Clinical trial

A Research Study to Compare Two Different Versions of Injectable Cagrilintide and Placebo in People With Excess Body Weight

Recruiting now · Phase 3 · 6 countries · Registry ID NCT07745504

Recruiting nowPhase 3Interventional

What this study is about

The purpose of this clinical study is to look at how well a study medicine called cagrilintide helps people living with excess body weight to lose weight. Participants will either get cagrilintide, the active study medicine being tested or placebo, a medicine that has no active medicine in it. Which treatment participants get is decided by chance. Cagrilintide is a new medicine under development that doctors cannot prescribe yet, but it has been tested in humans before. Participants will be in this clinical study for about 9 months.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionOverweight, Obesity

Full registry criteria

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. * Male or female (sex assigned at birth, inclusive of all gender identities). * Age 18 years or above at the time of signing the informed consent. * Body mass index (BMI) greater than or equal to (\>=) 30.0 kilograms per square meter (kg/m\^2), or BMI \>= 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. Exclusion criteria: * History of Type 1 Diabetes (T1D) or Type 2 Diabetes (T2D). * Previous dosing of marketed or non-marketed amylin-based compounds. * Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening.

Treatments and study arms

Cagrilintide

Drug

Cagrilintide will be administered subcutaneously.

Placebo cagrilintide

Drug

Placebo matched to cagrilintide will be administered subcutaneously.

Placebo semaglutide

Drug

Placebo matched to semaglutide will be administered subcutaneously.

Primary outcomes

Relative change in body weightFrom baseline (week 0) to end of treatment (week 26)

Measured as percentage (%).

Study locations

36 locations were listed when this page was built. The first 40 are shown.

General Hospital Of Athens Alexandra - Department of Endocrinology, Diabetes Center🇬🇷 Athens, Greece
General Hospital Of Athens G Gennimatas - Department of Endocrinology🇬🇷 Athens, Greece
General Hospital Venizeleio-Pananeio - Diabetic Clinic🇬🇷 Irakleio, Greece
Athens Medical Center S.A. (Iatriko Peristeriou) - Diabetes, obesity and cardiometabolic diseases department🇬🇷 Peristeri, Greece
Ippokratio General Hospital Of Thessaloniki - B' Internal Medicine clinic🇬🇷 Thessaloniki, Greece
St. Luke's Hospital S.A. - Endocrinology Department and Obesity Clinic🇬🇷 Thessaloniki, Greece
Stúdium Egészségház Kft.🇭🇺 Kalocsa, Bács-Kiskun county, Hungary
Trial Pharma Kft.🇭🇺 Kecskemét, Hungary
Borbánya Praxis E.Ü. Kft.🇭🇺 Nyíregyháza, Szabolcs-Szatmar Varmegye, Hungary
KomplexLabor Diagnosztika Kft.🇭🇺 Szeged, Hungary
ULS Do Oeste E.P.E. - Unidade Caldas da Rainha_CAMI - Unidade de Diabetes🇵🇹 Caldas da Rainha, Portugal
ULS Do Baixo Mondego, E.P.E. - HDFF_Serviço Cirurgia (Esp. Endocrinologia)🇵🇹 Figueira da Foz Municipality, Portugal
Hospital São Francisco, S.A_EECC🇵🇹 Leiria, Portugal
APDP - Associação Protectora dos Diabéticos de Portugal🇵🇹 Lisbon, Portugal
CVP Hospital Cruz Vermelha_Cardiologia🇵🇹 Lisbon, Portugal
ULS De Gaia/Espinho_H.Santos Silva_Endocrinologia🇵🇹 Vila Nova de Gaia, Portugal
Endocrinology, Diabetes and Metabolism Diseases Clinic🌐 Belgrade, Serbia
Institute for Cardiovascular Diseases of Vojvodina - Sremska Kamenica🌐 Kamenitz, Serbia
Clinical Centre Nis, Endocrinology, Diabetes and Metabolism🌐 Niš, Serbia
University Clinical Centre Nis, Clinic for Cardiology🌐 Niš, Serbia
Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis.🌐 Novi Sad, Serbia
Skånes Universitets Sjukhus🇸🇪 Lund, Sweden
Forsåker vårdcentral🇸🇪 Mölndal, Sweden
Dalecarlia Clinical Research AB🇸🇪 Rättvik, Sweden
Örebro US - Överviktsenheten🇸🇪 Örebro, Sweden
Hope Clin Res & Wellness🇺🇸 Conyers, Georgia, United States
PharmQuest🇺🇸 Greensboro, North Carolina, United States
East West Med Res Inst🇺🇸 Honolulu, Hawaii, United States
Midwest Inst For Clin Res🇺🇸 Indianapolis, Indiana, United States
The Alliance for Multispecialty Research LLC AMR🇺🇸 Lexington, Kentucky, United States
Health Res of Hampton Roads🇺🇸 Newport News, Virginia, United States
Coastal Carolina Res Ctr🇺🇸 North Charleston, South Carolina, United States
Walgreens - Store 11760🇺🇸 Oak Park, Illinois, United States
National Clin Res Inc.🇺🇸 Richmond, Virginia, United States
KDCILM, LLC & Accellacare US, Inc.🇺🇸 Wilmington, North Carolina, United States
Selma Medical Associates🇺🇸 Winchester, Virginia, United States