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Weight loss in people living with overweight or obesity and type 2 diabetes following treatment with cagrilintide
EU CTIS ID: 2024-519531-41-00
What this study is testing
To confirm superiority on body weight reduction of cagrilintide s.c. 00 mg once weekly versus placebo, as adjunct to lifestyle intervention counselling, in participants with overweight or obesity, and type 2 diabetes. To confirm superiority of cagrilintide 00 mg versus placebo on achievement of ≥ 5% weight reduction.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
- Female or male (sex at birth).
- Age 18 years or above at the time of signing the informed consent.
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
- Body mass index (BMI) ≥ 27.0 kg/m2.
- Diagnosed with type 2 diabetes ≥ 180 days before screening.
You likely can't join if
- Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening.
- Previous dosing of marketed or non-marketed amylin-based compounds.
- Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) or GLP-1 containing medication within 180 days before screening, apart from those randomised according to inclusion criteria 7bi.
See the full eligibility 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.
- Female or male (sex at birth).
- Age 18 years or above at the time of signing the informed consent.
- History of at least one self-reported unsuccessful dietary effort to lose body weight.
- Body mass index (BMI) ≥ 27.0 kg/m2.
- Diagnosed with type 2 diabetes ≥ 180 days before screening.
- Treatment with either lifestyle intervention, or: a. Stable treatment (same drug(s), dose and dosing frequency) for at least 90 days before screening with 1-3 marketed oral antidiabetic drugs (metformin, α-glucosidase inhibitors (AGI), glinides, sodium-glucose cotransporter 2 inhibitor (SGLT2i), thiazolidinediones, Dipeptidyl peptidase-4 inhibitor (DPP-4i) or sulphonylureas (SU) as a single agent or in combination according to local practice. b. For up to 30% of participants the following concomitant medication is allowed: i. Treatment for any indication with a stable dose of glucagon-like peptide-1 (GLP-1) containing medication, stable for at least 1 year before screening and/or ii. Treatment with basal insulin minimum (0.25 U/kg/day or 20 U/day) stable for at least 90 days before screening.
- Treatment, or intention to initiate treatment, with any medication prescribed for the indication of weight management within 180 days before screening.
- Previous dosing of marketed or non-marketed amylin-based compounds.
- Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (RA) or GLP-1 containing medication within 180 days before screening, apart from those randomised according to inclusion criteria 7bi.
The study team makes the final eligibility decision.
Where it's taking place
- Switzerland
- United States
- United Kingdom
- Korea, Republic of
- Canada
- Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Switzerland; United States; United Kingdom; Korea, Republic of; Canada; Argentina. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.