Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified March 2026 by Novo Nordisk A/S
Sponsor
Novo Nordisk A/S
Information Provided by (Responsible Party)
Novo Nordisk A/S
Clinicaltrials.gov Identifier
NCT07220642
Other Study ID Numbers:
NN9833-8242
First Submitted
October 22, 2025
First Posted
October 23, 2025
Last Update Posted
April 7, 2026
Last Verified
March 2026

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

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
ObesityOverweight
Drug: CagrilintideDrug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment300 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleEfficacy and Safety of Cagrilintide for Weight Management in Participants With Overweight or Obesity
Study Start DateNovember 4, 2025
Actual Primary Completion Date11mos 2w from now
Actual Study Completion Date1yr 1mo from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Cagrilintide
Participants will receive cagrilintide subcutaneously once weekly for 64 weeks.
Drug: Cagrilintide
Cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.
Placebo
Participants will receive placebo matched to cagrilintide subcutaneously once weekly for 64 weeks.
Drug: Placebo
Placebo matched to cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.

Outcome Measures

Primary Outcome Measures
  1. Relative change in body weight
    Measured as percentage (%) of body weight.
  2. Number of participants with achievement of greater than or equals (>=) 5 percent (%) body weight reduction
    Measured as count of participants.
Secondary Outcome Measures
  1. Number of participants with achievement of >= 10 % body weight reduction
    Measured as count of participants.
  2. Number of participants with achievement of >= 15 % body weight reduction
    Measured as count of participants.
  3. Change in waist circumference
    Measured as centimeter (cm).
  4. Ratio to baseline in triglycerides
    Measured as ratio.
  5. Ratio to baseline in high sensitivity C-Reactive Protein (hsCRP)
    Measured as ratio.
  6. Change in Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function score
    Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100.
  7. Change in body weight
    Measured as kilogram (kg).
  8. Change in SF-36v2® Health Survey Acute (SF-36v2® Acute) physical component summary score
    Measured as score on a scale. SF-36v2 Acute measures Health-Related Quality of Life (HRQoL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The physical component summary score ranges from 6.1 to 79.7.
  9. Change in SF-36v2® mental component summary score
    Measured as score on a scale. SF-36v2 Acute measures Health-Related Quality of Life (HRQoL). The measure consists of 36 items yielding 8 health domain scores and 2 component summary scores. SF-36v2 Acute scores are norm-based scores, that is. transformed to a scale where the 2009 US general population has a mean of 50 and a standard deviation of 10. Higher scores indicate better functional health and well-being. The mental component summary score ranges from -3.8 to 78.7.
  10. Change in IWQOL-Lite-CT total score
    Measured as score on a scale. IWQOL-Lite-CT measures weight-related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The total score ranges from 0-100.
  11. Number of participants with achievement of at least 14.6-point increase in IWQOL-Lite-CT Physical Function score (yes/no)
    Measured as count of participants. IWQOL-Lite-CT measures weight related physical and psychosocial functioning. The measure consists of 20 items yielding 3 composite scores, and 1 total score. Higher scores indicate better levels of functioning. The physical function score ranges from 0-100.
  12. Change in Systolic Blood Pressure (SBP)
    Measured as millimeter of mercury (mmHg).
  13. Change in Diastolic Blood Pressure (DBP)
    Measured as mmHg.
  14. Ratio to baseline of total cholesterol
    Measured as ratio.
  15. Ratio to baseline of High-Density Lipoprotein (HDL) cholesterol
    Measured as ratio.
  16. Ratio to baseline of Low-Density Lipoprotein (LDL) cholesterol
    Measured as ratio.
  17. Ratio to baseline of Very Low-Density Lipoprotein (VLDL) cholesterol
    Measured as ratio.
  18. Ratio to baseline of non-HDL cholesterol
    Measured as ratio.
  19. Ratio to baseline of free fatty acids
    Measured as ratio.
  20. Change in glycated haemoglobin (HbA1c) percentage-points (%-points)
    Measured as %-points.
  21. Change in HbA1c millimoles per mole (mmol/mol)
    Measured as mmol/mol.
  22. Change in Fasting Plasma Glucose (FPG) millimoles per litre (mmol/L)
    Measured as mmol/L.
  23. Change in FPG milligrams per deciliter (mg/dL)
    Measured as mg/dL.
  24. Ratio to baseline in fasting serum insulin
    Measured as ratio.
  25. Number of treatment emergent adverse events (TEAEs)
    Measured as count of events.
  26. 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
Inclusion criteria:
Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
Female or male (sex at birth)
Age 18 years or above at the time of signing the informed consent
History of at least one self-reported unsuccessful dietary effort to lose body weight (a\
)
Body mass index (BMI) greater than or equal to \>= 30.0 kilogram per square meter (kg/m\^2), or BMI greater than or equal to \>= 27.0 kg/m\^2 with the presence of at least one weight related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease (a\
)
Exclusion Criteria
Inclusion criteria:
Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study
Female or male (sex at birth)
Age 18 years or above at the time of signing the informed consent
History of at least one self-reported unsuccessful dietary effort to lose body weight (a\
)
Body mass index (BMI) greater than or equal to \>= 30.0 kilogram per square meter (kg/m\^2), or BMI greater than or equal to \>= 27.0 kg/m\^2 with the presence of at least one weight related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease (a\
) Exclusion criteria:
History of type 1 or type 2 diabetes (a\
)
Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening (a\
)
Previous dosing of marketed or non-marketed amylin-based compounds (a\
) (a\
) - As declared by the participant, reported in the medical records or at the investigator's discretion.

Contacts and Locations

Sponsors and CollaboratorsNovo Nordisk A/S
Locations
Diablo Clinical Research, Inc. | Walnut Creek California, United States, 94598Univ of Colorado at Denver | Aurora Colorado, United States, 80045Florida Inst For Clin Res LLC | Orlando Florida, United States, 32825Oviedo Medical Research, LLC | Oviedo Florida, United States, 32765Walgreens - Store 11760 | Oak Park Illinois, United States, 60302Midwest Inst For Clin Res | Indianapolis Indiana, United States, 46260StudyMetrix Research LLC | City of Saint Peters Missouri, United States, 63303PharmQuest Life Sciences LLC | Greensboro North Carolina, United States, 27408Selma Medical Associates | Winchester Virginia, United States, 22601-3834CIPREC Pueyrredon | Buenos Aires , Argentina, C1119ACNCEDIC Centro de Investigación Clínica | CABA , Argentina, C1060ABASydney Cardiometabolic Centre | Liverpool New South Wales, Australia, 2170Hunter Diabetes Centre | Merewether New South Wales, Australia, 2291G.A. Research Associates Ltd. | Moncton New Brunswick, Canada, E1G 1A7Nova Scotia Hlth Halifax | Halifax Nova Scotia, Canada, B3H 1V7Hamilton Medical Rsrch Grp | Hamilton Ontario, Canada, L8L 5G4Wharton Medical Clinic Clinical Trials (Hamilton) | Hamilton Ontario, Canada, L8L 5G8Milestone Research | London Ontario, Canada, N5W 6A2Centricity Research Oshawa | Oshawa Ontario, Canada, L1J 2K9Centricity Research Toronto | Toronto Ontario, Canada, M4G 3E8Centricity Research Mirabel | Mirabel Quebec, Canada, J7J 2K8Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec | Saint-Herblain , France, 44800Centre de Recherche Clinique Portes Du Sud | Vénissieux , France, 69200InnoDiab Forschung GmbH | Essen , Germany, 45136Wendisch - Dahl Hamburg - DZHW | Hamburg , Germany, 22607RED-Institut für medizinische Forschung und Fortbildung GmbH | Oldenburg in Holstein , Germany, 23758Fondazione Policlinico Universitario Agostino Gemelli IRCS | Rome RM, Italy, 00168AOUP Giaccone Palermo | Palermo Sicily, Italy, 90127A.O.U. Bologna_ Policlinico S.Orsola Malpighi | Bologna , Italy, 40138IRCCS Ospedale San Raffaele Milano | Milan , Italy, 20132Haukeland Universitetssykehus | Bergen , Norway, 5021Drammen sykehus - Vestre Viken HF | Drammen , Norway, 3004St. Olavs Hospital HF_Endokrinologisk avdeling | Trondheim , Norway, NO-7030Osteo-Medic s.c. A. Racewicz, J. Supronik | Bialystok , Poland, 15-351Care Clinic Sp. z o. o. | Katowice , Poland, 40-568Terpa Sp. z o.o. Sp. k. | Lublin , Poland, 20-333NBR Polska Tomasz Klodawski | Warsaw , Poland, 00-710Oak Tree Surgery | Liskeard Cornwall, United Kingdom, PL14 3XANorth Coast Medical Ltd | Newquay Cornwall, United Kingdom, TR7 1RUBrunel Medical Practice | Torquay Devon, United Kingdom, TQ1 4QX
Investigators
Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S