Weight Reduction in Overweight or Obese Individuals with Type 2 Diabetes after Treatment with Cagrilintid
Résumé de l'étude
We are conducting this study to investigate how much the study drug called Cagrilintid reduces body weight in people with overweight or obesity and type 2 diabetes. Overweight or obesity is the condition in which the body stores too much fat. People with overweight or obesity and type 2 diabetes have a higher risk of other diseases such as heart disease and kidney disease. Weight loss reduces the risk of these diseases. Overweight and obesity can be treated through diet and physical activity, but this does not lead to weight loss for everyone. Cagrilintid could help people lose more weight than through diet and physical activity alone. Researchers will investigate this in this study. This study, which will last approximately 1 year and 6 months, will involve 330 men and women from around the world. Participants will be randomly assigned (by a computer) to 2 treatment groups: Cagrilintid will be compared to a placebo that looks like the tested drug but contains no active ingredients. During the study, patients will need to attend some visits to the study center and have phone contacts with the study staff. They will also need to undergo some tests and examinations as well as fill out questionnaires. The collected information may help to better understand: • Overweight, obesity, and type 2 diabetes or related diseases • How the study drug works in the body • How to improve the treatment of people with overweight, obesity, and type 2 diabetes or related diseases.
(BASEC)
Intervention étudiée
The aim of this study is to investigate the efficacy and safety of the amylin analogue Cagrilintide as a treatment for weight reduction in overweight or obese individuals with type 2 diabetes. The study will compare the effect of a once-weekly subcutaneously administered injection of Cagrilintide 2.4 mg with a placebo (which looks like the tested drug but contains no active ingredient).
(BASEC)
Maladie en cours d'investigation
Overweight or Obesity and Type 2 Diabetes
(BASEC)
1. Body mass index (BMI) ≥ 27.0 kg/m² and a history of at least one self-reported unsuccessful diet attempt for weight reduction. 2. Diagnosed with type 2 diabetes (T2D) for at least 180 days prior to screening. 3. Treatment either with a lifestyle intervention or: a) A stable treatment for at least 90 days prior to screening with 1-3 approved oral antidiabetic agents. b) For up to 30% of participants, treatment with a stable dose of a GLP-1 (glucagon-like peptide-1) containing medication that has been stable for at least 1 year prior to screening and/or treatment with basal insulin that has been stable for at least 90 days prior to screening is allowed. (BASEC)
Critères d'exclusion
1. Treatment or intention to start treatment with a weight control medication within 180 days prior to screening. 2. Treatment with a GLP-1 receptor agonist or a medication containing GLP-1 within 180 days prior to screening, except for those who were randomized according to the inclusion criteria. 3. Previous dosing of marketed or non-marketed amylin-based compounds. (BASEC)
Lieu de l’étude
Bâle, Zurich, Autre
(BASEC)
Olten
(BASEC)
Sponsor
Novo Nordisk Pharma AG
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Maddalena Ghielmetti
+41 79 236 61 37
mdlg@clutternovonordisk.comNovo Nordisk Pharma AG The Circle 32/38 8058 Zürich
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
29.10.2025
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
Efficacy and safety of cagrilintide for weight management in participants with overweight or obesity and type 2 diabetes (BASEC)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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