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Not yet recruiting NCT07745504

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

Phase III Interventional Overweight Obesity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cagrilintide, Placebo cagrilintide, Placebo semaglutide.
Who it may be relevant to
Registry conditions: Overweight, Obesity. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Greece, Hungary, Portugal, Serbia +1
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Placebo-controlled Comparability Study to Compare Two Presentations of Cagrilintide for Weight Management in Participants With Overweight or Obesity

Overview

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.

Interventions

  • Drug Cagrilintide
    Cagrilintide will be administered subcutaneously.
  • Drug Placebo cagrilintide
    Placebo matched to cagrilintide will be administered subcutaneously.
  • Drug Placebo semaglutide
    Placebo matched to semaglutide will be administered subcutaneously.

Primary outcome measures

  • Relative change in body weight [Time frame: From baseline (week 0) to end of treatment (week 26)]
Secondary outcome measures (2)
  • Number of Treatment Emergent Adverse Events (TEAEs) [Time frame: From baseline (week 0) to end of study (week 33)]
  • Number of Treatment Emergent Serious Adverse Events (TESAEs) [Time frame: From baseline (week 0) to end of study (week 33)]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 11 centers
  • Hope Clin Res & Wellness — Conyers
  • East West Med Res Inst — Honolulu
  • Walgreens - Store 11760 — Oak Park
  • Midwest Inst For Clin Res — Indianapolis
  • The Alliance for Multispecialty Research LLC AMR — Lexington
  • PharmQuest — Greensboro
  • KDCILM, LLC & Accellacare US, Inc. — Wilmington
  • Coastal Carolina Res Ctr — North Charleston
  • … and 3 more centers
Greece · 6 centers
  • General Hospital Of Athens Alexandra - Department of Endocrinology, Diabetes Center — Athens
  • General Hospital Of Athens G Gennimatas - Department of Endocrinology — Athens
  • General Hospital Venizeleio-Pananeio - Diabetic Clinic — Irakleio
  • Athens Medical Center S.A. (Iatriko Peristeriou) - Diabetes, obesity and cardiometabolic d — Peristeri
  • Ippokratio General Hospital Of Thessaloniki - B' Internal Medicine clinic — Thessaloniki
  • St. Luke's Hospital S.A. - Endocrinology Department and Obesity Clinic — Thessaloniki
Portugal · 6 centers
  • ULS Do Oeste E.P.E. - Unidade Caldas da Rainha_CAMI - Unidade de Diabetes — Caldas da Rainha
  • ULS Do Baixo Mondego, E.P.E. - HDFF_Serviço Cirurgia (Esp. Endocrinologia) — Figueira da Foz Municipality
  • Hospital São Francisco, S.A_EECC — Leiria
  • APDP - Associação Protectora dos Diabéticos de Portugal — Lisbon
  • CVP Hospital Cruz Vermelha_Cardiologia — Lisbon
  • ULS De Gaia/Espinho_H.Santos Silva_Endocrinologia — Vila Nova de Gaia
Serbia · 5 centers
  • Endocrinology, Diabetes and Metabolism Diseases Clinic — Belgrade
  • Institute for Cardiovascular Diseases of Vojvodina - Sremska Kamenica — Kamenitz
  • Clinical Centre Nis, Endocrinology, Diabetes and Metabolism — Niš
  • University Clinical Centre Nis, Clinic for Cardiology — Niš
  • Clin. Centre Vojvodina, Clin. endocr., diab. and met. dis. — Novi Sad
Hungary · 4 centers
  • Stúdium Egészségház Kft. — Kalocsa
  • Borbánya Praxis E.Ü. Kft. — Nyíregyháza
  • Trial Pharma Kft. — Kecskemét
  • KomplexLabor Diagnosztika Kft. — Szeged
Sweden · 4 centers
  • Skånes Universitets Sjukhus — Lund
  • Forsåker vårdcentral — Mölndal
  • Örebro US - Överviktsenheten — Örebro
  • Dalecarlia Clinical Research AB — Rättvik

Identifiers

NCT: NCT07745504 · NN9833-8550 · U1111-1328-5168 · 2025-524249-29

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗