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ACTIVE NOT RECRUITING

NCT07220759

PHASE3

Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide

Sponsor: Novo Nordisk A/S

View on ClinicalTrials.gov

Summary

This study will look at how much cagrilintide helps people with overweight or obesity and type 2 diabetes lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participant will either get cagrilintide or placebo. Which treatment participant get is decided by chance. Participants are two times more likely to get cagrilintide than placebo. Like all medicines, the study medicine may have side effects. For each participant, the study will last for about 1 year and 6 months.

Official title: Efficacy and Safety of Cagrilintide for Weight Management in Participants With Overweight or Obesity and Type 2 Diabetes

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

330

Start Date

2025-11-05

Completion Date

2027-06-30

Last Updated

2026-03-06

Healthy Volunteers

Conditions

Overweight Obesity Type 2 Diabetes

Interventions

DRUG

Cagrilintide

Cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.

DRUG

Placebo (matched to Cagrilintide)

Placebo matched to cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.

Key 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.

Locations (67)

Univ of Alabama_Birmingham

Birmingham, Alabama, United States

Chambliss Clinical Trials, LLC

Montgomery, Alabama, United States

Elite Clinical Network - Tucson

Tucson, Arizona, United States

Scripps Whittier Diabetes Inst

La Jolla, California, United States

Clinical Trials Research

Lincoln, California, United States

Pacific Clinical Studies

Los Alamitos, California, United States

Walgreens - Store 4442

Kissimmee, Florida, United States

Optimal Research Sites

Orange City, Florida, United States

Center for Diab,Obes & Metab

Pembroke Pines, Florida, United States

Palm Beach Research Center

West Palm Beach, Florida, United States

East West Med Res Inst

Honolulu, Hawaii, United States

MediSphere Medical RC

Evansville, Indiana, United States

Walgreens - Store 3915

Las Vegas, Nevada, United States

Chear Center LLC

The Bronx, New York, United States

Centricity Res New Bern Multispeciality

New Bern, North Carolina, United States

Accellacare

Wilmington, North Carolina, United States

Spartanburg Medical Research

Spartanburg, South Carolina, United States

Holston Medical Group_Bristol

Bristol, Tennessee, United States

Velocity Clinical Res-Dallas

Dallas, Texas, United States

TPMG Clinical Research

Newport News, Virginia, United States

National Clin Res Inc.

Richmond, Virginia, United States

Buenos Aires Mácula

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

CICEMO- Consultorio de Investigación Clínica EMO

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli

Buenos Aires, Argentina

OCT Research ULC (dba Okanagan Clinical Trials)

Kelowna, British Columbia, Canada

G.A. Research Associates Ltd.

Moncton, New Brunswick, Canada

Nova Scotia Hlth Halifax

Halifax, Nova Scotia, Canada

Centricity Research Brampton Endocrinology

Brampton, Ontario, Canada

Hamilton Medical Rsrch Grp

Hamilton, Ontario, Canada

Wharton Med Clin Trials

Hamilton, Ontario, Canada

Milestone Research

London, Ontario, Canada

Centricity Res Pointe-Claire

Pointe-Claire, Quebec, Canada

Diex Recherche Victoriaville

Victoriaville, Quebec, Canada

Opca bolnica Karlovac

Karlovac, Croatia

Specijalna Bolnica za medicinsku rehabilitaciju Krapinske Toplice_Endocrinology

Krapinske Toplice, Croatia

Poliklinika SLAVONIJA OSIJEK

Osijek, Croatia

Poliklinika Solmed

Zagreb, Croatia

Lékařský dům Géčko

České Budějovice, Czechia

Milan Kvapil s.r.o.

Prague, Czechia

EUC Klinika Praha a.s.

Prague, Czechia

Debreceni Egyetem

Debrecen, Hajdú-Bihar, Hungary

QUALICLINIC Egészségügyi Szolgáltató és Kutatásszervező Kft

Budapest, Pest County, Hungary

Óbudai Egészségügyi Centrum

Budapest, Pest County, Hungary

Komáromi Selye János Kórház

Komárom, Hungary

Diabmed Dr Popescu Alexandrina SRL

Ploieşti, Prahova, Romania

CMI Dr. Pletea Noemi SRL

Bacau, Romania

Diabet Med SRL

Bucharest, Romania

S.C Milena Sante SRL

Galati, Romania

Clinica Korall S.R.L. Satu Mare

Satu Mare, Romania

Nemocnica akademika L. Derera, UNB

Bratislava, Slovakia

DIAB s.r.o.

Rožňava, Slovakia

IRIDIA s.r.o.

Vrútky, Slovakia

Pusan National University Yangsan Hospital

Yangsan, Gyeongsangnam-do, South Korea

Chonnam National University Hospital

Gwangju, South Korea

Seoul National University Hospital

Seoul, South Korea

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, South Korea

The Catholic University of Korea, Yeouido ST. Mary's Hospital

Seoul, South Korea

Kyunghee University Medical Center

Seoul, South Korea

Universitätsspital Basel

Basel, Switzerland

Centre hospitalier universitaire vaudois CHUV

Lausanne, Switzerland

Kantonsspital Olten

Olten, Switzerland

Diabetes Adipositas Zentrum Zürich

Zollikerberg, Switzerland

Oak Tree Surgery

Liskeard, Cornwall, United Kingdom

North Coast Medical Ltd

Newquay, Cornwall, United Kingdom

Brunel Medical Practice

Torquay, Devon, United Kingdom

Attenborough Surgery

Bushey, Hertfordshire, United Kingdom

Hammersmith and Fulham Partnership Research Unit - Richford Gate Primary Care Centre

London, United Kingdom

Clinical Research Directory

Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (67)