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 Following Treatment With Cagrilintide
Status
Active, not recruiting
Phase
Phase 3
Enrollment
300
Locations
40
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 lower their body weight. Cagrilintide is a new investigational medicine. Doctors may not yet prescribe cagrilintide. Participants will either get cagrilintide or placebo. Which treatment participants 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. Possible side effects will be followed carefully during the study. For each participant, the study will last for about 1 year and 6 months.
Interventions
Treatment arms and agents.
DRUG
Placebo
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 11, 2027
Study completion
Jun 29, 2027
Results posted
Not reported
Registry updated
Jun 30, 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 (%).
Secondary outcomes
Number of participants with achievement of greater than or equal to (>=) 10 percent (%) body weight reduction (yes/no)
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 (yes/no)
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 centimeters (cm).
Ratio to baseline in 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.
Relative change in visceral abdominal fat volume
Time frame · From baseline (week 0) to end of treatment (week 64)
Measured as %.
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 Systolic Blood Pressure (SBP)
Time frame · From baseline (week 0) to end of treatment (week 64)
Measured as millimeter of mercury (mmHg).
Change in body weight
Time frame · From baseline (week 0) to end of treatment (week 64)
Measured as kilograms (kg).
Number of participants with achievement of >= 5 % body weight reduction (yes/no)
Time frame · From baseline (week 0) to end of treatment (week 64)
Measured as count of participants.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- 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) greater than or equal to \>= 30.0 kilogram per square meter (kg/m\^2), or BMI greater than or equal to \>= 27.0 kg/m\^2 with the presence of at least one weight related comorbidity including, but not limited to, hypertension, dyslipidaemia, obstructive sleep apnoea or cardiovascular disease (a\*) Exclusion criteria: * History of type 1 or type 2 diabetes (a\*) * Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening (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
40 registered sites.
Argentina · Australia · Canada · France · Germany · Italy · Norway · Poland · United Kingdom · United States. Showing up to 24 locations stored in the fast local snapshot.
Diablo Clinical Research, Inc.
Walnut Creek, California, United States
Univ of Colorado at Denver
Aurora, Colorado, United States
Florida Inst For Clin Res LLC
Orlando, Florida, United States
Oviedo Medical Research, LLC
Oviedo, Florida, United States
Walgreens - Store 11760
Oak Park, Illinois, United States
Midwest Inst For Clin Res
Indianapolis, Indiana, United States
StudyMetrix Research LLC
City of Saint Peters, Missouri, United States
PharmQuest Life Sciences LLC
Greensboro, North Carolina, United States
Selma Medical Associates
Winchester, Virginia, United States
CIPREC Pueyrredon
Buenos Aires, Argentina
CEDIC Centro de Investigación Clínica
CABA, Argentina
Sydney Cardiometabolic Centre
Liverpool, New South Wales, Australia
Hunter Diabetes Centre
Merewether, New South Wales, Australia
G.A. Research Associates Ltd.
Moncton, New Brunswick, Canada
Nova Scotia Hlth Halifax
Halifax, Nova Scotia, Canada
Hamilton Medical Research Group
Hamilton, Ontario, Canada
Wharton Medical Clinic Clinical Trials (Hamilton)
Hamilton, Ontario, Canada
Milestone Research
London, Ontario, Canada
Centricity Research Oshawa
Oshawa, Ontario, Canada
Centricity Research Toronto
Toronto, Ontario, Canada
Centricity Research Mirabel
Mirabel, Quebec, Canada
Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec
Saint-Herblain, France
Centre de Recherche Clinique Portes Du Sud
Vénissieux, France
InnoDiab Forschung GmbH
Essen, Germany
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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2026-07
REDEFINE 3: A Research Study to See the Effects of CagriSema in People Living With Diseases in the Heart and Blood Vessels
Novo Nordisk · Cardiovascular Disease
Phase 3
Active, not recruiting
7,101
2026-07
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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Completed
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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.