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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Drug: Cagrilintide; Drug: Semaglutide; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Surrey, British Columbia, Canada, V3Z 2N6
      • Ocean West Research Clinic
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3H 1V7
      • Nova Scotia Health Authority
  • Ontario
    • Hamilton, Ontario, Canada, L8L 5G8
      • Wharton Medical Clinic Clinical Trials (Hamilton)
• France
  • Pierre-Bénite, France, 69310
    • Hospices Civils de Lyon-Hopital Lyon Sud-1
  • Pierre-Bénite, France, 69310
    • Hospices Civils de Lyon-Hopital Lyon Sud
  • Saint-Herblain, France, 44800
    • Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec
  • Toulouse, France, 31059
    • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil
• Germany
  • Essen, Germany, 45136
    • InnoDiab Forschung Gmbh
  • Hamburg, Germany, 22607
    • Wendisch - Dahl Hamburg - DZHW
  • Leipzig, Germany, 04107
    • AmBeNet GmbH
  • Münster, Germany, 48145
    • Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
  • Witten, Germany, 58455
    • Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann
• United Kingdom
  • Bradford-on-Avon, United Kingdom, BA15 1DQ
    • The Health Centre
  • Bristol, United Kingdom, BS10 5NB
    • Southmead Hospital
  • Cambridge, United Kingdom, CB2 0QQ
    • Addenbrooke's Hospital_Cambridge
  • Coventry, United Kingdom, CV2 2DX
    • University Hospital Coventry - WISDEM Centre
  • Soham, United Kingdom, CB7 5JD
    • Staploe Medical Centre
  • Swansea, United Kingdom, SA2 8PP
    • Joint Clinical Research Facility - Swansea
• United States
  • California
    • Costa Mesa, California, United States, 92627
      • Aurora FDRC Inc.
  • Florida
    • Plantation, Florida, United States, 33324
      • Clinical Trial Res Assoc,Inc
  • Indiana
    • Indianapolis, Indiana, United States, 46260
      • Midwest Inst For Clin Res
  • North Carolina
    • Wilmington, North Carolina, United States, 28401
      • Accellacare
  • Texas
    • Dallas, Texas, United States, 75230
      • Velocity Clinical Res-Dallas
  • Virginia
    • Arlington, Virginia, United States, 22206
      • Washington Cntr Weight Mgmt
  • Washington
    • Olympia, Washington, United States, 98502
      • Capital Clin Res Ctr,LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 60 weeks.	Drug: Cagrilintide; Participants will receive once-weekly cagrilintide subcutaneously.; Drug: Semaglutide; Participants will receive once-weekly semaglutide subcutaneously.
Placebo Comparator: Placebo Dose 1; Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 1 (cagrilintide and semaglutide) for 68 weeks.	Drug: Placebo; Participants will receive once-weekly placebo matched to cagrilintide and semaglutide subcutaneously.
Active Comparator: CagriSema Dose 2; Participants will receive once-weekly s.c injections of CagriSema (cagrilintide and semaglutide) at escalating doses every week in 12-week dose escalation period until target dose (dose 2) of CagriSema(cagrilintide and semaglutide) is achieved and maintained up to 56 weeks.	Drug: Cagrilintide; Participants will receive once-weekly cagrilintide subcutaneously.; Drug: Semaglutide; Participants will receive once-weekly semaglutide subcutaneously.
Placebo Comparator: Placebo Dose 2; Participants will receive once-weekly s.c injection of placebo matched to cagrisema dose 2 (cagrilintide and semaglutide) for 68 weeks.	Drug: Placebo; Participants will receive once-weekly placebo matched to cagrilintide and semaglutide subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Relative change in body weight	Measured in percentage (%).	From baseline (week 0) to end of treatment (week 68)
Achievement of ≥5% weight reduction	Measured as count of participant.	From baseline (week 0) to end of treatment (week 68)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in waist circumference	Measured in centimeter (cm).	From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Total cholesterol	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Triglycerides	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Achievement of ≥10% weight reduction	Measured as count of participant.	From baseline (week 0) to end of treatment (week 68)
Achievement of ≥15% weight reduction	Measured as count of participant.	From baseline (week 0) to end of treatment (week 68)
Achievement of ≥20% weight reduction	Measured as count of participant.	From baseline (week 0) to end of treatment (week 68)
Change in systolic blood pressure	Measured in millimeters of mercury.	From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Free fatty acids	Measured in ratio.	From baseline (week 0) to end of treatment (week 68)
Number of treatment emergent adverse events (TEAEs)	Measured as count of events.	From baseline (week 0) to end of study (week 74)
Number of treatment emergent serious adverse events (TESAEs)	Measured as count of events.	From baseline (week 0) to end of study (week 74)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2024
• Primary Completion (Actual): April 22, 2026
• Study Completion (Actual): April 22, 2026

Study Registration Dates

• First Submitted: April 24, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 3, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Glucagon-Like Peptide-1 Receptor Agonists; Physiological Effects of Drugs; Hypoglycemic Agents; semaglutide; cagrilintide
• Other Study ID Numbers: NN9838-7749; U1111-1298-3451 (Other Identifier: World Health Organization (WHO)); 2023-509273-24 (Other Identifier: European Medical Agency (EMA))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No