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

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified February 2026 by Novo Nordisk A/S
Sponsor
Novo Nordisk A/S
Information Provided by (Responsible Party)
Novo Nordisk A/S
Clinicaltrials.gov Identifier
NCT06388187
Other Study ID Numbers:
NN9838-7749
First Submitted
April 23, 2024
First Posted
April 28, 2024
Last Update Posted
March 29, 2026
Last Verified
February 2026

ClinicalTrials.gov processed this data on March 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Obesity
Drug: CagrilintideDrug: PlaceboDrug: CagrilintideDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment300 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleEfficacy 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
Study Start DateJune 23, 2024
Actual Primary Completion DateApril 20, 2026
Actual Study Completion DateApril 20, 2026

Groups and Cohorts

Group/CohortIntervention/Treatment
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.
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.
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.
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.

Outcome Measures

Primary Outcome Measures
  1. Relative change in body weight
    Measured in percentage (%).
  2. Achievement of ≥5% weight reduction
    Measured as count of participant.
Secondary Outcome Measures
  1. Achievement of ≥10% weight reduction
    Measured as count of participant.
  2. Achievement of ≥15% weight reduction
    Measured as count of participant.
  3. Achievement of ≥20% weight reduction
    Measured as count of participant.
  4. Change in waist circumference
    Measured in centimeter (cm).
  5. Change in systolic blood pressure
    Measured in millimeters of mercury.
  6. Ratio to baseline in lipids: Total cholesterol
    Measured in ratio.
  7. Ratio to baseline in lipids: High-density lipoprotein (HDL) cholesterol
    Measured in ratio.
  8. Ratio to baseline in lipids: Low-density lipoprotein (LDL) cholesterol
    Measured in ratio.
  9. Ratio to baseline in lipids: Very low-density lipoprotein (VLDL) cholesterol
    Measured in ratio.
  10. Ratio to baseline in lipids: Triglycerides
    Measured in ratio.
  11. Ratio to baseline in lipids: Free fatty acids
    Measured in ratio.
  12. Number of treatment emergent adverse events (TEAEs)
    Measured as count of events.
  13. Number of treatment emergent serious adverse events (TESAEs)
    Measured as count of events.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsNovo Nordisk A/S
Locations
Aurora FDRC Inc. | Costa Mesa California, United States, 92627Clinical Trial Res Assoc,Inc | Plantation Florida, United States, 33324Midwest Inst For Clin Res | Indianapolis Indiana, United States, 46260Accellacare | Wilmington North Carolina, United States, 28401Velocity Clinical Res-Dallas | Dallas Texas, United States, 75230Washington Cntr Weight Mgmt | Arlington Virginia, United States, 22206Capital Clin Res Ctr,LLC | Olympia Washington, United States, 98502Ocean West Research Clinic | Surrey British Columbia, Canada, V3Z 2N6Nova Scotia Health Authority | Halifax Nova Scotia, Canada, B3H 1V7Wharton Med Clin Trials | Hamilton Ontario, Canada, L8L 5G8Hospices Civils de Lyon-Hopital Lyon Sud-1 | Pierre-Bénite , France, 69310Hospices Civils de Lyon-Hopital Lyon Sud | Pierre-Bénite , France, 69310Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec | Saint-Herblain , France, 44800Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil | Toulouse , France, 31059InnoDiab Forschung GmbH | Essen , Germany, 45136Wendisch - Dahl Hamburg - DZHW | Hamburg , Germany, 22607AmBeNet GmbH | Leipzig , Germany, 04107Institut für Diabetesforschung GmbH Münster - Dr. med. Rose | Münster , Germany, 48145Forschungszentrum Ruhr KliFoCenter GmbH, Kahrmann | Witten , Germany, 58455The Health Centre | Bradford-on-Avon , United Kingdom, BA15 1DQSouthmead Hospital | Bristol , United Kingdom, BS10 5NBAddenbrooke's Hospital_Cambridge | Cambridge , United Kingdom, CB2 0QQUniversity Hospital Coventry - WISDEM Centre | Coventry , United Kingdom, CV2 2DXStaploe Medical Centre | Soham , United Kingdom, CB7 5JDJoint Clinical Research Facility - Swansea | Swansea , United Kingdom, SA2 8PP
Investigators
Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S