Weight Loss in People Living With Overweight or Obesity Following Treatment With Cagrilintide

NCT ID: NCT07220642

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-05

Study Completion Date

2027-07-14

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Sponsor staff involved in the clinical trial is masked according to company standard procedures.

Study Groups

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Cagrilintide

Participants will receive cagrilintide subcutaneously once weekly for 64 weeks.

Group Type EXPERIMENTAL

Cagrilintide

Intervention Type DRUG

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

Placebo

Participants will receive placebo matched to cagrilintide subcutaneously once weekly for 64 weeks.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Cagrilintide

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Transparency (dept. 2834)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Diablo Clinical Research, Inc.

Walnut Creek, California, United States

Site Status RECRUITING

Univ of Colorado at Denver

Aurora, Colorado, United States

Site Status RECRUITING

Florida Inst For Clin Res LLC

Orlando, Florida, United States

Site Status RECRUITING

Oviedo Medical Research, LLC

Oviedo, Florida, United States

Site Status RECRUITING

Walgreens - Store 11760

Oak Park, Illinois, United States

Site Status RECRUITING

Midwest Inst For Clin Res

Indianapolis, Indiana, United States

Site Status RECRUITING

StudyMetrix Research LLC

City of Saint Peters, Missouri, United States

Site Status RECRUITING

PharmQuest Life Sciences LLC

Greensboro, North Carolina, United States

Site Status RECRUITING

Selma Medical Associates

Winchester, Virginia, United States

Site Status RECRUITING

CIPREC Pueyrredon

Buenos Aires, , Argentina

Site Status RECRUITING

CEDIC Centro de Investigación Clínica

CABA, , Argentina

Site Status RECRUITING

Sydney Cardiometabolic Centre

Liverpool, New South Wales, Australia

Site Status RECRUITING

Hunter Diabetes Centre

Merewether, New South Wales, Australia

Site Status RECRUITING

G.A. Research Associates Ltd.

Moncton, New Brunswick, Canada

Site Status RECRUITING

Nova Scotia Hlth Halifax

Halifax, Nova Scotia, Canada

Site Status RECRUITING

Hamilton Medical Rsrch Grp

Hamilton, Ontario, Canada

Site Status RECRUITING

Wharton Med Clin Trials

Hamilton, Ontario, Canada

Site Status RECRUITING

Milestone Research

London, Ontario, Canada

Site Status RECRUITING

Centricity Research Oshawa

Oshawa, Ontario, Canada

Site Status RECRUITING

Centricity Research Toronto

Toronto, Ontario, Canada

Site Status RECRUITING

Centricity Research Mirabel

Mirabel, Quebec, Canada

Site Status RECRUITING

Centre Hospitalier Universitaire de Nantes-Hopital Nord Laennec

Saint-Herblain, , France

Site Status RECRUITING

Centre de Recherche Clinique Portes Du Sud

Vénissieux, , France

Site Status RECRUITING

InnoDiab Forschung GmbH

Essen, , Germany

Site Status ACTIVE_NOT_RECRUITING

Wendisch/Dahl Hamburg (DZHW)

Hamburg, , Germany

Site Status RECRUITING

RED-Institut für medizinische Forschung und Fortbildung GmbH

Oldenburg in Holstein, , Germany

Site Status ACTIVE_NOT_RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCS

Rome, RM, Italy

Site Status RECRUITING

AOUP Giaccone Palermo

Palermo, Sicily, Italy

Site Status RECRUITING

A.O.U. Bologna_ Policlinico S.Orsola Malpighi

Bologna, , Italy

Site Status RECRUITING

IRCCS Ospedale San Raffaele Milano

Milan, , Italy

Site Status NOT_YET_RECRUITING

Haukeland Universitetssykehus

Bergen, , Norway

Site Status RECRUITING

Drammen sykehus - Vestre Viken HF

Drammen, , Norway

Site Status RECRUITING

St. Olavs Hospital HF

Trondheim, , Norway

Site Status RECRUITING

Osteo-Medic s.c. A. Racewicz, J. Supronik

Bialystok, , Poland

Site Status RECRUITING

Care Clinic Sp. z o. o.

Katowice, , Poland

Site Status RECRUITING

Terpa Sp. z o.o. Sp. k.

Lublin, , Poland

Site Status RECRUITING

NBR Polska Tomasz Klodawski

Warsaw, , Poland

Site Status RECRUITING

Oak Tree Surgery

Liskeard, Cornwall, United Kingdom

Site Status RECRUITING

North Coast Medical Ltd

Newquay, Cornwall, United Kingdom

Site Status RECRUITING

Brunel Medical Practice

Torquay, Devon, United Kingdom

Site Status RECRUITING

Countries

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United States Argentina Australia Canada France Germany Italy Norway Poland United Kingdom

Central Contacts

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Novo Nordisk

Role: CONTACT

Phone: (+1) 866-867-7178

Email: [email protected]

Other Identifiers

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U1111-1314-8906

Identifier Type: OTHER

Identifier Source: secondary_id

2024-519530-24

Identifier Type: OTHER

Identifier Source: secondary_id

NN9833-8242

Identifier Type: -

Identifier Source: org_study_id