DRUG
Cagrilintide
Cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.
Weight Loss in People Living With Overweight or Obesity and Type 2 Diabetes Following Treatment With Cagrilintide
Status
Active, not recruiting
Phase
Phase 3
Enrollment
330
Locations
67
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Placebo (matched to Cagrilintide)
Placebo matched to cagrilintide will be administered subcutaneously with a pen-injector as an adjunt to lifestyle intervention counselling.
Timeline
From registration to results.
First posted
Oct 24, 2025
Study start
Nov 5, 2025
Primary completion
May 12, 2027
Study completion
Jun 30, 2027
Results posted
Not reported
Registry updated
Apr 21, 2026
Outcomes
What the study measures.
Primary outcomes
Relative change in body weight
Time frame · From baseline (week 0) to end of treatment (week 64)
Measured as percentage (%) of body weight.
Number of participants with achievement of greater than or equals (>=) 5% body weight reduction
Time frame · From baseline (week 0) to end of treatment (week 64)
Measured as count of participants.
Secondary outcomes
Number of participants with achievement of >= 10% body weight reduction
Time frame · From baseline (week 0) to end of treatment (week 64)
Measured as count of participants.
Number of participants with achievement of >= 15% body weight reduction
Time frame · From baseline (week 0) to end of treatment (week 64)
Measured as count of participants.
Change in waist circumference
Time frame · From baseline (week 0) to end of treatment (week 64)
Measured as centimeter (cm).
Ratio to baseline in lipids: triglycerides
Time frame · From baseline (week 0) to end of treatment (week 64)
Measured as ratio.
Ratio to baseline in high sensitivity C-reactive protein (hsCRP)
Time frame · From baseline (week 0) to end of treatment (week 64)
Measured as ratio.
Change in impact of weight on quality of life-lite clinical trials version (IWQOL-Lite-CT) physical function score
Time frame · From baseline (week 0) to end of treatment (week 64)
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.
Change in body weight
Time frame · From baseline (week 0) to end of treatment (week 64)
Measured as kilogram (kg).
Change in SF-36v2® health survey acute (SF-36v2® acute) physical component summary score
Time frame · From baseline (week 0) to end of treatment (week 64)
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.
Change in SF-36v2® mental component summary score
Time frame · From baseline (week 0) to end of treatment (week 64)
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.
Change in IWQOL-Lite-CT total score
Time frame · From baseline (week 0) to end of treatment (week 64)
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.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- 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).(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.
Study locations
67 registered sites.
Argentina · Canada · Croatia · Czechia · Hungary · Romania · Slovakia · South Korea · Switzerland · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
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
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Cagrilintide.
NCT IDStudyPhase / statusEnrollmentUpdated
A Research Study to Look at How Two Different Doses of CagriSema and One Dose of Semaglutide Help People Living With Obesity With or Without Type 2 Diabetes Lose Weight
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A Research Study to Look at How Well CagriSema Helps People Living With Obesity Lose Weight and Maintain Weight Loss in the Long-term
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A Research Study to See How Well CagriSema Helps People With Excess Body Weight Lose Weight
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REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels
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A Research Study to See How Much CagriSema Lowers Blood Sugar and Body Weight Compared to Tirzepatide in People With Type 2 Diabetes Treated With Metformin, SGLT2 Inhibitor or Both
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2026-07
A Research Study on How Well Cagrilintide and CagriSema Work in Children and Adolescents With Excess Body Weight
Novo Nordisk · Overweight · Obesity
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Recruiting
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2026-07
A Research Study to Compare Two Different Versions of Injectable CagriSema in People With Type 2 Diabetes
Novo Nordisk · Diabetes Mellitus, Type 2
Phase 2
Withdrawn
0
2026-07
A Research Study to Compare Different Versions of Injectable CagriSema and Placebo in People With Excess Body Weight
Novo Nordisk · Overweight · Obesity
Phase 3
Withdrawn
0
2026-07
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.