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

April 24, 2024 updated by: Novo Nordisk A/S

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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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 Med Clin Trials
  • France
      • Pierre-Benite, France, 69310
        • Hospices Civils de Lyon-Hopital Lyon Sud-1
      • Saint Herblain, France, 44800
        • Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec-1
      • Toulouse Cedex 9, France, 31059
        • Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1
  • Germany
      • Essen, Germany, 45136
        • InnoDiab Forschung GmbH
      • Hamburg, Germany, 22607
        • Wendisch/Dahl Hamburg
      • Leipzig, Germany, 04107
        • AmBeNet GmbH
      • Münster, Germany, 48145
        • Institut für Diabetesforschung GmbH Münster - Dr. med. Rose
      • Witten, Germany, 58455
        • Forschungszentrum Ruhr KliFoCenter GmbH, Dr. med. 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
        • WISDEM Centre
      • Soham, United Kingdom, CB7 5JD
        • The 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in percentage (%).
From baseline (week 0) to end of treatment (week 68)
Achievement of ≥5% weight reduction
Time Frame: From baseline (week 0) to end of treatment (week 68)
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
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in centimeter (cm).
From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Total cholesterol
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Triglycerides
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
From baseline (week 0) to end of treatment (week 68)
Achievement of ≥10% weight reduction
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured as count of participant.
From baseline (week 0) to end of treatment (week 68)
Achievement of ≥15% weight reduction
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured as count of participant.
From baseline (week 0) to end of treatment (week 68)
Achievement of ≥20% weight reduction
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured as count of participant.
From baseline (week 0) to end of treatment (week 68)
Change in systolic blood pressure
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in millimeters of mercury.
From baseline (week 0) to end of treatment (week 68)
Ratio to baseline in lipids: Free fatty acids
Time Frame: From baseline (week 0) to end of treatment (week 68)
Measured in ratio.
From baseline (week 0) to end of treatment (week 68)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 24, 2024

Primary Completion (Estimated)

February 27, 2026

Study Completion (Estimated)

April 10, 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)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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