A Research Study Looking Into How Cagrilintide Influences Food Intake and Appetite in People With Overweight or Obesity
Recruiting · NCT07557953 · Interventional (participants receive a specific treatment) · Lead sponsor: Novo Nordisk A/S
View the official record on ClinicalTrials.gov →Interventions studied
CagrilintidePlacebo Cagrilintide
What this trial is about
The study is testing cagrilintide, a study medicine, to understand how it affects food intake and appetite in people with overweight or obesity. Participants will receive either cagrilintide or placebo, and which treatment participants get is decided by chance. Cagrilintide is the treatment being tested, while placebo looks like the study medicine but does not contain any active medicine. The study will last for about 30 weeks.
Who can take part
Age range
18 Years to 64 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Male or female (sex at birth).
- Age 18-64 years (both inclusive) at the time of signing the informed consent.
- Body mass index (BMI) is greater than or equal to (≥) 27.0 kg/m\^2 at screening. Over-weight should be due to excess adipose tissue, as judged by the investigator.
- Considered to be generally healthy, except for overweight or obesity, based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.
Exclusion criteria
- Known or suspected hypersensitivity to study intervention(s) or related products.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
- Presence or history of any clinically relevant respiratory, metabolic, renal, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions.
- Glycated haemoglobin (HbA1c) ≥ 6.5% (48 millimoles per mole (mmol/mol)) at screening.
- History of type 1 or type 2 diabetes mellitus
- Any clinically significant body weight change (≥ 5% self-reported change) or dieting at-tempts (e.g., participation in a weight reduction program) within 90 days before screening.
- Use of incretin therapies within the last 6 months prior to screening or previous discontinuation of incretin therapy due to tolerability issues.
- Use of any weight lowering pharmacotherapy or pharmacotherapy that may cause weight gain, including systemic corticosteroids (except for a short course of treatment, i.e., 7-10 days), tri-cyclic antidepressants, atypical antipsychotic and mood stabilisers 6 months prior to screening.
- Previous dosing of marketed or non-marketed amylin-based compounds.
Where it is running
1 location listed.
- Parexel International GmbH - Berlin, Germany