Weight Reduction in Overweight or Obese Individuals with Type 2 Diabetes after Treatment with Cagrilintid
Summary description of the study
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 under investigation
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)
Disease under 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)
Exclusion criteria
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)
Trial sites
Basel, Zurich, Other
(BASEC)
Olten
(BASEC)
Sponsor
Novo Nordisk Pharma AG
(BASEC)
Contact
Contact Person Switzerland
Maddalena Ghielmetti
+41 79 236 61 37
mdlg@clutternovonordisk.comNovo Nordisk Pharma AG The Circle 32/38 8058 Zürich
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
29.10.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Efficacy and safety of cagrilintide for weight management in participants with overweight or obesity and type 2 diabetes (BASEC)
Academic title
not available
Public title
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Disease under investigation
not available
Intervention under investigation
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Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
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Primary and secondary end points
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available