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Clinical Trials in the USA / NCT07220759
Active, not recruiting Phase 3

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

NCT07220759 · tracked via the Priya Life Science USA tracker
Sponsor
Novo Nordisk A/S
Phase
Phase 3
Started
2025-11-05
Last updated
2026-09-04

Condition(s) studied

OverweightObesityType 2 Diabetes

Investigational drug(s) / intervention(s)

Cagrilintide →Placebo (matched to Cagrilintide)

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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). * Diagnosed with type 2 diabetes \>= 180 days before screening.(a\*) * 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.

Primary outcome measure(s)

Trial sites (67)

FacilityCityRegionStatus
Univ of Alabama_Birmingham Birmingham Alabama
Chambliss Clinical Trials, LLC Montgomery Alabama
Noble Clinical Research Tucson Arizona
Scripps Whittier Diabetes Inst La Jolla California
Headlands Research CTR Lincoln Lincoln California
Pacific Clinical Studies Los Alamitos California
Walgreens - Store 4442 Kissimmee Florida
Optimal Research Sites Orange City Florida
Center for Diab,Obes & Metab Pembroke Pines Florida
Palm Beach Research Center West Palm Beach Florida
East West Med Res Inst Honolulu Hawaii
MediSphere Medical RC Evansville Indiana
Walgreens - Store 3915 Las Vegas Nevada
Chear Center LLC The Bronx New York
Centricity Res New Bern Multispeciality New Bern North Carolina
Accellacare Wilmington North Carolina
Spartanburg Medical Research Spartanburg South Carolina
Holston Medical Group_Bristol Bristol Tennessee
Velocity Clinical Res-Dallas Dallas Texas
TPMG Clinical Research Newport News Virginia
National Clin Res Inc. Richmond Virginia
Buenos Aires Mácula Ciudad Autonoma de Buenos Aires Buenos Aires
CICEMO- Consultorio de Investigación Clínica EMO Ciudad Autonoma de Buenos Aires Buenos Aires
Centro Medico Dra. Laura Maffei e Investigacion Clínica Apli Buenos Aires Argentina
OCT Research ULC (dba Okanagan Clinical Trials) Kelowna British Columbia
G.A. Research Associates Ltd. Moncton New Brunswick
Nova Scotia Hlth Halifax Halifax Nova Scotia
Centricity Research Brampton Endocrinology Brampton Ontario
Hamilton Medical Research Group Hamilton Ontario
Wharton Medical Clinic Clinical Trials (Hamilton) Hamilton Ontario
Milestone Research London Ontario
Centricity Res Pointe-Claire Pointe-Claire Quebec
Diex Recherche Victoriaville Victoriaville Quebec
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

+ 27 more sites — see the full list on the official registry below.

More Novo Nordisk A/S trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07220759 on ClinicalTrials.gov ↗ ← All trials in the USA