Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes 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
NCT07220759
Other Study ID Numbers:
NN9833-8243
First Submitted
October 22, 2025
First Posted
October 23, 2025
Last Update Posted
April 20, 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
OverweightObesityType 2 Diabetes
Drug: CagrilintideDrug: Placebo (matched to Cagrilintide)

Study Design

Study TypeInterventional
Actual Enrollment330 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleEfficacy and Safety of Cagrilintide for Weight Management in Participants With Overweight or Obesity and Type 2 Diabetes
Study Start DateNovember 4, 2025
Actual Primary Completion Date1yr 6d 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 (matched to Cagrilintide)
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% 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 lipids: 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 in lipids: total cholesterol
    Measured as ratio.
  15. Ratio to baseline in lipids: high-density lipoprotein (HDL) cholesterol
    Measured as ratio.
  16. Ratio to baseline in lipids: low-density lipoprotein (LDL) cholesterol
    Measured as ratio.
  17. Ratio to baseline in lipids: very low-density lipoprotein (VLDL) cholesterol
    Measured as ratio.
  18. Ratio to baseline in lipids: non-HDL cholesterol
    Measured as ratio.
  19. Ratio to baseline in lipids: free fatty acids
    Measured as ratio.
  20. Change in glycated haemoglobin (HbA1c) in percentage-points (%-points)
    Measured as %-points.
  21. Change in HbA1c in millimole per mole (mmol/mol)
    Measured as mmol/mol.
  22. Change in fasting plasma glucose (FPG) in millimole per liter (mmol/L)
    Measured as mmol/L.
  23. Change in FPG in milligram 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
    Measured as count of events.
  26. Number of treatment emergent serious adverse events (TESAEs)
    Measured as count of events.
  27. Number of clinically significant hypoglycaemic episodes (level 2):<3.0 mmol/L [54 mg/dL], confirmed by blood glucose meter
    Measured as count of events.
  28. Number of severe hypoglycaemic episodes (level 3): hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery, with no specific glucose threshold
    Measured as count of events.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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) \>= 27.0 kilogram per square meter (kg/m\^2).(a\
)
Diagnosed with type 2 diabetes \>= 180 days before screening.
Treatment with either lifestyle intervention(a\
), or:
Stable treatment (same drug(s), dose and dosing frequency) for at least 90 days before screening with 1-3 marketed oral antidiabetic drugs (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, Dipeptidyl peptidase-4 inhibitor (DPP-4i) or sulphonylureas (SU) as a single agent or in combination according to local practice.(a\
)
For up to 30% of participants the following concomitant medication is allowed:
Treatment for any indication with a stable dose of glucagon-like peptide-1 (GLP-1) containing medication, stable for at least 1 year before screening (a\
) and/or
Treatment with basal insulin minimum (0.25 units per kilogram per day (U/kg/day) or 20 units per day \[U/day\]) stable for at least 90 days before screening.(a\
) Key
Exclusion Criteria
Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening.(a\
)
Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) or GLP-1 containing medication within 180 days before screening, apart from those randomized according to inclusion criteria 7bi.(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
Univ of Alabama_Birmingham | Birmingham Alabama, United States, 35294Chambliss Clinical Trials, LLC | Montgomery Alabama, United States, 36106Elite Clinical Network - Tucson | Tucson Arizona, United States, 85704Scripps Whittier Diabetes Inst | La Jolla California, United States, 92037Clinical Trials Research | Lincoln California, United States, 95648Pacific Clinical Studies | Los Alamitos California, United States, 90720Walgreens - Store 4442 | Kissimmee Florida, United States, 34746Optimal Research Sites | Orange City Florida, United States, 32763Center for Diab,Obes & Metab | Pembroke Pines Florida, United States, 33024Palm Beach Research Center | West Palm Beach Florida, United States, 33409East West Med Res Inst | Honolulu Hawaii, United States, 96814MediSphere Medical RC | Evansville Indiana, United States, 47714Walgreens - Store 3915 | Las Vegas Nevada, United States, 89146Chear Center LLC | The Bronx New York, United States, 10455Centricity Res New Bern Multispeciality | New Bern North Carolina, United States, 28562Accellacare | Wilmington North Carolina, United States, 28401Spartanburg Medical Research | Spartanburg South Carolina, United States, 29303Holston Medical Group_Bristol | Bristol Tennessee, United States, 37620Velocity Clinical Res-Dallas | Dallas Texas, United States, 75230TPMG Clinical Research | Newport News Virginia, United States, 23606National Clin Res Inc. | Richmond Virginia, United States, 23294Buenos Aires Mácula | Ciudad Autonoma de Buenos Aires Buenos Aires, Argentina, C1061AAECICEMO- Consultorio de Investigación Clínica EMO | Ciudad Autonoma de Buenos Aires Buenos Aires, Argentina, C1405BUBCentro Medico Dra. Laura Maffei e Investigacion Clínica Apli | Buenos Aires , Argentina, C1425AGCOCT Research ULC (dba Okanagan Clinical Trials) | Kelowna British Columbia, Canada, V1Y 1Z9G.A. Research Associates Ltd. | Moncton New Brunswick, Canada, E1G 1A7Nova Scotia Hlth Halifax | Halifax Nova Scotia, Canada, B3H 1V7Centricity Research Brampton Endocrinology | Brampton Ontario, Canada, L6S 0C6Hamilton Medical Rsrch Grp | Hamilton Ontario, Canada, L8L 5G4Wharton Medical Clinic Clinical Trials (Hamilton) | Hamilton Ontario, Canada, L8L 5G8Milestone Research | London Ontario, Canada, N5W 6A2Centricity Res Pointe-Claire | Pointe-Claire Quebec, Canada, H9R 4S3Diex Recherche Victoriaville | Victoriaville Quebec, Canada, G6P 3Z8Opca bolnica Karlovac | Karlovac , Croatia, 47000Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology | Krapinske Toplice , Croatia, 49217Poliklinika SLAVONIJA OSIJEK | Osijek , Croatia, 31000Poliklinika Solmed | Zagreb , Croatia, 10000Lékařský dům Géčko | České Budějovice , Czechia, 370 11Milan Kvapil s.r.o. | Prague , Czechia, 149 00EUC Klinika Praha a.s. | Prague , Czechia, 150 00Debreceni Egyetem | Debrecen Hajdú-Bihar, Hungary, 4032QUALICLINIC Egészségügyi Szolgáltató és Kutatásszervező Kft | Budapest Pest County, Hungary, 1036Óbudai Egészségügyi Centrum | Budapest Pest County, Hungary, 1036Komáromi Selye János Kórház | Komárom , Hungary, 2900Diabmed Dr Popescu Alexandrina SRL | Ploieşti Prahova, Romania, 100179CMI Dr. Pletea Noemi SRL | Bacau , Romania, 600154Diabet Med SRL | Bucharest , Romania, 050913S.C Milena Sante SRL | Galati , Romania, 800001Clinica Korall S.R.L. Satu Mare | Satu Mare , Romania, 440055Nemocnica akademika L. Derera, UNB | Bratislava , Slovakia, 831 01DIAB s.r.o. | Rožňava , Slovakia, 04801IRIDIA s.r.o. | Vrútky , Slovakia, 038 61Pusan National University Yangsan Hospital | Yangsan Gyeongsangnam-do, South Korea, 50612Chonnam National University Hospital | Gwangju , South Korea, 61469Seoul National University Hospital | Seoul , South Korea, 03080The Catholic University of Korea, Seoul ST. Mary's Hospital | Seoul , South Korea, 06591The Catholic University of Korea, Yeouido ST. Mary's Hospital | Seoul , South Korea, 07345Kyunghee University Medical Center | Seoul , South Korea, 130-872Universitätsspital Basel | Basel , Switzerland, 4031Centre hospitalier universitaire vaudois CHUV | Lausanne , Switzerland, 1011Kantonsspital Olten | Olten , Switzerland, 4600Diabetes Adipositas Zentrum Zürich | Zollikerberg , Switzerland, 8125Oak Tree Surgery | Liskeard Cornwall, United Kingdom, PL14 3XANorth Coast Medical Ltd | Newquay Cornwall, United Kingdom, TR7 1RUBrunel Medical Practice | Torquay Devon, United Kingdom, TQ1 4QXAttenborough Surgery | Bushey Hertfordshire, United Kingdom, WD23 2NNHammersmith and Fulham Partnership Research Unit - Richford Gate Primary Care Centre | London , United Kingdom, W6 7HY
Investigators
Study Director: Clinical Transparency' (dept. 2834), Novo Nordisk A/S