Weight Reduction in Overweight or Obese Individuals with Type 2 Diabetes after Treatment with Cagrilintid
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
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)
Luogo dello studio
Basilea, Zurigo, Altro
(BASEC)
Olten
(BASEC)
Sponsor
Novo Nordisk Pharma AG
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Maddalena Ghielmetti
+41 79 236 61 37
mdlg@clutternovonordisk.comNovo Nordisk Pharma AG The Circle 32/38 8058 Zürich
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
29.10.2025
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
Efficacy and safety of cagrilintide for weight management in participants with overweight or obesity and type 2 diabetes (BASEC)
Titolo accademico
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Titolo pubblico
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Malattie studiate
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Intervento studiato
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Tipo di studio
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Disegno dello studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Data di registrazione
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Inclusione del primo partecipante
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Sponsor secondari
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Contatti aggiuntivi
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ID secondari
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
Riepilogo dei risultati
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Link ai risultati nel registro primario
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