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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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*)

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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 Comparator
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.

Recruiting Locations

Univ of Alabama_Birmingham
Birmingham 4049979, Alabama 4829764 35294

Chambliss Clinical Trials, LLC
Montgomery 4076784, Alabama 4829764 36106

Elite Clinical Network - Tucson
Tucson 5318313, Arizona 5551752 85704

Scripps Whittier Diabetes Inst
La Jolla 5363943, California 5332921 92037

Clinical Trials Research
Lincoln 5366375, California 5332921 95648

Pacific Clinical Studies
Los Alamitos 5368304, California 5332921 90720

Walgreens - Store 4442
Kissimmee 4160983, Florida 4155751 34746

Optimal Research Sites
Orange City 4167055, Florida 4155751 32763

Cnt for Diab,Obes, and Metab
Pembroke Pines 4168139, Florida 4155751 33024

Palm Beach Research Center
West Palm Beach 4177887, Florida 4155751 33409

MediSphere Medical RC
Evansville 4257227, Indiana 4921868 47714

Walgreens - Store 3915
Las Vegas 5506956, Nevada 5509151 89146

Chear Center LLC
The Bronx 5110266, New York 5128638 10455

Centricity Res New Bern
New Bern 4481682, North Carolina 4482348 28562

Accellacare
Wilmington 4499379, North Carolina 4482348 28401

Spartanburg Medical Research
Spartanburg 4597200, South Carolina 4597040 29303

Holston Medical Group_Bristol
Bristol 4608657, Tennessee 4662168 37620

Velocity Clinical Res-Dallas
Dallas 4684888, Texas 4736286 75230

TPMG Clinical Research
Newport News 4776024, Virginia 6254928 23606

National Clin Res Inc.
Richmond 4781708, Virginia 6254928 23294

More Details

Status
Recruiting
Sponsor
Novo Nordisk A/S

Study Contact

Novo Nordisk
(+1) 866-867-7178
clinicaltrials@novonordisk.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.