 0) to end of treatment (week 68)
Secondary	Ratio to baseline in lipids: Total cholesterol	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Secondary	Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Secondary	Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Secondary	Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Secondary	Ratio to baseline in lipids: Triglycerides	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Secondary	Ratio to baseline in lipids: Free fatty acids	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)